Roche’s Tecentriq and Cotellic were 0 for 1 in phase 3 melanoma trials when combined in a single regimen—that is, until Friday.
That duo, plus Roche’s Zelboraf, topped the Tecentriq-free combination of Cotellic and Zelboraf at keeping disease at bay in previously untreated patients with BRAF V600 mutations, Roche said. Cotellic and Zelboraf are already approved on their own in that indication.
For now, the Swiss drugmaker is staying mum on the details of the win, but it’ll unveil them at an upcoming medical meeting. For now, the company's sharing the data with regulators around the world—including the FDA and the European Medicines Agency—in hopes of breaking into the disease area that launched the careers of chief PD-1 rivals Keytruda from Merck & Co. and Opdivo from Bristol-Myers Squibb.
With the positive trial, Roche rebounds from a phase 3 failure it registered earlier this year and detailed at the European Society for Medical Oncology (ESMO) meeting in September. In that study, the Tecentriq-Cotellic pairing came up short against Keytruda, the current standard of care, in newly diagnosed melanoma patients.
That result didn’t get the company down, though. "The negative impact of IMspire170 doesn't change our enthusiasm” for the latest Tecentriq-containing trial, dubbed IMspire150, Alan Sandler, M.D., Roche's senior vice president of oncology product development, said during ESMO.
But while Roche may be amped about the result, investors might not be all that worked up. The trial was "more of a ‘check the box’ vs. an ‘expand the market’ exercise,” Stifel analyst Stephen Willey wrote to clients earlier this year.