It’s been a strange road for Bristol-Myers Squibb’s Opdivo-Yervoy combo in first-line kidney cancer, but the New Jersey drugmaker now has the go-ahead it’s been chasing.
The FDA approved the regimen Monday based on data from the phase 3 CheckMate-214 trial, which showed that the immuno-oncology pairing could significantly top the standard of care—Pfizer’s Sutent—at helping patients live longer.
That trial also showed that the Opdivo-Yervoy tandem beat Sutent on overall survival, regardless of their PD-L1 expression level, and that the duo triggered a higher objective response rate than the older med did.
That data, presented last September at the European Society of Medical Oncology meeting, prompted regulators to grant the one-two punch a priority review in December. Before that, however, the regimen’s fate wasn’t so clear. In August, the company unveiled mixed results from the same trial: Opdivo and Yervoy hit their primary response-rate goal, but they didn’t significantly outperform Sutent when it came to keeping cancer progression at bay.
All’s well that ends well for Bristol-Myers, though, and the company will now get to work building market share before a rival immuno-oncology cocktail can move in. In December, Roche revealed that its Tecentriq and Avastin combined could top Sutent at holding off disease progression.
Meanwhile, kidney cancer approval kept a stream of positive news going for BMS. Earlier in the day, the company rolled out results showing that Opdivo and Yervoy could slash the risk of disease progression or death in first-line lung cancer patients with high tumor mutation burden.