![]() Survival rates were 51% and 39%, respectively, at 1 year, and 28% and 16%, respectively, at 2 years, reported Peter Enzinger, MD, Director of the Center for Esophageal and Gastric Cancer at Dana-Farber Cancer Institute. In all patients, median overall survival was 12.4 months with pembrolizumab/chemotherapy vs 9.8 months with chemotherapy (HR = 0.73, P <. As in CheckMate 649, overall survival and progression-free survival were the dual primary endpoints. ![]() Patients were randomly assigned to receive pembrolizumab at 200 mg every 3 weeks for up to 35 cycles plus chemotherapy (fluorouracil plus cisplatin) for up to 6 cycles or chemotherapy alone. The phase III KEYNOTE-590 trial enrolled 749 patients, regardless of PD-L1 expression, with previously untreated advanced/unresectable or metastatic esophageal adenocarcinoma or esophageal squamous cell carcinoma or esophagogastric junction Siewert type 1 adenocarcinoma. 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/chemotherapy vs 11.1 months for chemotherapy in the PD-L1 CPS ≥ 5 population (hazard ratio = 0.71, P <. The dual primary endpoints were overall survival and progression-free survival in patients with a PD-L1 CPS ≥ 5. In 2021, KEYNOTE-590 became the first randomized phase 3 study to demonstrate a significant and clinically meaningful improvement in both overall survival (OS) and progression-free survival (PFS) with the addition of an immune checkpoint inhibitorin this case, pembrolizumabto chemotherapy in the first-line setting for advanced esophageal cancer. The chemotherapy regimen was either FOLFOX (fluorouracil, leucovorin, oxaliplatin) every 2 weeks or XELOX (capecitabine, oxaliplatin) every 3 weeks. Nivolumab plus ipilimumab (nivolumab/ipilimumab data will be presented at a later date). FDA approval in September 2014, and in a randomized comparison to chemotherapy (KN002 detailed in the IB). In KEYNOTE-590, when KEYTRUDA was administered with cisplatin and fluorouracil to patients with metastatic or locally advanced esophageal or GEJ (tumors with epicenter 1 to 5 centimeters above the GEJ) carcinoma who were not candidates for surgical resection or definitive chemoradiation, KEYTRUDA was discontinued due to adverse reactions in 15.Nivolumab at 260 mg every 3 weeks or 240 mg every 2 weeks plus chemotherapy.Patients were randomly assigned to receive: The phase III trial included 1,581 patients with previously untreated HER2-negative advanced/unresectable or metastatic gastric cancer, gastroesophageal junction (GEJ) cancer, or esophageal adenocarcinoma, of whom 955 patients (60%) had a PD-L1 CPS ≥ 5. Nivolumab plus chemotherapy represents a potential standard first-line treatment.” “The study achieved statistical significance for both primary endpoints and all formally tested secondary endpoints. “Nivolumab is the first PD-1 inhibitor to demonstrate superior overall survival and progression-free survival in combination with chemotherapy vs chemotherapy alone in previously untreated patients with advanced gastric cancer, gastroesophageal junction cancer, or esophageal adenocarcinoma,” he said.
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