Officials with the FDA approved durvalumab (Imfinzi; AstraZeneca) with platinum-containing chemotherapy as neoadjuvant treatment, followed by single-agent durvalumab as adjuvant treatment after surgery for adults with resectable (tumors ≥4 cm and/or node positive) NSCLC and no known EGFR mutations or anaplastic lymphoma kinase rearrangements.
Researchers evaluated efficacy in AEGEAN (NCT03800134), a randomized, double-blind, placebo-controlled multicenter trial in 802 patients with previously untreated and resectable squamous or nonsquamous NSCLC. Patients were randomly assigned to either durvalumab or placebo, with platinum-based chemotherapy, every 3 weeks for up to 4 cycles followed by either continued single-agent durvalumab or placebo, every 4 weeks for up to 12 cycles.
The major efficacy outcome measures were event-free survival (EFS) by blinded independent central review assessment and pathological complete response (pCR) by blinded central pathology review. Median EFS was not reached (95% CI, 31.9, not estimable [NE]) in the durvalumab arm and 25.9 months (95% CI, 18.9, NE) in the placebo arm (HR, 0.68; 95% CI, 0.53-0.88; P=.0039). The pCR rate was 17% (95% CI, 13-21) and 4.3% (95% CI, 2.5-7) in the durvalumab and placebo arms, respectively. At the time of the prespecified interim analyses, OS was not formally tested for statistical significance; however, a descriptive analysis revealed no clear detriment.
The most commonly reported adverse events, FDA officials noted in an August 15, 2024, statement about the approval, included anemia, nausea, constipation, fatigue, musculoskeletal pain, and rash. Of the patients who received neoadjuvant durvalumab, 1.7% were unable to receive surgery due to adverse reactions compared with 1% in the placebo arm.1
Editor’s note: This report was based on statements issued by the FDA and pharmaceutical companies mentioned in the approvals.
References
- Food and Drug Administration. FDA approves neoadjuvant/adjuvant durvalumab for resectable non-small cell lung cancer. August 15, 2024. Accessed August 20, 2024. www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-neoadjuvantadjuvant-durvalumab-resectable-non-small-cell-lung-cancer