Pfizer and Merck KGaA are one step closer to a brand-new market for their immuno-oncology drug Bavencio. The companies reported winning data in a kidney cancer trial, setting them up for a "breakthrough" FDA approval—and a key expansion for the latecomer PD-L1 drug.
What's more, the potential nod puts Bavencio alongside Pfizer's Inlyta, a follow-up drug to its kidney cancer standard, Sutent. That means a new approval wouldn't just rev up Bavencio sales, but could drive Inlyta forward, too.
In an interim analysis of the Javelin Renal study, the Bavencio-plus-Inlyta combo bettered Sutent alone at fending off kidney cancer's advance in previously untreated patients. And it wasn't just PD-L1 positive patients who showed a "statistically significant improvement" over Sutent monotherapy, but also patients who didn't test positive PD-L1 expression of 1% or more.
The partners plan to take the data to regulators to support their application for a new approval and are submitting the numbers for presentation at an upcoming medical meeting. The trial will go on to assess whether the combo can help patients live longer.
A new first-line combo approval would obviously be good news for Pfizer and Merck, particularly given Bavencio's fourth-to-market status in the PD-1/L1 market, behind Bristol-Myers Squibb's blockbuster Opdivo, Merck & Co.'s powerhouse Keytruda and Roche's Tecentriq. With Inlyta having flunked a trial aiming for a monotherapy expansion in patients after surgery, the combo approval will be especially important for Pfizer's hopes for both drugs.
But kidney cancer is heating up, and once again Bavencio is behind. Opdivo and fellow BMS drug Yervoy won a first-line combo approval in April, and Roche’s Tecentriq-plus-Avastin one-two punch put up its second phase 3 win back in February. A Keytruda-Inlyta phase 3 trial is currently ongoing, and Keytruda and Eisai's Lenvima—which Merck & Co. now shares—nabbed a breakthrough designation for first-line kidney cancer, too.