Final analyses for pathologic response appear consistent with previous reports from the phase 3 AEGEAN trial evaluating neoadjuvant durvalumab and chemotherapy plus adjuvant durvalumab monotherapy in resectable non–small cell lung cancer.
Durvalumab (Imfinzi) plus chemotherapy before surgery followed by adjuvant durvalumab produced a statistically significant and clinically meaningful event-free survival (EFS) benefit vs neoadjuvant chemotherapy alone for patients with resectable stage IIA to IIIB non–small cell lung cancer (NSCLC), according to a press release on an interim analysis of the phase 3 AEGEAN trial (NCT03800134).1
Data from the final analyses indicted that pathologic complete response (pCR) and major pathological response (mPR) were comparable with previous reports from the AEGEAN trial.2 Investigators will continue to evaluate other secondary end points including overall survival (OS) and disease-free survival (DFS).
“Treating patients early with durvalumab both before and after surgery delivers a significant and clinically meaningful benefit in resectable non–small cell lung cancer, where new options are urgently needed to offer patients the best chance of long-term survival,” John V. Heymach, MD, PhD, professor and chair of Thoracic/Head and Neck Medical Oncology at the University of Texas MD Anderson Cancer Center, said in the press release. “The AEGEAN results provide compelling evidence that this novel durvalumab regimen can drive improved outcomes in this curative-intent setting.”
Investigators of the randomized, double-blind, multi-center, placebo-controlled phase 3 AEGEAN trial are assessing perioperative durvalumab for patients with resectable NSCLC regardless of PD-L1 expression. A total of 802 patients were randomly assigned to receive a 1500 mg fixed dose of durvalumab plus chemotherapy or matched placebo plus chemotherapy every 3 weeks, 4 weeks before surgery followed by adjuvant durvalumab or placebo every 4 weeks for up to 12 cycles following surgery.
The primary end points of the trial are pCR and EFS. Secondary end points include DFS, OS, mPR, health-related quality of life, and pharmacokinetics profile.
Patients 18 years or older with newly diagnosed and histologically/cytologically documented resectable NSCLC were eligible for enrollment on the trial. Additional inclusion criteria included having at least 1 measurable lesion per RECIST v1.1 criteria, a World Health Organization or ECOG performance status of 0 or 1, adequate organ and marrow function, PD-L1 status confirmation, and sufficient tumor biopsy sample for evaluation of EGFR and ALK status.
Patients with a history of allogeneic organ transplantation or active/prior documented autoimmune disorders were not able to enroll on the trial. Patients were also unsuitable for enrollment if they had history of another primary malignancy, history of active primary immunodeficiency, brain metastases or spinal cord compression, or known hypersensitivity to any of the study drugs.
“We have shown that adding [durvalumab] both before and after surgery significantly increased the time patients live without recurrence or progression events. We will continue to follow patients for [OS],” Susan Galbraith, executive vice president of oncology research and development at AstraZeneca, concluded.