With Yervoy-beating data, Opdivo poised to fight melanoma's return after surgery

MADRID, Spain—Bristol-Myers Squibb has been pitting its immunotherapies Opdivo and Yervoy against melanoma as a combination treatment. But that doesn’t mean it’s not still testing the newer Opdivo on its own in the disease—even against its partner.

In fact, in a head-to-head trial in patients with advanced melanoma who had undergone surgery to remove their tumors, Opdivo has so far done a better job preventing cancer’s return—and with less likelihood of severe side effects.

Details of an interim analysis revealed at the European Society of Medical Oncology Congress Monday showed the difference. Opdivo cut the chance of a recurrence by more than a third compared with Yervoy, which is now the standard of care in that setting, the company said.

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“At the time the tumor is removed, often there are small deposits of cancer that can’t be seen,”  said Fouad Namouni, Bristol-Myers' head of oncology development, ahead of Monday's data release Those deposits “ultimately drive recurrence,” he said, “and once the disease has spread throughout the body, it’s incurable.”

“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.”

The company also hopes to add to Opidvo’s list of approvals, and moving the therapy into the post-surgery setting could add around $1 billion in potential sales, though some of that would come from patients who might otherwise have used Yervoy, Leerink analysts have said. Opdivo brought in $3.77 billion in 2016 sales, about four times its 2015 total, while Yervoy delivered $1.05 billion, slightly down from the previous year.

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In the CheckMate-238 trial, at 18 months of follow-up, 66.4% of Opdivo patients were recurrence-free, compared with 52.7% of patients in the Yervoy group. The results held true regardless of whether patients had tested positive for a BRAF mutation, the genetic abnormality Yervoy was first designed to target, though it's now approved for patients without it.

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 med is now approved as monotherapy to treat patients with inoperable or metastatic melanoma in both mutated and wild-type patients, and so is the combo of the two meds.

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.

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Another advantage for Opdivo in the study was tolerability. Less than 10% of the study patients taking Opdivo dropped out because of side effects, compared with 42.6% of those in the Yervoy group. Two Yervoy patients died from treatment-related maladies, more than 100 days after treatment.

“This is actually the first adjuvant study of a PD-1 inhibitor to demonstrate recurrence-free survival against the standard of care,” Vicki Goodman, head of new asset development, noted in an interview.

CheckMate-238 is an ongoing trial expected to be wrapped up by November 2019, with final data on the primary endpoint collected in November of next year, according to ClinicalTrials.gov.

Editor's note: This story was updated with additional quotes.