Bristol-Myers Squibb's Opdivo superior to chemotherapy in Phase III trial in advanced melanoma

Bristol-Myers Squibb announced Sunday research data showing that its PD-1 inhibitor Opdivo (nivolumab) met its primary endpoint of overall survival, outperforming dacarbazine in a Phase III study of 418 treatment-naïve patients with advanced melanoma. The drugmaker revealed in June that it was halting the Checkmate-066 trial early after an independent Data Monitoring Committee determined that the therapy was associated with improved survival versus chemotherapy.

In the Checkmate-066 trial, which was presented at the Society for Melanoma Research International Congress and for which results were also published in the NEJM, 418 previously untreated patients with advanced melanoma were randomised to receive Opdivo or dacarbazine. Study data illustrated that 73 percent of patients in the Opdivo arm were alive after one year, compared to 42 percent for the dacarbazine group. Bristol-Myers Squibb noted that a survival benefit was observed in both PD-L1-positive and PD-L1-negative/indeterminate patients.

Meanwhile, median progression-free survival was 5.1 months for the Opdivo arm, compared to 2.8 months for the dacarbazine group. Additionally, 40 percent of Opdivo-treated patients experienced tumour shrinkage, versus 14 percent for the dacarbazine arm. Caroline Robert, author of the NEJM article, stated "the results from CheckMate-066 are significant as they represent the first time a PD-1 immune checkpoint inhibitor has shown a survival benefit in a randomised Phase 3 trial."

Opdivo became the first PD-1 inhibitor available anywhere in the world after the therapy was launched in Japan for the treatment of unresectable melanoma at an average annual cost of $143 000 per patient in September. Bristol-Myers Squibb, which was granted rights to the drug outside Japan, Korea and Taiwan by Ono Pharmaceutical in 2011, recently announced that Opdivo was granted priority review by the FDA and accelerated assessment by the European Medicines Agency.

Meanwhile, Merck & Co.'s Keytruda (pembrolizumab) became the first PD-1 inhibitor approved in the US in September (for further analysis, see Physician Views Poll Results: The PD-1 inhibitor class lands – how do US oncologists expect to initially use Merck & Co.'s Keytruda?). Bristol-Myers Squibb subsequently filed a lawsuit against Merck for allegedly infringing a new immunotherapy patent.

For related analysis, see ViewPoints: Investors respond in kind to impressive data for Bristol-Myers Squibb NSCLC immunotherapy.

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