AstraZeneca: FDA Approves Imfinzi To Treat Adult Patients With Limited-stage Small Cell Lung Cancer

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(RTTNews) - British drug maker AstraZeneca Plc (AZN.L, AZN) announced Thursday that the U.S. Food and Drug Administration has approved Imfinzi (durvalumab) to treat adult patients with limited-stage small cell lung cancer or LS-SCLC, whose disease has not progressed following concurrent platinum-based chemotherapy and radiation therapy.

In the U.S., Imfinzi is the first and only immunotherapy regimen for patients with LS-SCLC, which typically recurs and progresses rapidly, despite initial response to standard-of-care chemotherapy and radiotherapy.

According to the firm, the prognosis for LS-SCLC is particularly poor, as only 15-30 percent of patients will be alive five years after diagnosis.

The FDA decision was based on results from the ADRIATIC Phase III trial, a randomised, double-blind, placebo-controlled, multi-centre global trial, which evaluated Imfinzi monotherapy and Imfinzi plus Imjudo (tremelimumab) versus placebo in the treatment of patients with LS-SCLC who had not progressed following cCRT.

The trial results showed a 27 percent reduction in the risk of death versus placebo. Imfinzi also reduced the risk of disease progression or death by 24 percent versus placebo.

The results were presented during the Plenary Session of the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting and subsequently published in the New England Journal of Medicine.

Imfinzi earlier had secured FDA's Priority Review and Breakthrough Therapy Designation.

The drug is also approved in Switzerland in this setting based on the ADRIATIC results. Currently, regulatory applications are under review in the EU, Japan and several other countries in this indication.

Imfinzi is now the only immunotherapy approved for both limited- and extensive-stage small cell lung cancer, the company noted.

Suresh Senan, Professor of Clinical Experimental Radiotherapy at the Amsterdam University Medical Centers, The Netherlands, and international coordinating investigator in the trial, said, "Durvalumab is the first and only systemic treatment following curative-intent, platinum-based chemoradiotherapy to show improved survival for patients with this aggressive form of lung cancer. This finding represents the first advance for this disease in four decades. The ADRIATIC trial showed 57 percent of patients were still alive at three years after being treated with durvalumab, which underscores the practice-changing potential of this medicine in this setting."

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