Bristol-Myers Squibb stops late-stage study of Opdivo early after hitting main goal

Bristol-Myers Squibb stopped a Phase III trial of Opdivo (nivolumab) versus docetaxel in previously treated patients with advanced non-squamous non-small-cell lung cancer (NSCLC) early on the advice of an independent data monitoring committee after the study met its primary endpoint. In the CheckMate-057 trial, the PD-1 inhibitor demonstrated superior overall survival compared to docetaxel.

In the study, 582 patients with non-squamous NSCLC were randomised to treatment with Opdivo every two weeks or docetaxel every three weeks. The primary endpoint of the study was overall survival, while secondary endpoints included objective response rate and progression-free survival. Bristol-Myers Squibb noted that patients in the study will be offered an opportunity for open-label treatment with Opdivo in part as an effort to clarify long-term survival.

"The results...mark the second time Opdivo has demonstrated a survival advantage in lung cancer," remarked Michael Giordano, head of development, oncology at Bristol-Myers Squibb. In January, the company halted the Phase III CheckMate-017 study in patients with advanced squamous NSCLC after Opdivo met the primary endpoint, extending overall survival by an average 3.2 months versus docetaxel. The results supported FDA approval of the therapy last month for the treatment of advanced squamous NSCLC in patients who progressed on or after platinum-based therapy.

In December last year, the FDA granted accelerated approval to Opdivo for the treatment of patients with unresectable or metastatic melanoma who no longer respond to other drugs. The therapy was initially launched in Japan in September 2014 for the treatment of melanoma at a cost of $143 000 per year, making it the first PD-1 inhibitor to be marketed anywhere in the world.

Analysts have estimated that PD-1 and PD-L1 inhibitors could amass more than $30 billion in annual revenue by 2025. Sanford Bernstein analyst Tim Anderson said that Opdivo is expected to be the market leader among the PD-1 inhibitors, with peak annual sales of $7 billion by 2020. However, Anderson suggested that "because of the size of the I/O opportunity, in our view there will be more than one way to win."

Merck & Co. recently said it will apply around midyear to expand its PD-1 inhibitor Keytruda (pembrolizumab), currently approved in the US against melanoma, for use in patients with NSCLC whose disease progressed on or following platinum-containing chemotherapy. For related analysis, see ViewPoints: Bristol-Myers Squibb set to cash in on speedy approval of Opdivo in lung cancer.

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