Durvalumab Approved in Combination with Chemotherapy for Early-stage Lung Cancer
Durvalumab can now be used with chemotherapy for certain patients with resectable non-small cell lung cancer.
The U.S. Food and Drug Administration (FDA) has granted approval to the neoadjuvant combination of durvalumab (Imfinzi) and platinum-based chemotherapy, followed by adjuvant durvalumab for adult patients with resectable non-small cell lung cancer (NSCLC) who have tumors measuring ≥ 4 cm or have lymph node-positive disease. This approval applies to patients whose tumors lack epidermal growth factor receptor (EGFR) mutations and anaplastic lymphoma kinase (ALK) rearrangements.
Durvalumab is an immune checkpoint inhibitor, a type of immunotherapy that can improve the immune system’s ability to recognize and destroy cancer cells. This approval, the first for durvalumab in either the adjuvant or neoadjuvant setting, offers an additional treatment option for patients with earlier-stage, resectable NSCLC who can benefit from presurgical therapy and ultimately surgical resection.
The approval was based on the results of the randomized, double-blind, placebo-controlled, multicenter, phase III AEGEAN clinical trial, which enrolled 802 patients with untreated, resectable NSCLC. Patients were randomly assigned (1:1) to receive either durvalumab or placebo with chemotherapy prior to surgery. Following surgery, patients received either durvalumab or placebo as a single-agent treatment.
At the time of surgery, the study found that 17% of durvalumab-treated patients had no detectable cancer, compared to 4.3% of the placebo arm. With a median follow-up time of 11.7 months, the majority of those treated with durvalumab did not experience recurrence, progression that prevented surgery, or death, while placebo-treated patients experienced one of these events after a median of 25.9 months; this equated to a 32% lower risk of cancer recurrence, surgery-precluding disease progression, or death for those in the durvalumab arm. These results were reported at the American Association for Cancer Research (AACR) Annual Meeting 2023.
The recommended dosage of durvalumab is 1,500 mg for patients weighing more than 30 kg and 20 mg/kg for patients weighing less than 30 kg, to be administered every three weeks during the neoadjuvant phase and every four weeks during the adjuvant phase. When given on the same day, durvalumab should be administered before chemotherapy.
NSCLC is the most common type of lung cancer. According to federal statistics, an estimated 234,580 people will be diagnosed with lung cancer and 125,070 will die of the disease in the United States in 2024.
The FDA rendered its decision on August 15, 2024.
