'Glowing' NEJM editorial highlights off-label potential for AstraZeneca's Imfinzi

Stage 3 lung cancer nods for Imfinzi in developed markets could rack up about $2 billion per year in sales, Bernstein's Tim Anderson says.

AstraZeneca has had trouble easing concerns about its immuno-oncology portfolio, but a new editorial in the New England Journal of Medicine should do just that, one analyst says.

The journal has published full results from a phase 3 study showing that AZ’s PD-L1 contender Imfinzi could stave off non-small cell lung cancer progression for 11.2 months longer than placebo in stage 3 patients, along with an editorial that Bernstein analyst Tim Anderson described as “glowing.”

In it, author Naiyer Rizvi, director of immunotherapeutics for the hematology and oncology division at Columbia University Medical Center, concludes that the control arm didn’t skew results in Imfinzi’s favor, and he highlights a lower rate of brain metastases for patients who’d received Imfinzi. Notably, he also presents the possibility of off-label use; there may be a role for the med in patients whose tumors have been surgically removed, even though it’s only been formally studied in those whose tumors couldn’t be surgically excised, he writes.

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As Anderson wrote in a note to clients, the piece reaffirms the positive sentiment around the results. Sometimes, editorials can “embed surprise points of view, including a negative or cautious slant on seemingly positive study results.” But that’s “NOT the case” with this study, he said.

The way Anderson sees it, results from the trial, dubbed Pacific, could help Imfinzi churn out up to about $2 billion in per year in developed markets. An FDA approval in the setting, which could potentially come before the end of the year, would be a game-changer for the product, which currently generates “next to nothing”; its only indication is in second-line bladder cancer, a market that’s both small and extremely crowded.

If Imfinzi can win the stage 3 nod, it’ll have the market all to itself for a solid period of time; AZ “is well ahead of competitors in this particular setting,” Anderson pointed out. Merck may wind up with “some semblance of data” evaluating its Keytruda in that patient population once it wraps up its ongoing Keynote-042 trial, but “this would not lead to a labeled indication that directly encroaches on AstraZeneca’s territory,” he noted.

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That's good news for the British drugmaker, especially considering that the fate of its Imfinzi combo in the all-important first-line lung cancer space is still up in the air. Over the summer, the company recorded a progression-free survival miss for the duo of Imfinzi and CTLA4 candidate tremelimumab, though as R&D chief Sean Bohen reminded investors on AZ's Q3 conference call, it is "quite possible" that it could still turn out a positive result on the overall survival front.