Bristol-Myers Squibb's Opdivo combination fails maintenance therapy trial in small-cell lung cancer

Bristol-Myers Squibb announced Monday that the PD-1 inhibitor Opdivo (nivolumab) in combination with its CTLA-4 inhibitor Yervoy (ipilimumab) failed to significantly extend overall survival (OS) versus placebo in the Phase III CheckMate -451 study of certain patients with extensive-stage small-cell lung cancer (SCLC). Company shares fell as much as 4 percent on the news. 

In the study, patients with extensive-stage SCLC who did not experience disease progression after first-line platinum-based chemotherapy were randomised to treatment with Opdivo plus Yervoy, Opdivo alone or placebo. The primary endpoint was OS for Opdivo plus Yervoy versus placebo, while the secondary objective was OS between Opdivo monotherapy versus placebo. 

Bristol-Myers Squibb said no new safety signals were observed for the combination regimen, adding that it will work with the study investigators concerning the publication of the CheckMate -451 data. 

In August, the FDA granted accelerated approval to Opdivo for patients with metastatic SCLC whose disease progressed after platinum-based chemotherapy and at least one other line of therapy. The approval is supported by data from the SCLC cohort of the Phase I/II CheckMate -032 trial, with results showing that 12 percent of patients responded to treatment with Opdivo, regardless of PD-L1 expression.

The agency cleared the combination of Opdivo and Yervoy for use in patients with BRAF V600 wild-type unresectable or metastatic melanoma in 2015. The regimen is also approved for the first-line treatment of certain patients with renal cell carcinoma, as well as for certain patients with microsatellite instability high or mismatch repair deficient metastatic colorectal cancer. 

Last month, the FDA extended its review of Bristol-Myers Squibb's filing seeking approval of Opdivo plus Yervoy as a first-line treatment for certain patients with advanced non-small-cell lung cancer by three months. 

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