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. 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. Upon malignant transformation, structural loss in G/GEJ cells may allow antibodies more access to previously unavailable CLDN18.2. e-Poster Display Session, Presenter: Conquer Cancer Foundation Oops, you're using an old version of your browser so some of the features on this page may not be displaying properly. Norikazu Masuda, Session: Identifier: NCT03504397. Daniel Petrylak, Presenter: Secondary endpoints are overall survival; objective response rate; duration of response; and the safety/tolerability, pharmacokinetics, and immunogenicity of zolbetuximab. 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. ClinicalTrials.gov. 38, no. JCO OP DAiS, ASCO eLearning Patients will be randomized 1:1 to zolbe + mFOLFOX6 or placebo + mFOLFOX6. Permissions, Authors Cancer.Net, ASCO.org Presenter: Phase III. Park: Full/Part-time employment: Astellas Pharma. As of January 31, 2020, 127 sites were active and open to enrollment. Patients will be randomized 1:1 to receive zolbetuximab + CAPOX or placebo + CAPOX. Close 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 … 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 Rui-Hua Xu, Presenter: 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, 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 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. CancerLinQ ASP1948/PTZ-329 Anti-NRP1 antibody. 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. Overall, the development of targeted treatments for GC has failed, except for that of HER2- and VEGFR2-targeted drugs. Zolbetuximab has been investigated in 4 clinical trials, of which 4 are open and 0 are closed. ASCO Daily News 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 Patients will be randomly assigned 1:1 to receive either zolbetuximab plus CAPOX or placebo plus CAPOX. 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 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 … 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). Capecitabine + oxaliplatin (CAPOX) is a standard first-line treatment for advanced gastric cancer. All funding for this site is provided directly by ESMO. Randomization will be stratified by region (Asia vs non-Asia), number of metastatic sites (0 to 2 vs ≥3), and prior gastrectomy (yes vs no). Methods: This phase 3, double-blind, placebo-controlled study (NCT03653507) will enroll ~500 adult patients from global sites. Archive Primary endpoint: progression-free survival per independent review committee. DOI: 10.1200/JCO.2020.38.15_suppl.TPS4648 Journal of Clinical Oncology published online before print Details Editorial Roster is primarily based on Part 2 of the phase 2b trial, KCP-330-012 (STORM). Of the trials investigating zolbetuximab, 2 are phase 2 (2 open) and 2 are phase 3 (2 open). General Information Age Group Adults Status Recruiting Protocol Number NCT03504397 Background Information. 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 J.A. Receive our scientific and educational products, events, membership and educational initiatives. 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 Background: Gastric cancer is the fourth leading cause of cancer death worldwide. 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. S. Kim: Travel/Accommodation/Expenses: Astellas Pharma. Study design and conduct. Patients with ongoing anticancer therapies, an allergy to mAbs, or those who had had <3 weeks since a prior antitumour treatment were excluded. Shukui Qin, Presenter: D.H. Ilson: Advisory/Consultancy: Astellas Pharma. 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. Institutions Y-J. 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. Currently, two phase III trials are ongoing to test the 1L use of zolbetuximab in combination with mFOLFOX6 (SPOTLIGHT: NCT03504397) or CAPOX (GLOW: NCT03653507). Pancreatic cancer is the seventh leading cause of cancer death worldwide, *1 and shows low overall five-year survival rate as 4%. All other authors have declared no conflicts of interest. Enzinger: Advisory/Consultancy: Merck; Advisory/Consultancy: Astellas; Advisory/Consultancy: Celgene; Advisory/Consultancy: Lilly; Advisory/Consultancy: Loxo; Advisory/Consultancy: Taiho; Advisory/Consultancy: Zymeworks. TAPUR Study, Terms of Use | Privacy Policy | This study was funded by Astellas Pharma, Inc. K. Shitara: Advisory/Consultancy, Research grant/Funding (institution): Lilly; Advisory/Consultancy, Research grant/Funding (institution): Ono Pharmaceutical; Research grant/Funding (institution): Dainippon Sumitomo Pharma; Advisory/Consultancy, Research grant/Funding (institution): MSD; Research grant/Funding (institution): Daiichi Sankyo; Advisory/Consultancy, Research grant/Funding (institution): Taiho Pharmaceutical; Research grant/Funding (institution): Chugai Pharm; Advisory/Consultancy, Research grant/Funding (institution): Astellas Pharma; Research grant/Funding (institution): Medi Science; Honoraria (institution), Advisory/Consultancy: Novartis; Honoraria (institution), Advisory/Consultancy: AbbVie; Honoraria (institution): Yakult; Advisory/Consultancy: Bristol-Myers Squibb; Advisory/Consultancy: Takeda; Advisory/Consultancy: Pfizer; Advisory/Consultancy: GlaxoSmithKline. Tumor t… 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 *2 Pennathur A, et al., 2013; Sahin et al., 2008 *3 Ilic M, et al., 2016. 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. 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. STORM was a multicenter, open-label, single arm trial evaluating selinexor … A. Arozullah: Full/Part-time employment: Astellas Pharma. Patients were randomized to ZOL/EOX or EOX alone. Necessary cookies enable core functionality. Via Ginevra 4, 6900 Lugano - CH© Copyright 2021 European Society for Medical Oncology All rights reserved worldwide. Central testing of tumor tissue will determine CLDN18.2 and HER2 status (if unknown); patients will be considered CLDN18.2+ if ≥75% of tumor cells demonstrate moderate-to-strong membranous immunohistochemical staining. 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. 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. Between 3 September 2010, and 24 September 2012, 268 patients were screened. Patients are not permitted to have received prior treatment with chemotherapy for advanced or metastatic G or GEJ adenocarcinoma. JCO Oncology Practice 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. May 25, 2020. Zolbetuximab (zolbe), a chimeric IgG1 monoclonal antibody, binds to CLDN18.2 and mediates cell death through antibody-dependent cellular cytotoxicity and complement-dependent cytotoxicity. Details Clinical trial information: NCT03653507. 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. 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). Zolbetuximab + EOX was generally tolerated and AEs were manageable. ESMO is a Swiss-registered not-for-profit organisation. ASCO Author Services Domenica Lorusso. 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. The primary objective is to compare progression-free survival between treatment arms. Zolbetuximab 800/600 mg/m 2 is being evaluated in phase III studies based on clinical benefit observed in the overall population and in patients with moderate-to-strong CLDN18.2 expression in ≥70% of tumour cells. 2019 Sep 1;30(9):1487-1495. doi: 10.1093/annonc/mdz199. J.W. To sign up for ESMO newsletters, simply create a myESMO account here and select the newsletters you’d like to receive. MINIMAL Requirements: Google Chrome 24+, Mozilla Firefox 20+, Internet Explorer 11, Opera 15–18, Apple Safari 7, SeaMonkey 2.15-2.23. 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. Randomization will be stratified by region (Asia vs non-Asia), number of metastatic sites (0 to 2 vs ≥3), and prior gastrectomy (yes vs no). Ajani: Advisory/Consultancy, Research grant/Funding (institution): Astellas Pharma. Methods: This phase 3, double-blind, ... (0 to 2 vs ≥3), and prior gastrectomy (yes vs no). *3 *1 World Health Organization Cancer Fact Sheet 2018. Upon malignant transformation, structural loss in gastric or gastroesophageal junction (G/GEJ) adenocarcinoma cells may allow antibodies more access to previously unavailable CLDN18.2. For more detailed information on the cookies we use, please check our Privacy Policy. 15_suppl, Newest Articles 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. ASCO Career Center ASCO Connection The ASCO Post Claudin (CLDN)18.2 has emerged as a promising targetable biomarker. Brief Title: 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 Official Title: A Phase 3, Global, Multi-Center, Double-Blind, Randomized, Efficacy Study of Zolbetuximab (IMAB362) Plus mFOLFOX6 Compared With Placebo … 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 (NCT03504397) is enrolling ∼550 pts from global sites including China, Japan, Korea, and Taiwan. 2.2. Claudin (CLDN)18.2, a tight junction protein and new molecular target, is confined to gastric mucosa (ie, cells in the pit and base regions of the gastric glands) in healthy tissue. Zolbetuximab is currently under development also in pancreatic adenocarcinoma. 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. We report the patient-reported outcomes (PROs) of FAST in patients with advanced gastroesophageal adenocarcinoma. Phase III. Fluorouracil, folinic acid, and oxaliplatin (mFOLFOX6) is accepted first-line therapy for advanced/metastatic G/GEJ. Pancreatic adenocarcinoma. Why is this study being done? 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. Multiple cancers. Metastatic urothelial cancer, previously untreated (first line) ... Zolbetuximab IMAB362 Anti-Claudin 18.2 monoclonal antibody. 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: Fluorouracil (DB00544) Leucovorin (DB00650) Oxaliplatin (DB00526) Zolbetuximab (DB15118) NCT03653507

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