AstraZeneca's PD-L1 inhibitor Imfinzi gains FDA breakthrough therapy status in lung cancer

AstraZeneca announced Monday that the FDA granted breakthrough therapy designation to Imfinzi (durvalumab) for the treatment of patients with locally-advanced, unresectable non-small-cell lung cancer (NSCLC) whose disease has not progressed following platinum-based chemoradiation therapy. The company noted that the agency's decision for the PD-L1 inhibitor was based on data from the PACIFIC trial.

In May, AstraZeneca reported that the study of Imfinzi as sequential treatment in patients with locally-advanced, unresectable NSCLC who had not progressed following standard platinum-based chemotherapy concurrent with radiation therapy met one of its primary endpoints, significantly improving progression-free survival (PFS) versus placebo. Data from the trial have been submitted for presentation at an upcoming medical meeting.

FirstWord reports in this therapy area - KOL Insight NSCLC: Find out how KOLs expect the market to evolve, which pipeline treatments are most promising, and which clinical trials will shape treatment decisions. Learn more.

Imfinzi recently gained accelerated approval from the FDA for the treatment of certain patients with locally advanced or metastatic urothelial carcinoma. However, AstraZeneca announced last week that the Phase III MYSTIC study of the therapy, in combination with the CTLA-4 inhibitor tremelimumab, failed to improve PFS versus platinum-based standard-of-care chemotherapy in previously-untreated patients with metastatic first-line NSCLC, sending the company's shares down as much as 16 percent.

At the time, Berenberg analyst Alistair Campbell said the results from MYSTIC "leads us to lower 2023 Imfinzi sales from $4 billion to $1.3 billion." However, Campbell noted "we still think Imfinzi can achieve blockbuster sales based on the PACIFIC success in stage III unresectable lung cancer."

For related analysis, see ViewPoints: More uncertainty at AstraZeneca as initial MYSTIC data falls short, and KOL Views Results: MYSTIC suggests too much cutting and not enough measuring in I/O drug development, says leading medical oncologist.

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