Linear Publications
& Academic Presentations
Linear Clinical Research contributes to global medical innovation through peer-reviewed publications and conference presentations, advancing Australian clinical trials in collaboration with world-leading experts and sponsors.
Medical Oncology Published Papers
2024
Davar D, Cavalcante L, Lakhani N, Moser J, Millward M, McKean M, Voskoboynik M, Sanborn RE, Grewel JS, Narayan A, Patnaik A, Gainor JF, Sznol M, Enstrom A, Blanchfield L, LeBlanc H, Thomas H, Chisamore MJ, Peng SL, Naumovski A. Phase I studies of davoceticept (ALPN-202), a PD-L1-dependent CD28 co-stimulator and dual PD-L1/CTLA4 inhibitor, as monotherapy and in combination with pembrolizumab in advanced solid tumors (NEON-1 and NEON-2). J Immunother Cancer 2024, 12:e009474. https://doi.org/10.1136/jitc-2024-009474 PMID 39097413.
Ruan D-Y, Xu Y, Munster P, Deng Y, Richardson G, Yan D, Lee M-A, Lee K-W, Pan H, Hager S, Li X, Wei S, Hou X, Underhill C, Millward M, Nordman I, Zhang Y, Xiang Z, Xie X, Shi Z, Wang Y, Zhang L, Wang F, Xu R-H. Garsorasib with or without cetixumab in colorectal cancer with KRAS G12C mutation. Nature Cancer (submitted 2024).
Smith KM, O’Haire S, Markman B, Gan HK, O’Byrne K, Millward M, Tran B, Solomon B, Scott C, Kee D, McArthur G, Fellowes A, Khoung-Quang DAK, Ekert P, Xu H, Martyn M, Lynch E, Weerasuriya R, Gaff C, Fox SB, Desai J. The patient experience of complex genomic sequencing: Exploring patient preference, barriers, and enablers for delivery. JCO Precision Oncology (accepted for publication July 24, 2024).
Thavaneswaran S, Merseides A, Lin FP, Espinoza D, Grady J, Lee C, Desai J, Brown M, Grimson P, O’Byrne K, Harrup R, Nagrial A, Sebastian L, Chinchen S, Kansara M, Craft P, Millward M, Simes JR, Joshua AM, Thomas D. A signal-seeking Phase 2 study of Trastuzumab emtansine (TDM-1) in patients with tumours harbouring HER2 amplification or mutation. NPJ Precision Oncology (accepted for publication August 30, 2024).
Grivas P, Garralda E, Meric-Bernstein F, Mellinghoff IK, Goyal L, Harding JJ, Dees EC, Bahleda R, Azad NS, Karipott A, Kurzrock R, Taberno J, Kononen J, Ng MCH, Mehta R, Uboha NV, Bigot F, Boni V, Bowyer SB, Breder V, Cervantes A, Chan N, Cleary JM, Dhawan M, Eefsen RL, Ewing J, Graham DM, Guren LK, Kim JW, Koynov K, Oh D-Y, Redman R, Yen C-J, Spetzler D, Roubaudi-Fraschini M-C, Nicolas-Metrai V, Ait-Sarkouh R, Zanna C, Ennaji A, Pokorsha-Bocci-A, Flaherty KT. Evaluating Debio 1347 in patients with FGFR fusion-positive advanced solid tumors from the FUZE multicenter, open-label, Phase II basket trial. Clin Cancer Res (epub July 2, 2024). https://doi.org/10.1158/1078-0432.CCR-24-0012
2023
Frentzas S, Gan H, Cosman R, Coward J, Tran B, Millward M, Zhou Y, Wang W, Xia D, Wang ZM, Li B, Xia M, Desai J. A Phase 1a/1b first-in-human study (COMPASSION-01) evaluating cadonilimab in patients with advanced solid tumors. Cell Rep Med 2023 (epub 11 Oct 2023). https://doi.org/10.1016/j.xcrm.2023.101242 PMID 37852261.
Marschner J-P, Lemech C, Kichenadasse G, Alevizopoulos K, Otterlei M, Millward M. A Phase I, open-label, dose-escalation study of ATX-101, a novel PCNA targeting drug, in patients with solid tumors. Oncogene 2023, 42:541-544 (epub Dec 23, 2022). https://doi.org/10.1038/s41388-022-02582-6 PMID 36564469.
Lin FP-O, Thaveneswaran S, Napier CE, Grady JP, Kansara M, Sebastian L, Kee D, Zaheed M, Millward M, Brown MP, Charakidis M, Craft PS, Grimson PS, Harrup RA, O’Byrne KJ, Desai J, Lee CK, Ballinger ML, Simes J, Thomas DM. Genomic therapy matching in rare and refractory cancers: a cohort study in 3,383 patients in the Molecular Screening and Therapeutic (MoST) program. Nature Med (submitted 2023).
Sacher A, LoRusso P, Patel MR, Miller WH Jr, Garralda E, Forster MD, Santoro A, Falcon A, Kim TM, Paz-Ares L, Bowyer S, de Miguel M, Han S-W, Krebs MG, Lee J-S, Cheng ML, Arbour K, Massarelli E, Choi Y, Shi Z, Mandlekar S, Lin MT, Royer-Joo S, Chang J, Dharia NV, Schutzman JL, Desai J. Single-agent Divarasib (GDC-6036) in solid tumors with a KRAS G12C mutation. N Engl J Med 2023, 389:710-221. https://doi.org/10.1056/NEJMoa2303810
Desai J, Fong P, Moreno V, Frentzas S, Meniawy T, Markman B, Voskoboynik M, Rahman T, Budha N, Wu J, Marlow J, Yang S, Calvo E, Mertin-Liberal J. A Phase 1/2 study of the PD-L1 inhibitor, BGB-A333, alone and in combination with the PD-1 inhibitor, tislelizumab, in patients with advanced solid tumours. Br J Cancer 2023, 128:1418-1428. https://doi.org/10.1038/s41416-022-02128-3
Frentzas S, Kao S, Gao R, Zheng H, Rizwan A, Budha N, de la Hoz Pedroza L, Tan W, Meniawy T. AdvanTIG-105: a Phase I dose escalation study of the anti-TIGT monoclonal antibody ciperlimab in combination with lislelizumab in patients with advanced solid tumors. J Immunother Cancer 2023, 11:e005819. https://doi.org/10.1136/jitc-2022-005829
Friedlander M, Mileshkin L, Lombard J, Frentzas S, Gao B, Wilson M, Meniawy T, Baron-Hay S, Briscoe K, McCarthy N, Fountzilas C, Cervantes A, Ge R, Wu J, Spira A. Br J Cancer 2023, 129:79-810. https://doi.org/10.1038/s41416-023-02349-0
2022
Lickliter J, Voskoboynik M, Mileshkin L, Gan HK, Kichenadasse G, Zhang K, Zhang M, Tang Z, Mu S, Millward M. Phase IA/IB dose-escalation and dose-expansion study to evaluate the safety, pharmacokinetics, food effects, and antitumor activity of pamiparib in advanced solid tumors. Br J Cancer, 2022; 126(4):576-585 epub November 18, 2021. https://doi.org/10.1038/s41416-021-01632-2 PMID 34795408.
Ye L, Ariyapperuma M, Jacques A, Meniawy T, Millward M. Hospitalizations in solid tumor Phase I clinical trial patients: incidence, pattern and clinical outcomes at an Australian Phase I clinical trial unit. Asia Pac J Clin Oncol 2022, 18:287-294 (epub June 28, 2021). https://doi.org/10.1111/ajco.13622 PMID 34180591.
Rottey S, Clarke J, Aung K, Machiels J-P, Markman B, Heinhuis K, Millward M, Lolkema M, Patel S, de Souza P, Duca M, Curigliano G, Santoro A, Koyama T, Brown M, Vezina H, He C, Chu Q. Phase 1/2a trial of BMS-986148, an anti-mesothelin antibody-drug conjugate, alone or in combination with nivolumab in patients with advanced solid tumors. Clin Cancer Res 2022, 28(1):95-105 (epub October 6, 2021). https://doi.org/10.1158/1078-0432.CCR-21-1181 PMID 34615718.
Wang M, Yang JC-H, Mitchell P, Fang J, Camidge D, Nian W, Chiu C-H, Zhou J, Zhao Y, Su W-C, Yang T-Y, Zhu V, Millward M, Fan Y, Huang W-T, Cheng Y, Jiang L, Brungs D, Lyudmila B, Lee CK, Gao B, Xu H, Hsu WH, Zheng L, Janne P. Sunvozertinib, a selective EGFR inhibitor for previously treated non-small cell lung cancer with EGFR exon 20 insertion mutations. Cancer Discovery 2022, 12:1676-89. https://doi.org/10.1158/2159-8290.CD-21-1515 PMID 35404393.
2021
Italiano A, Cassier PA, Lin C-C, Alanko T, Peltola KJ, Gazzah A, Shiah H-S, Calvo E, Cervantes A, Roda D, Tosi D, Gao B, Millward M, Warburton L, Tanner M, Englert S, Lambert S, Parikh A, Afar D, Vosganian G, Moreno V. First-in-human study of Budigalimab, an anti-PD-1 inhibitor, in patients with non-small cell lung cancer and head and neck squamous cell carcinoma. Cancer Immunol Immunother (epub July 3, 2021). https://doi.org/10.1007/s00262-021-02973-w PMID 34216247.
Calvo E, Spira A, de Miguel-Luken M, Kondo S, Gazzah A, Millward M, Prenen H, Rottey S, Warburton L, Alanko T, Cassier P, Yoh K, Italiano A, Moreno V, Peltola K, Seto T, Toyozawa R, Afar D, Englert S, Komarnitsky P, Lambert S, Parikh A, Vosganian G, Gao B. Safety, pharmacokinetics and efficacy of budigalimab with rovalpituzumab teserine in patients with small cell lung cancer. Cancer Treat Res Commun. 2021, 28:100405 epub May 25, 2021. https://doi.org/10.1016/j.ctarc2021.100405 PMID 34329846.
Gan HK, Millward M, Jalving M, Garrido-Laguna I, Lickliter JD, Schellens JNM, Lolkema MP, Van Herpen C, Hug B, Tang L, O’Connor-Semmes R, Gagnon B, Ellis C, Ganji G, Matheny C, Drilon A. A phase I, first-in-human study of GSK2849330, an anti-HER3 monoclonal antibody, in HER3-expressing solid tumors. The Oncologist 2021, 10:e1844-1853 (epub July 21, 2021). https://doi.org/10.1002/onco.13860 PMID 34132450.
O’Malley DM, Neffa M, Monk BJ, Melkadze T, Huang M, Kryzhanivska A, Bulat I, Meniawy TM, Bagameri A, Wang EW, de Speville Uribe BD, Hegg R, Feliu AO, Ancukiewicz M, Lugowska I. Dual PD-1 and CTLA-4 checkpoint blockade using Balstilimab and alifrelimab combination as second-line treatment for advanced cervical cancer: An open-label Phase II study. J Clin Oncol 2021, 40:762-771. https://doi.org/10.1200/JCO.21.02067
2020
Sullivan RJ, Hollebecque A, Flaherty KT, Shapiro GI, Ahnert JR, Millward MJ, Zhang W, Gao L, Sykes A, Willard MD, Yu D, Schade AE, Crowe K-AJ, Flynn DL, Kaufman MD, Henry JR, Peng S-P, Benhadji KA, Conti I, Gordon MS, Tiu RV, Hong DS. A Phase I study of LY3009120, a pan-RAF inhibitor, in patients with advanced or metastatic cancer. Mol Cancer Ther 2020, 19:460-467, epub Oct 23, 2019. http://doi.org/10.1158/1535-7163.MCT-19-0681 PMID 31645440.
Desai J, Deva S, Lee JS, Lin C-C, Yen C-J, Yee C, Bhumsuk K, Jameson M, Hou M-H, Kang Y-K, Markman B, Lu C-H, Rau K-M, Lee K-H, Horvath L, Friedlander M, Hill A, Sandhu S, Barlow P, Wu C-Y, Zhang Y, Liang L, Wu J, Paton V, Millward M. Phase IA/IB study of single agent tislelizumab, an investigational anti-PD-1 antibody, in solid tumours. J Immunother Cancer 2020, 8:e000453, epub June 14, 2020. https://doi.org/10.1136/jitc-2019-000453 PMID 32540858.
Lickliter J, Gan H, Voskoboynik M, Arulananda S, Gao B, Nagriel A, Grimson P Harrison M, Zou JJ, Zhang L, Luo S, Lahn M, Kallender H, Mannucci A, Somma C, Woods K, Behren A, Fernandez-Penas P, Millward M, Meniawy T. A first-in-human dose study of camrelizumab in patients with advanced or metastatic cancer. Drug Design, Devel, Ther 2020, 14:1177-1189 (epub Mar 18, 2020). https://doi.org/10.2147/DDDT.S243787 PMID 32256049.
Desai J, Gan H, Barrow C, Jameson M, Atkinson V, Haydon A, Millward M, Begbie S, Brown M, Markman B, Patterson W, Hill A, Horvath L, Nagrial A, Richardson G, Jackson C, Friedlander M, Parente P, Tran B, Wang L, Chan Y, Tang Z, Huang W, Wu J, Zeng D, Luo L, Solomon B. A phase I, open-label, dose escalation/dose expansion study of Lirirafenib (BGB-283), an RAF family kinase inhibitor, in patients with solid tumors. J Clin Oncol 2020, 38:2140-2150 (epub March 17, 2020). https://doi.org/10.1200/JCO.19.02654 PMID 32182156.
Heinhuis KM, Carlino M, Joerger M, Di Nicola M, Meniawy T, Rottey S, Moreno V, Gazzah A, Delord J-P, Paz-Ares L, Britschgi C, Schilder RJ, O’Byrne K, Curigliano G, Romano E, Patah P, Wang R, Liu Y, Bajaj G, Siu L. Safety, tolerability, and potential clinical activity of a glucocorticoid-indiced TNF receptor-related protein agonist alone or in combination with nivolumab for patients with advanced solid tumours. JAMA Oncol 2020, 6(1):100-107. https://doi.org/10.1001/jamaoncol.2019.3848
2019
Gan H, Millward M, Hua Y, Qi C, Sai Y, Su W, Wang J, Zhang L, Frigault M, Morgan S, Yang L, Lickliter J. First-in-human Phase I study of the selective MET inhibitor, savolitinib, in patients with advanced solid tumors: Safety, pharmacokinetics and anti-tumor activity. Clin Cancer Res 2019, 25(16):4924-4932. epub April 5, 2019. https://doi.org/10.1158/1078-0432 PMID 30952639.
Friedlander M, Meniawy T, Markman B, Mileshkin L, Harnett P, Millward M, Lundy J, Freimund A, Norris C, Mu S, Wu J, Paton V, Gao B. Pamiparib in combination with the tizlelizumab in patients with advanced solid tumors: results from the dose escalation stage of a multicentre, open label, phase 1a/b trial. Lancet Oncol 2019, 20(9):1306-1315 epub Aug 1 2019. https://doi.org/10.1016/S1470-2045(19)30396-1 PMID 31378459.
2018
Dredge K, Brennan T, Hammond E, Lickliter J, Lin L, Bampton D, Handley P, Lankesheer F, Morrish G, Yang Y, Brown M, Millward M. A phase I study of the novel immunomodulatory agent PG545 (pixatimod) in sujects with advanced solid tumours. Br J Cancer 2018, 118(8):1035-1041. https://doi.org/10.1038/s41416-018-0006-0 PMID 29531325.
2016
Soria JC, Gan HK, Blagden SP, Plummer R, Arkenau HT, Ransom M, Evans TRJ, Zalcman G, Bahleda R, Hollebecque A, Lemech C, Dean E, Brown J, Gibson D, Peddareddigan V, Murray S, Nebot N, Mazumdar J, Swartz L, Auger KR, Fleming RA, Singh R, Millward M. A phase I, pharmacokinetic and pharmacodynamics study of GSK2256098, a focal adhesion kinase inhibitor, in patients with advanced solid tumors. Ann Oncol 2016, 27:2268-2274. https://doi.org/10.1093/annonc/mdw427 PMID 27733373.
2015
Winterhoff B, Freyer L, Hammond E, Giri S, Mondal S, Roy D, Teoman A, Mullany SA, Hoffman R, von Bismarck A, Chien J, Block MS, Millward M, Bamptom D, Dredge K, Shridhar V. PG545 enhances anti-cancer activity of chemotherapy in ovarian cancer models and increases surrogate biomarkers such as VEGF in preclinical and clinical plasma samples. Eur J Cancer 2015, 51:879-892. https://doi.org/10.1016/j.ejca.2015.02.007 PMID 25754234.
Medical Oncology Presentations at National and International meetings
2024
Cheng Y, Lisberg A, Lemech C, Abed A, Chaudhry A, Schmidt A, Lu X, Zhu Z, Gu W, Qiu Y, Shi R, Zhang B. A Phase 1/2a multicenter, open-lable, first-in-human, study to assess the safety, tolerability, pharmacokinetics, and preliminary antitumor activity od DB-1311 (a B7-H3-targeting ADC) in patients with advanced/metastatic solid tumors. American Association for Cancer Research Annual Meeting, San Diego, 2024 Abst CT165.
Ab Rahman AS, Hakeem MU, Abass R, Wainman L, Miller J, Abed A, Humphries TG, Meniawy T, Shinde R, Lau PK, Bowyer S, Millward M. Outcomes of patients with metastatic solid cancers treated on early phase clinical trials in Western Australia. American Society of Clinical Oncology Annual Meeting, Chicago 2024. Abst 323094.
Bermejo IM, Wang JS, Gutierrez M, Hamilton EP, Spira AI, Rasco DW, Powderly JD, Millward M, Frentzas S, Stec R, Sharma M, Shackleton MJ, Arance AM, Joaquin JG, Lugowska IA, Liu T, Shearer T, Gupta D, Jones JA, Moreno V. CLN-619 (anti-MICA/B antibody) alone and in combination with pembrolizumab for adncaed solid tumors: Updated results of a Ph1 study. American Society of Clinical Oncology Annual Meeting, Chicago 2024. Abst 2588.
Ascierto PA, Drummer R, Gaudy-Marqueste C, Bowyer S, Lipson EJ, Ghisoni E, Middleton MR, Ratto B, Jackson WJ, Cheong A, Mukherjee S, Wu J, Long GV. Efficacy and safety of triplen nivolumab, relatlimab, and ipiimumab in advanced melanoma: Results from RELATIVITY-048. American Society of Clinical Oncology Annual Meeting, Chicago 2024. Abst 9504.
Yonemori K, Banda K, Boni V, Sohn J, Meniawy T, Lombard JM, Kaufman PA, Richardson DL, Somme LB, Matsumoto K, Giridhar K, Saenz JAG, Prenen H, Uribe RDdeS, Dizon DS, Garcia-Corbacho J, Li Y, Nguyen B, Ismail-Khan R, Neven P. Imlunestrant, an oral selective estrogen receptor degrader (SERD), as monotherapy and in combination with abemaciclib, in endometrioid cancer: Results from the EMBER Phase 1a/1b study. American Society of Clinical Oncology Annual Meeting, Chicago 2024. Abst 5589.
Deva S, Li W, Bishnoi S, Lau P, Tran B, Ba Y, Galsky M, Wang Y, Zhang Y, Luo S, Chang V, Yu C, Zhang T, Zhang H, Tain Y, Naicker K, Yap TA. A first-in-human Phase 1a dose-escalation study of BGB-15025 (HPK1 inhibitor) as monotherapy and in combination with tislelizumab in patients with advanced solid tumors. American Society of Clinical Oncology Annual Meeting, Chicago 2024. Abst 2585.
Hamid O, Williams A, Lopez JS, Olson D, Sato T, Shaw HM, Friedman CF, Thistlethwaite F, Middleton MR, Lebbe C, Ma VT, Izar B, Lau PKH, Bechter OE, Kirk P, Yuan Y, Marshall S, Davar D. Phase I safety and efficacy of IMC-F106C, a PRAME x CD3 ImmTAC bispecific, in post-checkoint cutaneous melanoma. American Society of Clinical Oncology Annual Meeting, Chicago 2024. Abst 2585.
Wander SA, Stemmer SM, Rugo HS, Im S-A, Lau PKH, Paluch-Shimon S, Cahuzac C, Collier A, Shah MD, Ngo HX, Schwab RB, Zhu J, Oliviera M. Interim analysis of the giredestrant + everolimus arm in MORPEHUS breast cancer: A Phase I/II study of giredestrant treatment combinations in patients with estrogen receptor-positive, HER2-negative locally advanced/metastatic breast cancer. American Society of Clinical Oncology Annual Meeting, Chicago 2024. Abst 1059.
Sacher A, Miller WH Jr, Paz-Ares L, Ahn MJ, Patel M, Dziadziuszko R, Santoro A, Luo J, Markman B, Freres P, Van Dongen M, Desai J, Bowyer S, Cervantes A, Mourão Dias J, Falcon A, Krebs MG, Laurie S, Prenen H, Perets R, Massarelli E, Kim SH, de Miguel M, Deva S, Garralda E, Medina L, Guedes JD, Siena S, Guren T, Fernandez E, Latten Jansen L, De Cassia Costamilan R, Choi Y, Mandlekar S, Lin MT, Yau KK, Chang J, Royer-Joo S, Jun T, Dharia NV, Schutzman JL, Lorusso P. Divarasib Single-Agent Long-Term Follow-up and Atezolizumab Combination Treatment in Patients with KRAS G12C-Positive NSCLC. World Lung Cancer Conference, San Diego, 2024, Abst OA14.06.
Lin FP, Mersiades A, Lee J, Xu W, Chinchen S, Charakidis M, Thavaneswaran S, Hughes B, Underhill C, Takhar H, Harrup R, Nagrial A, Millward M, Desai J, Espinoza D, Lee CK, Solomon B, Simes RJ, Pavlakis N, Thomas DM. Phase 2 trial of vemurafenib and cobimetinib in BRAF-mutated solid tumours and first-line non-small-cell lung cancer: Australian Molecular Screening and Therapeutics (MoST) Substudy 12. European Society for Medical Oncology Annual Meeting, Barcelona, 2024, (accepted).
Cassier P, Mehnert J, Kim R, Chmielowski B, Millward M, Perez CA, Gonzalez-Cao M, Gambardella V, McKean M, Brose MS, Xing Y, Long GV, Kelly A, Lee G, Severson P, Williams RT, Gaudy-Marqueste C. A Phase 1 clinical trial evaluating Exarafenib, a selective pan-RAF inhibitor in combination with binimetinib in NRAS-mutant melanoma & BRAF-altered solid tumors. European Society for Medical Oncology Annual Meeting, Barcelona, 2024, (accepted).
Schram AM, Lopes GDL, El-Khoueiry A, Fontana E, Johnson M, Karasic T, Kumar S, Larusso P, Gregoric V, Millward M, Aix SP, Richardson D, Perez DR, Spira A, Tan DSP, Thompson J, Uprety D, Fellous M, Duke KL, Qin YG, Dumbava EE. PYNNACLE Phase 2 trial of Rezatapopt (PCI14586) in solid tumors with a TP53 Y220C mutation. European Society for Medical Oncology Annual Meeting, Barcelona, 2024, (accepted).
Lin C-C, Schneider RE, Gutierrez M, Shen L, Chung K, Doroshow D, Gao B, Millward M, Hsieh C-Y, Xu C, Cai S, Tian YE, Liu L, Shen C, Tan Y, He Y, Zhang C, Li L, Ma M, Xu L. Results from the first-in-human study of ATR inhibitor, IMP9064 monotherapy dose escalation in patients with advanced solid tumors. European Society for Medical Oncology Annual Meeting, Barcelona, 2024, (accepted).
Mehnert J, Gaudy-Marqueste C, Gonzalez-Cao M, Gambardella V, Millward M, Kim R, McKean M, Rodrigues-Abreu D, Long G, Kelly A, Lee G, Severson P, Williams RT, Cassier P, Chmielowski B, A Phase 1 clinical trial evaluating Exarafenib, a selective pan-RAF inhibitor in combination with binimetinib in NRAS-mutant melanoma. Society for Melanoma Research Annual Congress, New Orleans, 2024 (submitted).
2023
Yap TA, Kwiatkowski DJ, Desai J, Dagogo-Jack I, Millward M, Kindler HL, Tolcher AW, Frentzas S, Thurston AW, Post L, Dorr FA. First-in-class, first-in-human Phase I trial of VT3989, an inhibitor of yes-associated protein (YAP)/transcriptional enhancer activator domain (TEAD), in patients with advanced solid tumors enroiched for malignant mesotheliom and other tumors with neurofibromatosis 2 (NF2) mutations. American Association for Cancer Research Annual Meeting, New Orleans, 2023 Abst CT006.
Solomon B, Gao B, Subbiah V, Millward M, Rosen L, Desai J, Sbar EI, Collins N, Hoang T, Song X, Shao W, Jaggi J, Edris B, Ramachandran P, Luo L, Friedlander M. Safety, pharmacokinetics, and antitumor activity findings from a Phase Ib, open-label, dose-escalation and expansion study investigating RAF dimer inhibitor lifirafenib in combination with MEK inhibitor midrametinib in patients with advanced or refractory solid tumors. American Association for Cancer Research Annual Meeting, New Orleans, 2023 Abst CT033.
McKean M, Rozen E, Barve M, Meniawy T, Wang J, Li Z, Picard R, Brail L, Vecchio D, John T, Cohen E, Obara G, Parikh A. Preliminary dose-escalation results of ERAS-601 in combination with cetuximab in FLAGSHP1: A Phase I stusdy of ERAS-601, a potent SHP2 inhibitor, in patients with previously treated advanced or metastatic solid tumors. American Association for Cancer Research Annual Meeting, New Orleans, 2023 Abst CT184.
Fu S, Falchook GS, Barve M, McKean M, Tan TJ, Lemech C, Chee CE, Marina N, Abbadessa G, Meng R, Rotolo F, Wang H, Deng J, Wang W, Wang R, Meniawy T. Joint modelling of safety and peripheral mode-of-action biomarkers to support RP2D identification in Phase I study of SAR444245 as monotherapy or in combination with pembrolizumab in patients with advanced solid tumors. American Association for Cancer Research Annual Meeting, New Orleans, 2023 Abst 2155.
Lin FP-O, Thaveneswaran S, Napier CE, Grady JP, Kansara M, Sebastian L, Kee D, Zaheed M, Millward M, Brown MP, Charakidis M, Craft PS, Grimson PS, Harrup RA, O’Byrne KJ, Desai J, Lee CK, Ballinger ML, Simes J, Thomas DM. Genomic therapy in rare and refractory cancers: Updated results form a retrospective cohort study in the Molecular Screening and Therapeutic (MoST) program. American Society of Clinical Oncology Annual Meeting, Chicago 2023. Abst 1540.
Wang JS, Gutierrez M, Rasco DW, Bermejo IM, Powderly JD, Hamilton EP, Millward M, Arance MA, Stec R, Moreno V, Sharma N, Lugowska IA, Shackleton MJ, Frentzas S, Janik JE, Liu T, Shaprio I, Whalen K, Jones JA, Spira AI. A phase I dose-escalation study to investigate the safety, efficacy, pharmacokinetics, and pharmacodynamics activity of CLN-619 (Anti-MICA/B antibody) alone and in combination with pembrolizumab in patients with adnvaced solid tumors. American Society of Clinical Oncology Annual Meeting, Chicago 2023. Abst 2532.
Ruan D-Y, Lee MA, Deng Y, Lee K-W, Millward M, Grewel S, Gadgeel SM, Sanborn RE, Hou X, Wei S, Huh SJ, Liu F-R, Xie X, Xiang Z, Shi Z, Wang Y, Zhang L, Richardson GE, Xu R-H. Safety and efficacy of D-1553 in KRAS G12C-mutated colorectal cancer: Results from a Phase I/II study. American Society of Clinical Oncology Annual Meeting, Chicago 2023. Abst 3563.
Thavaneswaran S, Merseides A, Lin FP, Espinoza D, Grady J, Lee C, Desai J, Brown M, Grimson P, O’Byrne K, Harrup R, Nagrial A, Sebastian L, Chinchen S, Kansara M, Craft P, Millward M, Simes JR, Joshua AM, Thomas D. Trastuzumab emtansine (T-DMI) in advanced solid cancers with HER2 mutations or amplifications: Results from the Molecular Screening and Therapeutics (MoST) Program Substudy 2509. American Society of Clinical Oncology Annual Meeting, Chicago 2023. Abst 3127.
Borad MJ, Schram AM, Kim RD, Kamath SD, Sahai V, Dotan E, Kelley RK, Ponz-Sarvise M, Oh D-Y, Yachin J, Florou V, Cassier PA, Park JO, Liao C-Y, Millward M, Ramirez F, Ricard FJ, Hollebecque A, Subbiah V, Goyal L. Updated dose escalation results for ReFocus, a first-in-human study of highly selective FGFR2 inhibitor RLY-4008 in cholangiocarcinoma and other solid tumors. American Society of Clinical Oncology Annual Meeting, Chicago 2023. Abst 4009.
Desai J, Davar D, Deva S, Gao B, Liu T, Matos M, Menaiwy T, O’Byrne KJ, Sun M, Voskoboynik M, Yang K, Yu X, Chen X, Dong Y, Giovinazzo H, Leaw S, Patel D, Rahman T, Wu Y, Day D. A Phase I study of the OX-40 agonist, BGB-A445, with or without tislelizumab, an anti-PD-1 monoclonal antibody, in patients with advanced solid tumors. American Society of Clinical Oncology Annual Meeting, Chicago 2023. Abst 2574.
Liu JF, Fu S, Richardson GE, Vranjes Z, Meniawy T, Shannon CM, Hamilton EP, Blank SV, Mathews CA, Alidzanovic J, Ruseva RK, Shi Q, Harismendy O, Ptaszynski AM, Westin SN, Meric-Bernstam F, Thakar PH. Corelation of cyclin E1 expression and clinical outcomes in a Phase Ib dose-escalation study of azenosertib (ZN-c3), a WEE1 inhibitor, in combination with chemotherapy in patients with platinum-resistant or refractory epithelial ovarian, peritoneal, or fallopian tube cancer. American Society of Clinical Oncology Annual Meeting, Chicago 2023. Abst 5513.
Yap T, Desai J, Dagogo-Jack I, Millward M, Kindler HL, Tolcher AW, Frentzas S, Body AL, Thurston A, Post L, Dorr FA, Kwiatkowski DJ. First-in-human Phase I trial of VT3989, a first-in-class YAP/TEAD inhibitor in patients with advanced mesothelioma. World Lung Cancer Conference, Singapore, 2023, Abst P2.09-001.
Bowyer S, Spira A, Patil T, Lyssikatos J, Deng W, Collins H, Cho BC. Trials in Progreess: Phase 1a/b study of ELVN-002 in solid tumors with HER2 mutations, amplification, or overexpression. World Lung Cancer Conference, Singapore, 2023, Abst P2.09-27.
Lee S-E, Han J-Y, Lee KH, Lee G-W, Lemech C, Millward M, Roohullah A, Le X, Choi JY, Kim NY, Im S, Nirmal R, Park KE, Lee S, Moon H, Hwang S, Shin YK, Lee DH. Efficacy and safety outcomes of ABN401 in NSCLC patients with MET exon 14 skipping: A clinically relevant subgroup analysis. AACR-NCI-EORTC Molecular Targets and Cancer Therapeutics Meeting, Boston, 2023.
Schram AM, Subbiah V, Liao C-Y, Moreno V, Roda D, Ponz-Sarvise M, Doten E, Cassier PA, Moreno I, Varkaris A, Kim RD, Garralda E, Opdam F, Tai D, Italiano A, Oh D-H, Goyal L, Fontana E, Liu J, BoukovalaM, Ghiringelli F, Borad MT, Babiker H, Jin Z, Millward M, Yachnin J, Kamath AD, Coward JI, Yoo C, Kelley RK, Sahai V, Bridgewater J, Springfield C, Florou V, El-Khoueiry A, Eskens F, Lin B, Paulson S, Curigliano G, Murphy M, Deary A, Ricard F, Jen KY, Ramirez F, Blakesley RE, Schmidt-Kittler O, Mar BG, Park JO, Hollebecque A. Clinical activity of lirafugratinib (RLY-4008), a highly selective FGFR2 inhibitor, in patients with advanced FGFR2-altered solid tumors: the ReFocus study. AACR-NCI-EORTC Molecular Targets and Cancer Therapeutics Meeting, Boston, 2023.
Tran B, Millward M, Lemech C, Frentzas S, Day D, Latifi A, Desai J, Wabnitz P, Kearney P, Galkin A. AXA-042, a systemically administered TLR2/6 agonist, demonstrates target engagement and TLR pathway activation in patients with advanced solid tumors. European Society for Medical Oncology Annual Meeting, 2023, Madrid. Abst 1047P.
Lin C-C, Schneider RE, Gutierrez M, Shen L, Gao B, Chung K, Doroshow DB, Millward M, Hsieh C-Y, Xu C, Cai SX, Tian YE, Liu L, Chen C, Tan Y, Zhang C, Li L, Ma M, Chen X. First-in-human study of ATR inhibitor IMP9064 monotherapy and in combination with PARP inhibitor senaparib in patients with advanced solid tumors. European Society for Medical Oncology Annual Meeting, 2023, Madrid. Abst 681P.
Luen SJ, Ahearn ES, berger C, Desai J, Frentzas S, Gan H, Gualandi M, Markman B, Millward M, Rafiei A, Tran B, Renner C. A Phase Ia/Ib, first-in-human, dose-escalation study evaluating the safety, tolerability, and efficacy of IOS-1002, a LILRB1, LILRB2, and KIR3DL1 targeting HLA-derived fusion protein administered alone or in combination with a PD-1 antibody in patients with advanced solid tumors. European Society for Medical Oncology Annual Meeting, 2023, Madrid. Abst 714TiP.
Markman B, Coward J, Nagarial A, Abed A, Millward M. Phase I open-label, dose escalation and expansion study of YH003, an anti-CD40 agonist monoclonal antibody in combination with toripalimab in patients with advanced solid tumors. European Society for Medical Oncology Annual Meeting, 2023, Madrid. Abst 1041P.
Shapiro IM, Whalen KA, Liu L, Liu T, Michaelson JS, Spira AI, Wang J, Hamilton EP, Millward M, Arance AM, Moreno V, Melero I, Stec R, Jones JA. Characterization of the pharmacoynamic activity of CLN-619, an anti-MICA/B monoclonal antibody, in patients from an ongoing Phase I trial. Society for Immunotherapy of Cancer Annual Meeting, San Diego, 2023.
Perez C, Henry J, Kim S, El-Koureiy A, Gutierrez M, Pavlik A, Lee J, Bollini S, Jin F, Harrabi O, Heller KN, Humphries T. INCLINE-101: Preliminary safety, tolerability, pharmacokinetics, and pharmacodynamics of TAC-001 (TLR9 agonist conjugated to CD22 MAB) in patients with advanced or metastatic solid tumors. Society for Immunotherapy of Cancer Annual Meeting, San Diego, 2032 Abst 743.
Pavlakis N, Millward M, Richardson G, Andelkovic V, kichenadasse G, Thomas D, Fernandez AM, Thakkar D, Arbabzade T, Goey CH, Seet Q, Toy W, Paszkiewicz K, Ingram P, Boyd-Kirkup J, Kwek KY, A Phase Ib study of HMBD-001, a monoclonal antibody targeting HER3, with or without chemotherapy, in patients with genetic aberations in HER3 signaling. ESMO Asia, Singapore, 2023. Abst 88TiP.
Wu Y-L, Gao B, Goh J. Zhao J, Ma Z, Cui J, Yu X, Huang D, day D, Voskoboynik M, Chu Q, Zhou Q, Millward M, Pan H, Sun M, Peng Y, Liu M, Tian T, Li H, Guo J. Exploratory anakysis of peripheral pharmacodynamics biomarkers after sitravatinib and tislelizumab in advanced solid tumors: SAFFRON-3. ESMO-IO Congress, Geneva, 2023. Abst 44P.
Prenen H, Lesimple T, Robert M, Machiels J-P, Delafontaine B, Tomasini P, Meniawy T, Kotecki N, Van Custem E, Piha-Paul S, Schweizer M, Gadgeel S, Kondo S, Ouali K, Kuboki Y, Daniel J, Ebiana V, Howe J, Spitz S, Italiano A. A Phase I study exploring the safety and tolerability of the small molecule PD-L1 inhibitor, INCB099280, in selected advanced solid tumors. SAFFRON-3. ESMO-IO Congress, Geneva, 2023. Abst 155P.
Frentzas S, Park H, Budd GT, Ganju V, Shannon C, Hurvitz SA, Cuff C, Lau P, Eek R, O’Shaughnessy J, Boyle F, Aung S, Hessel C, Greene D, O’Keefe B, Zhang J, Hong Q, Lu J. Phase I dose escalation study of ARX788, a next-generation anti-HER2 antibody drug conjugate, in heavily pretreated breat cancer patients. San Antonio Breast Cancer Conference, 2023. Abst P01-04-01.
Hamilton E, Neven P, Pistilli B, Beeram M, Borges V, Campone M, Guimaraes JLM, Foukakis T, Kodahl AR, Lau P, Lim E, Lugowska I, Rychlik G, Gresty C, Miller C, Sommavilla R, Sudhan D, Rugo H. Capivasertib plus cyclin-dependent kinase 4/6 inhibitor and fulvestrant in hormone receptor-positive/human epidermal growth factor receptor-negative advanced breast cancer: Updated Phase Ib analysis from CAPItello-292. San Antonio Breast Cancer Conference, 2023. Abst PS12-09.
2022
Deva S, Millward M, Friedlander M, Gan HK, Horvath LG, Lee J-S, Hill A, Sandhu S, Liang L, Shi J, Zhang Y, Shi Y, Ma X, Wu X, Shen Z, Desai J. The combination of hyperamplification and tumor mutation burden as a pan-cancer biomarker in patients treated by PD-(L)1 blockade. American Association for Cancer Research Annual Meeting, New Orleans, 2022 Abst LB511.
McKean M, Perez CA, Cato S, Xing Y, Xie H, Millward M, Olzanski A, Kobayashi K, Miller N, Severson P, Tam B, Unger C. Design and rationale of a first in human Phase I/Ib study evaluating KIN-2787, a potent and highly selective pan-RAF inhibitor, in adult patients with BRAF- and NRAS- mutation positive solid tumors. American Association for Cancer Research Annual Meeting, New Orleans, 2022 Abst CT248.
Millward M, Moser JC, Davar D, Voskoboynik M, Lakhani NJ, Sanborn RE, Grewal J, Narayan A, Sznol M, Means G, Schieber K, Zayad H, Dela Cruz G, Peng SL. Monotherapy dose-escalation of davoceticept (ALPN-202), a conditional CD28 costimulator and dual checkpoint inhibitor, in advanced malignancies (NEON-1). American Association for Cancer Research Annual Meeting, New Orleans, 2022 Abst CT041.
Price T, Grewal J, Abed A, Moore M, Yeh Y-M, Gadgeel S, Richardson G, Underhill C, Ganju V, Lee K-W, Huh SJ, Kim S-W, Yang C-H, Chen Y-M, Yang C-T, Xiang Z, Shi Z, Wang Y, Zhang L, Millward M. A Phase I clinical trial to evaluate safety, tolerability, pharmacokinetics and efficacy of D-1553, a novel KRASG12C inhibitor, in patients with advanced or metastatic solid tumors harbouring KRAS G12C mutation. American Association for Cancer Research Annual Meeting, New Orleans, 2022 Abst CT504.
Pasic A, Richardson G, Vranjes A, Meniawy T, Rodriques J, Makris L, Misir S, Pultar P, Voliotis D, Fu S. A Phase 1b dose escalation study of ZN-c3, a WEE1 inhibitor, in combination with chemotherapy in subjects with platinum reistant or refractory ovarian, peritoneal, or fallopian tube cancer. American Association for Cancer Research Annual Meeting, New Orleans, 2022 Abst CT148.
Powderly JD, Guiterrez M, Wang JS, Hamilton EP, Sharma M, Spira AI, Millward M, Shakleton MJ, Frentzas S, Koczywas M, Mehta N, Christensen AM, Shapiro I, Whalen K, Michaelson J, Baeuerle P, Janik JE, Rasco DW. A phase I dose-escalation study to investigate the safety, efficacy, pharmacokinetics, and pharmacodynamic activity of CLN-619 (anti-MICA/MICB antibody) alone and in combination with pembrolizumab in patients with advanced solid cancers. American Society of Clinical Oncology Annual Meeting, Chicago 2022. Abst TPS2688.
Davar D, Moser JC, Millward M, Voskoboynik M, Lakhani NJ, Sanborn RE, Grewel JS, Narayan A, Sznol M, Dillon SR, Schieber K, Zayed H, Dela Cruz CM, Perez GN, Peng SL. Dose escalatiomn of davoceticept, a conditional CD28 costimulator and dual checkpoint inhibitor, in advanced malignancies. American Society of Clinical Oncology Annual Meeting, Chicago 2022. Abst 2560.
Janne PA, wang M, Camidge DR, Mitchell P, Fang J, Nian W, Chiu C-H, Zhou J, Zhao Y, Su W-C, Yang T-Y, Zhu VW, Millward M, Fan Y, Huang W-T, Cheng Y, Jiang L, Brungs D, Zheng L, Yang JC-H. Antitumor activity of sunvozertinib in NSCLC patients with EGFR exon 20 insertion mutations after platinum and anti-PD(L)-1 treatment failure. American Society of Clinical Oncology Annual Meeting, Chicago 2022. Abst 9015.
Lee DH, Roohullah A, Cho BC, Lemech CR, de Souza PL, Millward M, Choi JY, Park KE, Kim Y, Kim E, Lee S, Kim YM, Shin Y, Han J-Y. A phase I dose-escalation study of ABN401 (c-MET inhibitor) in patients with solid tumors. American Society of Clinical Oncology Annual Meeting, Chicago 2022. Abst 3105.
Jhaveri KL, Jeselsohn R, Lim E, Hamilton EP, Yonemori K, Beck JT, Kaufman PA, Sammons S, Bhave MA, Saura C, Calvo E, Meniawy T, Larson T, Ma CX, Garcia-Corbacho J, Cao S, Estrem ST, Milata JL, Nguyen B, Beeran M. A Phase Ia/b trial of imlnestrant (LY3484356), an oral selective estrogen receptor degrader (SERD) in ER-positive advanced breast cancer and endometrial cancer: Monotherapy results from EMBER. American Society of Clinical Oncology Annual Meeting, Chicago 2022. Abst 1021.
Coward J, Markman B, Nagrial A, Abed A, Walpole I. A Phase I open-label, dose escalation of YH003, an anti-CD40 monoclonal antibody, in combination with toripalimab (anti-PD-1 mAb) in patients with advanced solid tumors. American Society of Clinical Oncology Annual Meeting, Chicago 2022. Abst 2603.
Yang JC-H, Wang M, Mitchell P, Fang J, Nian W, Chiu C-H, Zhou J, Zhao Y, Su W-C, Camidge R, Yang T-Y, Zhu V, Millward M, Fan Y, Huang W-T, Cheng Y, Jiang L, Brunos D, Bazhenova L, Lee CK, Gao B, Zheng L, Janne PA. Sunvozertinib in NSCLC patients with exon 20 insertion mutations; Effect of prior treatment. World Lung Cancer Conference, Vienna, August 2022, Abst EP08.02.029.
Sacher A, Patel MR, Miller WH Jr, Desai J, Garralda E, Bowyer S, Kim TW, de Miguel M, Falcon A, Krebs MG, Lee J, Cheng M, Shachan-Shmueli E, Forster M, Jerusalem G, Massarelli E, Paz-Ares L Prenen H, Walpole I, Arbour K, Choi Y, Dharia NV, Lin M, Joo SR, Shi Z, Schutzman J, LoRusso P. World Lung Cancer Conference, Vienna, August 2022, Abst OA03.04.
Patel SP, Caravajal R, Feun LG, Haq R, Millward MJ, Shackleton M, Sullivan R, Joshua AM, Zhang J, Gao R, McLeaod JF, Xing E, Wang Z. A Phase 1b study of IN10018/FAKi in combination with cobimetinib in patients with uveal or NRAS melanoma. Society for Melanoma Research 19th International Congress, Edinburgh, October 2022.
Sebastian L, Desai J, Millward M, Chinchen S, Finlayson S, Ballinger M, Thavaneswaran S, Lin F, Lee C, Sjoquist K, Vachan B, Barrie N, Thomas D, Simes RJ. Site-reported benefits and challenges of implementing a platform study of molecular screening and therapeutics in Australia. International Clinical Trials Methodology Conference, Sydney 2022.
Abass R, Hakeen MU, Humphries T, Abed A, Lau P, Bowyer S, Meniawy T, Millward M. Characteristics of patients with durable responses in early Phase trials. Medical Oncology Group Australia Annual Meeting, Cairns, August 2022.
Hollebecque A, Borad MJ, Goyal L, Schram AM, Park JO, Cassier P, Kamath S, Tai D, Dotan E, Kim R, Sahai V, Oh D-Y, Liao C-YA, Millward M, Perez DR, Ferte C, Blakesley R, Wolf BB, Subbiah V, Kelley RK. Efficacy of RLY-4008, a highly selective FGFR2 inhibitor in patients with a FGFR2-fusion or rearrangement, FGFR inhibitor naïve cholangiocarcinoma: ReFocus trial. European Society for Medical Oncology Annual Meeting, September 2022, Paris. Abst LBA12.
Lee DH, Roohullah A, Cho BC, Lee S, Lemech C, de Souza P, Millward M, Choi J, Park KE, Kim E, Kim NY, Shin YK, Han J. A Phase I-II multicentre, open-label, dose-escalation study to evaluate the safety, pharmacokinetics, pharmacodynamics, and anti-tumor activity of ABN401 in patients with advanced solid tumors and dose-expansion in patients with non-small cell lung cancer harbouring c-MET dysregulation. European Society for Medical Oncology Annual Meeting, September 2022, Paris. Abst 1197TiP.
Gandhi A, Taylor J, Morici M, Reid A, Meniawy T, Khattak MA, Millward M, Gray ES, Zaenker P. Autoantibodies as potential biomarker of high grade immune-related adverse events in metastatic melanoma patients treated with check point inhibitors. European Society for Medical Oncology Annual Meeting, September 2022, Paris. Abst 130P.
Desai J, Han S-W, Forster MD, Kim TW, Casal GA, Shacham-Shmueli E, Bowyer SE, De Miguel MJ, Gonzalez AF, Jones RH, Krebs MG, Miller WH, Paz-Ares L, Lorusso P, Sacher A, Dharia N, Lin MT, Schutzman JL, Shi Z, Patel M. PHASE Ia study to evaluate GDC-6036 monotherapy in patients with colorectal cancer with KRAS G12C mutation. European Society for Medical Oncology Annual Meeting, September 2022, Paris. Abst 362P.
Sahai V, Hollebecque A, Broad MJ, Goyal L, Schram AM, Park JO, Cassier P, Kamath S, Tai D, Dotan E, Kim R, Ho D-Y, Liao C-HA, Millward M, Perez DR, Blakesley R, Wolf BB, Subbiah V, Kelly RK. Efficacy of RLY-4008, a highly selective FGFR2 inhibitor in patients with an FGFR2-fusion or rearrangement, FGFR inhibitor-naïve cholangiocarcinoma: ReFocus trial. Cholangiocarcinoma Summit, Chicago, 2022.
Nagasaka M, Carrizosa DR, Burkard ME, Elamin YY, Desai J, Gadgeel SM, Lin JJ, Waqar SN, Spigel DR, Chae YK, Cheema PK, Haura EB, Liu SV, Nguyen D, Reckamp KL, Tsai FY-C, Harrup R, Millward M, Kim TM, Jansen VM, Drilon A, Ou S-HI, Camidge DR, Patil T. Crestone: Initial safety and efficacy of Seribantumab in solid tumors harbouring NRG1 fusions. Asia Conference on Lung Cancer, Nara, 2022.
Kamath S, Tai D, Moreno I, Babiker H, Jin C, Yoo C, Ricard F, Jen KY, Coward J, Liu J, Opdam F, Millward M, Ponz-Sarvise M, Yachnin J, Kim R, Park JO, Subbiah V, Schram AM. ReFocus: A Phase 1/2 study of the highly selective FGFR2 inhibitor, in patients with advanced solid tumors including breast cancer. San Antonio Breast Cancer Symposium, San Antonio, 2002.
Park JO, Tai D, Hollebecque A, Borad MJ, Goyal L, Schram AM, Cassier O, Kamath S, Dotan E, Kim R, Sahai V, Liao C-YA, Millward M, Perez DR, Blakesley R, Wolf BB, Subbiah V, Kelley RK, Oh D-Y. Efficacy of RLY-4008, a highly selective FGFR2 inhibitor in patients with an FGFR2-fusion or rearrangement, FGFR-inhibitor naïve cholangiocarcinoma: ReFocus trial. ESMO Asia, Singapore, 2022.
Lin C-C, Kim TM, Desai P, Lee KH, Feng Y-H, Ngamphaiboon N, Kim S-B, Yang M-H, Muzaffar J, Chmielowski B, Swiecicki PL, Bowyer SE, Brahmer JR, Chisamore M, Goyal R, Nasrah N, Ho W, Cho BC. Phase I/II study of the orak CCR4 antagonist, FLX475, as monotherapy and in combination with pembrolizumab in advanced cancer. ESMO-IO, Geneva 2022. Abst 187P.
Tan W, Shi Y, Yan H, Shen Z, Budha N, Rizwan A, Huang R, Zheng H, Gao R, Frentzas S, Kao S, Meniawy T, Zhang Y. Peripheral pharmacodynamic effscts of ociperlimab in combination with tislelizumab in patients with advanced solid tumors: ADVANTIG-105 Phase I dose-escalation study. Society for Melanoma Research Annual Congress, Boston, 2022 Abst 768.
McKean M, Barve M, Hong D, Parikh A, Rosen E, Yang J, Picard R, Yi J, Brail L, Vecchio D, Meniawy T, John T, Wang J. Preliminary results from FLAGSHP-1: A Phase I dose escalation study of ERAS-601, a potent SHP2 inhibitor, in patients with previously treated advanced or metastatic solid tumors. AACR-NCI-EORTC Molecular Targets and Cancer Therapeutics Meeting, 2022. Abst 95.
Prenen H, Lesimple T, Robert M, Delafontaine B, Machiels J-P, Meniawy T, Van Custem E, Kotecki N, Piha-Paul SA, Schweizer MT, Gadgeel S, Daniel J, Viviers L, Howe J, Italiano A. A Phase I study exploring the safety and tolerability of the small molecule PD-L1 inhibitor, INCB099280, in patients with selected advanced solid tumors. Society for Immunotherapy of Cancer Annual Meeting, Boston, 2022 Abst 734.
Perez C, Henry J, Humphries T, Kim S, Diab A, Harrabi O, Jin F, Wan H, Bermingham C, El-Koureiy A. INCLINE-101, A Phase 1/2, open label, dose escalation and expansion study of TAC-001 (a TLR9 agonist conjugated to CD22 antibody) in patients with select advanced or metastatic solid tumors. Society for Immunotherapy of Cancer Annual Meeting, Boston, 2022 Abst 756.
2021
Goh J, Coward J, Gao B, Pires de Silva I, Voskoboynik M, Day D, Body AL, Gan H, Chen C, Xiang X, Fe C, Yang L, Millward M. Phase Ib study to assess safety/tolerability and preliminary anti-tumor activity of sitravatinib plus tislelizumab in patients with advanced platinum-resistant ovarian cancer. American Association for Cancer Research Annual Meeting, 2021 (virtual) Abst CT013.
Voskoboynik M, Moser JC, Lakhani N, Millward M, Davar D, Harb WA, Yang J, Means G, Manjarrez K, Tercero A, Zayed H, Hillson J, Dela Cruz C, Perez G, Peng SL. NEON-1: a first-in-human phase I open-label study of ALPN-202, a conditional CD28 costimulator and dual checkpoint inhibitor, in advanced malignancies. American Association for Cancer Research Annual Meeting, 2021 (virtual). Abst CT213.
Janku F, Abdul-Karin R, Azad A, Bedell J, Falchook G, Gan HK, Tan T, Wang JS, Chee CE, Ma L, Mooney J, Marina N, Abbadessa G, Milla M, Meniawy T. THOR-707 (SAR444245), a novel not-alpha IL-2, as monotherapy and in combination with pembrolizumab, in advanced/metastatic solid tumors: Interim results from HAMMER, an open-label multicenter Phase I/II study. American Association for Cancer Research Annual Meeting, 2021 (virtual). Abst LB041.
Lee DH, Aflah R, Cho BC, Lemech C, de Souza P, Millward M, Choi JY, Park K, Lee M, Kim YM, Shin Y, Han J-Y. A Phase I-2 multicentre, open-label, dose escalation and dose-expansion study to evaluate the safety, pharmacokinetics, pharmacodynamics, and antitumor activity of ABN410 in patients with adbvanced solid tumors. American Society of Clinical Oncology Annual Meeting, 2021 (virtual). Abst TPS3157.
Lemech CR, Kichenadasse G, Marschner J-P, Alevizopoulos K, Otterlei M, Millward M. A first-in-human study of ATX-101, a drug targeting proliferating cell nuclear antigen (PCNA), shows a favourable safety profile and disease stabilization in late tage, heavily pre-treated, solid tumor patients. American Society of Clinical Oncology Annual Meeting, 2021 (virtual). Abst 3067.
Moser JC, Voskoboynik M, Lakhani N, Millward M, Davar D, Harb WA, Yang J, Means G, Manjarrez K, Tercero A, Zayed H, Hillson J, Dela Cruz C, Perez G, Peng SL. First-in-human dose escalation of ALPN-202, a conditional CD28 costimulator and dual checkpoint inhibitor, in advanced malignancies. American Society of Clinical Oncology Annual Meeting, 2021 (virtual). Abst 2547.
Yang JC-H, Wang M, Mitchell P, Fang J, Nian W, Chiu C-H, Zhou J, Zhao J, Zhao Y, Su W-C, Camidge DR, Yang T-Y, Zhu VW, Millward M, Fan Y, Huang WT, Cheng Y, Jiang L, Zheng L, Ye X, Janne PA. Preliminary safety and efficacy results from Phase I studies of DZ9008 in NSCLC patients with EGFR exon 20 insertion mutations. American Society of Clinical Oncology Annual Meeting, 2021 (virtual). Abst 9008.
Jhaveri KL, Lim E, Hamilton EP, Saura C, Meniawy T, Jeselsohn R, Beck JT, Kaufman PA, Sammons S, Banda K, Okera M, Yonemori K, Harnden KK, Kim S-B, Sohn J, Ma CX, Aftimos PG, Wang XA, Young SRL, Beeram M. A first-in-human Phase 1a/b trial of LY3484356, an oral selective estrogen receptor degrader (SERD) in ER+ advanced breast cancer and endometrial endometrioid cancer: Results from the EMBER study. American Society of Clinical Oncology Annual Meeting, 2021 (virtual). Abst 1050.
Frentzas S, Meniawy T, Kao S, Wang R, Zheng H, Budha N, Pedroza L, Tan W. ADVANTIG-105: Phase I dose-escalation study of anti-TIGIT monoclonal antibody ociperlimab (BGB-A1317) in combination with tislelizumab in patients with advanced solif tumors. American Society of Clinical Oncology Annual Meeting, 2021 (virtual). Abst 2583.
Coward J, Abed A, Nagrial A, Markman B. Phase I open-label, dose escalation study of YH003, an antiCD40 monoclonal antibody in combination with toripalimab (anti-PD1 mAb) in patients with advanced solid tumors. American Society of Clinical Oncology Annual Meeting, 2021 (virtual). Abst 2580.
Lanne P, Wang M, Mitchell P, Fang J, Nian W, Chiu C-H, Zhou J, Zhao Y, Su W-C,, Camidge R, Yang T-Y, Zhu V, Millward M, Fan Y, Huang W-T, Cheng Y, Jiang CL, Brungs D, Bazhenova L, Lee CK, Gao B, Qi S, Yu Q, Ye X, Zheng L, Yang Z, Yang JC-H. Phase I studies of DZ9008, an oral, selective EGFR/HER2 inhibitor in advanced NSCLC with EGFR exon20 insertion mutation. World Lung Cancer Conference September 2021, (virtual) Abst OA15.02.
Solomon B, Millward M, Kim D-W, Park E, Lin JJ. FORGE-1: A phase 1/2 study of TPX-0131, a novel oral ALK tyrosine kinase inhibitor, in patients with ALK-positive advanced/metastatic non-small cell lung cancer. European Society for Medical Oncology Annual Meeting, September 2021 (virtual) Abst 1356P.
Lee DH, Roohullah A, Cho BC, Lemech CR, De Souza PL. Millward M, Choi JY, Park K-E, Kim NY, Lee M, Kim YM, Park S, Shin YK, Han J-Y. Phase I dose-escalation study to evaluate safety and clinical activity of c-MET inhibitor ABN401 in patients with advanced solid tumor. European Society for Medical Oncology Annual Meeting, September 2021 (virtual) Abst 1363P.
O’Malley D, Neffa M, Monk BJ, Melkadze T, Kryzhanivska A, Bulat IV, Meniawy T, Bondarenko I, Ortuzar-Feliu WI, Ancukiewicz M, Lugowska I. Balstilimab (anti-PD1) in combination with zalifrelimab (anti-CTLA4): Final results from a Phase II study in patients with recurrent/metastatic cervical cancer. European Society for Medical Oncology Annual Meeting, September 2021 (virtual) Abst 724MO.
Goh JC, Coward J, Gao B, Pires de Silva I, Voskoboynik M, Day D, Body AL, Gan HK, Chen C, Xiang X, Fei C, Yang L, Millward M. Safety/tolerability and preliminary anti-tumor activity of sitravantinib plus tislelizumab in patients with advanced platinum-resistant ovarian cancer. Chinese Society for Clinical Oncology Annual Meeting, Xiamen, September 2021.
Cote GM, Sebastian L, Choy E, Grimson P, Merriam P, Ballinger M, Colon C, Thavaneswaran S, Nathenson M, Lin F, Grady J, Thornton K, Millward M, Brown M, Harrup R, Espinoza D, Jain E, Painter C, Demetri G, George S, Simes RJ, Littlefield B, Thomas DM. Interim results of an international phase 2 study of the microtubule inhibitor, eribulin, in progressive metastatic angiosarcoma and epitheliod hemangioendothelioma. Connective Tissue Oncology Society Annual Meeting, November 2021 (virtual).
Falchook G, Gan H, Fu S, McKean M, Azad A, Sommerhalder D, Wang J, Tan T, Chee C, Barve M, Lemeque C, Acuff N, Pham H, Mooney J, Wang R, Marina N, Abbadessa G, Meniawy T. Phase 1/2 study of THOR-707 (SAR444245), a pegylated recombinant non-alpha IL-2, as monotherapy and in combination with pembrolizumab or cetuximab in patients with advanced solid tumors. Society for Melanoma Research Annual Congress, 2021 Abst481.
Goh JC, Coward J, Gao B, Pires de Silva I, Voskoboynik M, Day D, Body AL, Gan HK, Chen C, Xiang X, Fei C, Yang L, Millward M. Safety/tolerability and preliminary anti-tumor activity of sitravantinib plus tislelizumab in patients with advanced platinum-resistant ovarian cancer. ESMO-IO Congress, Geneva, December 2021. Abst 153P.
2020
Desai J, Voskoboynik M, Markman B, Frentzas S, Foster P, Budha N, Song J, Meniawy T. Preliminary safety and efficacy data of BGB-A333, an anti-PD-L1 monoclonal antibody, alone and in combination with tislelizumab in patients with advanced solid tumors. American Association for Cancer Research Annual Meeting, Atlanta 2019 (abst CT253).
Smith KM, Haire SO, Khung-Quang DA, Markman B, Gan HK, Ekert PG, O’Byrne KJ, Millward M, Solomon BJ, Tran B, Scott CL, Kee D, McArthur GA, Fellowes A, Weerasuriya R, Lynch E, Martyn M, Gaff C, Fox SB, Desai J. Evaluating barriers to uptake of comprehensive genomic profiling in advanced cancer patients. American Society of Clinical Oncology Annual Meeting, 2020 (virtual). J Clin Oncol 38:2020 (suppl) abst 2033.
Powderly JD, Chmielowski B, Brahmer JR, Piha-Paul SA, Bowyer SE, LoRusso P, Catenacci DVT, Wu C, Barve MA, Chrisamore MJ, Nasrah N, Johnson D, Ho W. Phase I/II dose escalation and expansion study of FLX475 alone and in combination with pembrolizumab in advanced cancer. American Society of Clinical Oncology Annual Meeting, 2020 (virtual). J Clin Oncol 38:2020 (suppl) abst TPS3163.
Desai J, Meniawy T, Beagle B, Li Z, Mu S, Wu J, Denlinger CS, Messersmith W. BGB-A425, an investigational anti-TIM-3 monoclonal antibody, in combination with tislelizumab, an anti-PD-1 monoclonal antibody, in patients with advanced solid tumors: A Phase 1/2 trial in progress. American Society of Clinical Oncology Annual Meeting, 2020 (virtual). J Clin Oncol 38:2020 (suppl) abst TPS3146.
Angevin E, Groenland SL, Lim AML, MMoreno Martin-Liberal J, Moreno V, Trigo JM, Le Tourneau C, Mathew M, Cho DC, Hansen AR, Vicente D, Maio M, Italiano A, Bauman JR, Chisamore MJ, Zhou H, Ellis CE, Ballas MS, Hoos A, Rischin D. Updated analysis of the inducible T-cell co-stimulatory receptor (ICOS) agonist GSK3359609 combination with pembrolizumab in patients with anti-PD-1/L1 treatment-naïve head and neck squamous cell carcinoma. American Society of Clinical Oncology Annual Meeting, 2020 (virtual). J Clin Oncol 38:2020 (suppl) abst 6517.
Millward M, Frentzas S, Gan HK, Prawira A, Tran B, Coward J, Jin X, Li B, Wang M, Kwek KY, Xia Y, Desai J. Safety and efficacy of AK104, a bispecific antibody targeting PD-1 and CTLA-4 in patients with mesothelioma which is relapsed or refractory to standard therapies. European Society for Medical Oncology Annual Meeting, September 2020 (virtual).
Martin-Liberal J, Fong PC, Moreno V, Frentzas S, Desai J, Meniawy T, Markman B, Voskoboynik M, Budha N, Wu J, Shen W, Singh M, Calvo E. BGB-A333, and anti-PD-L1 monoclonal antibody, in combination with tislelizumab in patients with urothelial cancer. European Society for Medical Oncology Annual Meeting, September 2020 (virtual) Abst 535MO.
Xu J, Xu N, Bai Y, Lin C-C, Millward M, Shi J, Zhang Y, Ma X, Shen Z, Huang R, Huang W, Shen L. Tumor-Immune signatures associated with response or resistance to tislelizumab (anti-PD-1) in esophageal squamous cell carcinoma. Society for Immunotherapy of Cancer (SITC) Annual Meeting, November 2020 (virtual). J Immunother Cancer 2020;8(suppl3): A86.
Ye L, Ariyapperuma M, Jacques A, Meniawy T, Millward M. Hospitalisations in Phase I solid tumour clinical trial patients: our experience at a Western Australian dedicated Phase I clinical trials unit. Clinical Oncological Society of Australasia Annual Meeting, November 2020 (virtual).
Janku F, Abdul-Karim R, Azad A, Bendell J, Gan H, Sen S, Tan T, Wang J, Marina N, Baker L, Ma L, Mooney J, Luo D, Levelque J, Milla M, Meniawy T. Preliminary results from an open-label dose escalation and expansion study of THOR-707, a novel not-alpha IL-2, as a single agent in adult subjects with advanced or metastatic solid tumors. AACR-NCI-EORTC Molecular Targets and Cancer Therapeutics Meeting, 2020. Abst 20.
2019
Millward M, Gan H, Joshua AM, Kuo J, Prawira A, Richardson G, Barbee SD, Inamdaur S, Pierce L, Qureshi M, Horvath L. FPT155-001: A Phase 1a/1b study of FPT155 in patients with advanced solid tumors. ASCO-SITC Clinical Immuno-Oncology Symposium, San Francsico, 2019.
Desai J, Markman B, Friedlander M, Gan H, Horvarth L, Townsend A, Millward M, Jameson M, Yen C-J, Hou M-M, Wu J, Liang L, Deva S. Long-term exposure to tizlelizumab, an investigational anti-PD-1 antibody, in a first in human Phase I study. American Association for Cancer Research Annual Meeting, Atlanta 2019 (abst CT084).
Goh J, Gao B, Markman B, Gan H, Voskoboynik M, Wu Y-L, Guo J, Zhou Q, Zhao J, Chen C, Qiu J, Xu Y, Yang L, Millward M. A Phase Ib study to assess safety, tolerability, pharmacokinetics, and preliminary antitumor activity of sitravatinib in combination with tizlelizumab in patients with advanced solid tumors. American Association for Cancer Research Annual Meeting, Atlanta 2019 (abst CT167).
Pant S, Bendell JC, Sullivan RJ, Shapiro G, Millward M, Gu M, Yuen E, Willard MD, Wang D, Joseph S, McMillan WT, Bhagwat SV, Tiu RV, Patel MR. A Phase I dose escalation study of ERK inhibitor, LY3214996, in advanced cancer patients. American Society of Clinical Oncology Annual Meeting, Chicago, 2019. J Clin Oncol 37, 2019 (suppl; abst 3001).
Bier C, Millward M, Kotasek D, Gorelick KJ, Goldberg JB. First-in-human trial evaluating immune activation and safety of PIN-2 administered intravenously to patients with advanced solid tumors. American Society of Clinical Oncology Annual Meeting, Chicago, 2019. J Clin Oncol 37, 2019 (suppl; abst 2600).
Goh J, Gao B, Markman B, Gan H, Voskoboynik M, Wu Y-L, Guo J, Zhou Q, Zhao J, Chen C, Qiu J, Xu Y, Yang L, Millward M. A Phase Ib study to assess safety, tolerability, pharmacokinetics, and preliminary antitumor activity of sitravatinib in combination with tizlelizumab in patients with advanced solid tumors. Chinese Society of Clinical Oncology Annual Meeting, Xiamen 2019.
Voskoboynik M, Mileshkin L, Gan H, Millward M, Au-Yeung G, Meniawy TM, Kichenadasse G, Zhang K, Zhang M, Mu S, Lickliter JD. Safety and antitumor activity of pamiparib (BGB-290), a PARP1/2 inhibitor, in patients with advanced solid tumors: updated Phase Ia/Ib dose-escalation/expansion results. European Society for Medical Oncology Annual Meeting, Barcelona 2019. Ann Oncol 30(suppl 5) doi: 10.1093/annonc/mdz244 v167.
Calvo E, Spira A, Prenen H, Ohe Y, Rottey S, Gazzah A, Millward M, Moreno V, Italiano A, Alanko T, Yoh K, Cassier P, Seto T, Afar D, Englert S, Komarnitsky P, Lambert S, Parikh A, Vosganian G, Gao B. Phase I open-label study evaluating the safety, pharmacokinetics, and preliminary efficacy of ABBV-181 and rovalpituzumab teserine in patients with small cell lung cancer. European Society for Medical Oncology Annual Meeting, Barcelona 2019. Ann Oncol 30(suppl 5) doi: 10.1093/annonc/mdz264 v715.
Rischin D, Groenland DL, Lim AML, Martin-Liberal J, Moreno V, Trigo-Perez JM, Le Tourneau C, Mathew M, Cho DC, Hansen AR, Vincente-Baz D, Maio M, Italiano A, Bauman JR, Chisamore M, Zhou H, Ellis C, Ballas M, Hoos A, Angevin E. Inducible T cell costimulatory (ICOS) receptor agonist, GSK3359609 alone and in combination with pembrolizumab: Preliminary results from INDUCE-1 expansion cohorts in head and neck squamous cell carcinoma. European Society for Medical Oncology Annual Meeting, Barcelona 2019. Abst 1119PD.
Markman B, Tran B, Coward J, Gan H, Prawira A, Jin X, Li B, Wang M, Xia Y, Desai J, Millward M. A Phase I study of AK-104, a tetravalent bispecific antibody that targets PD-1 and CTLA-4 co-expressing T cells, in patients with advanced cancer. Society for Immunotherapy of Cancer (SITC) Annual Meeting, National Harbor MD 2019.
Horvath L, Coward J, Gan H, Kuo J, Millward M, Richardson G, Deng W, Mitra S, Schmidt M, Xiang H, Prawira A. A Phase I study of FPT155, a first in class CD80 extracellular domain-FC fusion protein, in patients with advanced solid tumors. Society for Immunotherapy of Cancer (SITC) Annual Meeting, National Harbor MD 2019, Abst P442.
Luo D, Abdul-Karim R, Azad A, Bendell J, Gan H, Janku F, Sen S, Tan T, Wang JS, Schechet L, Baker L, Leveque JA, Meniawy T. Open-label, multicenter Phase 1/2 dose escalation and expansion study of THOR-707 as a single agent and in combination with a PD-1 inhibitor in adult subjects with advanced or metastatic solid tumors. Society for Immunotherapy of Cancer (SITC) Annual Meeting, National Harbor MD 2019, Abst P430.
Clarke J, Chu S-C, Siu L, Jean-Pascal M, Markman B, Kimberley H, Millward M, Lolkema M, Patel SP, de Souza P, Curigliano G, Santoro A, Brown M, Fleming R, Vezina H, He C, Rottey S. BMS-986148, an anti-mesothelin antibody-drug conjugate (ADC), alone or in combination with nivolumab demonstrates clinical activity in patients with select advanced solid tumors. AACR-NCI-EORTC Molecular Targets and Cancer Therapeutics Meeting, Boston 2019.
Gao B, Goh J, Markman B, Voskoboynik M, Gan H, Coward J, Palmieri D, So J, Meniawy T, Chen C, Xiang X, Qui J, Xu Y, Yang L, Millward M. Safety and anti-tumor activity of sitravatinib in combination with tislelizumab in patients with ovarian cancer. ESMO Immuno-Oncology Congress, Geneva, 2019.
2018
Friedlander M, Meniawy T, Markman B, Mileshkin L, Harnett P, Millward M, Lundy J, Freimund A, Norris C, Mu S, Paton V, Wang L, Gao B. A Phase 1A/1B open label, multiple dose, dose escalation and expansion study to investigate the safety, pharmacokinetics and anti-tumor activity of the anti-PD-1 monoclonal antibody BGB-A317 in combination with the PARP inhibitor BGB-290 in patients with advanced solid tumors. ASCO-SITC Clinical Immuno-Oncology Symposium, San Francsico, 2018.
Meniawy T, Markman B, Mileshkin L, Harnett P, Millward M, Lundy J, Freimund A, Norris C, Wu J, Paton V, Wang L, Gao B. A Phase Ib study of the anti-PD-1 monoclonal antibody tizlelizumab in combination with the PARP inhibitor pamiparib in advanced solid tumours. Medical Oncology Group Australia Annual Meeting, Adelaide, 2018.
Hansen A, Bauer TM, Moreno V, Maio M, Groenland S, Martin-Liberal J, Gan H, Rischin D, Millward M, Olszanski AJ, Cho DC, Paul E, Ballas M, Ellis C, Zhou H, Yadavilli S, Shaik JS, Schmidt EV, Hoos A, Angevin E. First in human study with GSK3359609 [GSK609], Inducible T cell Co-stimulator (ICOS) receptor agaonist in patients with advanced solid tumors: Preliminary results from INDUCE-1. European Society for Medical Oncology Annual Meeting, Munich 2018. Ann Oncol (2018) 29(Suppl_8):viii400-viii441. 10.1093/annonc/mdy288.
Coward J, Lemech C, Meniawy T, Dupont CD, Gonzalez AM, Lim M, Savitsky D, Carini M, Hu S, Shebanova O, Dow E, Ortuzar W, Buell JS, Stein RB, Youssoufian H. Phase 1/2 study of CTLA4 inhibitor AGEN1884 + PD-1 inhibitor AGEN2034 in patients with advanced/refractory solid tumors, with expansion into 2L cervical cancer. European Society for Medical Oncology Annual Meeting, Munich 2018. Ann Oncol (2018) 29(Suppl_8):viii400-viii441. 10.1093/annonc/mdy288.
Desai J, Voskoboynik M, Markman B, Hou J, Zeng D, Meniawy T. Phase 1/2 study investigating the safety, tolerability, pharmacokinetics, and preliminary anti-tumor activity of anti-PD-L1 monoclonal antibody BGB-A333 alone and in combination with anti-PD-1 monoclonal antibody tislelizumab in patients with advanced solid tumors. European Society for Medical Oncology Annual Meeting, Munich 2018, Abst 444TiP.
Deva S, Lee J-S, Lin C-C, Yen C-J, Millward M, Chao Y, Keam B, Jameson M, Hou M-M, Kang Y-K, Markman B, Lu C-H, Rau K-M, Lee K-H, Horvath L, Friedlander M, Hill A, Wu J, Hou J, Desai J. A Phase 1A/1B trial of tislelizumab, an anti-PD-1 antibody in patients with advanced solid tumors. European Society for Medical Oncology Immuno-Oncology Meeting, Geneva 2018.
Ariyapperuma M, Herbst Z, Lim A, Meniawy T, Millward M. Outcomes of patients going through trials at a Phase I clinical trials unit. Clinical Oncological Society of Australasia Annual Meeting, Perth 2018.
2017
Desai J, Gan H, Barrow C, Jameson MB, Solomon B, Atkinson V, Haydon A, Millward M, Begbie S, Brown M, Markman B, Patterson W, Hill A, Horvath L, Nagrial A, Richardson G, Jackson C, Friedlander M, Gibbs D, Parente P, Yang J, Wang L, Chen Y, Luo L. A Phase IB study of RAF dimer inhibitor BGB-283 in patients with BRAF or K-RAS/N-RAS mutated solid tumors. American Association for Cancer Research Annual Meeting, Washington DC, 2017 (Abst CT-005).
Angevin E, Bauer TM, Ellis CE, Gan H, Hall R, Hansen A, Hoos A, Jewell RC, Katz J, Martin-Liberal J, Maio M, Mayes PA, Mazumdar J, Millward M, Rischin D, Schellens JHM, Yadavilli S, Zhou. INDUCE-1: a Phase I open-label study of GSK2259609, an ICOS agonist antibody, administered alone and with pembrolizumab in patients with selected, advanced solid tumor. American Association for Cancer Research Annual Meeting, Washington DC, 2017 (Abst CT-039).
Friedlander M, Meniawy T, Markman B, Mileshkin L, Harnet P, Millward M, Lundy J, Freimund A, Norris C, Mu S, Wu J, Paton V, Wang L, Gao B. A Phase Ib study of the anti-PD-1 monoclonal antibody BGB-A317 in combination with the PARP inhibitor BGB-290 in advanced solid tumors. American Society of Clinical Oncology Annual Meeting, Chicago, 2017. J Clin Oncol 35, 2017 (suppl; abst 3013).
Angevin E, Barnette M, Bauer T, Cho D, Ellis C, Gan H, Hansen A, Hoos A, Jewell R, Katz J, Martin-Liberal J, Maio M, Mayes P, Millward M, Moreno V, Olzanski A, Rischin D, Schellens J, Yadavilli S, Zhou H. INDUCE-1: A Phase 1 open-label study of GSK3359609, an ICOS agonist antibody, administered alone and in combination with pembrolizumab in patients with advanced solid tumors. American Society of Clinical Oncology Annual Meeting, Chicago, 2017. J Clin Oncol 35, 2017 (suppl; abst TPS3113).
Hong D, Hollebecque A, Gordon M, Flaherty K, Shapiro G, Rodon J, Millward M, Ramdas N, Zhang W, Gao L, Sykes A, Willard M, Yu D, Schade A, Flynn D, Kaufman M, Peng S-B, Conti I, Tiu R, Sullivan R. A first-in-human dose Phase I study of LY3009120 in advanced cancer patients. American Society of Clinical Oncology Annual Meeting, Chicago, 2017. J Clin Oncol 35, 2017 (suppl; abst 2507).
Dredge K, Brennan T, Brown M, Lickliter J, Bampton D, Hammond E, Lin L, Yang Y, Millward M. An open-label, multi-centre Phase I study of the safety and tolerability of the novel immunomodulatory agent PG545 in subjects with advanced solid tumors. American Society of Clinical Oncology Annual Meeting, Chicago, 2017. J Clin Oncol 35, 2017 (suppl; abst 3083).
Siu LL, Steeghs N, Meniawy T, Joerger M, Spratley JL, Rottey S, Nagrial A, Cooper A, Meier R, Guan X, Phillips P, Bajaj G, Gokemeijer J, Korman JL, Ang KL, Carlino M. Preliminary results of a Phase I/IIa study of BMS-986156, a glucocorticoid-indiced TNF receptor-related gene agonist alone or in combination with nivolumab in patients with advanced solid tumours. American Society of Clinical Oncology Annual Meeting, Chicago, 2017. J Clin Oncol 35, 2017 (suppl; abst 104).
Lickliter J, Mileshkin L, Voskoboynik M, Millward M, Freimund A, Meniawy T, Tang T, Wei R, Li M, Paton V. Dose escalation/expansion study to investigate the safety, pharmacokinetics, food-effect, and anti-tumor activity of BGB-290 in patients with advanced solid tumors. European Society for Medical Oncology Annual Meeting, Madrid 2017 Ann Oncol 28(Suppl 5) 123.
Desai J, Millward M, Chao Y, Gan H, Voskoboynik M, Markman B, Townsend A, Atkinson V, Zhu A, Song J, Qi Q, Kang A, Deva S. Preliminary results from subsets of patients with advanced gastric cancer and esophageal carcinoma in a dose escalation/expansion study of BGB-A317, and anti-PD-1 monoclonal antibody. European Society for Medical Oncology Annual Meeting, Madrid 2017 Ann Oncol 28(Suppl 5) 129.
Lickliter J, Gan H, Gao B, Grimson P, Zou J, Kallender H, Sun K, Chen X, Behren A, Fernandez-Penas P, Nagrial A, Voskoboynik M, Woods K, Millward M, Meniawy T. A first-in-human study of a novel monoclonal antibody INCSHR01210 directed against programmed cell death protein 1 (PD-1) in patients with advanced or metastatic cancer. European Society for Medical Oncology Annual Meeting, Madrid 2017 Ann Oncol 28(Suppl 5) 419.
2016
Desai J, Markman B, Sandhu SK, Gan HK, Friedlander M, Tran B, Meniawy T, Boolell V, Colyer D, Norris C, Ameratunga M, Yang J, Li K, Wang L, Luo L, Qin Z, Millward M. A Phase I dose-escalation study of BGB-A317, an anti-programmed death-1 (PD-1) mAb in patients with advanced solid tumors. American Society of Clinical Oncology Annual Meeting, Chicago, 2016. (abst 3066).
Desai J, Markman B, Sandhu S, Gan HK, Friedlander M, Tran B, Meniawy T, Lundy J, Colyer D, Ameratunga M, Norris C, Yang J, Li K, Wang L, Luo L, Qin Z, Mu S, Tan X, Song J, Millward M. Updated safety, efficacy, and pharmacokinetics results from the Phase I study of BGB-A317, an anti-programmed death-1 (PD-1) mAb in patients with advanced solid tumors. Society for Immunotherapy in Cancer Annual Meeting, National Harbor, Maryland, 2016.
2015
Hua Y, Shen L, Gan HK, Lickliter J, Millward M, Xu J, Wang J, Sai Y, Su W, Frigault MM, Qi C,. First-in-human Phase I studies of a selective cMET inhibitor AZD6094 (HMPL504/volitinib) in patients with advanced solid tumors. American Association for Cancer Research Annual Meeting, Philadelphia, 2015 (abst CT305).
Gan HK, Lickliter J, Millward M, Gu Y, Su W, Qi C, Mu H, Frigault M, Morgan S, Gardner HAR, Albiges L, Pal SK, Burris HA, Chouriri TK. cMEt: Results in papillary renal cell carcinoma of a Phase I study of AZD6094 leading to a Phase II clinical trial with savolitinib in patients with advanced papillary renal cancer (PRC). ASCO GU Symposium, Orlando, 2015.
Likliter J, Gan H, Meniawy T, Yang J, Wang L, Luo L, Millward M. Phase I study of a novel PARP1/2 selective inhibitor BGB-290. AACR-NCI-EORTC Molecular Tagets and Cancer Therapeutics Meeting, Boston 2015 (Abst PR11).
2014
Dredge K, Hammond E, Winterhoff B, Teoman A, Giri S, Bampton D, Millward M, Shridhar V. The utility of plasma heparanase and vascular endothelial growth factor as pharmacodynamics markers following treatment with PG545, a heparan sulphate mimetic – preliminary evidence from preclinical and clinical settings. American Association for Cancer Research Annual Meeting, San Diego, 2014 (abst 3695).
Gan HK, Lickliter J, Millward M, Gu Y, Su W, Frigault M, Qi C, Mu H. Fist-in-human phase I study of a selective c-Met inhibitor volitinib (HMP504/AZD6094) in patients with advanced solid tumors. American Society of Clinical Oncology Annual Meeting, Chicago, 2014. (abst 11111).
McKeague M, Min W, Chung Z, Kotasek D, Markman B, Hidalgo M, Millward M, Jameson M, Harris D, Hughes B, Stagg R, Dupont J, Kapoun AM. Biomarker analysis in the Phase Ib study of the anticancer stem cell agent demcizumab in combination with pemetrexed and carboplatin demonstrates pharmacodynamics modulation of the Notch pathway in first-line treatment of patients with non-squamous NSCLC. 26th NCI/EORTC/AACR Symposium: Molecular Targets and Cancer Therapeutics, Barcelona 2014.
2012
Soria J-C, Gan HK, Arkenau H-T, Blagden SP, Plummer R, Ransom M, Evans TRJ, Zalcman G, Bahleda R, Hollebecque A, Lemech C, Brown J, Gopal V, Peddareddigari R, Gibson D, Murray SC, Nebot N, Mazumdar J, Fleming RA, Millward M. Phase I clinical and pharmacologic study of the focal adhesion kinase (FAK) inhibitor GSK2256098 in patients with advanced solid tumors. American Society of Clinical Oncology Annual Meeting, Chicago, 2012. J Clin Oncol 30, 2012 (suppl; abst 3000).
Gan H, Nebot N, Soria JC, Arkenau HT, Blagden S, Plummer R, Ransom M, Evans TRJ, Zalcman G, Peddareddigari V, Gibson D, Murray S, Mazumdar J, Fleming R, Auger K, Millward M. Pharmacokinetics/pharmacodynamics of GSK2256098, a focal adhesion kinase (FAK) inhibitor, in patients with advanced solid tumors. 24th NCI/EORTC/AACR Symposium: Molecular Targets and Cancer Therapeutics, Dublin 2012 Eur J Cancer 47(suppl 1), 2012.
Soria JC, Plummer R, Ransom M, Gan H, Arkenau HT, Zalcman G, Blagden S, Evans TRJ, Peddareddigari V, Mazumdar J, Murray S, Gibson D, Fleming RA, Auger K, Millward M. Loss of the tumor suppressor Merlin as a potential predictive biomarker of clinical activity for the oral focal adhesion kinase (FAK) inhibitor GSK2256098 in patients with recurrent mesothelioma. 24th NCI/EORTC/AACR Symposium: Molecular Targets and Cancer Therapeutics, Dublin 2012 Eur J Cancer 47(suppl 1), 2012.
Haematology Published Papers
2024
Roeker LE, Woyach JA, Cheah CY, Coombs CC, Shah NN, Wierda WG, Patel MR, Lamanna N, Tsai DE, Nair BC, Wang C, Zhao X, Liu D, Radtke D, Chapman S, Marella N, McNeely SC, Brown JR. Fixed-Duration Pirtobrutinib plus Venetoclax with or without Rituximab in Relapsed/Refractory CLL: Phase 1b BRUIN Trial. Blood. 2024 Jun 11:blood.2024024510. doi: 10.1182/blood.2024024510. Epub ahead of print. PMID: 38861666.
Roeker LE, Coombs CC, Shah NN, Jurczak W, Woyach JA, Cheah CY, Patel K, Maddocks K, Wang Y, Zinzani PL, Munir T, Koh Y, Thompson MC, Muehlenbein CE, Wang C, Sizelove R, Abhyankar S, Hasanabba S, Tsai DE, Eyre TA, Wang M. Safety of extended pirtobrutinib exposure in relapsed and/or refractory B-cell malignancies. Acta Haematol. 2024 Jun 1. doi: 10.1159/000539587. Epub ahead ofprint. PMID: 38824917.
Budde LE, Assouline S, Sehn LH, Schuster SJ, Yoon SS, Yoon DH, Matasar MJ, Bosch F, Kim WS, Nastoupil LJ, Flinn IW, Shadman M, Diefenbach C, Cheah CY, Ma CY, Huang H, Kwan A, Wei MC, Yin S, Bartlett NL. Durable Responses With Mosunetuzumab in Relapsed/Refractory Indolent and Aggressive B-Cell Non-Hodgkin Lymphomas: Extended Follow-Up of a Phase I/II Study. J Clin Oncol. 2024 Mar 28:JCO2302329. doi: 10.1200/JCO.23.02329. Epub ahead of print. PMID: 38547425.
2023
Mato AR, Woyach JA, Brown JR, Ghia P, Patel K, Eyre TA, Munir T, Lech Maranda E, Lamanna N, Tam CS, Shah NN, Coombs CC, Ujjani CS, Fakhri B, Cheah CY, Patel MR, Alencar AJ, Cohen JB, Gerson JN, Flinn IW, Ma S, Jagadeesh D, Rhodes JM, Hernandez-Ilizaliturri F, Zinzani PL, Seymour JF, Balbas M, Nair B, Abada P, Wang C, Ruppert AS, Wang D, Tsai DE, Wierda WG, Jurczak W. Pirtobrutinib after a Covalent BTK Inhibitor in Chronic Lymphocytic Leukemia. N Engl J Med. 2023 Jul 6;389(1):33-44. doi: 10.1056/NEJMoa2300696. PMID: 37407001.
Wang ML, Jurczak W, Zinzani PL, Eyre TA, Cheah CY, Ujjani CS, Koh Y, Izutsu K, Gerson JN, Flinn I, Tessoulin B, Alencar AJ, Ma S, Lewis D, Lech-Maranda E, Rhodes J, Patel K, Maddocks K, Lamanna N, Wang Y, Tam CS, Munir T, Nagai H, Hernandez-Ilizaliturri F, Kumar A, Fenske TS, Seymour JF, Zelenetz AD, Nair B, Tsai DE, Balbas M, Walgren RA, Abada P, Wang C, Zhao J, Mato AR, Shah NN. Pirtobrutinib in Covalent Bruton Tyrosine Kinase Inhibitor Pretreated Mantle-Cell Lymphoma. J Clin Oncol. 2023 Aug 20;41(24):3988-3997. doi:10.1200/JCO.23.00562. Epub 2023 May 16. PMID: 37192437; PMCID: PMC10461952.
Bartlett NL, Assouline S, Giri P, Schuster SJ, Cheah CY, Matasar M, Gregory GP, Yoon DH, Shadman M, Fay K, Yoon SS, Panizo C, Flinn I, Johnston A, Bosch F, Sehn LH, Wei MC, Yin S, To I, Li CC, Huang H, Kwan A, Penuel E, Budde LE. Mosunetuzumab monotherapy is active and tolerable in patients with relapsed/refractory diffuse large B-cell lymphoma. Blood Adv. 2023 Sep 12;7(17):4926-4935. doi: 10.1182/bloodadvances.2022009260. PMID: 37067952; PMCID: PMC10463194.
2021
Mato AR, Shah NN, Jurczak W, Cheah CY, Pagel JM, Woyach JA, Fakhri B, Eyre TA, Lamanna N, Patel MR, Alencar A, Lech-Maranda E, Wierda WG, Coombs CC, Gerson JN, Ghia P, Le Gouill S, Lewis DJ, Sundaram S, Cohen JB, Flinn IW, Tam CS, Barve MA, Kuss B, Taylor J, Abdel-Wahab O, Schuster SJ, Palomba ML, Lewis KL, Roeker LE, Davids MS, Tan XN, Fenske TS, Wallin J, Tsai DE, Ku NC, Zhu E, Chen J, Yin M, Nair B, Ebata K, Marella N, Brown JR, Wang M. Pirtobrutinib in relapsed or refractory B-cell malignancies (BRUIN): A phase 1/2 study. Lancet. 2021 Mar;397(10277):892-901)
Haematology Presentations at National and International meetings
2024
SAFETY AND EFFICACY RESULTS OF A PHASE 1 STUDY OF THE NOVEL BCL2 INHIBITOR SONROTOCLAX (BGB-11417) FOR RELAPSED/REFRACTORY WALDENSTRÖM’S MACROGLOBULINEMIA. Cheah C et al, European Haematology Association June 2024.
PRELIMINARY EFFICACY AND SAFETY OF THE BRUTON TYROSINE KINASE (BTK) DEGRADER BGB-16673 IN PATIENTS WITH RELAPSED OR REFRACTORY (R/R) INDOLENT NHL: RESULTS FROM THE PHASE 1 BGB-16673-101 STUDY. Cheah C et al, European Haematology Association June 2024.
MOSUNETUZUMAB DEMONSTRATES CLINICALLY MEANINGFUL OUTCOMES IN HIGH-RISK PATIENTS WITH HEAVILY PRE-TREATED R/R FL AFTER ≥3 YEARS OF FOLLOW-UP: SUBGROUP ANALYSIS OF A PIVOTAL PHASE II STUDY. Cheah C et al, European Haematology Association June 2024.
EXTENDED FOLLOW-UP BEYOND 2.5 YEARS SHOWS LONG-TERM EFFICACY IN COMPLETE RESPONDERS FOLLOWING EPCORITAMAB MONOTHERAPY IN RELAPSED OR REFRACTORY LARGE B-CELL LYMPHOMA. Cheah C et al, European Haematology Association June 2024.
PIRTOBRUTINIB IN COVALENT BTK-INHIBITOR PRE-TREATED MANTLE CELL LYMPHOMA: UPDATED RESULTS AND SUBGROUP ANALYSIS FROM THE PHASE 1/2 BRUIN STUDY WITH >3 YEARS FOLLOW-UP FROM START OF ENROLLMENT. Cheah C et al, European Haematology Association June 2024.
2023
Pirtobrutinib in Post-cBTKi CLL/SLL: ~30 Months Follow-up and Subgroup Analysis With/Without Prior BCL2i from the Phase 1/2 BRUIN Study. Cheah C et al, American Society of Hematolgy December 2023 – 325
Genomic Evolution and Resistance during Pirtobrutinib Therapy in Covalent BTK-Inhibitor (cBTKi) Pre-Treated Chronic Lymphocytic Leukemia Patients: Updated Analysis from the BRUIN Study. Cheah C et al, American Society of Hematolgy December 2023 – 326
Combination Treatment with Sonrotoclax (BGB-11417), a Second-Generation BCL2 Inhibitor, and Zanubrutinib, a Bruton Tyrosine Kinase (BTK) Inhibitor, Is Well Tolerated and Achieves Deep Responses in Patients with Treatment-Naïve Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (TN-CLL/SLL): Data from an Ongoing Phase 1/2 Study. Cheah C et al, American Society of Hematolgy December 2023 – 327
Mosunetuzumab Monotherapy Continues to Demonstrate Durable Responses in Patients with Relapsed and/or Refractory Follicular Lymphoma after ≥2 Prior Therapies: 3-Year Follow-up from a Pivotal Phase II Study. Cheah C et al, American Society of Hematolgy December 2023 – 603
Mosunetuzumab Monotherapy Demonstrates Activity and a Manageable Safety Profile in Patients with Relapsed or Refractory Richter’s Transformation. Cheah C et al, American Society of Hematolgy December 2023 – 614
Pirtobrutinib in Relapsed/Refractory (R/R) Mantle Cell Lymphoma (MCL) Patients with Prior cBTKi: Safety and Efficacy Including High-Risk Subgroup Analyses from the Phase 1/2 BRUIN Study. Cheah C et al, American Society of Hematolgy December 2023 – 981
Pirtobrutinib, a Highly Selective, Non-Covalent (Reversible) BTK Inhibitor in Relapsed / Refractory Marginal Zone Lymphoma: Results from Phase 1/2 BRUIN Study. Cheah C et al, American Society of Hematolgy December 2023 – 1660
Pirtobrutinib in Richter Transformation: Updated Efficacy and Safety Results with 18-Month Median Survival Follow-up from the Phase 1/2 BRUIN Study. Cheah C et al, American Society of Hematolgy December 2023 – 1737
Pirtobrutinib, a Highly Selective, Non-Covalent (Reversible) BTK Inhibitor in Relapsed/Refractory Follicular Lymphoma: Results from the Phase 1/2 BRUIN Study. Cheah C et al, American Society of Hematolgy December 2023 – 3026
Monotherapy with Second-Generation BCL2 Inhibitor Sonrotoclax (BGB-11417) Is Well Tolerated with High Response Rates in Patients with Relapsed/Refractory Marginal Zone Lymphoma: Data from an Ongoing Phase 1 Study. Cheah C et al, American Society of Hematolgy December 2023 – 3032
Fixed-Duration Pirtobrutinib Combined with Venetoclax ± Rituximab in Relapsed/Refractory Chronic Lymphocytic Leukemia: Updated Results, Including MRD Data, from the BRUIN Phase 1b Study. Cheah C et al, American Society of Hematolgy December 2023 – 3269
First Results from a Phase 1, First-in-Human Study of the Bruton’s Tyrosine Kinase (BTK) Degrader Bgb-16673 in Patients (Pts) with Relapsed or Refractory (R/R) B-Cell Malignancies (BGB-16673-101). Cheah C et al, American Society of Hematolgy December 2023 – 4401
Epcoritamab SC + R-Mini-CHOP Leads to High Complete Metabolic Response Rates in Patients with Previously Untreated Diffuse Large B-Cell Lymphoma Ineligible for Full-Dose R-CHOP: First Disclosure from Arm 8 of the Epcore NHL 2 Trial. Cheah C et al, American Society of Hematolgy December 2023 – 4457
First Report of Phase 1 Studies of DZD8586, a BBB Penetrant LYN/BTK Dual Inhibitor, in Patients with B-Cell Non-Hodgkin Lymphoma (B-NHL). Cheah C et al, American Society of Hematolgy December 2023 – 4465
A Phase 1 Cohort Dose Escalation and Expansion Trial to Determine the Safety, Tolerance, Maximum Tolerated Dose, and Preliminary Antineoplastic Activity of IKS03 in Patients with Advanced B-Cell Non-Hodgkin Lymphomas (NHL). Lewis K et al, American Society of Hematolgy December 2023 – 3095
2020
LOXO-305, A Next Generation, Highly Selective, Non-Covalent BTK Inhibitor in Previously Treated Mantle Cell Lymphoma, Waldenström’s Macroglobulinemia, and Other Non-Hodgkin Lymphomas: Results from the Phase 1/2 BRUIN Study. Cheah C, Lewis C, et al, American Society of Hematolgy December 2020 – 117
LOXO-305, A Next Generation, Highly Selective, Non-Covalent BTK Inhibitor in Previously Treated CLL/SLL: Results from the Phase 1/2 BRUIN Study. Cheah C, et al, American Society of Hematolgy December 2020 – 542
Mosunetuzumab Shows Promising Efficacy in Patients with Multiply Relapsed Follicular Lymphoma: Updated Clinical Experience from a Phase I Dose-Escalation Trial. Cheah C, et al, American Society of Hematolgy December 2020 – 702
Clinical Activity of TG-1701, As Monotherapy and in Combination with Ublituximab and Umbralisib (U2), in Patients with B-Cell Malignancies. Cheah C, et al, American Society of Hematolgy December 2020 – 1130
Subcutaneous Mosunetuzumab in Relapsed or Refractory B-Cell Lymphoma: Promising Safety and Encouraging Efficacy in Dose Escalation Cohorts. Cheah C, et al, American Society of Hematolgy December 2020 – 2096
Updated results of the selective Bruton tyrosine kinase (BTK) inhibitor TG-1701, as monotherapy and in combination with ublituximab and umbralisib (U2) in patients (pts) with B-cell malignancies. Cheah C, et al, American Society of Hematolgy December 2020
TG-1701, A SELECTIVE BRUTON TYROSINE KINASE (BTK) INHIBITOR, AS MONOTHERAPY AND IN COMBINATION WITH UBLITUXIMAB AND UMBRALISIB (U2) IN CHRONIC LYMPHOCYTIC LEUKEMIA (CLL) AND LYMPHOMA. Cheah C, et al, American Society of Hematolgy December 2020
PRELIMINARY SAFETY DATA FROM PATIENTS (PTS) WITH RELAPSED/REFRACTORY (R/R) B-CELL MALIGNANCIES TREATED WITH THE NOVEL B-CELL LYMPHOMA 2 (BCL2) INHIBITOR BGB-11417. Cheah C, et al, American Society of Hematolgy December 2020
2019
An Individualized Risk Mitigation Approach for Safety: Experience from the Mosunetuzumab (CD20/CD3 Bispecific Antibody) Development Program in Relation to Neurotoxicity Risk. Cheah C et al, American Society of Hematology Annual Scientific Meeting, San Diego 2019.
Results from a First-in-Human, Proof-of-Concept Phase 1 Trial in Pretreated B-Cell Malignancies for Loxo-305, a Next-Generation, Highly Selective, Non-Covalent BTK Inhibitor. Cheah C et al, American Society of Hematology Annual Scientific Meeting, San Diego 2019.
Phase 1 Study of TG-1701, a Selective Irreversible Inhibitor of Bruton’s Tyrosine Kinase (BTK), in Patients with Relapsed/Refractory B-Cell Malignancie. Cheah C et al, American Society of Hematology Annual Scientific Meeting, San Diego 2019.s
Mosunetuzumab Induces Complete Remissions in Poor Prognosis Non-Hodgkin Lymphoma Patients, Including Those Who Are Resistant to or Relapsing After Chimeric Antigen Receptor T-Cell (CAR-T) Therapies, and Is Active in Treatment through Multiple Lines. Cheah C et al, American Society of Hematology Annual Scientific Meeting, San Diego 2019.
117 – LOXO-305, A Next Generation, Highly Selective, Non-Covalent BTK Inhibitor in Previously Treated Mantle Cell Lymphoma, Waldenström’s Macroglobulinemia, and Other Non-Hodgkin Lymphomas: Results from the Phase 1/2 BRUIN Study