Dr Heymach on Results from the AEGEAN Trial of Durvalumab in Resectable NSCLC

John V. Heymach, MD, PhD, chair, Thoracic/Head and Neck Medical Oncology, David Bruton Endowed Chair in Cancer Research, The University of Texas MD Anderson Cancer Center, discusses findings the phase 3 AEGEAN trial (NCT03800134) in patients with resectable non–small cell lung cancer (NSCLC).

At the 2023 AACR Annual Meeting, Heymach shared preliminary findings from the first interim analysis of the phase 3 trial, which examined the use of perioperative durvalumab (Imfinzi) plus neoadjuvant platinum-based chemotherapy vs placebo plus chemotherapy in patients with treatment-naïve, resectable stage IIA to IIIB NSCLC. Findings showed that patients treated the durvalumab therapy (n = 366) achieved a pathologic complete response (pCR) rate of 17.2% vs 4.3% with placebo (n = 374), translating to an absolute difference of 12.9% (95% CI, 8.7%-17.6%; P = .000036). Moreover, it was also found that the major pathologic response (MPR) rates with durvalumab were 33.3%, compared with 12.3% for placebo, translating to an absolute difference of 21.0% (95% CI, 15.1%-26.9%; P = .000002).

In the durvalumab arm, the median event-free (EFS) was not reached (NR; 95% CI, 31.9-NR) vs 25.9 months (95% CI, 18.9-NR) in the placebo arm (stratified HR, 0.68; 95% CI, 0.53-0.88; P = .003902). The 12- and 24-month EFS rates were 73.4% and 63.3%, respectively, for patients treated with durvalumab, compared with 64.5% and 52.4%, respectively, for those given placebo.

The combined approach of neoadjuvant immunotherapy with chemotherapy has the potential to induce and improve antitumor activity while the tumor is in place prior to surgery, Heymach begins. Following surgery, the goal of continued systemic therapy with a PD-L1 inhibitor is to irradicate microscopic metastases, Heymach notes.

Although the results are still early, some patients enrolled on the study are still receiving durvalumab, and benefits could grow over time with longer-term follow-up, Heymach concludes.