OREANDA-NEWS. Bristol-Myers Squibb Company (NYSE:BMY) announced today results from two trials evaluating the Opdivo and Yervoy combination regimen in advanced melanoma. In the pivotal Phase 3 trial, CheckMate -067 trial, at a minimum follow-up of 18 months, the Opdivo and Yervoy combination demonstrated continued clinical benefit with a 58% reduction in the risk of disease progression versus Yervoy monotherapy (HR=0.42 [99.5% CI: 0.31-0.57; p<0.0001]), while Opdivo monotherapy demonstrated a 45% risk reduction versus Yervoy alone (HR=0.55 [99.5% CI: 0.43-0.76; p<0.0001]). Durable responses were also observed with the combination regimen in a subgroup of patients who discontinued therapy due to treatment-related adverse events (n=35) and appeared consistent with the overall randomized patient population (n=95), based on a post-hoc analysis from the Phase 2 study, CheckMate -069. Among this subgroup of patients, the objective response rate was 66%, and 20% achieved a complete response, with a minimum follow-up of two years. At two years, the median duration of response was not reached and 74% remain in response. The safety profile of the Opdivo and Yervoy combination regimen in both CheckMate -067 and -069 was consistent with previously reported studies of the combination, and most treatment-related adverse events were managed using established algorithms.

“The data from CheckMate -067 provide new insights on the long-term durability of the progression-free survival benefit seen with the nivolumab and ipilimumab combination regimen in advanced melanoma relative to ipilimumab monotherapy,” said Jedd D. Wolchok, M.D., Ph.D., Chief, Melanoma and Immunotherapeutics Service, at Memorial Sloan Kettering Cancer Center. “In addition, in a post-hoc analysis from CheckMate -069, we observed that even for patients who discontinue treatment with the combination regimen due to toxicity, efficacy outcomes appeared consistent with that seen in the overall study population. These data are encouraging and provide additional important information about the efficacy and safety of the combination regimen in these patients.”

The CheckMate -067 data will be presented at the 52nd Annual Meeting of the American Society of Clinical Oncology (ASCO) in an oral abstract session on Monday, June 6, from 2:39 PM – 2:51 PM CDT (Abstract #9505). The CheckMate -069 data were presented in a poster discussion session on Saturday, June 4 (Abstract #9518).

Vicki Goodman, M.D., Development Lead, Melanoma and Genitourinary Cancers, Bristol-Myers Squibb, commented, “With the CheckMate -067 and -069 data presented at ASCO, we observe, with longer follow-up, the durability of progression-free survival and response for the Opdivo and Yervoy combination regimen in advanced melanoma. These findings further validate our research strategy to study the combination of Immuno-Oncology agents, and we remain committed to building on this research and evaluating more ways to improve long-term survival and patient outcomes in advanced cancers.”