Bristol-Myers Squibb could have yet another approval for its Opdivo-plus-Yervoy combo on the way. The FDA has started a priority review on the two-drug combo as a treatment for kidney cancer, based on data released just three months ago.
The combination regimen, which pairs Bristol's PD-1 immunotherapy Opdivo with its CTLA4 drug Yervoy, is up for an approval for intermediate- and poor-risk patients with advanced renal cell carcinoma, and the FDA is due to decide next April.
The news comes right on the heels of Roche's report that its Tecentriq-plus-Avastin combo beat Pfizer's standard-of-care therapy Sutent at holding off kidney cancer in previously untreated patients. Tecentriq is a head-to-head competitor to Opdivo, while Avastin is one of Roche's longstanding blockbusters.
In the meantime, Bristol-Myers is pressing ahead in the regulatory stage, with its application based on data from a phase 3 study dubbed Checkmate-214. The Opdivo-Yervoy combo had previously won a breakthrough designation for this particular indication, its second.
In September at the European Society for Medical Oncology Congress, BMS unveiled results showing that patients lived longer when treated up front with the combo rather than with Sutent. That followed a presentation of mixed results in August, when BMS reported its combo met a response-rate endpoint, but missed on progression-free survival, failing to demonstrate that the meds could stave off cancer growth better than Sutent.
Reacting to Roche's data this week, Ferndandez wrote that the survival benefit for Bristol's combo "places a high hurdle for Tecentriq plus Avastin, particularly in intermediate- and poor-risk patients."
But the Swiss drugmaker remains confident enough with its combo to press forward. Horning said in a statement the company will "discuss these data with health authorities globally and hope to bring this combination forward as a potential new treatment option as soon as possible.’’