UK-based pharmaceutical giant AstraZeneca (AZ, NASDAQ: AZN) has reported receiving a new indication approval from the US Food and Drug Administration (FDA) for its programmed death-ligand 1 (PD-L1) inhibitor, Imfinzi (durvalumab). The approval is for the use of Imfinzi in treating adult patients with limited-stage small cell lung cancer (LS-SCLC) who have not experienced disease progression following concurrent platinum-based chemotherapy and radiation therapy. This indication had previously earned the drug priority review and breakthrough therapy designation (BTD) statuses from the FDA.
Phase III ADRIATIC Study Results
The approval was supported by the results of the Phase III ADRIATIC study, which demonstrated that an estimated 57% of patients treated with Imfinzi were alive at three years, compared to 48% for the placebo group. This data sets a new benchmark in the treatment of LS-SCLC, with a median overall survival of 22.5 months for patients treated with Imfinzi. Additionally, Imfinzi reduced the risk of disease progression or death by 24%, with a median progression-free survival (PFS) of 16.6 months for Imfinzi-treated patients versus 9.2 months for those on placebo.
Safety Profile and Consistency
The safety profile of Imfinzi was found to be generally manageable and consistent with the known profile of the medicine, with no new safety signals observed in the study. This consistency in safety further supports the drug’s use in the treatment of LS-SCLC, providing patients with a new therapeutic option.-Fineline Info & Tech
