Roche’s Tecentriq-Avastin-chemo combo may have just scored quicker trip into the first-line lung cancer arena.
The company said Monday that the triplet won FDA priority review for previously untreated patients with advanced lung cancer, and that means it could go toe-to-toe with Merck & Co. by Sept. 5.
The regulatory boost follows data rolled out in late March, which showed the trio topped an Avastin-chemo combo at prolonging lung cancer patients’ lives. That survival benefit extended across various subgroups, too—including patients with tumors expressing varying levels of PD-L1, the biomarker Tecentriq is designed to target.
If Roche can snag an FDA green light, it could mean new life for Avastin, an elder member of the Basel, Switzerland-based company’s cancer lineup. The agency has already approved Mvasi, a biosimilar version of the drug from Amgen and Allergan, in all of Avastin’s currently approved indications, including those in colorectal, lung, kidney and cervical cancers.
The Roche regimen will have to go up against formidable competition from Merck, though. The drugmaker already has first-line approvals for solo immuno-oncology star Keytruda and a combo of Keytruda and chemo, and both treatment options have put up big efficacy numbers.
Of course, until Roche puts out data on a Tecentriq-chemo pairing—sans Avastin—it’ll be an apples-to-oranges comparison with Merck’s chemo combo. Investors will be watching closely for those results, which are expected later this year.