![]() Median progression-free survival was 7.7 and 6.1 months, respectively (HR = 0.68 P <. 0001) and for all randomly assigned patients (HR = 0.80 P =. The differences were also statistically significant for the PD-L1 CPS ≥ 1 population (HR = 0.77 P =. Median overall survival was 14.4 months with nivolumab plus chemotherapy vs 11.1 months for chemotherapy in the PD-L1 CPS ≥ 5 population (hazard ratio = 0.71 P <. Overall survival consistently favored nivolumab plus chemotherapy vs chemotherapy across multiple prespecified subgroups,” Dr. “A statistically significant and clinically meaningful overall survival benefit was seen in patients whose tumors expressed a PD-L1 CPS ≥ 5 and in all randomly assigned patients. The dual primary endpoints were overall survival and progression-free survival in patients with a PD-L1 CPS ≥ 5. ![]() The chemotherapy regimen was either FOLFOX (fluorouracil, leucovorin, oxaliplatin) every 2 weeks or XELOX (capecitabine plus oxaliplatin) every 3 weeks. Patients were randomly assigned to one of three regimens: nivolumab at 260 mg every 3 weeks or 240 mg every 2 weeks plus chemotherapy chemotherapy alone or nivolumab plus ipilimumab (nivolumab/ipilimumab data will be presented at a later date). Of these patients, 955 (60%) had tumors with a PD-L1 CPS ≥ 5 expression. The phase III trial included 1,581 patients with previously untreated HER2-negative advanced/unresectable or metastatic gastric cancer (70% of the population), as well as gastroesophageal junction cancer and esophageal adenocarcinoma. Nivolumab plus chemotherapy represents a potential standard first-line treatment,” Dr. 1 “The study achieved statistical significance for both primary endpoints and all formally tested secondary endpoints. Markus Moehler, MD, Professor of Medicine, Johannes-Gutenberg University Clinic, Mainz, Germany, reported the prespecified interim analysis of overall survival and the final progression-free survival analysis of CheckMate 649. “Breaking through the 1-year overall survival barrier for patients with PD-L1 CPS ≥ 5 is a milestone.” “It’s a good day for patients with gastric cancer! The results of these two trials represent a paradigm shift in the treatment of advanced disease,” said invited discussant Elizabeth Smyth, MD, of Cambridge University Hospitals NHS Foundation Trust in the United Kingdom.
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