Merck’s Keytruda finally has some immuno-oncology competition in the previously untreated non-small cell lung cancer market, courtesy of Roche and its freshly minted Tecentriq-Avastin combo.

Late Thursday, the FDA greenlighted the regimen—containing Roche's PD-L1 drug Tecentriq, its older blockbuster Avastin and chemotherapy— for patients without EGFR or ALK mutations. 

Even with an FDA approval in the bag, though, the real test for Roche might still be to come. The company will face off against Merck’s Keytruda, which has some major survival numbers backing its own chemo combo approval, as well as a lengthy head start on the market. 

The approval comes on the back of data from the Impower150 study, which showed that the Tecentriq cocktail could top an Avastin-chemo pairing at lengthening patients’ lives. The survival benefit extended across various subgroups and levels of the biomarker PD-L1, Roche said. 

Roche has been waiting a long time for the thumbs-up; back in September, U.S. regulators extended their review period by three months to give themselves "time to review additional information requested in support" of Roche’s filing, the company said. The slowdown neutralized the priority review the agency had previously bestowed on the combo, which speeds up the regulatory process. 

And if Roche wants to make headway against Merck, it will also have to convince doctors to go with a three-drug regimen that could come along with more side effects than Merck’s duo does, not to mention a higher cost. 

But Roche will happily take the opportunity just to compete in the field, which represents the most lucrative market for immuno-oncology drugmakers because of the sheer number of untreated patients needing therapy. 

Right now, that chance is more than its other rivals can tout. Bristol-Myers Squibb’s Opdivo recently ran into a regulatory roadblock and a worrying new analysis that could frustrate the company’s biomarker-driven approach to first-line lung cancer. And AstraZeneca’s Imfinzi, for its part, has yet to produce any positive phase 3 data in the same setting, despite the British drugmaker’s best efforts.

"The fact remains that Merck will most likely have a dominant position in this market, and that Roche will be the No. 2, followed probably by BMS (IO+IO strategy, with no chemotherapy) and potentially AZN," Oddo BHF analyst Pierre Corby wrote in a note to clients. He predicted peak sales for Tecentriq of 1.5 billion CHF ($1.51 billion) in the new indication.

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