AEGEAN Trial: Addition of Perioperative Durvalumab to Neoadjuvant Chemotherapy in Resectable NSCLC

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The addition of perioperative durvalumab to neoadjuvant chemotherapy may be associated with a tolerable surgical safety profile and may not adversely impact surgery in patients with resectable non–small cell lung cancer (NSCLC), according to new findings presented by Mitsudomi et al at the International Association for the Study of Lung Cancer (IASLC) 2023 World Conference on Lung Cancer (Abstract OA12.05).

Study Methods and Results 

In the new double-blind, placebo-controlled phase III AEGEAN trial, researchers randomly assigned 802 patients with treatment-naive resectable NSCLC (stage II to IIIB and Eastern Cooperative Oncology Group performance status 0 or 1) to receive either 1,500 mg of perioperative durvalumab or placebo intravenously alongside platinum-based chemotherapy prior to surgery. Following surgery, the patients received 1,500 mg of durvalumab or placebo intravenously.

Lobectomy, sleeve resection, and bilobectomy were allowed as planned surgery at enrollment. The protocol was then amended, with enrollment ongoing to exclude patients with tumors classified as T4 for any reason other than size (> 7 cm) or whose planned surgery was pneumonectomy.

Efficacy analyses were performed in the modified intent-to-treat population—which comprised 740 patients with no documented EGFR mutations/ALK gene rearrangements. The researchers noted that the primary endpoints of the trial were pathologic complete response and event-free survival.

In the modified intent-to-treat population, the researchers found that 80.6% of the patients who received perioperative durvalumab and 80.7% who received placebo underwent surgery and 77.6% and 76.7% of the patients completed surgery, respectively. Disease progression was the most common reason for canceled (6.8% vs 7.8%) or noncompleted (1.4% vs 2.1%) surgery.

Among treated patients who underwent surgery, 17.3% of the patients in the perioperative durvalumab arm and 22.2% of the patients in the placebo arm had delayed surgery, most commonly for logistical reasons. The median time from the last neoadjuvant treatment dose to surgery was the same in each arm (34.0 days). Among patients who underwent surgery, similar proportions in the perioperative durvalumab and placebo arms had open (49.2% vs 50.7%) and minimally invasive procedures (49.2% vs 47.0%). Further, lobectomy was the most common procedure (88.1% vs 85.4%), followed by pneumonectomy (9.2% vs 9.6%). Among those who completed surgery, a numerically higher proportion had R0 resection in the perioperative durvalumab arm vs the placebo arm (94.7% vs 91.3%).


The researchers emphasized that it was encouraging to observe these comprehensive outcomes described in a robust phase III trial, which demonstrated that adding perioperative durvalumab to neoadjuvant chemotherapy did not adversely impact the feasibility, type, extent, or timing of surgery in patients with resectable NSCLC—and was associated with a tolerable surgical safety profile. Further, the researchers underscored that the addition of perioperative durvalumab resulted in numerically higher R0 resection rates.

“The AEGEAN trial demonstrated a clinically meaningful improvement in [event-free survival] with the addition of perioperative durvalumab to neoadjuvant chemotherapy, alongside significantly improved pathological complete response and major pathological response,” said lead study author Tetsuya Mitsudomi, MD, Professor in the Division of Thoracic Surgery in the Department of Surgery at the Kindai University Faculty of Medicine in Osaka, Japan. “Understanding surgical outcomes can further inform the use of this treatment and is an important consideration for patients and physicians,” he concluded.

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