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FDA OK makes AstraZeneca the leader in one new segment of the all-important lung cancer market

AstraZeneca $AZN has found a way to jump out in front of a pack of heavyweight PD-1/L1 rivals duking it out for a big piece of the blockbuster lung cancer market.

The day after Pfizer and Merck KGaA were forced to throw in the towel on a pivotal second-line lung cancer study for Bavencio, the FDA handed the UK pharma giant an approval to market Imfinzi to patients whose stage III non-small cell lung cancer hasn’t progressed after chemoradiation and whose tumors can’t be surgically removed.

“This is the first treatment approved for stage III unresectable non-small cell lung cancer to reduce the risk of the cancer progressing, when the cancer has not worsened after chemoradiation,” said FDA cancer czar Richard Pazdur. And now patients have a better shot at prolonged survival than they had before.

How important is this for AstraZeneca?

CEO Pascal Soriot put it in perspective last fall when he said: “We’re going to be first in half the pool in lung cancer.”

The approval only 5 months after the data were unveiled underscores the FDA’s desire to push through cancer drugs from top players like this at an unprecedented speed, when the data comes up in their favor. It also is a prospective major commercial win for AstraZeneca, which turned to this success to salve the bitter sting of the big MYSTIC failure last summer for the pairing of Imfinzi and their in-house CTLA-4 tremelimumab.

Their PACIFIC data in the fall helped mollify investors, reviving hope that AstraZeneca revenue may still be down, but it’s making major strides on cancer that could turn it around for the company this year.

AstraZeneca believes it can hold on to this segment of the market for some time before a rival shows up, which would earn kudos for trial strategy where the major players like Merck and Bristol-Myers Squibb have been pulling out all the stops.

“Having stage III to ourselves is really critical,” Soriot told a small group of reporters at ESMO. “I think in lung cancer we can be a leader.”

Their PACIFIC trial revealed a progression-free survival advantage of more than 11 months for a group of patients taking Imfinzi (durvalumab) over placebo — 16.8 versus 5.6 months. That represents a 48% drop in the risk of progression.


AstraZeneca CEO Pascal Soriot is interviewed in London, September 2017 Getty/Bloomberg


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