Immunotherapy’s FDA approval expected to improve lung cancer treatment

Editor's Note

The US Food & Drug Administration (FDA) has approved immunotherapy durvalumab for perioperative treatment of resectable non-small cell lung cancer (NSCLC), according to an August 15 announcement.

The approval is for durvalumab (Imfinzi, AstraZeneca) in combination with platinum-based chemotherapy as a neoadjuvant treatment, followed by durvalumab alone as an adjuvant treatment after surgery for adults with resectable non-small cell lung cancer (NSCLC). This treatment is specifically for patients with tumors ≥ 4 cm and/or node-positive NSCLC who do not have known EGFR mutations or ALK rearrangements.

According to the announcement, approval is based on results from the AEGEAN trial, a randomized, double-blind, placebo-controlled study involving 802 patients with previously untreated, resectable NSCLC (Stage IIA to select Stage IIIB). Patients were randomized to receive either durvalumab or placebo alongside platinum-based chemotherapy every three weeks for up to four cycles before surgery. After surgery, patients continued with either durvalumab or placebo every four weeks for up to 12 cycles.

FDA reports various findings from the trial, including a significant improvement in event-free survival (EFS) for the durvalumab group. Additionally, the pathological complete response (pCR) rate was notably higher in the durvalumab arm than in the placebo arm, and a descriptive analysis indicated no clear detriment in overall survival. Common adverse reactions to durvalumab included anemia, nausea, constipation, fatigue, musculoskeletal pain, and rash.