Landmark 10-year follow-up data from CheckMate -067 which showed continued durable long-term survival benefit with Opdivo (nivolumab) + Yervoy (ipilimumab) in advanced melanoma

With a minimum follow up of 10 years, median overall survival (OS) was 71.9 months with Opdivo plus Yervoy (95% CI: 38.2-114.4) - the longest reported median OS in a Phase III advanced melanoma trial - 36.9 months with Opdivo (95% CI: 28.2-58.7) and 19.9 months with Yervoy (95% CI: 16.8-24.6). These data are being presented and were included in an official press conference at the European Society for Medical Oncology (ESMO) Congress 2024 in Barcelona, Spain (LBA43), as well as simultaneously published in The New England Journal of Medicine.

Among all randomized patients in the trial, 64% of patients who received the combination, 50% of Opdivo -treated patients and 33% of Yervoy -treated patients did not receive subsequent systemic therapy at the 10-year follow up mark.

“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, Department of Medical Oncology, The Royal Marsden. “Remarkably, 43% of patients treated with nivolumab and ipilimumab are alive ten years later and many did not need subsequent therapy.”

In addition, at 10 years of follow up, the Opdivo plus Yervoy combination showed melanoma-specific survival (MSS) rates of 52% (median not reached) compared to 44% (median of 49.4 months) and 23% (median of 21.9 months) among patients treated with Opdivo alone and Yervoy alone, respectively.

“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,” said Dana Walker, M.D., M.S.C.E., vice president, global program lead, melanoma and gastrointestinal and genitourinary cancers, Bristol Myers Squibb. “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.”

Durable, sustained clinical benefit was also observed with Opdivo plus Yervoy or Opdivo alone across relevant subgroups, including in patients with BRAF mutation and wild-type tumors. Among patients with BRAF -mutant tumors, the rate of OS at 10 years was 52% (95% CI: 42-62) in patients who received Opdivo plus Yervoy , 37% (95% CI: 27-46) for Opdivo alone, and 25% (95% CI: 17-34) for Yervoy alone. In patients with BRAF wild-type tumors, the rate of OS at 10 years was 39% (95% CI: 32-46) in patients who received Opdivo plus Yervoy , 37% (95% CI: 31-44) for Opdivo alone and 17% (95% CI: 12-23) for Yervoy alone. At 10 years of follow up, the objective response rate (ORR) was higher for the two Opdivo groups, in combination with Yervoy and alone, at 58.3% and 44.9%, respectively than the Yervoy group at 19.0%. The median duration of response (DoR) was not reached for those who received Opdivo plus Yervoy, while the median DoR was 103.2 months for Opdivo -treated patients and 19.2 months for Yervoy -treated patients.

The safety profile for Opdivo plus Yervoy was consistent with prior findings, with no new safety signals observed and no additional treatment-related deaths occurring since the prior three analyses. Grade 3/4 treatment-related adverse events were reported in 62.6% of patients in the combination group, 24.6% of patients in the Opdivo group, and 29.6% of patients in the Yervoy group.

Citation:"Final, 10-Year Outcomes with Nivolumab plus Ipilimumab in Advanced Melanoma";Authors: Jedd D. Wolchok, M.D., Ph.D., Vanna Chiarion-Sileni, M.D., Piotr Rutkowski, M.D., Ph.D., C. Lance Cowey, M.D., M.P.H., Dirk Schadendorf, M.D. , John Wagstaff, M.D., Paola Queirolo, M.D., +25, for the CheckMate 067 Investigators* Published NEJM, September 15, 2024