Bristol-Myers' Opdivo gets into high gear for new melanoma approval

Early, early, early. Bristol-Myers Squibb has been on a sprint with Opdivo in a new group of melanoma patients—with an early trial halt, a quick unveiling of detailed data, and now, a speedy review at the FDA for a new approval.

The agency put Opdivo in the fast lane as a treatment for high-risk melanoma patients whose tumors have been surgically removed, based on data from a study, called Checkmate-238, that tested the immunotherapy against its fellow Bristol-Myers drug Yervoy.

The idea is to prevent the cancer from coming back rather than waiting to treat a recurrence, Fouad Namouni, M.D., Bristol-Myers' head of oncology development, told FiercePharma when the study data was released last month. “At the time the tumor is removed, often there are small deposits of cancer that can’t be seen," he said. Those deposits “ultimately drive recurrence, and once the disease has spread throughout the body, it’s incurable.”

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In the Checkmate-238 study, Opdivo cut the chance of a melanoma recurrence by more than a third compared with Yervoy, which is now the standard of care in that setting, the company said. At 18 months of follow-up, 66.4% of Opdivo patients were recurrence-free, compared with 52.7% of patients in the Yervoy group.

“Potentially we can prevent those types of recurrence and improve survival, by treating at an earlier stage before it spreads throughout the body,” Namouni said. “Hopefully we can demonstrate a survival benefit in these patients.”

Opdivo patients also suffered fewer side effects; 10% of the Opdivo patients dropped out of the study because of side effects, compared with more than 40% of Yervoy patients.

Moving the therapy into the postsurgery field could add around $1 billion in potential sales, Leerink Partners analysts have said, though some of that would come from patients who might otherwise have used Yervoy. Opdivo brought in $3.77 billion in 2016 sales, about four times its 2015 total, while Yervoy delivered $1.05 billion, down slightly from the previous year.

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Opdivo has proven effective at treating advanced melanoma after a recurrence; in fact, in a previous trial, more than one-third of patients were still alive after five years. The drug is now approved as monotherapy to treat patients with inoperable or metastatic melanoma in both mutated and wild-type patients, and so is the Opdivo-Yervoy combo.

Median recurrence-free survival hadn’t yet been reached at the time the analysis was conducted, and overall survival—a secondary endpoint—has not yet been calculated, either, with up to 48 months of follow-up planned.

With the early stop, the study did not produce data showing that Opdivo could actually extend patients' lives. Follow-up is planned through 2019 to generate some numbers in that vein, but the Yervoy patients in Checkmate-238 were given the chance to switch to Opdivo, and those crossovers can muddy comparisons.