Phase III CheckMate -648 trial of Opdivo shows survival benefits in oesophageal squamous cell carcinoma.- BMS

Bristol Myers Squibb announced positive topline results from the Phase III CheckMate -648 trial evaluating treatment with Opdivo (nivolumab) plus chemotherapy or Opdivo plus Yervoy (ipilimumab ) in patients with unresectable advanced or metastatic oesophageal squamous cell carcinoma (ESCC). In the study, Opdivo plus chemotherapy demonstrated a statistically significant and clinically meaningful benefit for the primary and secondary endpoints of overall survival (OS) in patients whose tumors express PD-L1 and in the all-randomized patient population at the pre-specified interim analysis. Additionally, Opdivo plus chemotherapy demonstrated a statistically significant and clinically meaningful improvement in the primary endpoint of progression-free survival (PFS) by blinded independent central review (BICR) in patients whose tumors express PD-L1. Opdivo plus Yervoy also met its primary and secondary endpoints by demonstrating statistically significant and clinically meaningful improvement in overall survival in patients whose tumors express PD-L1 and in the all-randomized population. Opdivo plus Yervoy did not meet its other primary endpoint of progression-free survival by BICR in patients whose tumors express PD-L1. The safety profiles of Opdivo and the combination of Opdivo and Yervoy were consistent with those previously reported. Comment: The data from CheckMate -648 build upon those from CheckMate -649, together making Opdivo the first and only PD-1/L1 inhibitor to demonstrate superior first-line survival in upper GI cancers across histologies and tumor locations (stomach, gastroesophageal junction, and esophagus). They also add to the existing body of data demonstrating the clinical benefit of Opdivo in esophageal cancer, from the late-line metastatic setting to earlier stages of disease.