FDA approves neoadjuvant/adjuvant durvalumab for resectable non-small cell lung cancer

Regulatory approval: On Aug 15, 2024, the FDA approved durvalumab (Imfinzi) with platinum-containing chemotherapy as neoadjuvant therapy, followed by adjuvant single-agent durvalumab after surgery, for adults with resectable (tumors ≥4 cm and/or node-positive) NSCLC without known EGFR mutations or ALK rearrangements. Approval was supported by AEGEAN (NCT03800134), which showed improved event-free survival (HR 0.68) and higher pCR (17% vs 4.3%) versus placebo.

FDA approval (Aug 15, 2024): perioperative durvalumab for resectable NSCLC

The FDA approved durvalumab (Imfinzi, AstraZeneca) in combination with platinum-containing chemotherapy as neoadjuvant treatment, followed by single-agent durvalumab as adjuvant treatment after surgery for adults with resectable NSCLC (tumors ≥4 cm and/or node-positive) with no known EGFR mutations or ALK rearrangements.

Supporting trial: AEGEAN (NCT03800134)

Efficacy and safety were evaluated in AEGEAN, a randomized, double-blind, placebo-controlled multicenter trial (N=802) enrolling previously untreated, resectable squamous or non-squamous NSCLC (Stage IIA to select Stage IIIB; AJCC 8th). Patients were randomized 1:1 to durvalumab or placebo with platinum-based chemotherapy q3w for up to 4 cycles (neoadjuvant), then durvalumab or placebo q4w for up to 12 cycles (adjuvant).

Co-primary outcomes: event-free survival (EFS; blinded independent central review) and pathologic complete response (pCR; blinded central pathology review).

  • Median EFS: not reached (95% CI 31.9–NE) with durvalumab vs 25.9 months (95% CI 18.9–NE) with placebo; HR 0.68 (95% CI 0.53–0.88); p=0.0039.
  • pCR: 17% (95% CI 13–21) vs 4.3% (95% CI 2.5–7).
  • OS: at prespecified interim analyses, OS was not formally tested; descriptive analysis reported no clear detriment.

Safety and dosing (label highlights)

Most common adverse reactions (≥20%): anemia, nausea, constipation, fatigue, musculoskeletal pain, rash. Surgery was not received due to adverse reactions in 1.7% (durvalumab) vs 1% (placebo) of neoadjuvant-treated patients.

Recommended dosing: ≥30 kg: 1,500 mg q3w (neoadjuvant) and q4w (adjuvant); <30 kg: 20 mg/kg. Administer durvalumab prior to chemotherapy on the same day.

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