Positive Phase 3 data for Opdivo (nivolumab) in advanced melanoma patients previously treated with yervoy (ipilimumab) presented at the ESMO 2014 Congress; first phase 3 results presented for a PD-1 immune checkpoint inhibitor

Bristol-Myers Squibb Company (NYSE:BMY) today announced positive results from CheckMate -037, a Phase 3 randomized, controlled open-label study of Opdivo (nivolumab), an investigational PD-1 immune checkpoint inhibitor, versus investigator’s choice chemotherapy (ICC) in patients with advanced melanoma who were previously treated with Yervoy (ipilimumab). Based on a planned interim analysis of the co-primary endpoint, the objective response rate (ORR) was 32% (95% CI = 24, 41) in the Opdivo arm (n=120) and 11% (95% CI = 4, 23) in the ICC reference arm (n=47) in patients with at least six months of follow up. The majority (95%) of responses were ongoing in the Opdivo arm and the median duration of response was not reached. ORR was based on RECIST criteria as evaluated by an independent radiologic review committee (IRRC). These data were highlighted at a ESMO 2014 Congress press briefing today in Madrid and will be presented during the Presidential Symposium at 4 p.m. CEST (Abstract #LBA3_PR).

“These data are important as they mark the first presentation of results from a Phase 3 randomized study for the PD-1 immune checkpoint inhibitor class,” said Jeffrey S. Weber, MD, Ph.D., director of the Donald A. Adam Comprehensive Melanoma Research Center at Moffitt Cancer Center. “Additionally, the response rate and duration of response in patients treated with Opdivo are consistent with findings from the early Phase 1 trial in previously treated advanced melanoma (Study -003).”

Safety was reported on all patients treated in the Opdivo (n=268) and ICC (n=102) arms. The majority of Opdivo treatment-related adverse events (AEs) were Grade 1/2 and managed using recommended treatment algorithms. Grade 3/4 drug-related AEs were less frequent for the Opdivo arm (9% versus 31% of patients treated chemotherapy). Serious Grade 3/4 drug-related AEs were reported in 5% and 9% of patients treated with Opdivo and ICC, respectively. There was no Grade 3/4 pneumonitis (inflammatory lung disease) with Opdivo. Discontinuations due to drug-related AEs, of any grade, occurred in 2% of Opdivo-treated patients and 8% of patients administered ICC. There were no deaths related to study drug toxicity.

“This second set of positive Phase 3 data for Opdivo in patients with advanced melanoma supports a deeper understanding of the potential of immuno-oncology in this disease,” said Michael Giordano, M.D., senior vice president, Head of Development, Oncology. “These results confirm our belief in the potential of immuno-oncology, and our broad development program continues to evaluate Opdivo in advanced melanoma across lines of therapy, both as a single agent and as part of a combination regimen.”

In June, Bristol-Myers Squibb announced that a randomized blinded comparative Phase 3 study evaluating Opdivo versus dacarbazine in patients with previously untreated BRAF wild-type advanced melanoma (CheckMate -066) was stopped early because an analysis conducted by the independent Data Monitoring Committee showed evidence of superior overall survival in patients receiving Opdivo compared to the control arm. The Company is working with investigators on the future presentation and publication of the results from CheckMate -066.

Bristol-Myers Squibb has proposed the name Opdivo (pronounced op-dee-voh), which, if approved by health authorities, will serve as the trademark for nivolumab.