Bristol Myers Squibb has presented groundbreaking 10-year follow-up data from its CheckMate -067 trial, which highlights the long-term survival benefits of the Opdivo (nivolumab) and Yervoy (ipilimumab) combination in treating advanced melanoma. These results, revealed at the European Society for Medical Oncology (ESMO) Congress 2024 in Barcelona, Spain, mark the longest reported median overall survival from a Phase 3 advanced melanoma trial. The data were also published in The New England Journal of Medicine.

Unprecedented Survival Outcomes

The CheckMate -067 trial data demonstrate that more than 40% (43%) of patients treated with the combination of Opdivo and Yervoy are alive ten years post-treatment. A decade ago, the survival rate for this patient population was approximately 25% after only one year. The median overall survival (OS) was recorded at 71.9 months for the combination therapy group, compared to 36.9 months for those treated with Opdivo alone, and 19.9 months for Yervoy alone. This represents a significant advancement in the treatment of advanced melanoma, with the Opdivo and Yervoy combination offering the longest median OS recorded in such trials.

“These data continue to demonstrate the impressive and durable clinical benefit of nivolumab in combination with ipilimumab, with survival curves remaining stable for some years now,” said James Larkin, Ph.D., FRCP, Consultant Medical Oncologist at The Royal Marsden. “Remarkably, 43% of patients treated with nivolumab and ipilimumab are alive ten years later, and many did not need subsequent therapy.”

Durable Clinical Benefits Across Patient Subgroups

The benefits of Opdivo plus Yervoy extend across different patient subgroups. In patients with BRAF-mutant tumors, the 10-year OS rate was 52% for those receiving the combination therapy, 37% for Opdivo alone, and 25% for Yervoy alone. For patients with BRAF wild-type tumors, the 10-year OS rate was 39% for the combination therapy, 37% for Opdivo alone, and 17% for Yervoy alone.

Furthermore, melanoma-specific survival (MSS) rates at 10 years were 52% for the combination therapy, compared to 44% for Opdivo alone and 23% for Yervoy alone. These statistics show that the combination therapy not only prolongs life but also delays the need for subsequent systemic therapy.

Safety Profile and Future Implications

The safety profile of the combination therapy remains consistent with prior findings, with no new safety signals or additional treatment-related deaths reported since previous analyses. However, Grade 3/4 treatment-related adverse events were noted in 62.6% of patients in the combination group, compared to 24.6% and 29.6% in the Opdivo and Yervoy monotherapy groups, respectively.

Dana Walker, M.D., M.S.C.E., vice president and global program lead for melanoma and gastrointestinal and genitourinary cancers at Bristol Myers Squibb, emphasized the significance of these results: “Just over a decade ago, an advanced melanoma diagnosis meant that you likely only had months to live. The dual immunotherapy combination of Opdivo plus Yervoy has radically changed this outlook for many of these patients. Our goal was – and still is today – to redefine survival expectations for patients with melanoma; these data demonstrate our commitment to that objective and continue to provide hope.”

Looking Ahead

The CheckMate -067 trial results highlight the transformative potential of immunotherapy in treating advanced melanoma. As Bristol Myers Squibb continues to innovate in cancer treatment, the company remains committed to advancing research and improving survival outcomes for patients worldwide.

  advanced melanoma treatment, Bristol Myers Squibb, Cancer immunotherapy, CheckMate -067, ESMO Congress 2024, long-term survival benefit, melanoma clinical trial, Opdivo, Yervoy