By Don Tracy, Associate Editor

FDA’s Oncologic Drugs Advisory Committee acknowledged that Imfinzi met its primary endpoint of event-free survival in the treatment of resectable non-small cell lung cancer.
The FDA’s Oncologic Drugs Advisory Committee (ODAC) has found that AstraZeneca's Imfinzi (durvalumab) achieved the primary endpoint of event-free survival (EFS) in the treatment of resectable non-small cell lung cancer (NSCLC) in the Phase III AEGEAN trial. However, AstraZeneca noted that although the contribution by phase of neoadjuvant and adjuvant components of the perioperative regimen could not be clearly assigned based on the trial design, its potential should not be overlooked. Results of the trial were published in The New England Journal of Medicine.
“The majority of patients with resectable lung cancer face recurrence of their disease even after surgery and neoadjuvant chemotherapy. The Committee acknowledged the potential to address this urgent unmet need with durvalumab both before and after surgery, which can significantly increase the time patients live without progression and recurrence events in this curative-intent setting,” said John V. Heymach, MD, PhD, professor, chair thoracic/head and neck medical oncology, The University of Texas MD Anderson Cancer Center, Houston, Texas, in a press release.
The randomized, double-blind, multi-center, placebo-controlled global AEGEAN trial evaluated Imfinzi as perioperative treatment for patients with resectable stage IIA-IIIB (Eighth Edition AJCC Cancer Staging Manual) NSCLC, irrespective of PD-L1 expression. As part of the study, 802 patients were randomly assigned to receive a 1500 mg fixed dose of Imfinzi plus chemotherapy or placebo plus chemotherapy every three weeks for four cycles prior to surgery, followed by Imfinzi or placebo every four weeks (for up to 12 cycles) after surgery. The primary endpoints of the trial were pathologic complete response (pCR) and EFS, with secondary endpoints including major pathologic response, defined as residual viable tumor of less than or equal to 10% in the resected primary tumor following neoadjuvant therapy, disease-free survival, overall survival (OS), safety, and quality of life.
The trial demonstrated a 32% reduction in recurrence, progression, or death risk compared to chemotherapy alone, and a significant increase in pCR rates with the Imfinzi regimen. In the final pCR analysis, treatment resulted in a pCR rate of 17.2% versus 4.3% for patients treated with neoadjuvant chemotherapy alone (difference in pCR 13.0%; 95% CI 8.7-17.6).
Imfinzi was well tolerated, with no new safety signals identified. The addition of Imfinzi to neoadjuvant chemotherapy was reported to be consistent with the known profile of the combination and did not compromise patients' ability to complete surgery versus chemotherapy alone.1
According to the American Cancer Society (ACS), an estimated 80% to 85% of all lung cancers are NSCLC. It is the second most common cancer in the United States, accounting for the most cancer deaths annually. For 2024, the ACS estimates that there will be around 234,580 new cases of lung cancer and 125,070 deaths.2
“The committee’s discussion of the AEGEAN data highlighted the significant benefit delivered by this Imfinzi-based regimen for patients with resectable lung cancer. We are committed to working closely with the FDA to bring this novel immunotherapy option to patients that offers a flexible chemotherapy backbone,” said Susan Galbraith, EVP, oncology R&D, AstraZeneca, in the press release.
Currently, Imfinzi is approved in Switzerland and the UK for the treatment of adults with resectable NSCLC in stage II and III without known EGFR mutations or ALK rearrangements, with regulatory applications currently under review in the EU, China, and several other countries.1