Generic name: durvalumab
Disease area: cancer immunotherapy
2022 sales estimate: $1.9 billion
Just because AstraZeneca will be fourth to the checkpoint inhibitor race with durvalumab doesn’t mean there won’t be a place for the contender in the market. The question is just how big that place might be.
Like PD-1 and PD-L1 competitors Bristol-Myers Squibb, Merck and Roche, AstraZeneca is taking aim at the lucrative non-small cell lung cancer market. While the British drugmaker has long been working on a combination approach, pairing durvalumab with fellow pipeline prospect tremelimumab, a CTLA-4 drug, it recently stepped up its efforts at snagging a first-line monotherapy nod—perhaps to exploit the void left by Bristol-Myers’ Opdivo, which flopped its own first-line monotherapy trial last year.
That move, however, pushed back the estimated completion date for AZ’s phase 3 NSCLC trial, meaning it could be awhile before durvalumab is playing in the lung cancer space. And company chief Pascal Soriot has already cautioned analysts to expect delays to the program, pointing out that regulators aren’t feeling as much of a rush to approve checkpoint drugs now that the first wave is already on the market.
Also like its immuno-oncology rivals, though, AstraZeneca is working to snag green lights for its wannabe star in other markets, too. Last February, the med won the FDA’s breakthrough therapy designation to treat urothelial bladder cancer, where it would battle Roche’s Tecentriq—and potentially Bristol-Myers' Opdivo, which is already under FDA review for that use—upon getting the go-ahead to launch. The British drugmaker is working on a head and neck cancer approval, too; in November, however, AZ dropped plans to file an early application in that field after bleeding events cropped up in two clinical trials.