DOI: 10.1200/JCO.2020.38.15_suppl.TPS4648 Journal of Clinical Oncology
Ajani: Advisory/Consultancy, Research grant/Funding (institution): Astellas Pharma. To sign up for ESMO newsletters, simply create a myESMO account here and select the newsletters you’d like to receive. Patients will be randomized 1:1 to zolbe + mFOLFOX6 or placebo + mFOLFOX6. Enzinger: Advisory/Consultancy: Merck; Advisory/Consultancy: Astellas; Advisory/Consultancy: Celgene; Advisory/Consultancy: Lilly; Advisory/Consultancy: Loxo; Advisory/Consultancy: Taiho; Advisory/Consultancy: Zymeworks. Phase of Trial Phase 3 Trial summary A study of zolbetuximab (IMAB362) plus mFOLFOX6 versus placebo plus mFOLFOX6 in subjects with Claudin 18.2 positive, HER2-negative, locally advanced unresectable or metastatic gastric or gastroesophageal junction adenocarcinoma. published online before print Patients will receive zolbe 800 mg/m2 IV on Cycle 1 Day 1 (loading dose), then 600 mg/m2 IV every 3 weeks; mFOLFOX6 will be administered on Days 1, 15, and 29 of each 42-day cycle (4 cycles). Zolbetuximab (zolbe), a chimeric IgG1 monoclonal antibody, binds to CLDN18.2 and mediates cell death through antibody-dependent cellular cytotoxicity and complement-dependent cytotoxicity. ClinicalTrials.gov. A Phase 3, Global, Multi-Center, Double-Blind, Randomized, Efficacy Study of Zolbetuximab (IMAB362) Plus CAPOX Compared With Placebo Plus CAPOX as First-line Treatment of Subjects With Claudin (CLDN) 18.2-Positive, HER2-Negative, Locally Advanced Unresectable or Metastatic Gastric or Gastroesophageal Junction (GEJ) Adenocarcinoma Eligibility Archive Capecitabine + oxaliplatin (CAPOX) is a standard first-line treatment for advanced gastric cancer. Contact Us Permissions, Authors STORM was a multicenter, open-label, single arm trial evaluating selinexor … Cookies. A Phase 3 Efficacy, Safety and Tolerability Study of Zolbetuximab (Experimental Drug) Plus mFOLFOX6 Chemotherapy Compared to Placebo Plus mFOLFOX6 as Treatment for Gastric and Gastroesophageal Junction (GEJ) Cancer (Spotlight) Sponsor: Astellas Pharma Global Development, Inc. J.W. Domenica Lorusso. TAPUR Study, Terms of Use | Privacy Policy | E. van Cutsem: Advisory/Consultancy: Astellas; Advisory/Consultancy: AstraZeneca; Advisory/Consultancy, Research grant/Funding (institution): Bayer; Advisory/Consultancy, Research grant/Funding (institution): Bristol-Myers Squibb; Advisory/Consultancy, Research grant/Funding (institution): Celgene; Advisory/Consultancy: Incyte; Advisory/Consultancy, Research grant/Funding (institution): Lilly; Advisory/Consultancy, Research grant/Funding (institution): Merck Sharp & Dohme; Advisory/Consultancy, Research grant/Funding (institution): Merck KGaA; Advisory/Consultancy, Research grant/Funding (institution): Novartis; Advisory/Consultancy, Research grant/Funding (institution): Roche; Advisory/Consultancy, Research grant/Funding (institution): Servier; Research grant/Funding (institution): Amgen; Research grant/Funding (institution): Boehringer Ingelheim; Research grant/Funding (institution): Ipsen. All other authors have declared no conflicts of interest. D. Catenacci: Advisory/Consultancy: Astellas Pharma; Advisory/Consultancy: Merck; Advisory/Consultancy: BMS; Advisory/Consultancy: Lilly; Advisory/Consultancy: Gritstone; Advisory/Consultancy: Taiho; Advisory/Consultancy: Genentech/Roche; Advisory/Consultancy: Daichii Sankyo. Some of these cookies are essential, while others help us improve your experience by providing insights into how the site is being used. Meeting Abstracts, About Phase III. Subscribers Zolbetuximab is a chimeric IgG1 monoclonal antibody that specifically binds to CLDN18.2 and mediates cell death through antibody-dependent cellular cytotoxicity and complement-dependent cytotoxicity. Patients will be randomly assigned 1:1 to receive either zolbetuximab plus CAPOX or placebo plus CAPOX. *3 *1 World Health Organization Cancer Fact Sheet 2018. A Phase 3, Global, Multi-Center, Double-Blind, Randomized, Efficacy Study of Zolbetuximab (IMAB362) Plus mFOLFOX6 Compared With Placebo Plus mFOLFOX6 as First-line Treatment of Subjects With Claudin (CLDN)18.2-Positive, HER2-Negative, Locally Advanced Unresectable or Metastatic Gastric or Gastroesophageal Junction (GEJ) Adenocarcinoma Via Ginevra 4, 6900 Lugano - CH© Copyright 2021 European Society for Medical Oncology All rights reserved worldwide. A Phase 3, Global, Multi-Center, Double-Blind, Randomized, Efficacy Study of Zolbetuximab (IMAB362) Plus mFOLFOX6 Compared With Placebo Plus mFOLFOX6 as First-line Treatment of Subjects With Claudin (CLDN)18.2-Positive, HER2-Negative, Locally Advanced Unresectable or Metastatic Gastric or Gastroesophageal Junction (GEJ) Adenocarcinoma JCO OP DAiS, ASCO eLearning A multicentre, phase IIa study of zolbetuximab as a single agent in patients with recurrent or refractory advanced adenocarcinoma of the stomach or lower oesophagus: the MONO study Ann Oncol. 10.1016/annonc/annonc356, SPOTLIGHT: Phase III study of zolbetuximab + mFOLFOX6 versus placebo + mFOLFOX6 in first-line Claudin18.2⁺/HER2⁻ advanced or metastatic gastric or gastroesophageal junction adenocarcinoma (G/GEJ), HER2CLIMB-02: A randomized, double-blind, phase III study of tucatinib or placebo with T-DM1 for unresectable locally-advanced or metastatic HER2+ breast cancer, KEYLYNK-009: A phase II/III, open-label, randomized study of pembrolizumab (pembro) + olaparib (ola) vs pembro + chemotherapy after induction with first-line (1L) pembro + chemo in patients (pts) with locally recurrent inoperable or metastatic TNBC, MADELINE Asia: A mobile app-based prospective observational study of patient reported outcomes in advanced breast cancer in Asia, Prospective observational study monitoring circulating tumour DNA in resectable colorectal cancer patients undergoing radical surgery: GALAXY study in CIRCULATE-Japan, GLOW: Phase III study of first-line zolbetuximab + CAPOX versus placebo + CAPOX in Claudin18.2⁺/HER2⁻ advanced/metastatic gastric or gastroesophageal junction adenocarcinoma (G/GEJ), Perioperative sintilimab in combination with concurrent chemoradiotherapy for patients with locally advanced gastric or gastroesophageal junction (GEJ) adenocarcinoma, A randomized, double-blind, phase III study of pembrolizumab plus chemotherapy as first-line therapy in patients with HER2-negative, advanced gastric or gastroesophageal junction (G/GEJ) adenocarcinoma: KEYNOTE-859, Pembrolizumab (pembro) or placebo added to docetaxel and prednisone/prednisolone for metastatic castration-resistant prostate cancer (mCRPC) previously treated with next-generation hormonal agents (NHAs): KEYNOTE-921 phase III study, ENGOT-cx11/KEYNOTE-A18: A Phase 3, Randomized, Double-Blind Study of Pembrolizumab With Chemoradiotherapy in Patients With High-Risk Locally Advanced Cervical Cancer, LAURA: Osimertinib maintenance following definitive chemoradiation therapy (CRT) in patients (pts) with unresectable stage III epidermal growth factor receptor mutation positive (EGFRm) non-small cell lung cancer (NSCLC), Interpreting Oncological Study Publications, Cancer Diagnosis and Treatment Evaluation, Rehabilitation Issues During Cancer Treatment and Follow-Up, Cancer Treatment in Special Clinical Situations, Clinical Pharmacology of Anti-Cancer Agents, ESMO Members: Build Your Own ESMO Library, International Prognostic Index Tools for Lymphoma, Anti-Cancer Agents and Biological Therapy, Drug-Drug Interactions with Kinase Inhibitors, PARP inhibition and DNA Damage Response (DDR), Cancer Aetiology, Epidemiology and Prevention, Cancer in Special situations (pregnancy, young, elderly, hereditary...), Multikinase Inhibitor-Related Skin Toxicity, Precision Medicine and Validated Biomarkers, ESMO Recommendations in Precision Medicine, Translational Research: Biomarkers & Diagnostics. Editorial Roster Methods: This phase 3, double-blind, placebo-controlled study (NCT03653507) will enroll ~500 adult patients from global sites. Annals of Oncology (2020) 31 (suppl_6): S1287-S1318. Details ASCO Meetings Patients are required to have CLDN18.2+/HER2− locally advanced unresectable or metastatic G or GEJ adenocarcinoma that is radiographically evaluable per RECIST v1.1. MINIMAL Requirements: Google Chrome 24+, Mozilla Firefox 20+, Internet Explorer 11, Opera 15–18, Apple Safari 7, SeaMonkey 2.15-2.23. A Phase 3 efficacy, safety and tolerability study of zolbetuximab (experimental drug) plus mFOLFOX6 chemotherapy compared to placebo plus mFOLFOX6 as treatment for gastric and gastroesophageal junction (GEJ) cancer. ASCO Author Services A Phase 3, Global, Multi-Center, Double-Blind, Randomized, Efficacy Study of Zolbetuximab (IMAB362) Plus mFOLFOX6 Compared with Placebo Plus mFOLFOX6 as First-line Treatment of Subjects with Claudin (CLDN)18.2 Positive, HER2-Negative, Metastatic … Zolbetuximab will be administered by IV infusion as an 800 mg/m2 loading dose (Cycle 1, Day 1) followed by 600 mg/m2 Q3W in combination with CAPOX. A Phase 3 Efficacy, Safety and Tolerability Study of Zolbetuximab (Experimental Drug) Plus mFOLFOX6 Chemotherapy Compared to Placebo Plus mFOLFOX6 as Treatment for Gastric and Gastroesophageal Junction (GEJ) Cancer This site uses cookies. Key secondary endpoint: overall survival. Clinical trial information: NCT03653507. D.H. Ilson: Advisory/Consultancy: Astellas Pharma. Other secondary endpoints: objective response rate; duration of response; safety/tolerability, pharmacokinetics, and immunogenicity of zolbe.
JCO Clinical Cancer Informatics DOI: 10.1200/JCO.2020.38.15_suppl.TPS4648 Journal of Clinical Oncology - A Phase 3, Global, Multi-Center, Double-Blind, Randomized, Efficacy Study of Zolbetuximab (IMAB362) Plus CAPOX Compared with Placebo Plus CAPOX as First-line Treatment of Subjects with Claudin (CLDN) 18.2-Positive, HER2-Negative, Locally Advanced Unresectable or Metastatic Gastric or Gastroesophageal Junction (GEJ) Adenocarcinoma Phase II (NCT01630083) results showed prolonged survival of patients (pts) with CLDN18.2+ advanced G/GEJ treated with zolbe + epirubicin, oxaliplatin, and capecitabine (EOX) vs EOX alone. Eligible pts should have locally advanced unresectable or metastatic G/GEJ that is CLDN18.2+/human epidermal growth factor receptor 2-negative (HER2–) and radiologically evaluable lesions per RECIST v1.1. General Information Age Group Adults Status Recruiting Protocol Number NCT03504397 Background Information. Multiple cancers. For more detailed information on the cookies we use, please check our Privacy Policy. Gastric and gastroesophageal junction adenocarcinoma. We report the patient-reported outcomes (PROs) of FAST in patients with advanced gastroesophageal adenocarcinoma. J.A. Patients with ongoing anticancer therapies, an allergy to mAbs, or those who had had <3 weeks since a prior antitumour treatment were excluded. Full Title A Phase 3, Global, Multi-Center, Double-Blind, Randomized, Efficacy Study of Zolbetuximab (IMAB362) Plus mFOLFOX6 Compared with Placebo Plus mFOLFOX6 as First-line Treatment of Subjects with Claudin (CLDN)18.2-Positive, HER2- Negative, Locally Advanced Unresectable or Metastatic Gastric or Gastroesophageal Junction (GEJ) Adenocarcinoma (WIRB) Purpose The chemotherapy … This global, phase III, double-blind, placebo-controlled study (NCT03653507) will enroll ∼500 adult pts with CLDN18.2+/HER2– locally advanced unresectable or metastatic GC or GEJ not previously treated with chemotherapy for advanced/metastatic disease. JCO Global Oncology S-E. Al-Batran: Advisory/Consultancy, Research grant/Funding (institution): Merck; Advisory/Consultancy, Speaker Bureau/Expert testimony, Research grant/Funding (institution): Roche; Advisory/Consultancy, Speaker Bureau/Expert testimony, Research grant/Funding (institution): Celgene; Advisory/Consultancy, Research grant/Funding (institution): Lilly; Advisory/Consultancy, Speaker Bureau/Expert testimony: Nordic Pharma; Advisory/Consultancy: Bristol-Myers Squibb; Advisory/Consultancy: MSD Sharp & Dohme; Speaker Bureau/Expert testimony: AIO gGmbH; Speaker Bureau/Expert testimony: MCI; Speaker Bureau/Expert testimony: promedicis; Speaker Bureau/Expert testimony: Forum für Medizinische Fortbildung; Officer/Board of Directors: IKF Klinische Krebsforschung GmbH; Research grant/Funding (institution): Sanofi; Research grant/Funding (institution): Vifor; Research grant/Funding (institution): Medac; Research grant/Funding (institution): Hospira; Research grant/Funding (institution): German Cancer Aid (Krebshilfe); Research grant/Funding (institution): German Research Foundation; Research grant/Funding (institution): Federal Ministry of Education and Research. ASCO Career Center Conquer Cancer Foundation Zolbetuximab will be administered at a loading dose of 800 mg/m2 IV on Cycle 1 Day 1 followed by 600 mg/m2 IV every 3 weeks. SPOTLIGHT (NCT03504397) is enrolling ∼550 pts from global sites including China, Japan, Korea, and Taiwan. Cancer.Net, ASCO.org Details is primarily based on Part 2 of the phase 2b trial, KCP-330-012 (STORM). Receive our scientific and educational products, events, membership and educational initiatives. All funding for this site is provided directly by ESMO. This multicenter, first-in-human, phase I, single dose–escalation study was conducted at six centres in Germany and Latvia from July 2009 to May 2010. Of the trials investigating zolbetuximab, 2 are phase 2 (2 open) and 2 are phase 3 (2 open). A study of zolbetuximab (IMAB362) plus mFOLFOX6 versus placebo plus mFOLFOX6 in subjects with Claudin 18.2 positive, HER2-negative, locally advanced unresectable or metastatic gastric or gastroesophageal junction adenocarcinoma. Close Results of a phase 2 study (NCT01630083) showed prolonged survival of patients with CLDN18.2-positive (CLDN18.2+) advanced G/GEJ adenocarcinoma treated with zolbetuximab + epirubicin, oxaliplatin, and capecitabine (EOX) vs EOX alone. Y-J. ASP1948/PTZ-329 Anti-NRP1 antibody. Zolbetuximab will be administered at a loading dose of 800 mg/m 2 IV on Cycle 1 Day 1 followed by 600 mg/m 2 IV every 3 weeks. Bang: Advisory/Consultancy, Research grant/Funding (institution): AstraZeneca; Advisory/Consultancy, Research grant/Funding (institution): Novartis; Advisory/Consultancy, Research grant/Funding (institution): Genentech/Roche; Advisory/Consultancy, Research grant/Funding (institution): MSD; Advisory/Consultancy, Research grant/Funding (institution): Merck Serano; Advisory/Consultancy, Research grant/Funding (institution): Bayer; Advisory/Consultancy, Research grant/Funding (institution): BMS; Advisory/Consultancy, Research grant/Funding (institution): Eli Lilly; Advisory/Consultancy, Research grant/Funding (institution): Taiho; Advisory/Consultancy, Research grant/Funding (institution): Daiichi Sankyo; Advisory/Consultancy, Research grant/Funding (institution): Astellas; Advisory/Consultancy, Research grant/Funding (institution): BeiGene; Advisory/Consultancy, Research grant/Funding (institution): GreenCross; Advisory/Consultancy: Samyang Biopharm; Advisory/Consultancy: Hanmi; Advisory/Consultancy, Research grant/Funding (institution): Genexine; Research grant/Funding (institution): GSK; Research grant/Funding (institution): Pfizer; Research grant/Funding (institution): Boeringer Ingelheim; Research grant/Funding (institution): MacroGenics. In healthy tissue, CLDN18.2, a tight junction protein, is confined to gastric mucosa (ie, cells in the pit and base regions of gastric glands). Why is this study being done? Zolbetuximab + EOX was generally tolerated and AEs were manageable. Zolbetuximab (zolbe), a chimeric IgG1 monoclonal antibody, binds to CLDN18.2 and mediates cell death through antibody-dependent cellular cytotoxicity and complement-dependent cytotoxicity. A Phase 3 Efficacy, Safety and Tolerability Study of Zolbetuximab (Experimental Drug) Plus mFOLFOX6 Chemotherapy Compared to Placebo Plus mFOLFOX6 as Treatment for Gastric and Gastroesophageal Junction (GEJ) Cancer - NCT03504397 SPOTLIGHT is a new clinical study for adult patients who have any of: - advanced unresectable gastric or GEJ cancer - metastatic … Institutions Patients were randomized to ZOL/EOX or EOX alone. A total of 26 patients (cohort 1, n = 1; cohorts 2 and 3, n = 25) discontinued treatment before completing five infusions. 2.2. Oops, you're using an old version of your browser so some of the features on this page may not be displaying properly. Fluorouracil, folinic acid, and oxaliplatin (mFOLFOX6) is accepted first-line therapy for advanced/metastatic G/GEJ. ASCO Daily News Between 3 September 2010, and 24 September 2012, 268 patients were screened. Reviewers Patients will be randomized 1:1 to receive zolbetuximab + CAPOX or placebo + CAPOX. Presenter: Zolbetuximab plus first-line EOX (epirubicin, oxaliplatin, capecitabine; ZOL/EOX) significantly prolonged progression-free survival and overall survival in the FAST trial vs EOX alone. e-Poster Display Session, Presenter: Necessary cookies enable core functionality. Secondary endpoints are overall survival; objective response rate; duration of response; and the safety/tolerability, pharmacokinetics, and immunogenicity of zolbetuximab. Prior chemotherapy for advanced/metastatic G/GEJ is not permitted. Shukui Qin, Presenter: Background: Gastric cancer is the fourth leading cause of cancer death worldwide. Overall, the development of targeted treatments for GC has failed, except for that of HER2- and VEGFR2-targeted drugs. The primary objective is to compare progression-free survival between treatment arms. F. Lordick: Research grant/Funding (institution), Travel/Accommodation/Expenses: Bristol Myers Squibb; Travel/Accommodation/Expenses: Astellas; Travel/Accommodation/Expenses: AstraZeneca; Travel/Accommodation/Expenses: Eli Lilly; Travel/Accommodation/Expenses: Elsevier; Travel/Accommodation/Expenses: Biontech GmbH; Travel/Accommodation/Expenses: Excerpta Medica; Travel/Accommodation/Expenses: Medscape; Travel/Accommodation/Expenses: E-Cancer; Travel/Accommodation/Expenses: Servier; Travel/Accommodation/Expenses: Merck Serono; Travel/Accommodation/Expenses: Merck Sharpe Dohme; Travel/Accommodation/Expenses: Springer Nature Verlag GmbH. Primary endpoint: progression-free survival per independent review committee. A Phase 3, Global, Multi-Center, Double-Blind, Randomized, Efficacy Study of Zolbetuximab (IMAB362) Plus mFOLFOX6 Compared With Placebo Plus mFOLFOX6 as First-line Treatment of Subjects With Claudin (CLDN)18.2-Positive, HER2-Negative, Locally Advanced Unresectable or Metastatic Gastric or Gastroesophageal Junction (GEJ) Adenocarcinoma. 38, no. May 25, 2020. Weill Cornell Medical College, New York, NY; The University of Texas - MD Anderson Cancer Center, Houston, TX; Institut für Klinisch-Onkologische Forschung, Frankfurt, Germany; Seoul National University College of Medicine, Seoul, South Korea; Gastrointestinal Oncology Program, The University of Chicago, Chicago, IL; Dana-Farber Cancer Institute, Boston, MA; Memorial Sloan Kettering Cancer Center, New York, NY; University of Colorado Comprehensive Cancer Center, Aurora, CO; University Cancer Center Leipzig, Leipzig, Germany; National Cancer Center Hospital East, Kashiwa, Japan; University Hospitals Gasthuisberg Leuven, KU Leuven, Leuven, Belgium; Astellas Pharma Global Development, Inc., Northbrook, IL; Sun Yat-sen University Cancer Centre, Guangzhou, China, Professional English and Academic Editing Support, https://doi.org/10.1200/JCO.2020.38.15_suppl.TPS4648, Management of Immune-Related Adverse Events in Patients Treated With Immune Checkpoint Inhibitor Therapy: American Society of Clinical Oncology Clinical Practice Guideline, Venous Thromboembolism Prophylaxis and Treatment in Patients With Cancer: ASCO Clinical Practice Guideline Update, Abemaciclib Combined With Endocrine Therapy for the Adjuvant Treatment of HR+, HER2−, Node-Positive, High-Risk, Early Breast Cancer (monarchE), Prognostic Index for Acute- and Lymphoma-Type Adult T-Cell Leukemia/Lymphoma, Updated Analysis From KEYNOTE-189: Pembrolizumab or Placebo Plus Pemetrexed and Platinum for Previously Untreated Metastatic Nonsquamous Non–Small-Cell Lung Cancer, Integration of Palliative Care Into Standard Oncology Care: American Society of Clinical Oncology Clinical Practice Guideline Update, Patient-Clinician Communication: American Society of Clinical Oncology Consensus Guideline, Updating the American Society of Clinical Oncology Value Framework: Revisions and Reflections in Response to Comments Received, American Society of Clinical Oncology Statement: A Conceptual Framework to Assess the Value of Cancer Treatment Options, Symptom Monitoring With Patient-Reported Outcomes During Routine Cancer Treatment: A Randomized Controlled Trial, 2318 Mill Road, Suite 800, Alexandria, VA 22314, © 2021 American Society of Clinical Oncology. Tumor t… Central tumor tissue testing will determine CLDN18.2/HER2 status (if unknown); pts are considered CLDN18.2+ if ≥75% of tumor cells show moderate-to-strong immunohistochemical staining. ASCO Connection Zolbetuximab has been investigated in 4 clinical trials, of which 4 are open and 0 are closed. A Phase 3, Double-Blind, Randomized, Efficacy Study of Zolbetuximab Plus CAPOX Compared with Placebo Plus CAPOX of Subjects with Claudin 18.2-Positive, HER2-Negative, Locally Advanced Unresectable or Metastatic Gastric or GEJ Adenocarcinoma Norikazu Masuda, Session: *2 Pennathur A, et al., 2013; Sahin et al., 2008 *3 Ilic M, et al., 2016. Shigehira Saji, Presenter: Daniel Petrylak, Presenter: R-H. Xu: Honoraria (institution): Merck; Honoraria (institution): Roche. A Phase 3, Global, Multi-Center, Double-Blind, Randomized, Efficacy Study of Zolbetuximab (IMAB362) Plus CAPOX Compared With Placebo Plus CAPOX as First-line Treatment of Subjects With Claudin (CLDN) 18.2-Positive, HER2-Negative, Locally Advanced Unresectable or Metastatic Gastric or Gastroesophageal Junction (GEJ) Adenocarcinoma As of June 30, 2020, 190 sites have been initiated. Pancreatic adenocarcinoma.
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