Lung cancer continues to be a significant health challenge, with non-small cell lung cancer (NSCLC) making up 80% to 85% of all lung cancer cases. The Food and Drug Administration’s (FDA) Oncologic Drugs Advisory Committee (ODAC) recently reviewed AstraZeneca’s Imfinzi (durvalumab) in combination with neoadjuvant chemotherapy for the treatment of resectable NSCLC. The Phase III AEGEAN trial demonstrated that Imfinzi achieved the primary endpoint of event-free survival (EFS), presenting a significant advancement in the treatment of resectable NSCLC. These results 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.
Lung Cancer: AEGEAN Trial Evaluates Imfinzi with Chemotherapy for Resectable Stage IIA-IIIB NSCLC
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. In this 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 were pathologic complete response (pCR) and EFS, with secondary endpoints including major pathologic response, disease-free survival, overall survival (OS), safety, and quality of life.
The AEGEAN trial results indicated a 32% reduction in the risk of recurrence, progression, or death compared to chemotherapy alone. Additionally, the trial showed a significant increase in pCR rates with the Imfinzi regimen. In the final pCR analysis, the treatment resulted in a pCR rate of 17.2% compared to 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 consistent with the known profile of the combination and did not compromise patients’ ability to complete surgery versus chemotherapy alone.
Lung Cancer: Urgent Need for Effective Treatments as ACS Estimates 234,580 New Cases and 125,070 Deaths
Lung cancer remains the second most common cancer in the United States and the leading cause of cancer deaths annually. The American Cancer Society (ACS) estimates that in 2024, there will be around 234,580 new cases of lung cancer and 125,070 deaths. This highlights the urgent need for effective treatments to improve patient outcomes.
“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.
Imfinzi is already 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. Regulatory applications are currently under review in the EU, China, and several other countries. The positive outcome of the AEGEAN trial represents a significant step forward in the management of resectable NSCLC. This combination therapy has the potential to change the standard of care, providing a new option for patients who face high recurrence rates even after surgery and neoadjuvant chemotherapy. The continued collaboration between AstraZeneca and regulatory authorities aims to make this treatment available to patients worldwide, offering hope for improved survival and quality of life.
Resource: AstraZeneca, July 26, 2024
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