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Neoadjuvant treatment with durvalumab plus platinum-based chemotherapy led to a statistically significant improvement in pathologic complete response and major pathologic response compared with chemotherapy alone in patients with resectable non–small cell lung cancer, according to findings from a planned interim analysis of the phase 3 AEGEAN trial.
Neoadjuvant treatment with durvalumab (Imfinzi) plus platinum-based chemotherapy led to a statistically significant improvement in pathologic complete response (pCR) and major pathologic response (MPR) compared with chemotherapy alone in patients with resectable non–small cell lung cancer (NSCLC), according to findings from a planned interim analysis of the phase 3 AEGEAN trial (NCT03800134).1
The trial will continue as planned to evaluate the coprimary end point of event-free survival (EFS) to which the company, investigators, and patients remain blinded. The pCR data will be made available to global health agencies and presented at an upcoming medical meeting when EFS results are available.
The combination also demonstrated comparable safety and tolerability to the known profile of the combination and did not reduce the number of patients able to undergo successful surgery vs chemotherapy alone.
“Treating resectable lung cancer early provides the best chance for a cure, yet lung cancer will still recur within 5 years for the majority of patients despite chemotherapy and successful surgery. Engaging the immune response with Imfinzi both before and after surgery is an exciting new strategy, and we hope these early findings from AEGEAN will lead to improved survival for lung cancer patients in this potentially curative setting,” Susan Galbraith, executive vice president of Oncology R&D at AstraZeneca said in a news release.
AEGEAN is a randomized, double-blind, placebo-controlled, multicenter, global trial evaluating durvalumab as perioperative treatment in patients with resectable stage IIA to IIIB (tumors ≥4 cm or node positive) NSCLC with no EGFR or ALK genomic tumor aberrations, irrespective of PD-L1 expression. In the trial, 802 patients were randomized to neoadjuvant therapy consisting of a 1500 mg fixed dose of durvalumab every 3 weeks plus chemotherapy or placebo plus chemotherapy for 4 cycles. Patients then received adjuvant durvalumab or placebo every 4 weeks for up to 12 cycles.
All patients received 1 of the following platinum-based standard of care chemotherapy options based on tumor histology and investigator discretion: carboplatin/paclitaxel; cisplatin/gemcitabine; pemetrexed (Alimta)/cisplatin; or pemetrexed/carboplatin.
To be eligible for enrollment, patients had to be at least 18 years of age and have newly diagnosed and previously untreated histologically or cytologically documented NSCLC with resectable stage IIA to select stage IIIB disease; World Health Organization or ECOG performance status of 0 or 1; at least 1 lesion, not previously irradiated, that qualifies as a RECIST 1.1 target lesion at baseline; and no prior exposure to immune-mediated therapy excluding anticancer vaccines.2
Patients also had to have adequate organ and marrow function, tumor PD-L1 assessment, tumor biopsy sample for confirmation of evaluation of EGFR and ALK status, and intended surgery of lobectomy, sleeve resection, or bilobectomy.
The coprimary end points are pCR, defined as no viable tumor following neoadjuvant therapy, and EFS, defined as the time from randomization to an event like tumor recurrence or progression.
Key secondary end points are MPR, defined as residual viable tumor of less than or equal to 10% following neoadjuvant therapy, disease-free survival (DFS), overall survival (OS), safety and quality of life. Investigators will also evaluate EFS, pCR, DFS, MPR, and OS in the PD-L1–positive population (≥1%).