BMS receives FDA approval for Opdivo Injection for metastatic colorectal cancer

Approval based on CheckMate -142, in which Opdivo demonstrated an objective response rate of 28% among patients who received prior treatment with a fluoropyrimidine, oxaliplatin, and irinotecan.

Approval for this indication has been granted under accelerated approval based on overall response rate (ORR) and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials. The recommended dose is 240 mg administered as an intravenous infusion over 60 minutes every 2 weeks until disease progression or unacceptable toxicity. In the CheckMate -142 trial, among patients who received prior treatment with a fluoropyrimidine, oxaliplatin and irinotecan, 28% responded to treatment with Opdivo. The percentage of patients with a complete response was 1.9% and the percentage of patients with a partial response was 26%. Among these responders, the median duration of response was not reached. Among all enrolled patients, 32% responded to treatment with Opdivo; 2.7% experienced a complete response, 30% experienced a partial response.

“As part of our commitment to address hard-to-treat cancers, with today’s approval, Opdivo provides a new treatment option for these patients who have historically faced a poor prognosis,” said Chris Boerner, president, US Commercial, BMS. “This approval is one example of how our commitment to translational medicine and investigating predictive biomarkers may help us discover treatment approaches to address different patients’ unique needs.”

“Patients with metastatic colorectal cancer who have dMMR or MSI-H tumors are less likely to respond to conventional chemotherapy,” said Heinz-Josef Lenz, Terrence Lanni Chair in Gastrointestinal Cancer Research, University of Southern California. “While the challenges of treating these patients have been significant, tumours characterized by these biomarkers are immunogenic. Therefore, advances in immunotherapy research are encouraging in presenting new treatment options for appropriate patients with MSI-H metastatic colorectal cancer.”