Merck’s Keytruda knows how to make an entrance. On Thursday, it hit the scene with kidney cancer combination data that could snag it a new indication months earlier than anticipated.
A phase 3 study pairing Merck’s immuno-oncology treatment with Pfizer tyrosine kinase inhibitor Inlyta in previously untreated patients showed that the duo could both increase the time to cancer progression and lengthen patients’ lives when compared with Pfizer’s Sutent, the New Jersey drugmaker said Thursday. The trial also hit its secondary endpoint, with the combo significantly topping Sutent in terms of overall response rate.
One key fact Merck was quick to point out? The survival and response benefits were consistent across risk groups and expression levels of biomarker PD-L1.
While the companies are staying mum on the exact numbers for now, Merck did note that it intends to file the data with global regulators “in the near future,” as Roger Perlmutter, M.D., Ph.D., president of Merck Research Laboratories, said in a statement.
And the way Evercore ISI analyst Umer Raffat sees it, Merck “could end up with a commercial TKI combo ~9-12 months earlier than expected,” considering that “this was supposed to be a late 2019/2020 readout,” he wrote in a note to clients.
Archrival Bristol-Myers Squibb, whose Opdivo-Yervoy regimen already bears an FDA approval in first-line kidney cancer, won’t appreciate the early company. The indication “is a big growth driver currently” for BMS, Raffat wrote.
But Keytruda isn’t the only member of the PD-1/PD-L1 class threatening to encroach on Bristol’s territory. In September, a Pfizer combination of Inlyta and Merck KGaA-partnered PD-L1 player Bavencio came through with a positive trial showing, details of which will roll out this weekend at the European Society for Medical Oncology (ESMO) annual meeting. And if Pfizer can snag an approval, it may have an opportunity to box out its competitors by bundling the drugs and serving up a discount.