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FDA Approves First Combination of Two Immuno-Oncology Agents

Bristol-Myers Squibb receives melanoma indication for Opdivo plus Yervoy

The FDA has approved nivolumab (Opdivo, Bristol-Myers Squibb) in combination with ipilimumab (Yervoy, Bristol-Myers Squibb) for the treatment of patients with BRAF V600 wild-type unresectable or metastatic melanoma.

The combination was approved through an accelerated pathway based on tumor response rate and durability of response. The approval was based on results from the pivotal CheckMate-069 study and provides clinical rationale for targeting the immune system with two immuno-oncology agents in metastatic melanoma.

The results demonstrated a statistically significant increase in the study’s primary endpoint, the confirmed objective response rate, in patients with BRAF wild-type melanoma treated with nivolumab plus ipilimumab (60%; 95% confidence interval [CI], 48–71%; P < 0.001) compared with those treated with ipilimumab monotherapy (11%; 95% CI, 3–25%).

Complete responses were seen in 17% of patients. Partial responses were seen in 43% of the combination regimen group and 11% of the monotherapy group. The combination regimen demonstrated a 60% reduction in the risk of progression versus monotherapy alone (hazard ratio, 0.40; 95% CI, 0.22–0.71; P < 0.002). Median progression-free survival was 8.9 months with the combination (95% CI, 7.0, not available) and 4.7 months with ipilimumab alone (95% CI, 2.8–5.3).

Yervoy was approved in 2011, while Opdivo was  approved at the end of 2014. The two drugs raked in sales of approximately $783 million in the first half of 2015. Reuters reported that the two-drug combination will cost $256,000 a year and that Wall Street analysts expect such drugs to generate at least $20 billion in sales per year by 2020.

The medications belong to a class of drugs called checkpoint inhibitors, which boost the immune system's response to cancer and are safer and more effective than chemotherapy. Many large pharmaceutical companies have their own checkpoint inhibitors. Drugmakers such as Pfizer, AstraZeneca, GlaxoSmithKline, Merck, and Eli Lilly are working toward developing checkpoint inhibitor combinations, either alone or with other companies.

Sources: Bristol-Myers Squibb, October 1, 2015; Reuters, October 1, 2015.

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