AstraZeneca announced Friday that a Phase III study of Imfinzi (durvalumab) as sequential treatment in patients with locally-advanced, unresectable non-small-cell lung cancer (NSCLC) who had not progressed following standard platinum-based chemotherapy concurrent with radiation therapy met one of its primary endpoints. Shares in the company, which said that the PD-L1 inhibitor is the first immuno-oncology medicine to show superior progression-free survival (PFS) in this setting, rose as much as 5 percent on the news.
In the PACIFIC study, AstraZeneca noted that a planned interim analysis conducted by an independent Data Monitoring Committee concluded that the trial has already shown a significant and clinically-meaningful PFS benefit in patients receiving Imfinzi compared to placebo. The study is evaluating overall survival as the other primary endpoint, which the drugmaker said "will be assessed in due course as specified by the protocol.
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Sean Bohen, chief medical officer at AstraZeneca, said "we look forward to working with regulatory authorities around the world to bring Imfinzi to lung cancer patients as soon as possible." The company recently received accelerated approval from the FDA for Imfinzi in previously treated patients with advanced bladder cancer.
"The surprise early positive readout of the PACIFIC trial...is a major inflection point for AstraZeneca," remarked analysts at Deutsche Bank, adding "in theory, this could open a market opportunity of $1.75 billion to $3.5 billion (or more) for the drug, which is not included in our current forecasts." Meanwhile, Berenberg analysts said that the PACIFIC trial results put AstraZeneca ahead of rivals Roche and Merck & Co., whose studies for similar treatments are expected in 2019.
Imfinzi is also being tested as a first-line treatment for patients with NSCLC as monotherapy in the Phase III MYSTIC and PEARL trials. It is also being developed in combination with the CTLA-4 inhibitor tremelimumab as part of the late-stage MYSTIC, NEPTUNE and POSEIDON studies.
Berenberg analysts suggested that the efficacy of Imfinzi in the PACIFIC study augured well for results from the MYSTIC trial, which are expected in June or July. "While MYSTIC is still very important, PACIFIC clearly lessens its importance, and provides more reassurance that Imfinzi is an active drug and therefore must have a chance of working in MYSTIC," analysts at Berenberg added.
For related analysis, read ViewPoints: AstraZeneca becomes a trend setter in immuno-oncology.
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