Results from the phase 3 AEGEAN trial showed an improved pathological complete response in patients with resectable non–small cell lung cancer treated with durvalumab plus neoadjuvant chemotherapy vs chemotherapy alone.
A statistically significant and meaningful improvement in pathologic complete response (pCR) was observed following treatment with durvalumab (Imfinzi) and neoadjuvant chemotherapy vs neoadjuvant chemotherapy alone for resectable non–small cell lung cancer (NSCLC), according to results from the phase 3 AEGEAN trial (NCT03800134).1
An improvement in major pathologic response in the experimental arm was also found to be statistically significant. The trial will go on to determine event-free survival (EFS)—a co-primary end point of the trial—during which all patients and investigators will remain blinded. Additional findings will be presented at an upcoming meeting when the EFS results are available.
“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 [durvalumab] both before and after surgery is an exciting new strategy, and we hope these early findings from AEGEAN will lead to improved survival for [patients with] lung cancer in this potentially curative setting,” Susan Galbraith, executive vice president of Oncology Research & Development, said in the press release.
The AEGEAN study is a randomized, double-blind trial that enrolled 802 patients. Patients were treated with a 1500 mg fixed-dose of durvalumab every 3 weeks plus platinum-based chemotherapy or placebo plus platinum-based chemotherapy for up to 4 cycles prior to surgery, followed by durvalumab or placebo every 4 weeks for up to 12 cycles after surgery. The secondary end points include disease-free survival, major pathological response, overall survival, and EFS in those with a PD-L1-TC of 1% or more.
Eligibility criteria required that all patients be 18 years or older, have newly diagnosed or previously untreated, and histologically or cytologically documented stage IIA to stage IIIB resectable NSCLC.Patients must have had at least 1 lesion that was not previously irradiated, no prior exposure to immune-mediated therapies, and have adequate organ and marrow function.
Exclusion criteria included having a history of allogeneic organ transplantation, active or prior autoimmune or inflammatory disorders, having a history of or active primary malignancies or immunodeficiencies, and active infection such as tuberculosis, hepatitis B and C, or human immunodeficiency virus.
In 2018, durvalumab was approved by the FDA for unresectable stage III NSCLC whose disease has not progressed after treatment with chemoradiation.2 In 2020, durvalumab plus standard of care chemotherapy was approved by the FDA for extensive-stage small cell lung cancer.3