Bristol Myers' Opdivo win tees up showdown with Keytruda in earlier-stage melanoma

On the heels of Merck & Co. rival Keytruda’s green light as an adjuvant treatment for earlier-stage melanoma, Bristol Myers Squibb’s Opdivo has ginned up data suggesting it won’t be locked in advanced disease for long.

Opdivo, also known as nivolumab, has notched a win in the late-stage CheckMate -76K trial testing the drug solo in the adjuvant setting for patients with completely resected stage IIB/C melanoma, Bristol Myers said Thursday. The drug met its primary endpoint and charted both statistically significant and clinically meaningful benefit in staving off disease recurrence or death versus placebo, the company added.

No new safety signals flared up at the time of the Opdivo interim analysis, BMS pointed out.

The trial win doesn’t come as a total shock following a similar approval for Merck’s PD-1 rival Keytruda back in December. That month, the FDA signed off on the New Jersey pharma’s immune-oncology cash cow for adults and kids with stage IIB/C melanoma following complete resection.

Keytruda’s earlier-stage melanoma approval leveraged data from the KEYNOTE-716 trial, which found Merck’s drug—like Opdivo—also boasted a statistically significant improvement in recurrence-free survival at the time of the study’s first interim analysis.

Now, with its own phase 3 win on hand, Opvido has the data to potentially tussle with Keytruda earlier in the melanoma lifecycle. Bristol's drug was approved in stage IIIB/C and stage IV disease after surgery back in 2017.

“Treating with Opdivo in earlier stages of cancer, when the immune system may be more responsive, has the potential to help prevent recurrence—a critical goal of improving patient outcomes,” Gina Fusaro, Ph.D., melanoma program development lead at BMS, said in a statement included in the company’s data reveal.

Next up for BMS is a “full evaluation” of the Checkmate-76K study. Bristol says it plans to present the data at an upcoming conference and share it with health authorities, too.

Opdivo’s latest melanoma victory follows several regulatory and pricing wins for the drug, tempered by a combo flop in postsurgery kidney cancer. In late May, Bristol’s drug won FDA backing both in combination with chemotherapy and with Yervoy in newly diagnosed, advanced esophageal squamous cell carcinoma (ESCC), giving BMS a shot to challenge Keytruda in previously untreated patients.

And in July, Opdivo snared the blessing of U.K. cost watchdog NICE in muscle-invasive bladder cancer patients whose disease is at high risk of returning after surgery.

Still, it hasn’t all been smooth sailing for Opdivo, which stumbled in kidney cancer with its sibling Yervoy earlier this summer. An independent data review panel in July concluded that the immuno-oncology duo had failed as an adjuvant in a phase 3 study in localized kidney cancer.

The Opdivo-Yervoy flop followed Roche’s disclosure that Tecentriq had tripped in high-risk patients, too, making Merck’s Keytruda the only PD-1/L1 inhibitor with a clinical win—and an approval—in postsurgery early-stage kidney cancer.