Bristol Myers Squibb has announced that the US FDA has approved Opdivo (nivolumab) for patients with advanced esophageal squamous cell carcinoma (ESCC). The drug is indicated after the patients were prior treated with fluoropyrimidine and platinum-based chemotherapy.
The approval is based on Phase 3 ATTRACTION-3 trial, which evaluated the efficacy in terms of overall survival. Opdivo was compared with taxane chemotherapy.
ATTRACTION-3 is a Phase-3, active-controlled, open-label trial, evaluated the efficacy of Opdivo versus docetaxel or paclitaxel. The drug was administered in patients with unresectable advanced, recurrent or metastatic esophageal squamous cell carcinoma, refractory or intolerant to at least one prior fluoropyrimidine- and platinum-based regimen. Overall survival was considered as the primary endpoint. In addition, the overall response rate, progression-free survival, and duration of response were also evaluated. The median overall survival was 10.9 months in patients on the Opdivo arm compared to 8.4 months in patients on docetaxel or paclitaxel arm. No statistically significant difference was observed in the overall response rate. Progression-free survival was 1.7 months in the Opdivo arm compared to 3.4 months in patients on chemotherapy.
The drug has received PRIORITY designation earlier for this indication.
Opdivo was developed in collaboration between BMS and Ono Pharmaceuticals. In 2011, an agreement was made; accordingly, BMS gained the territorial rights to develop and commercialize the drug. Ono Pharmaceuticals has retained the rights in Japan, South Korea, and Taiwan.