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Mini oral session 1 - Gastrointestinal tumours, upper digestive

LBA81 - 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

Date

21 Oct 2023

Session

Mini oral session 1 - Gastrointestinal tumours, upper digestive

Topics

Targeted Therapy;  Immunotherapy

Tumour Site

Oesophageal Cancer;  Gastric Cancer;  Gastro-Oesophageal Junction Cancer

Presenters

Florian Lordick

Citation

Annals of Oncology (2023) 34 (suppl_2): S1254-S1335. 10.1016/S0923-7534(23)04149-2

Authors

F. Lordick1, M.A. Shah2, K. Shitara3, J.A. Ajani4, Y. Bang5, P.C. Enzinger6, D.H. Ilson7, E. Van Cutsem8, J. Gallego Plazas9, J. Huang10, L. Shen11, S.C. Oh12, P. Sunpaweravong13, H.H.F. Soo14, H.M. Türk15, J.W. Park16, D. Moran17, P. Bhattacharya18, Y.J. Cao19, R. Xu20

Author affiliations

  • 1 Department Of Medicine, University Cancer Center Leipzig, University of Leipzig Medical Center, 04103 - Leipzig/DE
  • 2 Medical Oncology & Hematology, Weill Cornell Medical College, New York/US
  • 3 Department Of Gastrointestinal Oncology, National Cancer Center Hospital East, Kashiwa/JP
  • 4 Gi Medical Oncology, The University of Texas MD Anderson Cancer Center, 77030-4095 - Houston/US
  • 5 Department Of Internal Medicine, Seoul National University College of Medicine, Seoul/KR
  • 6 Center For Esophageal And Gastric Cancer, Dana Farber Cancer Institute, Boston/US
  • 7 Medical Oncology, Memorial Sloan Kettering Cancer Center, New York/US
  • 8 Digestive Oncology, University Hospitals Gasthuisberg, Leuven, and KULeuven, Leuven/BE
  • 9 Department Of Medical Oncology, Hospital General Universitario de Elche, Elche/ES
  • 10 Department Of Medical Oncology, National Cancer Center / National Clinical Research Center for Cancer / Cancer Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College, Beijing/CN
  • 11 Department Of Gastrointestinal Oncology, Key Laboratory of Carcinogenesis and Translational Research (Ministry of Education/Beijing), Peking University Cancer Hospital and Institute, Beijing/CN
  • 12 Department Of Internal Medicine, Korea University Guro Hospital, Seoul/KR
  • 13 Department Of Internal Medicine, Faculty Of Medicine, Prince of Songkla University, Amphoe Hat Yai/TH
  • 14 Department Of Oncology And Radiotherapy, Penang Hospital, Penang/MY
  • 15 Faculty Of Medicine, Department Of Medical Oncology, BezmialemVakif University, 34093 - Istanbul/TR
  • 16 Data Science, Astellas Pharma Global Development, Inc., Northbrook/US
  • 17 Clinical Pharmacology And Exploratory Development Department, Astellas Pharma Global Development, Inc., Northbrook/US
  • 18 Development Division, Astellas Pharma Global Development, Inc., Northbrook/US
  • 19 Medical Sciences, Astellas Pharma USA, Northbrook/US
  • 20 Department Of Medical Oncology, Sun Yat-sen University Cancer Center State Key Laboratory of Oncology in South China, Collaborative Innovation Center of Cancer Medicine, 510060 - Guangzhou/CN

Resources

This content is available to ESMO members and event participants.

Abstract LBA81

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], P = 0.0007) and OS (interim; median 14.4 vs 12.2 mo, HR 0.77 [95% CI 0.62, 0.97], P = 0.0118) in pts with CLDN18.2+, HER2−, LA unresectable or mG/GEJ adenocarcinoma. We present an updated efficacy and safety analysis with 8.7 mo additional follow-up from the primary analysis.

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], P = 0.0004). Median OS in zolbetuximab vs PBO arms was 14.3 vs 12.2 mo (HR 0.77 [95% CI 0.62, 0.95], P = 0.0079); 24-mo OS rate was 28.3% vs 18.8%, with follow-up ongoing through final analyses. Most common TEAEs with zolbetuximab + CAPOX were nausea (zolbetuximab arm: 68.9% vs PBO arm: 50.2%), vomiting (66.1% vs 31.3%), and decreased appetite (41.3% vs 34.5%); incidences of serious TEAEs were similar between arms (48.0% vs 50.6%).

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., and was funded by Astellas Pharma 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; 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, Research Funding: Astellas Pharma Inc., Merck, Bristol Myers Squibb, Oncolys BioPharma; Financial Interests, 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 Pharmaceutical, MSD, Eisai, Amgen. J.A. Ajani: Financial Interests, Research Funding: Astellas Pharma Inc., Turning Point Therapeutics, Bristol Myers Squibb, Merck, Taiho Pharmaceutical, Delta-Fly Pharma, Inc., Roche, ProLynx Inc., Zymeworks, Daiichi Sankyo, Leap Therapeutics, Inc., Gilead Sciences, Inc., Lanova Pharma; Financial Interests, Speaker, Consultant, Advisor: Bristol Myers Squibb, Merck, Astellas Pharma Inc., Amgen, Taiho Pharmaceutical, Zymeworks, BeiGene, AstraZeneca, Daiichi Sankyo, Bayboratories, Gilead Sciences, Inc.; Financial Interests, Advisory Board: Daiichi Sankyo, Bristol Myers Squibb, Merck, GRAIL, BeiGene. Y. Bang: Financial Interests, Research Funding: Astellas Pharma Inc., Merck, Genentech, Roche, Serono, Daiichi Sankyo, MSD, Amgen, BeiGenE; Financial Interests, Speaker, Consultant, Advisor: MSD, Daiichi Sankyo, Merck Serono, Astellas Pharma Inc., Daewoong Pharmaceutical, ALX Oncology, Hanmi Pharmaceutical, Samyang Biopharm Corporation. P.C. Enzinger: Financial Interests, Research Funding: Astellas Pharma Inc.; Financial Interests, 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, Research Funding: Astellas Pharma Inc.; Financial Interests, 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, 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, Astra-Zeneca, BMS, Daiichi Sankyo, Lilly, Servier; Non-Financial Interests, Member of Board of Directors: Spanish Society Medical Oncology, Spanish Group Of Neuroendocrine an Endocrine Tumours; Non-Financial Interests, Project Lead: AGAMENON-SEOM Registry of Esophagohastric Cancer. J. Huang: Financial Interests, Research Funding: Astellas Pharma Global Development, 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: Financial Interests, Research Funding: Astellas Pharma Global Development, Inc.. P. Sunpaweravong: Financial Interests, Personal, Advisory Board: Roche, Eisai, BMS, AstraZeneca, MSD, Ipsen, Pfizer, Amgen; Financial Interests, Personal, Invited Speaker: Novartis, BMS, Mundipharma, Bayer; Financial Interests, Institutional, Local PI: Roche, Novartis, AstraZeneca, MSD. H.H.F. Soo: Financial Interests, Research Funding: Astellas Pharma Global Development, Inc.. H.M. Türk: Financial Interests, Research Funding: Astellas Pharma Global Development, Inc.. J.W. Park: Financial Interests, Full or part-time Employment: Astellas Pharma Global Development, Inc.. D. Moran: Financial Interests, Full or part-time Employment: Astellas Pharma Global Development, Inc.. P. Bhattacharya: Financial Interests, Full or part-time Employment: Astellas Pharma Global Development, Inc.. Y.J. Cao: Financial Interests, 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, Astalas, Merck, Junshi.

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