Clinical outcomes by type of surgery with perioperative durvalumab in patients with resectable non-small cell lung cancer.

OBJECTIVE

To assess outcomes with perioperative durvalumab by type of surgery in patients with resectable non-small cell lung cancer (NSCLC) from the AEGEAN study.

METHODS

AEGEAN is a double-blind, placebo-controlled phase 3 study (NCT03800134) of adults with treatment-naïve, resectable NSCLC (stage II-IIIB[N2]) who were randomized 1:1 to neoadjuvant chemotherapy plus durvalumab or placebo before surgery followed by adjuvant durvalumab or placebo.

PRIMARY ENDPOINTS: pathological complete response (pCR) and event-free survival (EFS) in the modified intent-to-treat (mITT) population, which excluded patients with documented EGFR/ALK aberrations.

RESULTS

Of 295 and 302 patients in the durvalumab and placebo arms, respectively, who underwent surgery (mITT population), 80.7% versus 73.2% had lobectomy, 7.5% versus 12.3% had sleeve resection/bilobectomy, and 9.2% versus 9.6% had pneumonectomy. pCR rates were higher in the durvalumab versus placebo arm, regardless of surgery type (lobectomy: 21.0% vs 5.4%; sleeve resection/bilobectomy: 36.4% vs 5.4%; and pneumonectomy: 7.4% vs 3.4%). EFS benefit favored the durvalumab versus placebo arm, regardless of surgery type (lobectomy: hazard ratio [HR], 0.64 [95% confidence interval (CI), 0.46-0.88; sleeve resection/bilobectomy: HR, 0.59 [95% CI, 0.22-1.40]; and pneumonectomy: HR, 0.80 [95% CI, 0.36-1.74]). The rates of maximum grade ≥3 surgical complications were low across both arms, regardless of surgery type (lobectomy: 4.2% vs 9.5%; sleeve resection/bilobectomy: 13.6% vs 5.4%; and pneumonectomy: 14.8% vs 6.9%).

CONCLUSIONS

Clinical benefit with perioperative durvalumab plus neoadjuvant chemotherapy versus neoadjuvant chemotherapy alone was generally maintained across the surgery subgroups.