Immuno-oncology, Regulatory

FDA promises Roche a snap decision on Tecentriq triple for frontline lung cancer as it falls even further behind Merck, Bristol-Myers

Roche is getting some help from the FDA in its quest to start making up some of the multibillion-dollar distance that separates the global player from Merck and Bristol-Myers Squibb in the blockbuster rivalry over the lung cancer market. The agency is handing Roche and its big cancer division Genentech a priority review for a triple using its PD-L1 checkpoint Tecentriq plus Avastin and chemo in frontline lung cancer.

The PDUFA date on the application is September 5, though the agency has been known to hit the green light on the already established PD-1/L1 drugs ahead of deadline.

Roche has already detailed a doubling in 12-month progression-free survival rates among a broad group of frontline lung cancer patients in the closely-watched IMpower150 study, compared to Avastin and chemo, setting the stage for a quick regulatory OK on both sides of the Atlantic. Researchers have also reported that the triple Tecentriq regimen scored significant OS results, which we’ll hear more about at the upcoming ASCO session.

The triple hit a hazard ratio of 0.62 in IMpower 150, impressing analysts.

Roche will need to muster all the help it can get in the checkpoint race. In Q1 Merck hit $1.46 billion in Keytruda revenue, up 151% as the pharma giant continued to outpace Bristol-Myers on lung cancer. Bristol-Myers’ Opdivo, which got out to an early lead, scored $1.51 billion, leaving them vulnerable to dropping back to the number two spot.

Roche, meanwhile, reported Q1 revenue of only $139 million for Tecentriq.

There are 5 PD-1/L1 drugs on the market, including AstraZeneca’s Imfinzi and Pfizer/MerckKGaA’s Bavencio. Regeneron and Sanofi are likely to make 6 in the US, with a trio of checkpoints under review in China and dozens more in the clinic.


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