Bristol-Myers Squibb has unveiled clinical data from the first randomised study to evaluate Opdivo and Yervoy in combination in patients with previously untreated advanced melanoma, showing a strong survival benefit.
In the Phase II CheckMate-069 trial, the Opdivo (nivolumab) and Yervoy (ipilimumab) regimen demonstrated a two-year overall survival rate of 69% compared to 53% for Yervoy alone in patients with BRAF wild-type advanced melanoma.
“Both nivolumab and ipilimumab have changed survival expectations in advanced melanoma over the last few years and these latest data show us that combining these two immunotherapies is an effective two-pronged attack against the cancer,” said Dr James Larkin, consultant medical oncologist at The Royal Marsden.
The overall survival rates using the regimen “are very promising and provide further hope for patients and their families affected by this disease,” he noted.
The Opdivo/Yervoy combination remains investigational and is not yet licensed in the UK; as single agents, both are approved for use on the NHS in England and Wales to treat patients with advanced melanoma. But the Committee for Medicinal Products for Human Use (CHMP) has recommended that the regimen be licensed for use in Europe and a formal decision is expected in the first half of this year.
Additional data released by BMS show that more than one-third of patients with advanced melanoma given Opdivo survived for at least five years, demonstrating a durable effect in those who respond to the treatment.
According to data from the CA209-003 trial, assessing the drug in heavily pre-treated patients, those receiving Opdivo showed an overall survival rate of 34%, with an evident plateau in survival at around four years.