Bristol-Myers squib’s Opdivo combined with Yervoy resulted in 52% of patients with being alive at five years, while 74% of patients treated with of those patients remained treatment-free, the longest follow-up to date results for dual Immuno-Oncology (I-O) therapy in a Phase 3, randomized, controlled trial.
PRINCETON, N.J.–(BUSINESS WIRE)–$BMY #BMS—Bristol-Myers Squibb Company (NYSE: BMY) today announced five-year results from the Phase 3 CheckMate -067 clinical trial, which continues to demonstrate improved overall survival with the first-line combination of Opdivo (nivolumab) plus Yervoy (ipilimumab), versus Yervoy alone, in patients with advanced metastatic melanoma. With a minimum follow-up of 60 months (five years), five-year overall survival rates were 52% for the Opdivo plus Yervoy combination, 44% for Opdivo alone, and 26% for Yervoy alone. Data from CheckMate -067 will be featured in the official Press Programme and in a Proffered Paper session at the European Society for Medical Oncology (ESMO) 2019 Congress in Barcelona, Spain (Presentation #LBA68_PR; Saturday, September 28 at 8:30 AM CEST) and simultaneously published in The New England Journal of Medicine.
The safety profile for Opdivo plus Yervoy was consistent with prior findings, with no new safety signals and no additional treatment-related deaths. At this five-year analysis, treatment-related adverse events were consistent with those previously reported and occurred in 300 (96%) patients in the combination group, 271 (87%) patients in the Opdivo group, and 268 (86%) patients in the Yervoy group; grade 3/4 adverse events occurred in 186 (59%), 73 (23%), and 86 (28%) patients, respectively.
The percentage of patients experiencing an objective response remained stable at 58% for Opdivo plus Yervoy, 45% for Opdivo alone, and 19% for Yervoy, while the percentage of patients experiencing a complete response continued to increase, with complete response rates at five years of 22% for Opdivo plus Yervoy, 19% for Opdivo alone, and 6% for Yervoy alone. In addition, the proportion of patients alive and treatment-free was 74% in the Opdivo plus Yervoy group and 58% and 45% for Opdivo alone and Yervoy alone, respectively.
Among patients with BRAF-mutant or wild-type tumors, the rate of overall survival at five years was 60% and 48%, respectively, in patients who received Opdivo plus Yervoy; 46% and 43% for Opdivo alone; and 30% and 25% for Yervoy alone. Health-related quality of life continued to be maintained during or following treatment with Opdivo alone or the combination of Opdivo plus Yervoy.
“Historically, positive five-year survival outcomes for patients with metastatic melanoma have been difficult to achieve,” said James Larkin, FRCP, Ph.D., CheckMate -067 lead investigator and Consultant Medical Oncologist at The Royal Marsden NHS Foundation Trust. “Now, with over half of patients treated with the nivolumab plus ipilimumab combination surviving to five years, and 74% of surviving patients remaining treatment-free, we have set a new and encouraging precedent.”
“The sustained long-term efficacy seen in the five-year CheckMate -067 data demonstrates the importance of dual Immuno-Oncology therapy,” said Arvin Yang, M.D., Ph.D., development lead, Melanoma and Genitourinary Cancers, Bristol-Myers Squibb. “This five year milestone represents exciting progress in delivering on our mission to significantly increase survival rates and maintain quality of life for patients with cancer across tumor types.”