The trial has not achieved its primary endpoint of OS with Opdivo (nivolumab) 1mg/kg in combination with Yervoy (ipilimumab) 3mg/kg against placebo as a maintenance therapy for patients with extensive-stage small cell lung cancer (SCLC) after completion of first-line platinum-based chemotherapy.
Opdivo 1 mg/kg plus Yervoy 3mg/kg combination has not generated any new safety signals in the CheckMate -451 study.
The CheckMate -451 is a global, double-blind and randomized phase 3 study designed to assess Opdivo in combination with Yervoy and Opdivo monotherapy against placebo as a maintenance therapy in patients with extensive-stage SCLC.
Opdivo is a programmed death-1 (PD-1) immune checkpoint inhibitor designed to harness the body’s own immune system for restoring anti-tumor immune response.
The global development program of the inhibitor is based on the firm’s scientific expertise in the field of immuno-oncology. The program is comprised of various clinical trials across all phases, including phase 3, in different tumor types.
Opdivo was first approved in July 2014. It is currently approved in over 65 countries, including the US, the EU, Japan and China.
In October 2015, the Opdivo and Yervoy combination regimen secured regulatory approval to treat metastatic melanoma. It is presently approved in over 50 countries.
Opdivo as a single agent intended to treat patients with BRAF V600 mutation-positive unresectable or metastatic melanoma. As a single agent, it is also intended to treat patients with BRAF V600 wild-type unresectable or metastatic melanoma.
Other Checkmate trials include Checkmate 067 trial for advanced melanoma, Checkmate 214 trial for intermediate or poor risk advanced renal cell carcinoma, Checkmate 142 trial for MSI-H/dMMR metastatic colorectal cancer.
In 2011, Bristol-Myers Squibb entered into a collaboration agreement with Ono Pharmaceutical to expand it territorial rights to develop and commercialize Opdivo across the globe, excluding Japan, South Korea and Taiwan. Ono had retained the rights in these regions.
In July 2014, both firms further expanded their collaboration to develop and commercialize multiple immunotherapies.