Immuno-oncology, Results

AstraZeneca spells out a major drop in the risk of death for stage 3 NSCLC patients taking Imfinzi — and why that’s important

AstraZeneca’s top team under Pascal Soriot $AZN has spent the past 5 years proving that it could do serious blockbuster development work. And few trials have been as important to forging that rep as PACIFIC, which offered clear evidence that its PD-L1 checkpoint Imfinzi allowed patients with unresectable stage 3 non-small cell lung cancer to live longer.

Dave Fredrickson

This morning, AstraZeneca execs turned up at the World Conference on Lung Cancer in Toronto to spell out the promising overall survival data the pharma giant had claimed with a top-line report last spring. The study was published in the New England Journal of Medicine.

Their presentation spotlighted a 32% reduction in the risk of death — HR 0.68 — for these stage 3 patients, while the median OS rate had yet to be hit. 

Why is a one-third drop in the risk of death that important?

At stage 3, says Dave Fredrickson, the head of the Oncology Business Unit at AstraZeneca, patients can still hold on to a reasonable hope that they can be cured.

“At stage 4,” he tells me, “the 5-year survival rate is below 10%.” Adding this therapy after chemoradiotherapy offers some expectation that they’re not necessarily facing a death sentence and “maybe bending 5-year survival times.”

Researchers have yet to do that. Mapping out a durable response takes some time. 

Overall Survival in the Intention-to-Treat Population. Source: NEJM

In the meantime, says Fredrickson, “we have seen quite brisk uptake since we have had approval in the US of the PACIFIC regimen.” And that is making this drug the standard of care in a major niche market.

“Half of patients in stage 3 are treated with radiochemotherapy. Half of those patients are being treated with Imfinzi afterwards,” he says, a 50% share that’s crucial for a company angling in behind Merck and Bristol-Myers Squibb, the two dominant giants in immuno-oncology.

Fredrickson adds that AstraZeneca’s development strategy gives it an 18- to 24-month window ahead of the arrival of any rivals. During that time, the R&D group is working on more research programs to see if they can take the regimen to earlier stages of the disease, with a special trial in China designed to quickly break into that booming healthcare market.

The positive results for AstraZeneca on PACIFIC were especially important after their PD-L1 drug failed to make the first hurdle on MYSTIC. OS data on that study are due sometime before the end of the year. And if it’s a failure, as many suspect it is, the pharma giant will still have PACIFIC and stage 3 NSCLC to boast about.

That’s a big deal for AstraZeneca.


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