- Hanneke Van Laarhoven (Amsterdam, NL)
- Raghav Sundar (Singapore, SG)
134MO - Updated efficacy and safety results from phase III GLOW study evaluating zolbetuximab + CAPOX as first-line (1L) treatment for patients with claudin-18 isoform 2-positive (CLDN18.2+), HER2−, locally advanced (LA) unresectable or metastatic gastric or gastroesophageal junction (mG/GEJ) adenocarcinoma
- Soo Hoo Hwoei Fen (Kuala Lumpur, MY)
- Florian Lordick (Leipzig, DE)
- Manish A. Shah (New York, US)
- Kohei Shitara (Kashiwa, JP)
- Jaffer A. Ajani (Houston, US)
- Yung-Jue Bang (Seoul, KR)
- Peter C. Enzinger (Boston, US)
- David H. Ilson (New York, US)
- Eric Van Cutsem (Leuven, BE)
- Javier Gallego Plazas (Elche, ES)
- Jing Huang (Beijing, CN)
- Lin Shen (Beijing, CN)
- Sang Cheul Oh (Seoul, KR)
- Patrapim Sunpaweravong (Amphoe Hat Yai, TH)
- Soo Hoo Hwoei Fen (Kuala Lumpur, MY)
- Haci M. Türk (Istanbul, TR)
- Jung Wook Park (Northbrook, US)
- Diarmuid Moran (Northbrook, US)
- Pranob Bhattacharya (Northbrook, US)
- Ying J. Cao (Northbrook, US)
- Rui-Hua Xu (Guangzhou, CN)
Abstract
Background
The phase 3 GLOW study showed statistically significant improvement with 1L zolbetuximab + capecitabine + oxaliplatin (CAPOX) vs placebo (PBO) + CAPOX in PFS (final; median 8.2 vs 6.8 mo, HR 0.69 [95% CI 0.54, 0.87],
Methods
Pts were randomly assigned 1:1 to zolbetuximab IV 800 mg/m2 (cycle 1, day [D] 1) followed by 600 mg/m2 (every 3 weeks) + CAPOX (oral capecitabine BID on D1–14 and oxaliplatin IV on D1) for eight 21-day cycles or to PBO + CAPOX; pts without progressive disease (PD) continued beyond cycle 8 with zolbetuximab or PBO, + capecitabine at investigator’s discretion, until PD or discontinuation criteria were met. Primary endpoint was PFS per RECIST v1.1 by IRC; OS was a key secondary endpoint.
Results
At data cutoff (June 29, 2023), 507 pts were assigned to zolbetuximab + CAPOX (n = 254) or PBO + CAPOX (n = 253). In zolbetuximab vs PBO arms, median follow-up was 17.8 vs 15.1 mo for PFS and 26.1 vs 26.2 mo for OS, respectively. Median PFS in zolbetuximab vs PBO arms was 8.3 vs 6.8 mo (HR 0.68 [95% CI 0.55, 0.85],
Conclusions
Zolbetuximab + CAPOX continued to demonstrate statistically significant improvement in PFS and OS compared with PBO + CAPOX, with no new safety signals, supporting zolbetuximab + CAPOX as a potential new option for 1L treatment of patients with CLDN18.2+, HER2−, LA unresectable or mG/GEJ adenocarcinoma.
Clinical trial identification
NCT03653507.
Editorial acknowledgement
Medical writing support, conducted in accordance with Good Publication Practice (GPP 2022) and the International Committee of Medical Journal Editors (ICMJE) guidelines, was provided by Ann Ferguson, PhD, and Jing Xu, PhD, of Oxford PharmaGenesis Inc.
Legal entity responsible for the study
Astellas Pharma Inc.
Funding
Astellas Pharma Inc.
Disclosure
F. Lordick: Financial Interests, Personal, Advisory Board: Amgen, Astellas, BMS, Bayer, BeiGene, Biontech, Eli Lilly, Elsevier, MSD, Novartis, Roche, Daiichi Sankyo, PAGE; Financial Interests, Personal, Invited Speaker: AstraZeneca, BMS, Eli Lilly, Imedex, Incyte, MSD, MedUpdate, Medscape, Merck Serono, Roche, Servier, StreamedUp!, Daiichi Sankyo, Novartis, Art Tempi; Financial Interests, Personal, Writing Engagement: Deutscher Ärzteverlag, Iomedico, Springer-Nature; Financial Interests, Institutional, Research Grant: BMS, Gilead. M.A. Shah: Financial Interests, Personal, Research Funding: Astellas Pharma Inc., Merck, Bristol Myers Squibb, and Oncolys BioPharma; Financial Interests, Personal, Leadership Role: ASCO Leadership Council. K. Shitara: Financial Interests, Personal, Advisory Board: Lilly, Bristol Myers Squibb, Takeda, Pfizer, Ono Pharmaceutical, MSD, Taiho Pharmaceutical, Novartis, AbbVie, GSK, Daiichi Sankyo, Amgen, Boehringer Ingelheim, Guardant Health Japan Corp, Astellas Pharma Inc.; Financial Interests, Personal, Invited Speaker: Janssen Pharmaceutical K.K.; Financial Interests, Institutional, Research Grant: Astellas, Ono Pharmaceutical, Daiichi Sankyo, Taiho Pharmaceutical, Chugai, MSD, Eisai, Amgen. J.A. Ajani: Financial Interests, Personal, Research Funding: Astellas Pharma Inc., Turning Point Therapeutics, Inc., Bristol Myers Squibb, Merck, Taiho Pharmaceutical, Delta-Fly Pharma, Inc., Roche, ProLynx Inc, Zymeworks, Daiichi Sankyo, Leap Therapeutics, Inc., Gilead Sciences, Inc., and Lanova Pharma; Financial Interests, Personal, Speaker, Consultant, Advisor: Bristol Myers Squibb, Merck, Astellas Pharma Inc., Amgen, Taiho Pharmaceutical, Zymeworks, BeiGene, AstraZeneca, Daiichi Sankyo, Bayer, GRAIL, Novartis, Geneos, Servier Laboratories, and Gilead Sciences, Inc.; Financial Interests, Personal, Other, travel: Daiichi Sankyo, Bristol Myers Squibb, and Merck. Y. Bang: Financial Interests, Personal, Research Funding: Astellas Pharma Inc., Genentech, Roche, Merck Serono, Daiichi Sankyo, MSD, Amgen, and BeiGene; Financial Interests, Personal, Speaker, Consultant, Advisor: MSD, Daiichi Sankyo, ALX Oncology, Hanmi Pharmaceutical, Merck Serono, Astellas Pharma Inc., Samyang Biopharm Corporation, and Daewoong Pharmaceutical. P.C. Enzinger: Financial Interests, Personal, Research Funding: Astellas Pharma Inc.; Financial Interests, Personal, Speaker, Consultant, Advisor: ALX Oncology, Arcus Biosciences, Astellas Pharma Inc., AstraZeneca, Blueprint Medicines, Bristol Myers Squibb, Chimeric Therapeutics, Celgene, Coherus BioSciences, Daiichi Sankyo, Five Prime Therapeutics, Inc., IDEAYA Biosciences, Istari Oncology, Legend. D.H. Ilson: Financial Interests, Personal, Research Funding: Astellas Pharma Inc.; Financial Interests, Personal, Speaker, Consultant, Advisor: Amgen, Bayer, Astellas Pharma Inc., Merck, Daiichi Sankyo, Taiho Pharmaceutical, Natera Inc, Bristol Myers Squibb, Eli Lilly and Company, Roche, and AstraZeneca; Financial Interests, Personal, Advisory Board: MacroGenics, and Merck. E. van Cutsem: Financial Interests, Personal, Advisory Board: AbbVie, ALX, Amgen, Array, Astellas, AstraZeneca, Bayer, BeiGene, Boehringer Ingelheim, Bristol Myers Squibb, Daiichi, GSK, Incyte, Ipsen, Lilly, Merck Sharp & Dohme, Merck KGaA, Mirati, Novartis, Nordic, Pierre Fabre, Pfizer, Roche, Seattle Genetics, Servier, Takeda, Terumo, Taiho, Zymeworks; Financial Interests, Institutional, Research Grant: Amgen, Bayer, Boehringer Ingelheim, Bristol Myers Squibb, Ipsen, Lilly, Merck Sharp & Dohme, Merck KGaA, Novartis, Roche, Servier. J. Gallego Plazas: Financial Interests, Personal, Advisory Board: AAA, Amgen, Bayer, BMS, Eisai, Ipsen, Lilly, Merck, MSD, Pierre Fabre, Roche, Servier; Financial Interests, Personal, Invited Speaker: AAA, Amgen, Bayer, BMS, Ipsen, Lilly, Merck, MSD, Novartis, Servier; Financial Interests, Personal, Other, Educational: Amgen, Ipsen, Merck, Novartis, Pierre Fabre, Roche; Financial Interests, Institutional, Funding: Astellas, AstraZeneca, BMS, Daiichi Sankyo, Lilly, Servier; Non-Financial Interests, Personal, Member of Board of Directors: Spanish Society Medical Oncology, Spanish Group of Neuroendocrine an Endocrine Tumours; Non-Financial Interests, Personal, Project Lead: AGAMENON-SEOM Registry of Esophagohastric Cancer. J. Huang: Financial Interests, Personal, Research Funding: Astellas Pharma Inc. L. Shen: Financial Interests, Personal, Other, Consulting fees: Mingji biopharmaceutical, Haichuang pharmaceutical, Herbour biomed; Financial Interests, Personal, Advisory Board: MSD, Merck, BMS, BI, Sanofi, Roche, Servier, AZ; Financial Interests, Institutional, Funding: Beijing Xiantong Biomedical Technology, Qilu Pharmaceutical, ZaiLab Pharmaceutical (Shanghai), Alphamab Oncology, Yaojie Ankang (Nanjing) Technology Co., Ltd., BeiGene, Ltd., Qiyu Biotechnology (Shanghai) Co., Ltd., BriSTAR immunotech; Financial Interests, Institutional, Local PI: Merck Healthcare KGaA, Roche; Financial Interests, Institutional, Trial Chair: Rongchang Pharmaceutical, Innovent, BeiGene, Ltd., Qilu Pharmaceutical, NovaRock Biotherapeutics Limited. S.C. Oh, H.H.F. Soo, H.M. Türk, J.W. Park, D. Moran, P. Bhattacharya: Financial Interests, Personal, Research Funding: Astellas Pharma Inc. Y.J. Cao: Financial Interests, Personal, Full or part-time Employment: Astellas Pharma Global Development, Inc. R. Xu: Financial Interests, Personal, Invited Speaker: BMS, MSD; Financial Interests, Personal, Advisory Board: Henrui, BeiGene, Astellas, Merck, Junshi.
135MO - Updated efficacy and safety results from phase III SPOTLIGHT study evaluating zolbetuximab + mFOLFOX6 as first-line (1L) treatment for patients with claudin-18 isoform 2-positive (CLDN18.2+), HER2−, locally advanced (LA) unresectable or metastatic gastric or gastroesophageal junction (mG/GEJ) adenocarcinoma
- Yoon-Koo Kang (Seoul, KR)
- Jaffer A. Ajani (Houston, US)
- Florian Lordick (Leipzig, DE)
- Yung-Jue Bang (Seoul, KR)
- Peter C. Enzinger (Boston, US)
- David H. Ilson (New York, US)
- Manish A. Shah (New York, US)
- Eric Van Cutsem (Leuven, BE)
- Rui-Hua Xu (Guangzhou, CN)
- Giuseppe Aprile (Vicenza, IT)
- Jianming Xu (Beijing, CN)
- Roberto A. Pazo Cid (Zaragoza, ES)
- Yoon-Koo Kang (Seoul, KR)
- Jianning Yang (Northbrook, US)
- Diarmuid Moran (Northbrook, US)
- Pranob Bhattacharya (Northbrook, US)
- Maria Matsangou (Northbrook, US)
- Ahsan Arozullah (Northbrook, US)
- Jung Wook Park (Northbrook, US)
- Kohei Shitara (Kashiwa, JP)
Abstract
Background
The phase 3 SPOTLIGHT study showed statistically significant improvement with 1L zolbetuximab + a modified folinic acid, 5-FU, and oxaliplatin regimen (mFOLFOX6) vs placebo (PBO) + mFOLFOX6 in PFS (final; median 10.6 vs 8.7 mo, HR 0.75 [95% CI 0.60, 0.94],
Methods
Pts were randomly assigned 1:1 to zolbetuximab IV 800 mg/m2 (cycle 1, day [D] 1) followed by 600 mg/m2 (every 3 weeks) + mFOLFOX6 IV (D1, 15, 29) for four 42-day cycles or to PBO + mFOLFOX6; pts without progressive disease (PD) continued with zolbetuximab or PBO, + folinic acid and 5-FU at investigator’s discretion, until PD or discontinuation criteria were met. Primary endpoint was PFS per RECIST v1.1 by IRC; OS was a key secondary endpoint.
Results
At data cutoff (June 29, 2023), 565 pts were assigned to zolbetuximab + mFOLFOX6 (n = 283) or PBO + mFOLFOX6 (n = 282). In zolbetuximab vs PBO arms, median follow-up was 17.9 vs 15.2 mo for PFS and 31.1 vs 29.6 mo for OS, respectively. Median PFS was 11.0 vs 8.9 mo (HR 0.73 [95% CI 0.59, 0.91],
Conclusions
With longer follow-up, zolbetuximab + mFOLFOX6 continued to demonstrate statistically significant improvement in PFS and OS compared with PBO + mFOLFOX6, with no new safety signals—supporting zolbetuximab + mFOLFOX6 as a potential new option for 1L treatment of pts with CLDN18.2+, HER2–, LA unresectable or mG/GEJ adenocarcinoma.
Clinical trial identification
NCT03504397.
Editorial acknowledgement
Medical writing support, conducted in accordance with Good Publication Practice (GPP 2022) and the International Committee of Medical Journal Editors (ICMJE) guidelines, was provided by Ann Ferguson, PhD, of Oxford PharmaGenesis Inc.
Legal entity responsible for the study
Astellas Pharma Inc.
Funding
Astellas Pharma Inc.
Disclosure
J.A. Ajani: Financial Interests, Personal, Research Funding: Astellas Pharma Inc., Bristol Myers Squibb, Merck & Co., Zymeworks, Taiho Pharmaceutical, Delta-Fly Pharma, Inc., ProLynx Inc, Daiichi Sankyo, Leap Therapeutics, Inc., Turning Point Therapeutics, Inc., Lanova Pharma, and Gilead Sciences, Inc; Financial Interests, Personal, Speaker, Consultant, Advisor: Bristol Myers Squibb, Merck & Co., Astellas Pharma Inc., Taiho Pharmaceutical, Zymeworks, BeiGene, AstraZeneca, Amgen, Novartis, Gilead Sciences, Inc., Servier Laboratories, Arcus Biosciences, and GRAIL; Financial Interests, Personal, Other, travel: Daiichi Sankyo, Bristol Myers Squibb, Aadi Bioscience, and Merck & Co. F. Lordick: Financial Interests, Personal, Advisory Board: Amgen, Astellas, BMS, Bayer, BeiGene, Biontech, Eli Lilly, Elsevier, MSD, Novartis, Roche, Daiichi Sankyo, PAGE; Financial Interests, Personal, Invited Speaker: AstraZeneca, BMS, Eli Lilly, Imedex, Incyte, MSD, MedUpdate, Medscape, Merck Serono, Roche, Servier, StreamedUp!, Daiichi Sankyo, Novartis, Art Tempi; Financial Interests, Personal, Writing Engagement: Deutscher Ärzteverlag, Iomedico, Springer-Nature; Financial Interests, Institutional, Research Grant: BMS, Gilead. Y. Bang: Financial Interests, Personal, Research Funding: Astellas Pharma Inc., Genentech, Roche Holding AG, Merck Serono, Daiichi Sankyo, MSD, Amgen, and BeiGene; Financial Interests, Personal, Speaker, Consultant, Advisor: MSD, Daiichi Sankyo, ALX Oncology, Hanmi Pharmaceutical, Merck Serono, Astellas Pharma Inc., Samyang Biopharm Corporation, and Daewoong Pharmaceutical. P.C. Enzinger: Financial Interests, Personal, Research Funding: Astellas Pharma Inc.; Financial Interests, Personal, Speaker, Consultant, Advisor: ALX Oncology, Arcus Biosciences, Astellas Pharma Inc., AstraZeneca, Blueprint Medicines, Bristol Myers Squibb, Chimeric Therapeutics, Celgene, Coherus BioSciences, Daiichi Sankyo, Five Prime Therapeutics, Inc., IDEAYA Biosciences, Istari Oncology, Legend. D.H. Ilson: Financial Interests, Personal, Research Funding: Astellas Pharma Inc.; Financial Interests, Personal, Speaker, Consultant, Advisor: Amgen, Bayer, Astellas Pharma Inc., Merck & Co., Daiichi Sankyo, Natera Inc, Taiho Pharmaceutical, Bristol Myers Squibb, Eli Lilly and Company, Roche Holding AG, and AstraZeneca; Financial Interests, Personal, Advisory Board: MacroGenics, and Merck & Co. M.A. Shah: Financial Interests, Personal, Research Funding: Astellas Pharma Inc., Merck & Co., Bristol Myers Squibb, and Oncolys BioPharma; Financial Interests, Personal, Leadership Role: ASCO Leadership Council. E. van Cutsem: Financial Interests, Personal, Advisory Board: AbbVie, ALX, Amgen, Array, Astellas, AstraZeneca, Bayer, BeiGene, Boehringer Ingelheim, Bristol Myers Squibb, Daiichi, GSK, Incyte, Ipsen, Lilly, Merck Sharp & Dohme, Merck KGaA, Mirati, Novartis, Nordic, Pierre Fabre, Pfizer, Roche, Seattle Genetics, Servier, Takeda, Terumo, Taiho, Zymeworks; Financial Interests, Institutional, Research Grant: Amgen, Bayer, Boehringer Ingelheim, Bristol Myers Squibb, Ipsen, Lilly, Merck Sharp & Dohme, Merck KGaA, Novartis, Roche, Servier. R. Xu: Financial Interests, Personal, Invited Speaker: BMS, MSD; Financial Interests, Personal, Advisory Board: Henrui, BeiGene, Astellas, Merck, Junshi. G. Aprile: Financial Interests, Personal, Research Funding: Astellas Pharma Inc.; Financial Interests, Personal, Speaker, Consultant, Advisor: Amgen, AstraZeneca, Bristol Myers Squibb, Merck & Co., MSD, and Novartis; Financial Interests, Personal, Financially compensated role: Amgen, AstraZeneca, Bristol Myers Squibb, Eli Lilly and Company, Merck & Co., MSD, and Novartis. J. Xu: Financial Interests, Personal, Research Funding: Astellas Pharma Inc. R.A. Pazo Cid: Financial Interests, Personal, Advisory Board: Roche, BMS, Servier, Ipsen, Lilly, AstraZeneca; Financial Interests, Personal, Invited Speaker: Servier, BMS, Roche, Eisai; Financial Interests, Personal and Institutional, Local PI, Support for manuscript presentation (funding, provision of study materials, medical writing, article processing charges): Ipsen, Astellas. Y. Kang: Financial Interests, Personal, Advisory Board: ALX Oncology, Zymeworks, Amgen, Novartis, Macrogenics, Daehwa, Blueprint, Surface Oncology, BMS, Merck, Roche, Liscure. J. Yang: Financial Interests, Personal, Full or part-time Employment: Astellas Pharma Inc. D. Moran, P. Bhattachary: Financial Interests, Personal, Full or part-time Employment: Astellas Pharma Inc. M. Matsangou: Financial Interests, Personal, Full or part-time Employment: Astellas Pharma Global Development, Inc. A. Arozullah: Financial Interests, Personal, Full or part-time Employment: Astellas Pharma Inc.; Financial Interests, Personal, Stocks/Shares: Astellas Pharma Inc. J.W. Park: Financial Interests, Personal, Full or part-time Employment: Astellas Pharma Inc. K. Shitara: Financial Interests, Personal, Advisory Board: Lilly, Bristol Myers Squibb, Takeda, Pfizer, Ono, MSD, Taiho, Novartis, AbbVie, GSK, Daiichi Sankyo, Amgen, Boehringer Ingelheim, Guardant Health Japan Corp, Astellas Pharma Inc.; Financial Interests, Personal, Invited Speaker: Janssen Pharmaceutical K.K.; Financial Interests, Institutional, Research Grant: Astellas, Ono, Daiichi Sankyo, Taiho, Chugai, MSD, Eisai, Amgen.
136MO - Bemarituzumab (bema)+FOLFOX6 as first-line treatment in patients with FGFR2b overexpressing locally advanced or metastatic gastric/gastroesophageal junction cancer (G/GEJC): East Asia subgroup of FIGHT final analysis
- Yoon-Koo Kang (Seoul, KR)
- Yoon-Koo Kang (Seoul, KR)
- Shukui Qin (Nanjing, CN)
- Keun-Wook Lee (Seongnam, KR)
- Sang Cheul Oh (Seoul, KR)
- In-Ho Kim (Seoul, KR)
- Jong Gwang Kim (Daegu, KR)
- Yong Li (Shijiazhuang, CN)
- Zhuchen Yan (Tianjin, CN)
- Jin Li (Shanghai, CN)
- Li-Yuan Bai (New Taipei City, TW)
- Catherine Pui Kwan Chan (Hong Kong, HK)
- Akeem Yusuf (Thousand Oaks, US)
- Anita Zahlten-Kuemeli (South San Francisco, US)
- Kate Taylor (Uxbridge, GB)
- Kensei Yamaguchi (Koto-ku, JP)
Abstract
Background
Despite decline in incidence and improvement in mortality rates for advanced G/GEJC in Asia, outcomes remain quite poor. As novel biomarkers emerge, they may reveal more opportunities to improve outcomes in advanced G/GEJC via targeted therapeutics. The global, randomized, phase 2, double-blind FIGHT study (NCT03694522) suggested that bema can improve PFS and OS in patients (pts) with FGFR2b+ (any 2+/3+ IHC staining and/or
Methods
89 East Asian pts (57.4% of total) were enrolled in FIGHT; all received FOLFOX6. 45 received bema (15mg/kg) and 44 received placebo (pbo) once Q2W and 7.5mg/kg bema or pbo on C1D8. Of these, 29 and 31, respectively, had FGFR2b overexpression in ≥10% of tumor cells with any 2+/3+ staining intensity by IHC (FGFR2b+ ≥10%).
Results
At 24mo of follow-up (data cutoff 13 May 2022), bema+mFOLFOX6 showed improved median PFS (95% CI) of 12.9mo (8.8-17.9) vs 8.2mo (5.6-10.3) for pbo+mFOLFOX6 (HR 0.50, 95% CI 0.29-0.87); median OS (95% CI) was also improved at 24.7mo (13.8-33.1) vs 12.9mo (9.3-21.4) (HR 0.56, 95% CI 0.32-0.96). ORR was 48.9% vs 34.1%. Treatment benefit was more pronounced in patients with FGFR2b+ ≥10%: PFS HR 0.28 (95% CI 0.13-0.57), OS HR 0.43 (95% CI 0.22-0.86). Observed safety within this subgroup was consistent with those in the global study. Corneal treatment-emergent adverse events (TEAEs) occurred in 68.2% (n=30) bema and 13.6% (n=6) pbo pts. Study drug was discontinued for any-grade corneal TEAEs not resolved within 28 days; 56.7% (17/30) of pts with a corneal TEAE discontinued bema.
Conclusions
In East Asian pts (N=89) with FGFR2b+ advanced or metastatic G/GEJC, bema+mFOLFOX6 continued to show clinically meaningful outcomes over pbo+mFOLFOX6 after 24mo of follow-up. The efficacy and safety results from the East Asian subgroup were consistent with those of the global FIGHT final analysis.
Clinical trial identification
NCT03694522.
Editorial acknowledgement
Medical writing assistance was provided by Tim Peoples, MA, ELS, contractor to Amgen Inc.
Legal entity responsible for the study
Amgen Inc.
Funding
Five Prime Therapeutics, Inc.
Disclosure
Y. Kang: Financial Interests, Personal, Advisory Board: ALX Oncology, Zymeworks, Amgen, Novartis, Macrogenics, Daehwa, Blueprint, Surface Oncology, BMS, Merck, Roche, Liscure. K. Lee: Financial Interests, Personal, Advisory Board: BMS (Korea), Bayer (Korea), Daiichi Sankyo (Korea), Merck Sharp & Dohme (Korea), Metafines, Vifor pharma (Korea), Astellas (Korea); Financial Interests, Personal, Invited Speaker: Boryung Co.; Financial Interests, Institutional, Local PI: ABLBIO, ALX Oncology, Amgen, Arcus Biosciences, Astellas Pharma, AstraZeneca, BeiGene, Bolt therapeutics, Daiichi Sankyo, Exelixis, Genexine, Green Cross Corp, InventisBio, LSK BioPharma, Leap therapeutics, Macrogenics, MedPacto, Merck KGaA, Merck Sharp & Dohme, Oncologie, Ono pharmaceutical, Pfizer, Pharmacyclics, Y-BIOLOGICS, Seagen, Taiho Pharmaceutical, Trishula therapeutics, Zymeworks,; Non-Financial Interests, Personal, Leadership Role, SMC chair of ASPEN-06 study: ALX Oncology. J. Li: Financial Interests, Personal, Speaker’s Bureau: AstraZeneca, Lilly. L. Bai: Financial Interests, Personal, Speaker, Consultant, Advisor: Lilly, Pfizer, SynCoreBio, Bristol Myers Squibb. C.P.K. Chan: Financial Interests, Personal, Full or part-time Employment, Employee: Amgen; Financial Interests, Personal, Stocks or ownership, Stockholder: Amgen. A. Yusuf: Financial Interests, Personal, Full or part-time Employment, Employee: Amgen; Financial Interests, Personal, Stocks or ownership, Stockholder: Amgen. A. Zahlten-Kuemeli: Financial Interests, Personal, Full or part-time Employment, Employee: Amgen; Financial Interests, Personal, Stocks or ownership, Stockholder: Amgen. K. Taylor: Financial Interests, Personal, Full or part-time Employment, Employee: Amgen; Financial Interests, Personal, Stocks or ownership, Stockholder: Amgen. K. Yamaguchi: Financial Interests, Personal, Invited Speaker: Taiho Pharm; Financial Interests, Personal, Advisory Board: Daiichi Sankyo, Bristol Mayers Squibbb, Ono Pharm, Eli Lilly Japan; Financial Interests, Institutional, Funding: Taiho Pharm. All other authors have declared no conflicts of interest.
Invited Discussant 134MO, 135MO and 136MO
- Hanneke Van Laarhoven (Amsterdam, NL)
- Hanneke Van Laarhoven (Amsterdam, NL)
Q&A and discussion
- All Speakers (Lugano, CH)
- All Speakers (Lugano, CH)
138MO - Pembrolizumab (Pembro) or placebo (Pbo) plus chemotherapy (Chemo) for advanced HER2-negative gastric/gastroesophageal junction (G/GEJ) adenocarcinoma (KEYNOTE-859): Asia subgroup analysis
- Chia Jui Yen (Tainan City, TW)
- Do-Youn Oh (Seoul, KR)
- Yuxian Bai (Harbin, CN)
- Min Hee Ryu (Seoul, KR)
- Jeeyun Lee (Seoul, KR)
- Jin Li (Shanghai, CN)
- Suxia Luo (Zhengzhou, CN)
- Hongming Pan (Hangzhou, CN)
- YANLI Qu (Urumqi, CN)
- Jianwei Lu (Nanjing, CN)
- Lin Yang (Shenzhen, CN)
- Hisateru Yasui (Kobe, JP)
- Hiroshi Yabusaki (Niigata, JP)
- Chia Jui Yen (Tainan City, TW)
- Wendy W. Chan (Hong Kong, HK)
- Kensei Yamaguchi (Koto-ku, JP)
- Kun-Huei Yeh (Taipei City, TW)
- Lina Yin (Kenilworth, US)
- Sonal Bordia (Whippany, US)
- Pooja Bhagia (Kenilworth, US)
- Sun Young Rha (Seoul, KR)
Abstract
Background
In the global, double-blind, placebo-controlled, phase 3 KEYNOTE-859 study (NCT03675737) of pembro + fluoropyrimidine- and platinum-containing chemo for patients (pts) with advanced HER2-negative G/GEJ adenocarcinoma, OS, PFS, and ORR were significantly improved with manageable safety, regardless of PD-L1 expression. Results for the subgroup of pts enrolled in Asia are reported.
Methods
Pts with previously untreated HER2-negative locally advanced or metastatic G/GEJ adenocarcinoma with known PD-L1 CPS were randomized 1:1 to pembro 200 mg (pembro arm) or pbo (pbo arm) every 3 weeks for ≤35 cycles; all pts received investigator’s choice of 5-FU + cisplatin (FP) or capecitabine + oxaliplatin (CAPOX). The primary end point was OS; key secondary end points were PFS and ORR per RECIST v1.1 by blinded independent central review and safety. Data are from the interim analysis (3 Oct 2022 data cutoff).
Results
The Asia subgroup included 263 pts in the pembro arm and 262 pts in the pbo arm. The median (range) follow-up (defined from randomization to database cutoff date) was 28.6 (15.3-46.2) mo. Baseline characteristics were generally well balanced between treatment arms. Median OS was 17.3 mo (95% CI, 14.8-19.5) for the pembro arm vs 13.0 mo (11.8-14.4) for the pbo arm (HR, 0.71; 95% CI, 0.58-0.87); median PFS was 8.4 mo (95% CI, 7.2-9.6) for the pembro arm vs 6.7 mo (5.7-6.9) for the pbo arm (HR, 0.69; 0.57-0.85). ORR was 61.2% in the pembro arm and 48.9% in the pbo arm, estimated difference, 12.4% (95% CI, 3.9-20.7). Grade 3-5 treatment-related AEs occurred in 59.5% of pts in the pembro arm and 44.7% of pts in the pbo arm (grade 5: 1 [0.4%] vs 2 pts [0.8%]). Immune-mediated AEs and infusion reactions occurred in 83 pts (31.7%) and 34 pts (13.0%) in the pembro and pbo arms, respectively.
Conclusions
Consistent with the global KEYNOTE-859 results, the addition of pembro to FP or CAPOX provided improvement in OS, PFS, and ORR numerically, with no new safety signals for pts enrolled in Asia. Results continue to support pembro + chemo as a 1L treatment option for pts with locally advanced or metastatic HER2-negative G/GEJ adenocarcinoma.
Clinical trial identification
NCT03675737.
Editorial acknowledgement
Medical writing and/or editorial assistance was provided by Andrea Humphries, PhD, CMPP, of ApotheCom (Yardley, PA, USA).
Legal entity responsible for the study
Merck Sharp & Dohme LLC., a subsidiary of Merck & Co., Inc., Rahway, NJ, USA.
Funding
Merck Sharp & Dohme LLC., a subsidiary of Merck & Co., Inc., Rahway, NJ, USA.
Disclosure
Y. Bai: Financial Interests, Personal, Funding: Ono Pharmaceutical, Bristol Myers Squibb, AstraZeneca; Financial Interests, Personal, Advisory Role: Ono Pharmaceutical, Bristol Myers Squibb, AstraZeneca, MSD, Eli Lily, Taiho Pharmaceutical, Novartis, Daehwa, Daiichi Sankyo, Astellas. M.H. Ryu: Financial Interests, Personal, Funding: Ono Pharmaceutical, Bristol Myers Squibb, AstraZeneca; Financial Interests, Personal, Advisory Role: Ono Pharmaceutical, Bristol Myers Squibb, AstraZeneca, MSD, Eli Lily, Taiho Pharmaceutical, Novartis, Daehwa, Daiichi Sankyo, Astellas. H. Yasui: Financial Interests, Personal, Invited Speaker: Taiho Pharmaceutical, Chugai Pharma, Bristol Myers Squibb, Daiichi Sankyo, Terumo, Eli Lilly Japan, Merck Biopharma, Yakult Honsha, Bayer Yakuhin; Financial Interests, Institutional, Local PI: MSD, Daiichi Sankyo, Ono Pharmaceutical, Astellas Pharma, Amgen. K. Yamaguchi: Financial Interests, Personal, Invited Speaker: Taiho Pharm; Financial Interests, Personal, Advisory Board: Daiichi Sankyo, Bristol Mayers Squibbb, Ono Pharm, Eli Lilly Japan; Financial Interests, Institutional, Funding: Taiho Pharm. K. Yeh: Financial Interests, Personal, Advisory Board: Daiichi Sankyo, PhytoHealth, Novartis, Ono, Merck, AstraZeneca; Non-Financial Interests, Personal, Member: American Society of Clinical Oncology, American Association for Cancer Research. L. Yin, S. Bordia, P. Bhagia: Financial Interests, Personal, Full or part-time Employment: Merck; Financial Interests, Personal, Stocks/Shares: Merck. S.Y. Rha: Financial Interests, Personal, Advisory Board: Indivumed, Amgen, LG biochemical, Astellas; Financial Interests, Personal, Invited Speaker: MSD, Lilly, Daiichi Sankyo; Financial Interests, Personal, Steering Committee Member: Amgen; Financial Interests, Institutional, Funding: MSD, Lilly; Financial Interests, Institutional, Research Grant: BMS, Daiichi Sankyo; Financial Interests, Institutional, Local PI: Indivumed, AstraZeneca; Financial Interests, Personal, Other, Durg supply for clinical trial: Merck; Financial Interests, Institutional, Coordinating PI, Drug supply for clincal trial: MSD; Financial Interests, Institutional, Local PI, drug supply for clinical trial: Zymeworks; Financial Interests, Institutional, Local PI, drug supply for clincial trial: Beigine; Financial Interests, Personal, Coordinating PI, Drug supply for clnical trial: Incyte. All other authors have declared no conflicts of interest.
139MO - Tislelizumab (TIS) plus chemotherapy (Chemo) vs placebo (PBO) plus chemo as first-line (1L) treatment of advanced gastric or gastroesophageal junction adenocarcinoma (GC/GEJC): Final analysis results of the RATIONALE-305 study
- Ken Kato (Chuo-ku, JP)
- Rui-Hua Xu (Guangzhou, CN)
- Do-Youn Oh (Seoul, KR)
- Ken Kato (Chuo-ku, JP)
- Hendrik-Tobias Arkenau (London, GB)
- Josep Tabernero (Barcelona, ES)
- Marcia Cruz-Correa (San Juan, PR)
- Anastasia V. Zimina (Omsk, RU)
- Yuxian Bai (Harbin, CN)
- Jianhua Shi (Linyi, CN)
- Keun-Wook Lee (Seongnam, KR)
- Hidekazu Hirano (Chuo-ku, JP)
- David R. Spigel (Nashville, US)
- Lucjan S. Wyrwicz (Warsaw, PL)
- Roberto A. Pazo Cid (Zaragoza, ES)
- Liyun Li (Beijing, CN)
- Yaling Xu (Shanghai, CN)
- M. Brent McHenry (Cambridge, US)
- Silu Yang (Beijing, CN)
- Markus Moehler (Mainz, DE)
Abstract
Background
TIS (anti-PD-1 antibody) plus (+) chemo demonstrated significant overall survival (OS) benefit vs PBO + chemo as 1L treatment in patients (pts) with advanced GC/GEJC at a pre-specified interim analysis of the PD-L1-positive (tumor area positivity score ≥5%) population in the global, phase 3 RATIONALE-305 study (NCT03777657). Here, we present primary analysis results in the intent-to-treat (ITT) population at the pre-specified final analysis.
Methods
Adults with previously untreated, HER2-negative, locally advanced, unresectable, or metastatic GC/GEJC, regardless of PD-L1 expression status, were randomized (1:1) to receive TIS 200 mg or PBO IV once every 3 weeks plus investigator (INV)-choice of chemo (5-FU + cisplatin or capecitabine + oxaliplatin). The primary endpoints were OS in the PD-L1-positive and ITT populations. Secondary endpoints included progression-free survival, objective response rate, and duration of response by INV per RECIST v1.1, and safety.
Results
At data cutoff, 997 pts were randomized (501 pts to TIS + chemo; 496 pts to PBO + chemo). Minimum study follow-up was 24.6 mo. OS in the TIS arm was significantly improved compared with the PBO arm in the ITT population (median OS: 15.0 mo vs 12.9 mo, respectively; HR=0.80 [95% CI: 0.70, 0.92]; 1-sided ITT population. Data cutoff: 28 February 2023. Chemo, chemotherapy; CI, confidence interval; HR, hazard ratio; ITT, intent-to-treat; mDoR, median duration of response; mo, months; ORR, objective response rate; OS, overall survival; PBO, placebo; PFS, progression-free survival; TIS, tislelizumab.
Endpoint TIS + chemo (n=501) PBO + chemo (n=496) Median, mo (95% CI) 15.0 (13.6, 16.5) 12.9 (12.1, 14.1) HR (95% CI) 0.80 (0.70, 0.92) 0.0011 Median, mo (95% CI) 6.9 (5.7, 7.2) 6.2 (5.6, 6.9) HR (95% CI) 0.78 (0.67, 0.90) 47.3 (42.9, 51.8) 40.5 (36.2, 45.0) 8.6 (7.9, 11.1) 7.2 (6.0, 8.5)
Conclusions
In the ITT population, TIS + chemo showed statistically significant and clinically meaningful improvement in OS vs PBO + chemo and was well tolerated. These data support the TIS + chemo combination as a potential 1L treatment option for pts with advanced GC/GEJC.
Clinical trial identification
NCT03777657 (first posted December 17, 2018).
Editorial acknowledgement
This study was sponsored by BeiGene, Ltd. Medical writing support, under the direction of the authors, was provided by Victoria Dagwell, MSc, and Gemma Walker, BSc, of Ashfield MedComms, an Inizio company, and was funded by BeiGene, Ltd.
Legal entity responsible for the study
BeiGene, Ltd.
Funding
BeiGene, Ltd.
Disclosure
R. Xu: Financial Interests, Personal, Invited Speaker: BMS, MSD; Financial Interests, Personal, Advisory Board: Henrui, BeiGene, Astellas, Merck, Junshi. D. Oh: Financial Interests, Personal, Advisory Board: AstraZeneca, Novartis, Genentech/Roche, Merck Serono, Bayer, Taiho, ASLAN, Halozyme, Zymeworks, BMS/Celgene, BeiGene, Basilea, Turning Point, Yuhan, Arcus Biosciences, IQVIA, MSD; Financial Interests, Institutional, Research Grant: AstraZeneca, Novartis, Array, Eli Lilly, Servier, BeiGene, MSD, Handok. K. Kato: Financial Interests, Personal, Invited Speaker: Ono Pharmaceutical, Bristol Myers Squibb, Merck and Co; Financial Interests, Personal, Advisory Board: Ono Pharmaceutical, Bristol Myers Squibb, Merck and Co, Bayer, AstraZeneca, BeiGene, Taiho, Merck Biophrma, Amgen, Novartis, Daiichi Sankyo; Financial Interests, Institutional, Coordinating PI: Ono Pharmaceuticals, Merck & Co; Financial Interests, Institutional, Local PI: Bayer, AstraZeneca, BeiGene, Chugai, Taiho, Oncolys Biopharma, Janssen Pharmaceutical. H. Arkenau: Financial Interests, Personal, Speaker’s Bureau: iOnctura, lab genius; Financial Interests, Personal, Advisory Board: BeiGene. J. Tabernero: Financial Interests, Personal, Advisory Board, scientific consultancy role: Orion Biotechnology, Array Biopharma, AstraZeneca, Bayer, Boehringer Ingelheim, Chugai, Daiichi Sankyo, F. Hoffmann-La Roche Ltd, Genentech Inc., HalioDX SAS, Ikena Oncology, IQVIA, Lilly, Menarini, Merck Serono, Merus, MSD, Mirati, Neophore, Novartis, Peptomyc, Pfizer, Pierre Fabre, Samsung Bioepis, Sanofi, Seattle Genetics, Servier, Taiho, Tessa Therapeutics, TheraMyc, Hutchinson MediPharma International, Scandion Oncology, Ona Therapeutics, Sotio Biotech, Inspirna Inc, Scorpion Therapeutics, Tolremo Therapeutics; Financial Interests, Personal, Invited Speaker, educational collaboration: Medscape Education, Physicians Education Resource (PER), PeerView Institute for Medical Education, Imedex / HMP; Financial Interests, Personal, Invited Speaker, educacional collaboration: MJH Life Sciences; Financial Interests, Personal, Advisory Board: Cardiff Oncology; Financial Interests, Personal, Stocks/Shares: Oniria Therapeuics; Financial Interests, Institutional, Research Grant, ACRCelerate: Colorectal Cancer Stratified: Fundación Científica de la Asociación Española Contra el Cáncer; Financial Interests, Institutional, Research Grant, OPTIMISTICC: Opportunity to Investigate the Microbiome’s Impact on Science and Treatment In Colorectal Cancer: Cancer Research UK; Financial Interests, Institutional, Funding, Clinical Trials & Research: Amgen Inc, Array Biopharma Inc, AstraZeneca Pharmaceuticals LP, Bristol Myers Squibb International Corporation, Celgene International SARL, Debiopharm International SA, F. Hoffmann-La Roche Ltd, Genentech Inc, Janssen-Cilag International NV, Merck Health KGAA, Merck, Sharp & Dohme de España, SA, Novartis Farmacéutica SA, PharmaMar SA, Sanofi-Aventis Recherche & Développement, Servier, Taiho Pharma USA, Inc, BeiGene, Boehringer Ingelheim, HalioDX SAS, Hutchinson Medipharma, MedImmune, Menarini, Merus N V, Pfizer, Mirati; Non-Financial Interests, Personal, Member of Board of Directors, Board of Directors: Cancer Core Europe, Spanish Association Against Cancer -AECC; Non-Financial Interests, Personal, Member of Board of Directors, General Assembly: Horizon Europe Cancer Mission; Non-Financial Interests, Personal, Leadership Role, External Scientific Committee: Institute for Health Research INCLIVA – Clinical Hospital of Valencia, IdiSNA –Universidad de Navarra; Non-Financial Interests, Personal, Leadership Role, Scientific Advisory Board: Spanish National Cancer Research Centre (CNIO); Non-Financial Interests, Personal, Advisory Role, International Scientific Evaluation Committee: Bosch Health Campus (BHC); Non-Financial Interests, Personal, Advisory Role, Review Board: National Decade Against Cancer (NCT) - German Consortium for Translational Cancer Research (DKTK); Non-Financial Interests, Personal, Advisory Role, Scientific Advisory Board: Karolinska Comprehensive Cancer Centre; Non-Financial Interests, Personal, Advisory Role, International Review Committee (IRC): Oncode Institute; Non-Financial Interests, Personal, Advisory Role, Scientific Advisory Board (SAB): Oslo University Hospital Comprehensive Cancer Centre (OUH CCC); Non-Financial Interests, Personal, Leadership Role, Governance Advisory Committee: European Organization for Research and Treatment of Cancer -EORTC; Non-Financial Interests, Personal, Leadership Role, Vice Chairman: World Innovative Networking (WIN) Consortium in Personalized Cancer Medicine; Non-Financial Interests, Personal, Other, Coordinating PI & Steering Committee Member. Clinical Trials & Research: Array Biopharma Inc., AstraZeneca Pharmaceutical LP, Boehringer Ingelheim, MedImmune, Menarini, Merck Healthcare KGAA, Merck, Sharp & Dohme de España SA, Pfizer, Servier; Non-Financial Interests, Personal, Principal Investigator, Clinical Trials & Research: Array Biopharma Inc., AstraZeneca Pharmaceutics LP, BeiGene, Boehringer Ingelheim, Bristol Myers Squibb International Corporation, Celgene International SARL, Debiopharm International SA, F. Hoffmann-La Roche Ltd, Genentech Inc., HalioDX SAS, Hutchinson Medipharma, Janssen-Cilag International NV, MedImmune, Menarini, Merck Healthcare KGAA, Merck, Sharp & Dohme de España SA, Merus NV, Mirati, Novartis Farmacéutica SA, Pfizer, Sanofi-Aventis Recherche & Développement, Servier, Taiho Pharma USA Inc; Non-Financial Interests, Personal, Other, Steering Committee Member. Clinical Trials & Research: Debiopharm International SA, F. Hoffmann-La Roche Ltd, Genentech Inc., HalioDX SAS, Hutchinson Medipharma, Janssen-Cilag International NV, Merus NV, Taiho Pharma USA Inc; Non-Financial Interests, Personal, Other, Coordinating PI. Clinical Trials & Research: Mirati; Non-Financial Interests, Personal, Member: AACR, ASCO, EACR, EORTC, SEOM; Other, Personal, Other, President: Oncology Master Plan – Catalonia Department of Health; Other, Personal, Other, Advisory Committee: Advisory Committee on Pharmaceutical Provision Financing under the Spanish National Health System. M. Cruz-Correa: Financial Interests, Institutional, Research Grant: Merck, SeaGen, BMS, Taiho, Pfizer, Janssen, AbbVie, Genentech, Incyte, HUYABIO, BeiGene. A.V. Zimina: Non-Financial Interests, Personal, Principal Investigator, Participation as PI in YUHAN LASER-301 trial.: YUHAN. K. Lee: Financial Interests, Personal, Advisory Board: BMS (Korea), Bayer (Korea), Daiichi Sankyo (Korea), Merck Sharp & Dohme (Korea), Metafines, Vifor pharma (Korea), Astellas (Korea); Financial Interests, Personal, Invited Speaker: Boryung Co.; Financial Interests, Institutional, Local PI: ABLBIO, ALX Oncology, Amgen, Arcus Biosciences, Astellas Pharma, AstraZeneca, BeiGene, Bolt therapeutics, Daiichi Sankyo, Exelixis, Genexine, Green Cross Corp, InventisBio, LSK BioPharma, Leap therapeutics, Macrogenics, MedPacto, Merck KGaA, Merck Sharp & Dohme, Oncologie, Ono pharmaceutical, Y-BIOLOGICS, Pfizer, Pharmacyclics, Seagen, Taiho Pharmaceutical, Trishula therapeutics, Zymeworks,; Non-Financial Interests, Personal, Leadership Role, SMC chair of ASPEN-06 study: ALX Oncology. H. Hirano: Financial Interests, Personal, Invited Speaker: Taiho Pharmaceutical, Ono Pharmaceutical, Teijin Phama, Novartis; Financial Interests, Personal, Writing Engagement: Nichi-Iko; Financial Interests, Institutional, Research Grant: Chugai Pharmaceutical, Daiichi Sankyo, Taiho Pharmaceutical, Ono Pharmaceutical, Janssen Pharmaceutical, Merck Biopharma, Bristol Myers Squibb, Pfizer, Eisai, Amgen, Astellas, Seagen, MSD, Insyte, BeiGene, Novartis. D.R. Spigel: Financial Interests, Institutional, Other, Consulting: AstraZeneca, BeiGene, Bristol Myers Squibb, Evidera, GSK, Ipsen Biopharmaceuticals, Janssen, Jazz Pharmaceuticals, Lilly, Molecular Templates, Monte Rosa Therapeutics, Novartis, Pfizer, Regeneron, Sanofi-Aventis, AbbVie, Novocure, Roche/Genentech; Financial Interests, Institutional, Research Grant, Serve as PI: Amgen, Aeglea Biotherapeutics, Agios, Arrys Therapeutics, Astellas, AstraZeneca, Bayer, BeiGene, BIND Therapeutics, Blueprint Medicine, Boehringer Ingelheim, Bristol Myers Squibb, Celgene, Celldex Therapeutics, Clovis, Daiichi Sankyo, Eisai, Lilly, Genentech/Roche, G1 Therapeutics, Gilead Sciences, GSK, GRAIL, Hutchinson MediPharma, ImClone Systems, Ipsen, Janssen, Loxo, MacroGenics, MedImmune, Merck, Nektar, Neon Therapeutics, Novartis, Novocure, Rgenix, SeaGen, Taiho Oncology, Tarveda, Tizona Therapeutics, Transgene, UT Southwestern, Verastem, Arcus Biosciences, Molecular Template, Cyteir Therapeutics, BioNTech, Apollomics, Pure Tech Health, Elevation Oncology, Repare Therapeutics, Razor Genomics, Denovo Biopharma, Erasca, Kronos Bio, Zai Laboratory, Faeth Therapeutics, Ascendis Pharma, Lyell Immunopharma, Synthekine, Shenzhen Chipscreen Biosciences, AbbVie, AnHeart Therapeutics, Calithera, Endeavor, FujiFilm Pharmaceuticals, Incyte, Jazz Pharmaceuticals, Millennium Pharmaceuticals, Moderna, Monte Rosa Therapeutics, Peloton Therapeutics, Stemline Therapeutics, Tango Therapeutics, Tesaro. L.S. Wyrwicz: Financial Interests, Personal, Advisory Board: BMS, Servier; Financial Interests, Personal and Institutional, Local PI: BMS, MSD, Servier, BeiGene, Roche, AstraZeneca; Financial Interests, Personal, Steering Committee Member: AstraZeneca. R.A. Pazo Cid: Financial Interests, Personal, Advisory Board: Roche, BMS, Servier, Ipsen, Lilly, AstraZeneca; Financial Interests, Personal, Invited Speaker: Servier, BMS, Roche, Eisai; Financial Interests, Personal and Institutional, Local PI, Support for manuscript presentation (funding, provision of study materials, medical writing, article processing charges): Ipsen, Astellas. L. Li: Financial Interests, Personal, Full or part-time Employment: BeiGene (Beijing) Co., Ltd.; Financial Interests, Personal, Stocks/Shares: BeiGene (Beijing) Co., Ltd.; Financial Interests, Personal, Training: BeiGene (Beijing) Co., Ltd. Y. Xu: Financial Interests, Personal, Full or part-time Employment: BeiGene (Shanghai) Co., Ltd; Financial Interests, Personal, Stocks/Shares: BGNE (NASDAQ). M.B. McHenry: Financial Interests, Personal, Full or part-time Employment: BeiGene; Financial Interests, Personal, Stocks/Shares, Stockholder: BeiGene. S. Yang: Financial Interests, Personal, Full or part-time Employment: BeiGene. M. Moehler: Financial Interests, Personal, Advisory Board: BMS, Servier, Amgen, Lilly, BeiGene, Novartis, Taiho, Daiichi, Amgen, MD; Financial Interests, Personal, Invited Speaker: MSD, BMS, Falk foundation, AIO, BeiGene, Amgen; Financial Interests, Institutional, Advisory Board: Bayer, Sanofi; Financial Interests, Personal, Other, Chair: EORTC. All other authors have declared no conflicts of interest.
Invited Discussant 138MO and 139MO
- Raghav Sundar (Singapore, SG)
- Raghav Sundar (Singapore, SG)
Q&A and discussion
- All Speakers (Lugano, CH)
- All Speakers (Lugano, CH)