Biopharmaceutical company AstraZeneca plc (STO:AZN) (LON:AZN) (Nasdaq:AZN) announced on Monday that the European Commission has approved Imfinzi (durvalumab) as the first immunotherapy for adults with limited-stage small cell lung cancer (LS-SCLC) who have not experienced disease progression following platinum-based chemoradiation therapy.

This approval is based on the ADRIATIC Phase III trial, which demonstrated a 27% reduction in the risk of death for Imfinzi versus placebo. Median overall survival was 55.9 months for Imfinzi compared to 33.4 months for placebo, with 57% of Imfinzi-treated patients alive at three years versus 48% for placebo.

Imfinzi also reduced the risk of disease progression or death by 24%, with a median progression-free survival of 16.6 months versus 9.2 months for placebo. The safety profile was consistent with previous findings, with no new safety concerns observed.

Suresh Senan, principal investigator of the ADRIATIC trial, described the approval as a "turning point" for LS-SCLC treatment, while AstraZeneca executive Dave Fredrickson highlighted Imfinzi's role in transforming patient outcomes.

Already approved in the United States and other markets, Imfinzi is under regulatory review in Japan and additional countries for LS-SCLC. It is also approved in combination with chemotherapy for extensive-stage SCLC based on the CASPIAN trial.