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AstraZeneca’s Imfinzi (Durvalumab) Approved for Limited-Stage Small Cell Lung Cancer in the U.S.

NextEdge Admin

06 Dec 2024

2 min 36 sec

AstraZeneca’s Imfinzi (durvalumab) has received FDA approval for the treatment of adults with limited-stage small cell lung cancer (LS-SCLC) whose disease has not progressed following concurrent platinum-based chemotherapy and radiation therapy. The approval was granted after the drug secured Priority Review and Breakthrough Therapy Designation, based on results from the Phase III ADRIATIC trial. These results were presented at the 2024 ASCO Annual Meeting and published in the New England Journal of Medicine.

LS-SCLC is a highly aggressive cancer with a poor prognosis, as it often recurs and progresses rapidly after initial chemotherapy and radiotherapy. Only 15-30% of patients survive for five years after diagnosis. In the ADRIATIC trial, Imfinzi demonstrated a 27% reduction in the risk of death compared to placebo, with a median overall survival (OS) of 55.9 months for Imfinzi versus 33.4 months for placebo. Three-year survival was 57% for Imfinzi-treated patients versus 48% for those on placebo. Additionally, Imfinzi reduced the risk of disease progression or death by 24%, with median progression-free survival (PFS) of 16.6 months versus 9.2 months for placebo.

This approval marks a significant advancement for LS-SCLC, providing the first systemic treatment option following curative-intent, platinum-based chemoradiotherapy in four decades. Imfinzi is now the only immunotherapy approved for both limited- and extensive-stage SCLC. The safety profile of Imfinzi was manageable, with no new safety signals.

The approval follows similar regulatory achievements in Switzerland, with applications under review in the EU, Japan, and other countries. This breakthrough offers new hope for patients with LS-SCLC, a disease known for its high recurrence rate and poor outcomes.