After a disappointing combo announcement that knocked nearly 16% off of shares, AstraZeneca’s immuno-oncology portfolio needed a boost—and it got one Monday.
The FDA handed the battered company a breakthrough designation for its PD-L1 med, Imfinzi, as a maintenance therapy in surgery-ineligible non-small cell lung cancer patients. And now, AstraZeneca hopes “to bring it to patients as soon as possible,” R&D chief Sean Bohen said in a statement.
If it can, it’ll go where no other PD-1/PDL-1 med has gone before, and as the fifth-to-market medication in its class, for Imfinzi, that’s a big deal. Right now, the drug’s only approval is in bladder cancer, where rivals Keytruda from Merck, Opdivo from Bristol-Myers Squibb, Bavencio from Pfizer and Merck KGaA, and Tecentriq from Roche also have clearances.
RELATED: AstraZeneca gains major I-O ground with Imfinzi lung cancer maintenance stunner
“When investors count the major I-O manufacturers, AZ is invariably last,” Bernstein’s Tim Anderson wrote to clients the day the British drugmaker touted its maintenance results. “Not any longer—this was a shrewd investment decision ... AstraZeneca deserves a tip of the hat.”
With lung cancer affecting such a mammoth population, even the maintenance green light AstraZeneca is chasing represents a hefty opportunity. If the company can rack up regulatory go-aheads around the world, the patient pool will number 47,000 patients, Anderson said. And while that’s a smaller market than the 60,000-patient, second-line NSCLC population in the U.S., it’s about equal to the sum of the U.S. market for all other immuno-oncology indications.
Needless to say, an approval would be even more welcome by AstraZeneca after last week’s crushing news on the lung-cancer combo front. A miss from a pairing of Imfinzi and unapproved CTLA4 med tremelimumab—a duo that couldn’t outperform solo Imfinzi or chemo at improving progression-free survival—cast major doubt on the combo’s overall survival prospects in that population, and on PD-1/PD-L1 and CTLA4 marriages on the whole.
It also dealt a big blow to AstraZeneca’s sales ambitions, which looked questionable even before the flop. The company is under pressure to hit a massive top-line target its CEO, Pascal Soriot, offered up in the face of a Pfizer buyout threat, and even he has since said it's a bit of a stretch.