On July 21, 2023 Bristol Myers Squibb (NYSE: BMY) reported that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended approval of Opdivo (nivolumab) as a monotherapy for the adjuvant treatment of adults and adolescents 12 years of age and older with completely resected stage IIB or IIC melanoma (Press release, Bristol-Myers Squibb, JUL 21, 2023, View Source [SID1234633355]). If approved, Opdivo would become the only PD-1 inhibitor that – between two approvals* – is indicated as an adjuvant treatment for patients within stages IIB, IIC, III, as well as stage IV resected melanoma. The European Commission (EC), which has the authority to approve medicines for the European Union (EU), will now review the CHMP recommendation.

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"Many patients with stage IIB or stage IIC melanoma face the difficult reality of disease recurrence within five years of surgery," said Gina Fusaro, Ph.D., vice president, global program lead, Bristol Myers Squibb. "In the data from the CheckMate -76K trial, Opdivo was shown to significantly reduce the risk of disease recurrence for these patients. The CHMP’s recommendation brings us closer to potentially providing Opdivo for use in treating additional earlier stages of melanoma in the adjuvant setting, addressing an unmet need for patients in the EU."

The positive opinion is based upon safety and efficacy results from the Phase 3 CheckMate -76K trial, in which, with a minimum follow-up of 7.8 months, Opdivo reduced the risk of recurrence or death by 58% versus placebo (hazard ratio [HR] 0.42; 95% CI 0.30-0.59; p < 0.0001).The safety profile of Opdivo was consistent with previously reported studies.

Results from CheckMate -76K were presented as late-breaking data at the 2022 Society for Melanoma Research (SMR) Annual Meeting.

CheckMate -76K is part of Bristol Myers Squibb’s development program which explores the use of Opdivo and Opdivo-based combinations in earlier stages of cancer.

Bristol Myers Squibb thanks the patients and investigators involved in the CheckMate –76K trial.

* In 2018 , based upon data from the CheckMate –238 trial, Opdivo was approved by the European Commission for the adjuvant treatment of adult patients with melanoma with involvement of lymph nodes or metastatic disease who have undergone complete resection.

About CheckMate -76K

CheckMate -76K is a randomized Phase 3, double-blind study evaluating adjuvant Opdivo (nivolumab) 480 mg Q4W for up to 12 months versus placebo in patients with completely resected stage IIB or IIC melanoma.

The primary endpoint of the trial is recurrence-free survival (RFS). Secondary endpoints of the trial include overall survival (OS), distant metastases-free survival (DMFS), progression-free survival on next-line therapy (PFS2), and safety endpoints.

About Melanoma

Melanoma is a form of skin cancer characterized by the uncontrolled growth of pigment-producing cells (melanocytes) located in the skin. Metastatic melanoma is the deadliest form of the disease and occurs when cancer spreads beyond the surface of the skin to other organs. Globally, the World Health Organization estimates that by 2035, melanoma incidence will reach 424,102, with 94,308 related deaths. Melanomas can be mostly treatable when caught in very early stages; however, survival rates can decrease as the disease progresses.