Bristol Myers Squibb Reveals 10-Year Data on Opdivo® + Yervoy® Survival Benefit in Advanced Melanoma

Bristol Myers Squibb recently unveiled long-term data from the CheckMate -067 clinical trial, highlighting significant survival benefits for advanced melanoma patients treated with Opdivo (nivolumab) plus Yervoy (ipilimumab) or Opdivo alone, compared to Yervoy monotherapy. The 10-year follow-up results were presented at the European Society for Medical Oncology (ESMO) Congress 2024 in Barcelona, Spain, and published in The New England Journal of Medicine.

The trial involved 945 patients with advanced or metastatic melanoma who were previously untreated. The study's most remarkable finding is the median overall survival (OS) of 71.9 months for patients receiving the Opdivo and Yervoy combination, which is the longest reported median OS in a Phase 3 advanced melanoma trial. In comparison, the median OS for patients treated with Opdivo alone was 36.9 months, and 19.9 months for those treated with Yervoy alone.

At the decade mark, 64% of patients in the combination group did not require further systemic therapy, while this figure was 50% for the Opdivo monotherapy group and 33% for the Yervoy group. James Larkin, a Consultant Medical Oncologist at The Royal Marsden, noted the durability of the clinical benefits, with 43% of patients in the combination therapy group still alive after ten years.

Additionally, the melanoma-specific survival (MSS) rate was 52% for the combination therapy, compared to 44% for Opdivo alone and 23% for Yervoy alone. Dana Walker, Global Program Lead for melanoma at Bristol Myers Squibb, emphasized that the dual immunotherapy regimen has significantly altered the survival outlook for advanced melanoma patients.

Subgroup analysis showed consistent clinical benefits across various patient groups, including those with BRAF-mutant and BRAF wild-type tumors. For patients with BRAF-mutant tumors, the 10-year OS rates were 52% for the combination therapy, 37% for Opdivo alone, and 25% for Yervoy alone. Among patients with BRAF wild-type tumors, the 10-year OS rates were 39% for the combination, 37% for Opdivo alone, and 17% for Yervoy alone.

The objective response rate (ORR) was significantly higher for the combination therapy and Opdivo alone (58.3% and 44.9%, respectively) compared to Yervoy monotherapy (19.0%). The median duration of response (DoR) was not reached for the combination therapy, while it was 103.2 months for Opdivo alone and 19.2 months for Yervoy alone.

The safety profile of the combination therapy was consistent with previous findings. No new safety concerns were reported, and treatment-related adverse events were in line with earlier analyses. Grade 3 or 4 treatment-related adverse events occurred in 62.6% of patients in the combination group, 24.6% in the Opdivo group, and 29.6% in the Yervoy group.

CheckMate -067 is a pivotal Phase 3 trial that tested the efficacy of combining Opdivo and Yervoy or using Opdivo alone against Yervoy alone in advanced melanoma patients. The trial's primary endpoints were overall survival (OS) and progression-free survival (PFS), and secondary endpoints included objective response rates (ORR) and safety assessments.

Melanoma, a severe form of skin cancer, has been rising in incidence globally, with significant mortality rates in its advanced stages. Early detection greatly enhances treatability, but survival rates drop as the disease progresses. The latest results from the CheckMate -067 trial offer a beacon of hope, underscoring the potential of combination immunotherapy to extend and improve the lives of melanoma patients significantly.