AstraZeneca gains major I-O ground with Imfinzi lung cancer maintenance stunner

AstraZeneca's Imfinzi is the first immuno-oncology med to post superior progression-free survival results in patients with stage 3, unresectable non-small cell lung cancer.

Less than two weeks after snagging its first FDA nod for Imfinzi, AstraZeneca is out with more positive data for the checkpoint inhibitor. But this time, it’s positive data that could boost the entire immuno-oncology field.

AZ surprised the market Friday with rosy interim results from a trial testing Imfinzi as a maintenance therapy in surgery-ineligible patients with stage 3 non-small cell lung cancer. The med hit its primary endpoint in progression-free survival, and it’s the first in its class to do so in that setting.

That feat is a significant one, Bernstein analyst Tim Anderson pointed out in an early-morning note to clients. If the company was to win global regulatory go-aheads in that population—and AZ said it is already engaged in “active discussion” with authorities about its submissions—the opportunity in the G7 markets would number 47,000 patients.

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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, including second-line head-and-neck cancer, second-line bladder cancer and second-line kidney cancer, Anderson wrote. In other words, it’s big.

And unlike second-line NSCLC patients, who stay on treatment for a median three months, stage 3 maintenance therapy patients stay on for what’s likely closer to a year, Anderson figures. Plus, AstraZeneca “will have the only offering at launch,” and for a good two to three years, he added.

“When investors count the major I-O manufacturers,”—Bristol-Myers Squibb, Merck, Roche and AstraZeneca—AZ is “invariably last,” he wrote. “Not any longer—this was a shrewd investment decision ... AstraZeneca deserves a tip of the hat.”

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AstraZeneca could certainly use the boost. It’s struggled hard to rebound from big-time patent expirations, and it’s depending on Imfinzi—which earlier this month snagged its first FDA go-ahead, a bladder cancer nod—to come up big. The immunotherapy won’t be able to shoulder the turnaround on its own, though; the British drugmaker also needs PARP med Lynparza, among others, to keep expanding.

Meanwhile, AstraZeneca likely won’t be the only pharma giant to benefit from its latest bout of good news. Its trial, dubbed Pacific, “shows that I-O has a place in nonmetastatic disease,” Anderson wrote, and it’s “the kind of breakthrough that promises to pull upward on the I-O market size.

“If success replicated in the many ongoing trials in early stage disease—after Pacific, why not?—all companies will benefit from the expansion,” he added.