Bristol's Opdivo-Yervoy combo fails to top Opdivo in adjuvant melanoma

Bristol-Myers Squibb’s Opdivo-Yervoy combo has changed the game in late-stage melanoma, but it's hit a roadblock in expanding to post-surgery treatment.

In patients with advanced cancer but no evidence of disease after surgery, and with levels of biomarker PD-L1 checking in below 1%, the duo couldn’t top solo Opdivo at staving off recurrence, BMS said Wednesday.

But the study, dubbed Checkmate-915, isn’t over. The company is also testing the pair against Opdivo in the all-comer population—i.e., patients with any level of PD-L1—to see whether two drugs are better than one in preventing recurrence among other patients.

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The company has reason to believe they might be. Opdivo and its fellow members of the PD-1/L1 class have shown that in some disease settings, they work better among patients with higher levels of the protein.

For now, though, the news is a dent in BMS’ plans to extend the pair’s melanoma reach—and to boost its revenue potential in the adjuvant setting. Right now, Opdivo and Yervoy together bear a green light only in patients whose melanoma is metastatic or can’t be surgically removed, and only solo Opdivo has the FDA’s OK for adjuvant therapy.

In a hyper-competitive immuno-oncology marketplace, melanoma has been a cornerstone of Opdivo’s sales—particularly as it's stumbled in lung cancer, considered the most lucrative disease-area for the drug and its rivals.

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And in September, BMS added more evidence to support use of its cancer-fighting combo in advanced melanoma. At the European Society for Medical Oncology annual meeting, the New Jersey drugmaker presented data showing that Opdivo and Yervoy had kept more than half of patients in the Checkmate-067 study alive for five years.