FDA puts Bristol-Myers' Opdivo-Yervoy combo in fast lane for new kidney cancer nod

A combo of Opdivo-plus-Yervoy won the FDA's breakthrough therapy designation in certain kidney cancer patients.

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.

No detailed data from the Roche trial are expected until next year, but Roche CMO Sandra Horning said in a statement that the company is "encouraged by these results as they add to the emerging body of evidence that supports our rationale for this combination." 

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. 

The ESMO data showed a 37% reduction of risk of death for the combo in comparison with Sutent, despite the fact that it missed on the goal of delaying cancer growth. Leerink analyst Seamus Ferndandez described the finding as a "strong positive" for the combo, adding that the "overall survival benefit likely confirms the durability of the signal seen on progression-free survival, leading to a very high likelihood of approval.” 

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.’’