Bristol-Myers adds to impressive Opdivo survival data with PhIII melanoma results

Bristol-Myers Squibb ($BMY) has pulled the covers off of impressive Phase III data on Opdivo (nivolumab), pointing to a 73% survival rate among advanced melanoma patients after one year of therapy compared to 42% for the long-used chemo drug dacarbazine.

Bristol-Myers announced back in the summer that it was stopping Checkmate-066 early due to the clear benefits it was seeing for Opdivo in comparison with the control arm as a front-line therapy. And today the company followed up with the numbers. There was an impressive 58% reduction in the risk of death for patients with patients with wild-type BRAF advanced melanoma, investigators reported today. Of the 418 patients in the study, 40% in the Opdivo arm saw their tumors shrink, compared to 14% receiving chemo, which is likely to play a dwindling role in fighting melanoma. And the Opdivo arm also suffered from fewer adverse events.

The new late-stage data add to a growing and impressive body of data for the PD-1 checkpoint inhibitor, one of the leaders in a new class of drugs that can allow a strong immune response against cancer. Bristol-Myers has been racing ahead with studies on nivolumab to demonstrate its potential, most recently documenting a benefit for patients suffering from lung cancer, a major market opportunity for Bristol-Myers.

Bristol-Myers has been hustling through the clinic with nivolumab as it races against rivals like Merck ($MRK), AstraZeneca ($AZN) and Roche ($RHHBY). Merck recently won the first U.S. approval for its drug, now sold as Keytruda. The drugs dismantle the biologic machinery cancer cells used to stay hidden from the immune system. And a legion of investigators says that alone or in combination with other drugs they represent an important new development in the cancer field.

"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 randomized Phase III trial," said Caroline Robert, a professor at the Institute Gustave Roussy and lead author of the New England Journal of Medicine manuscript. (Earlier studies were single-arm affairs.) "This represents a major milestone in the study of treatment naïve patients with wild-type BRAF advanced melanoma."

The Phase III study was originally expected to run into the second half of next year, ISI's Mark Schoenebaum noted last June. And it was primarily for EU regulators, not the FDA. Nevertheless, it bodes well for other studies being conducted at Bristol-Myers.

- here's the release
- get the research abstract

Special Report: The top 15 late-stage blockbusters in the pipeline - Nivolumab, Bristol-Myers Squibb

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