FDA Approves Durvalumab for Patients With Limited-Stage Small Cell Lung Cancer
On December 4th, 2024, the US Food and Drug Administration (FDA) approved durvalumab for adult patients with limited-stage small cell lung cancer (SCLC) who have not experienced disease progression following concurrent platinum-based chemotherapy and radiation. This approval was based on results from the ADRIATIC trial.
In this double-blind, placebo-controlled trial, 740 patients with limited-stage SCLC who had not experienced disease progression following concurrent platinum-based chemotherapy and radiation were randomized on a 1-to-1-to-1 basis to receive either single-agent durvalumab, durvalumab plus tremelimumab, or placebo. Primary end points included overall survival (OS) and progression-free survival (PFS), assessed via blinded independent central review among patients who received durvalumab and placebo.
At analysis, the median OS was 55.9 months in the durvalumab arm and 33.4 months in the placebo arm (hazard ratio [HR], 0.73; 95% confidence interval [CI], 0.57 to 0.93; P = .0104). The median PFS was 16.6 months and 9.2 months, respectively (HR, 0.76; 95% CI, 0.61 to 0.95; P = .0161). The most common adverse events occurring in ≥ 20% of patients included pneumonitis or radiation pneumonitis and fatigue.
The recommended dose of durvalumab for patients with a body weight of ≥ 30 kg is 1500 mg every 4 weeks and the recommended dose for patients with a body weight of < 30 kg, administered until disease progression, unacceptable toxicity, or 24 months.
Source:
FDA approves durvalumab for limited-stage small cell lung cancer. Accessed on December 5, 2024. https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-durvalumab-limited-stage-small-cell-lung-cancer
