On December 4, 2024, the U.S. Food and Drug Administration approved durvalumab (Imfinzi) for adults with limited-stage small cell lung cancer (SCLC) whose disease has not progressed following concurrent platinum-based chemotherapy and radiation therapy.
Efficacy was evaluated in ADRIATIC (ClinicalTrials.gov identifier NCT03703297), a randomized, double-blind, placebo-controlled trial in 730 patients with limited-stage SCLC whose disease had not progressed following concurrent platinum-based chemotherapy and radiation therapy. Patients were randomly assigned 1:1:1 to receive durvalumab as a single agent, durvalumab in combination with tremelimumab, or placebo.
The major efficacy outcome measures were overall survival and progression-free survival assessed by blinded independent central review for the comparison between durvalumab as a single agent and placebo. Durvalumab demonstrated a statistically significant overall survival improvement compared to placebo with a hazard ratio (HR) of 0.73 (95% confidence interval [CI] = 0.57–0.93; P = .0104). The median overall survival was 55.9 months (95% CI = 37.3 to not reached) in the durvalumab arm and 33.4 months (95% CI = 25.5–39.9) in the placebo arm.
Durvalumab also demonstrated a statistically significant progression-free survival improvement compared to placebo with HR of 0.76 (95% CI = 0.61–0.95; P = .0161). The median progression-free survival was 16.6 months (95% CI = 10.2–28.2) and 9.2 months (95% CI = 7.4–12.9) in the durvalumab and placebo arms, respectively.
The most common adverse reactions (≥ 20%) were pneumonitis or radiation pneumonitis and fatigue.
The recommended durvalumab dose is 1,500 mg every 4 weeks for patients with a body weight of ≥ 30 kg and 20 mg/kg every 4 weeks for patients with a body weight of < 30 kg until disease progression or unacceptable toxicity or a maximum of 24 months.
