Bristol-Myers Squibb Company today announced four-year data from the Phase 3 CheckMate -067 clinical trial - the longest follow-up to date - which continues to demonstrate durable, long-term survival benefits with the first-line combination of Opdivo (nivolumab) and Yervoy (ipilimumab), versus Yervoy alone, in patients with advanced melanoma. With a minimum follow-up of 48 months, four-year overall survival rates were 53% for the Opdivo plus Yervoy combination, 46% for Opdivo alone, and 30% for Yervoy alone. Additionally, the percentage of patients experiencing a complete response have continued to increase with complete response rates of 21% for Opdivo plus Yervoy, 18% for Opdivo alone, and 5% for Yervoy alone.
In addition, results of an analysis of patients who were alive at the time of the four-year analysis showed that a higher proportion of patients were treatment-free (i.e., off study treatment and free of systemic subsequent therapy) in the combination group (71%) compared with the monotherapy groups (50% for Opdivo and 39% for Yervoy). The safety profile for Opdivo plus Yervoy in CheckMate -067 at four years was consistent with prior findings, with no new safety signals and no additional treatment-related deaths.
Data from CheckMate -067 (Presentation #LBA44) will be featured in an oral presentation at the European Society for Medical Oncology (ESMO) 2018 Congress in Munich, Germany, October 19-23, with simultaneous publication in The Lancet Oncology.
"These four-year results from CheckMate -067, which represent the longest follow-up to date for patients receiving combination therapy with nivolumab and ipilimumab, enhance our understanding of the potential long-term survival benefits of combination therapy, regardless of PD-L1 expression levels, to combat this aggressive form of melanoma," said CheckMate -067 investigator F. Stephen Hodi, M.D., director of the Melanoma Center at Dana-Farber Cancer Institute, and investigator at the Ludwig Center at Harvard. "To the best of our knowledge, we have not seen a 53% overall survival rate with any available treatment at four years of follow-up in a randomized setting."
"These latest results from CheckMate -067 provide further support of the long-term scientific rationale for combining Opdivo and Yervoy for the treatment of advanced melanoma," said Arvin Yang, M.D., Ph.D., development lead, melanoma and genitourinary cancers, Bristol-Myers Squibb. "This study advances our mission of understanding how we can best harness the body's immune system to fight this aggressive form of cancer and provide healthcare professionals and patients with a durable and safe treatment option."