Opdivo Approved in Europe for Additional Use in Melanoma Patients

July 31, 2018
  • Approval makes Opdivo the only PD-1 with EC approval in adjucant setting
  • The indication is for both BRAF mutant and wild-type melanoma
  • Approval based on superior results vs Yervoy in Ph III trial

Bristol-Myers Squibb Company (NYSE:BMY) announced on 7/31/18 that the European Commission (EC) has approved Opdivo (nivolumab) for the adjuvant treatment of adult patients with melanoma with involvement of lymph nodes or metastatic disease who have undergone complete resection. This indication is for both BRAF mutant and wild-type melanoma patients. With this decision, Opdivo becomes the first and only PD-1 therapy to receive an EC approval in the adjuvant setting and has gained its eighth indication across six distinct tumor types in the European Union (EU).

“Stage III and IV melanoma patients are at high risk for disease recurrence after surgical removal and, therefore, in need of effective interventions to prevent recurrence,” said James Larkin, M.D., Ph.D., Consultant Medical Oncologist, The Royal Marsden. “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.”

The EU approval is based on results from the ongoing Phase 3 randomized double-blind CheckMate -238 trial, which studied Opdivo 3 mg/kg versus Yervoy 10 mg/kg in patients who have undergone complete resection of stage IIIB/C or stage IV melanoma according to the AJCC Cancer Staging Manual 7th edition. The 18-month recurrence-free survival (RFS) was 66.4% for Opdivo (95% CI: 61.8 to 70.6) versus 52.7% for Yervoy (95% CI: 47.8 to 57.4). Meanwhile, Opdivo reduced the risk of disease recurrence by 35% versus Yervoy (HR 0.65; 95% CI: 0.53 to 0.80; p <0.0001). Additionally, adjuvant treatment with Opdivo was well tolerated, with 14.4% of patients experiencing treatment-related grade 3/4 adverse events and 9.7% discontinuing due to toxicity

In December 2017, the U.S. Food and Drug Administration (FDA) approved Opdivo as an adjuvant therapy to treat melanoma patients with involvement of lymph nodes or metastatic disease who have undergone complete resection.

Opdivo is a programmed death-1 (PD-1) immune checkpoint inhibitor that is designed to uniquely harness the body’s own immune system to help restore anti-tumor immune response. By harnessing the body’s own immune system to fight cancer, Opdivo has become an important treatment option across multiple cancers.

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