Bristol Myers Squibb announced that the European Commission (EC) has approved its Opdivo (nivolumab) as an adjuvant treatment for patients with completely resected stage IIB or IIC melanoma.

EC has expanded Opdivo’s label as a monotherapy for adults and adolescents 12 years of age and older who have undergone complete resection.

Opdivo is a programmed death-1 (PD-1) immune checkpoint inhibitor. It uses the body’s own immune system to help restore anti-tumour immune response.

The approval was based on the findings from the Phase 3 CheckMate -76K trial with a minimum follow-up of 7.8 months.

According to the results, Opdivo lowered the risk of recurrence or death in patients with stage IIB or IIC melanoma by 58% compared to placebo.

Additionally, 12-month recurrence-free survival (RFS) rates for Opdivo were 89% versus 79% for placebo.

Its safety profile was also found to be similar to previously reported studies.

Bristol Myers Squibb global program lead and VP Gina Fusaro said: “With this approval, we can now offer patients in the European Union with stage IIB or IIC resected melanoma an efficacious treatment option that significantly reduced the risk of disease recurrence.

“This approval builds on our long-standing commitment to bring innovative medicines to patients across the cancer spectrum, including in earlier stages of cancer. We thank all the patients, researchers, and physicians who were involved along the way to help make this additional option for patients possible.”

CheckMate -76K is a randomised, double-blind trial that assessed adjuvant Opdivo 480 mg Q4W for up to 12 months against placebo.

The primary endpoint of the study was defined as the recurrence-free survival (RFS).

Key secondary endpoints included overall survival (OS), distant metastases-free survival (DMFS), progression-free survival on next-line therapy (PFS2), and safety endpoints.

The company is also using CheckMate -76K to evaluate Opdivo and Opdivo-based combinations in earlier lines of cancer treatment.

As of now, the Opdivo clinical development programme has treated over 35,000 patients.

In March last year, the US Food and Drug Administration (FDA) cleared Opdivo plus chemotherapy to treat a type of non-small cell lung cancer (NSCLC).