FDA Grants Approval to Neoadjuvant/Adjuvant Durvalumab for Patients With Resectable Non-Small Cell Lung Cancer

On August 15, 2024, the US Food and Drug Administration (FDA) approved durvalumab with a platinum-containing regimen, followed by surgery and single-agent durvalumab for adult patients with resectable non-small cell lung cancer (NSCLC) with no known epidermal growth factor receptor (EGFR) mutations or anaplastic lymphoma kinase (ALK) rearrangements. This regulatory decision was based on results from the AEGEAN trial.

In this multicenter, double-blind, placebo-controlled trial, 802 treatment-naive patients with resectable squamous or non-squamous NSCLC were randomized on a 1-to-1 basis to receive either durvalumab or placebo with a platinum-based chemotherapy every 3 weeks for up to 4 cycles, followed by surgical resection and 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 and pathological complete response (pCR) by blinded central pathology review. 

At analysis, median EFS was not reached in the durvalumab arm and 25.9 months in the placebo arm (hazard ratio [HR] 0.68; 95% confidence interval [CI], 0.53 to 0.88; P = .0039). The pCR rate was 17% in the durvalumab arm and 4.3% in the placebo arm. Overall survival was not formally tested for statistical significance however, descriptive analysis revealed no clear detriment. The most common adverse reactions occurring in ≥ 20% of patients included anemia, nausea, constipation, fatigue, musculoskeletal pain, and rash. In the durvalumab arm, 1.7% of patients were unable to undergo surgical resection due to adverse reactions compared to 1% of patients in the placebo arm. 

The recommended durvalumab dose for patients with a body weight ≥ 30 kg is 1,500 mg every 3 weeks and every 4 weeks. The recommended durvalumab dose for patients with a body weight < 30 kg is 20 mg/kg. Durvalumab should be administered prior to chemotherapy when administered on the same day. 

Source: 

FDA approves neoadjuvant/adjuvant durvalumab for resectable non-small cell lung cancer. United States Food and Drug Administration. Accessed on August 16, 2024. https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-neoadjuvantadjuvant-durvalumab-resectable-non-small-cell-lung-cancer