New long-term data on Opdivo and the Opdivo + Yervoy regimen shows survival benefit across lines of therapy in advanced melanoma
Longest follow-up for the Opdivo + Yervoy regimen from study 004 shows 3-year overall survival rate of 68% across Phase I dosing cohorts.
Bristol-Myers Squibb (BMS) has announced new long-term data of Opdivo in treatment-naïve BRAF wild-type advanced melanoma from CheckMate -066. In the trial, Opdivo continued to demonstrate superior overall survival versus dacarbazine with 57.7% of patients alive at 2 years compared to 26.7% of patients treated with dacarbazine. The safety profile of Opdivo was consistent with prior studies. The 2-year survival and safety data from CheckMate -066 represent the longest follow-up from a randomized study of any PD-1 immune checkpoint inhibitor in the first-line setting of advanced melanoma. These data will be presented as a late-breaking presentation at the Society for Melanoma Research (SMR) 2015 International Congress in San Francisco, CA, 18–21 from November.
BMS is also presenting updated data from various Phase I cohorts of Study 004 evaluating the Opdivo + Yervoy Regimen in patients with unresectable or metastatic melanoma, including up to 3-year overall survival. The Phase Ib Study 004 is a dose-finding study on which the proof of concept for Opdivo + Yervoy Regimen approval was based.
“The long-term survival data for our Immuno-Oncology agent,Opdivo, as a single agent and in combination with Yervoy presented at SMR shows our continued commitment to improve outcomes for patients with advanced melanoma,” said Michael Giordano, M.D., senior vice president, head of Oncology Development, BMS. “The Opdivo + Yervoy Regimen has shown compelling potential for providing improved duration of response and long-term survival for some patients, and, as single agents, Opdivo and Yervoy continue to play a critical role as core components of the treatment continuum for advanced melanoma in appropriate patients.”
The global incidence of melanoma has been increasing over the past three decades, and despite recent advances in treatment, patients with advanced or metastatic disease often have a poor prognosis. Currently, 5-year survival rates for advanced melanoma are between 5% and 19%
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