Dr Stiles on the FDA Approval of Perioperative Durvalumab Plus Chemo in NSCLC

Brendon M. Stiles, MD, associate director, Surgical Oncology, chief, Divisions of Thoracic Surgery and Surgical Oncology, and professor of cardiothoracic surgery, Department of Cardiothoracic and Vascular Surgery, Montefiore Einstein Comprehensive Cancer Center, discusses the implications of the FDA approval of durvalumab (Imfinzi) in combination with platinum-containing chemotherapy as neoadjuvant treatment, followed by adjuvant durvalumab, for the treatment of adult patients with resectable (tumors ≥4 cm and/or node positive) non–small cell lung cancer (NSCLC) without known EGFR mutations or ALK rearrangements.

The approval of perioperative durvalumab plus chemotherapy marks a significant advancement in the treatment of patients with early-stage NSCLC, Stiles notes, highlighting its potential use for patients with stage II or III disease, where intervention is crucial.

The regulatory decision was supported by data from the phase 3 AEGEAN trial (NCT03800134). Findings from the first interim analysis of the study presented at the 2023 AACR Annual Meeting showed that perioperative durvalumab plus neoadjuvant platinum-based chemotherapy (n = 366) demonstrated a statistically significant improvement in the risk of recurrence, progression, or death compared with chemotherapy plus placebo (n = 374; HR, 0.68; 95% CI, 0.53-0.88; P = .0039). The median event-free survival was not reached (NR; 95% CI, 31.9-not estimable [NE]) in the durvalumab arm vs 25.9 months (95% CI, 18.9-NE) in the chemotherapy arm.

Additionally, patients treated with the durvalumab regimen experienced a pathologic complete response rate of 17% (95% CI, 13%-21%) vs 4.3% (95% CI, 2.5%-7%) for those treated with the placebo regimen. The major pathologic response rates in the durvalumab and placebo arms were 33.3% and 12.3%, respectively (absolute difference, 21.0%; 95% CI, 15.1%-26.9%; P = .000002).

Ongoing research within the lung cancer space has helped move treatments into earlier settings and build upon the established standard of care, Stiles explains. He underscores the significance of being able to deliver neoadjuvant therapy to patients with stage II or III disease. This approval opens the door for the use of immunotherapy before and after surgery, which could benefit patients, Stiles concludes.