Adding perioperative durvalumab to neoadjuvant chemotherapy can improve outcomes in patients with resectable non-small cell lung cancer (NSCLC), according to research presented at the AACR Annual Meeting 2023.
In the phase 3 AEGEAN trial, perioperative durvalumab improved the pathologic complete response (pCR) rate and prolonged event-free survival (EFS) in patients with resectable NSCLC.
“AEGEAN is the first phase 3 study to describe the benefit of perioperative immunotherapy plus neoadjuvant chemotherapy,” said study presenter John V. Heymach, MD, PhD, of The University of Texas MD Anderson Cancer Center in Houston.
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“Perioperative durvalumab plus neoadjuvant chemotherapy is a potential new treatment for patients with resectable NSCLC,” he added.
Trial and Treatment Details
The AEGEAN trial (ClinicalTrials.gov Identifier: NCT03800134) included 802 patients with treatment-naive, stage IIA-IIIB(N2), resectable NSCLC.
Patients were randomly assigned to receive durvalumab (n=366) or placebo (n=374), each in combination with neoadjuvant chemotherapy. Baseline characteristics were generally balanced between the treatment arms.
All patients received 4 cycles of chemotherapy, which consisted of cisplatin/carboplatin plus pemetrexed for patients with non-squamous NSCLC. Patients with squamous NSCLC received carboplatin plus paclitaxel or cisplatin/carboplatin plus gemcitabine. Patients in the durvalumab arm received 1500 mg of the drug every 3 weeks for 4 cycles.
Most patients in the durvalumab and placebo arms completed chemotherapy (84.7% and 87.2%, respectively) and 4 cycles of either durvalumab or placebo (86.9% and 88.5%). Most patients went on to surgery — 80.6% in the durvalumab arm and 80.7% in the placebo arm. The R0 resection rate was 94.7% and 91.3%, respectively.
After surgery, patients in the durvalumab arm received the drug again, at 1500 mg every 4 weeks for up to 12 cycles. Twenty-four percent of patients completed this treatment, and 23.2% were still receiving it at last follow-up.
Efficacy and Safety Results
The median follow-up was 11.7 months. The median EFS was not reached in the durvalumab arm and was 25.9 months in the placebo arm (hazard ratio, 0.68; 95% CI, 0.53-0.88; P =.004).
The 12-month EFS rate was 73.4% with durvalumab and 64.5% with placebo. The 24-month EFS rate was 63.3% and 52.4%, respectively.
In the final pCR analysis, 17.2% of patients achieved a pCR in the durvalumab arm, as did 4.3% of patients in the placebo arm (P =.000036). The major pathologic response rate was 33.3% with durvalumab and 12.3% with placebo (P =.000002).
The rate of grade 3-4 adverse events considered possibly related to treatment was 32.3% in the durvalumab arm and 33.1% in the placebo arm. Grade 3-4 immune-mediated adverse events occurred in 4.0% and 2.5% of patients, respectively.
Dr Heymach said this study is ongoing, and disease-free survival and overall survival will be assessed.
Disclosures: This research was supported by AstraZeneca. Some study authors declared affiliations with biotech, pharmaceutical, and/or device companies. Please see the original reference for a full list of disclosures.
Reference
Heymach JV, Harpole D, Mitsudomi T, et al. AEGEAN: A phase 3 trial of neoadjuvant durvalumab + chemotherapy followed by adjuvant durvalumab in patients with resectable NSCLC. AACR 2023. April 14-19, 2023. Abstract CT005.
This article originally appeared on Cancer Therapy Advisor
