Bristol Myers Squibb announced that the US FDA approved Opdivo plus chemotherapy (fluoropyrimidine- and platinum-containing chemotherapy) and Opdivo plus Yervoy (ipilimumab) for treating adult patients with unresectable advanced or metastatic esophageal squamous cell carcinoma (ESCC) as a first-line therapy irrespective of PD-L1 status.
The approval was based on the Phase 3 CheckMate -648 trial, which evaluated Opdivo plus chemotherapy and Opdivo plus Yervoy versus chemotherapy alone.
Opdivo plus chemotherapy - Opdivo plus chemotherapy showed superior overall survival compared to chemotherapy alone. The median overall survival was 13.2 months in Opdivo plus chemotherapy versus 10.7 months in the chemotherapy alone. In patients who expressed PD-L1, the median overall survival was 15.4 months in Opdivo plus chemotherapy versus 9.1 months in patients on chemotherapy alone. The median progression-free survival was 5.8 months for Opdivo plus chemotherapy combination versus 5.6 months in chemotherapy alone arm. In patients expressing PD-L1, the median progression-free survival was 6.9 months for Opdivo plus chemotherapy combination versus 4.4 months in patients on chemotherapy alone.
Opdivo plus Yervoy - The median overall survival was 12.8 months in Opdivo plus Yervoy arm versus 10.7 months with chemotherapy alone. Among the patients who expressed PD-L1, the median overall survival was 13.7 months in Opdivo plus Yervoy arm compared to 9.1 months in patients on chemotherapy alone. The median progression-free survival was 4.0 months for Opdivo plus Yervoy and 4.4 months for chemotherapy alone in patients expressing PD-L1. Median PFS was not statistically significant in patients expressing PD-L1.
The approval was reviewed under FDA’s Real-Time Oncology Review (RTOR) pilot program, a program aimed at approving effective treatments at the earliest.