Opdivo Approved for Adjuvant Treatment of Melanoma in European Union

Bristol-Myers Squibb (BMS) recently announced that the European Commission (EC) has approved nivolumab (Opdivo) for the adjuvant treatment of adult patients with melanoma that have lymph node involvement or metastatic disease and who have undergone complete resection.

With the approval, nivolumab has become the first programmed cell death protein-1 (PD-1) inhibitor to receive an EC approval in the adjuvant setting. The indication also applies for both BRAF mutant and wild-type expressing melanoma patients and makes it the 8th indication for nivolumab across 6 distinct tumor types in the European Union.

“We are excited that Opdivo has become the first PD-1 agent to receive an approved indication in the adjuvant setting. Today’s approval helps strengthen patients’ confidence in reducing the risk of recurrence and progression of melanoma after primary treatment and furthers our commitment to continuously explore new approaches that benefit more patients,” said Fouad Namouni, MD, head of oncology development at BMS, in a statement.

The approval is based on results from the ongoing phase 3 randomized, double-blind CheckMate-238 trial which is investigating nivolumab versus ipilimumab (Yervoy) in patients who have undergone complete resection of stage IIIB/C or stage IV melanoma. The trial randomized 906 patients 1:1 to receive either nivolumab 3 mg/kg every 2 weeks (n = 453) or ipilimumab 10 mg/kg (n = 453) every 3 weeks for 4 doses, and then every 12 weeks beginning at week 24. Patients were treated until disease recurrence, unacceptable toxicity, or withdrawal of consent for up to 1 year.

The primary endpoint of the trial is recurrence-free survival (RFS), defined as the time between randomization and the date of first recurrence, new primary melanoma, or death. The 18-month RFS was 66.4% for nivolumab (95% confidence interval [CI], 61.8 to 70.6) versus 52.7% for ipilimumab (95% CI, 47.8 to 57.4).

In addition, adjuvant treatment of nivolumab was well tolerated, with only 14.4% of patients experiencing treatment-related grade 3 or 4 adverse events and 9.7% discontinuing due to toxicity.

“This is an important new treatment option, as the data support the benefit of nivolumab across a broad range of patients to address concerns around recurrence post-surgery,” said James Larkin, MD, PhD, consultant medical oncologist at The Royal Marsden in a statement.