Bristol-Myers wraps nivolumab PhIII cancer trial early on promising survival benefit

Bristol-Myers Squibb claimed bragging rights to the first batch of Phase III data on an immuno-oncology drug that clearly demonstrated an improvement over a standard therapy for overall survival.

The big biotech announced Tuesday evening that it hit the brakes earlier than planned on a late-stage study of its closely-watched immuno-oncology drug nivolumab after the monitoring committee overseeing interim data concluded that the PD-1 drug provided a clear survival benefit over dacarbazine for BRAF wild-type advanced melanoma when used as a frontline therapy.

As generally happens in these cases, the patients in the control arm will now be invited to use nivolumab to treat their melanoma.

Michael Giordano

"The outcome of CheckMate-066 is an important milestone in the field of immuno-oncology as it represents the first well-controlled, randomized Phase III trial of an investigational PD-1 checkpoint inhibitor to demonstrate an overall survival benefit," says Michael Giordano, Bristol-Myers' chief of oncology development, in a statement.

The company added that it plans to share these results with regulators. Regulators at the FDA have already designated this drug as a "breakthrough" therapy deserving an open door at the agency as Bristol-Myers hunts for its first approval for the drug. Shares of Bristol-Myers ($BMY) were up a little more than 2% in after-market trading.

The Phase III study was originally expected to run into the second half of next year, noted ISI's Mark Schoenebaum in a quick investor's note. And it was primarily for EU regulators, not the FDA. But it could portend good things for another key study, possibly highlighting a shot at a clinical shortcut.

"If nothing else, the early stopping of CHECKMATE 066 (nivolumab vs the chemotherapy dacarbazine in ~400 naïve patients) in our minds increases the probability that the next ph 3 trial for BMY in melanoma, CHECKMATE 037 (Nivolumab vs chemotherapy following failure of Yervoy in ~400 patients) could very well stop early for benefit," wrote Schoenebaum. "The primary completion data for CHECKMATE 037 data is May 2015 according to clinicaltrials.gov."

Bristol-Myers has been hustling through the clinic with nivolumab as it races against rivals like Merck ($MRK), AstraZeneca ($AZN) and Roche ($RHHBY) in proving that these drugs can have a major impact on the treatment of cancer. The drugs dismantle the biologic machinery cancer cells used to stay hidden from the immune system. And investigators say that alone or in combination with other drugs they represent an important new development in the cancer field.

Some analysts estimate that this type of immuno-oncology drug could open up a new market to drugmakers worth anywhere from $25 billion to $35 billion a year. Those kinds of numbers have not gone unnoticed, driving a multitude of new research deals and collaborations as everyone active in oncology looks to carve out a place for themselves in the burgeoning field.

Dacarbazine (DTIC) has been used as a singe therapy against melanoma since 2006.

- here's the release

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