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Regulatory approval was granted for first-line use of nivolumab combined with FOLFOX in metastatic gastroesophageal cancer based on results of the industry-sponsored, phase 3 CHECKMATE 649 trial. The trial demonstrated improvements in response, progression-free survival (PFS), and overall survival (OS) at 12-month follow up in the target population of patients with programmed cell death-ligand 1 (PDL-1) combined positive scores (CPS) >5% and in all patients treated (NEJM JW Oncol Hematol Aug 2021 and Lancet 2021; 398:27). There is ongoing debate about the utility of nivolumab in patients with low or negative expression of PDL-1.
Investigators now report updated results from CHECKMATE 649 at a minimum follow up of 24 months, including finding…