FDA approves durvalumab for limited-stage small cell lung cancer
Regulatory approval: On Dec 4, 2024, the FDA approved durvalumab (Imfinzi) for adults with limited-stage small cell lung cancer whose disease has not progressed after concurrent platinum-based chemotherapy and radiation therapy. Approval was supported by the phase 3 ADRIATIC trial, where durvalumab improved overall survival (HR 0.73) and progression-free survival (HR 0.76) versus placebo. Common adverse reactions (≥20%) included pneumonitis/radiation pneumonitis and fatigue.
FDA regulatory approval (Dec 4, 2024)
The US Food and Drug Administration (FDA) approved durvalumab (Imfinzi; AstraZeneca) for adults with limited-stage small cell lung cancer (LS-SCLC) whose disease has not progressed following concurrent platinum-based chemotherapy and radiation therapy.
Evidence supporting approval: ADRIATIC (NCT03703297)
Efficacy and safety were evaluated in ADRIATIC, a randomized, double-blind, placebo-controlled trial enrolling 730 patients with LS-SCLC without progression after concurrent chemoradiation. Patients were randomized 1:1:1 to durvalumab, durvalumab + tremelimumab, or placebo.
The major efficacy outcomes for durvalumab monotherapy vs placebo were overall survival (OS) and progression-free survival (PFS) assessed by blinded independent central review:
- OS: HR 0.73 (95% CI, 0.57–0.93; p=0.0104); median OS 55.9 months (95% CI, 37.3–NR) vs 33.4 months (95% CI, 25.5–39.9).
- PFS: HR 0.76 (95% CI, 0.61–0.95; p=0.0161); median PFS 16.6 months (95% CI, 10.2–28.2) vs 9.2 months (95% CI, 7.4–12.9).
Safety and dosing
Most common adverse reactions (≥20%) were pneumonitis/radiation pneumonitis and fatigue. Recommended dosing: 1,500 mg every 4 weeks for body weight ≥30 kg, or 20 mg/kg every 4 weeks for <30 kg, until progression/unacceptable toxicity or up to 24 months.
The review was conducted under Project Orbis; reviews at other agencies may be ongoing.