In August, 2024, the FDA approved the Checkpoint Inhibitor immunotherapy drug Imfinzi (durvalumab) in combination with chemotherapy for the treatment of adult patients with resectable, EGFR-negative and ALK-negative, stage IIA-IIIB non-small cell lung cancer (NSCLC).
Previous clinical studies have demonstrated that combining chemotherapy with immune checkpoint inhibitor drugs prolong survivals when used as adjuvant or neoadjuvant therapy for early stage IB-IIIB NSCLC. The results of the AGEAN clinical trial suggest that combining neoadjuvant (before surgery) and adjuvant (post-surgery) immunotherapy with chemotherapy may be the best strategy to reduce the risk of cancer recurrence and prolong survival. The addition of perioperative Imfinzi to neoadjuvant chemotherapy improves pathological complete response (pCR) rates and prolongs cancer free survival in patients with stage II to IIIB NSCLC, according to findings from the phase 3 AEGEAN clinical trial.
The AEGEAN clinical trial directly compared a treatment strategy of neoadjuvant Imfinzi + platinum-based chemotherapy and post-surgical Imfinzi maintenance to treatment with neoadjuvant chemotherapy alone in 802 patients. The initial trial results were released at the September 2023 World Lung Meetings and published in the New England Journal of Medicine. The updated event free survival (EFS) and other results from the second planned interim analysis of the trial based on 25.9 months follow-up were recently reported at the 2024 World Conference on Lung Cancer.
Results from the recent planned interim analysis of EFS showed a statistically significant and clinically meaningful 32% reduction in the risk of recurrence, progression events or death versus chemotherapy alone in patients treated with the Imfinzi-based regimen before and after surgery (32% data maturity; EFS hazard ratio of 0.68; 95% confidence interval [CI] 0.53-0.88; p=0.003902).
Imfinizi was generally well tolerated and associated with a manageable side effect profile. At this second interim analysis of EFS, no patients remained on treatment and among all patients who started adjuvant treatment:
- 68.6% in the Imfinzi arm and 63.7% in the placebo arm completed all adjuvant treatment
- Progressive disease was the reason for discontinuation in 14.9% in the Imfinzi arm and 29.5% in the placebo arm
About Imfinzi
Imfinzi is a human monoclonal antibody directed against programmed death ligand-1 (PD-L1). PD-L1 can be expressed by cancer cells, and it helps them evade detection by the immune system through binding to PD-1 on cytotoxic T lymphocytes. Imfinzi blocks the PD-L1 interaction with PD-1, countering the cancer’s immune-evading tactics. Imfinzi empowers the patient’s immune system to attack the cancer.
More Reading
Imfinizi in Non-Small Cell Lung Cancer
Newly Diagnosed With Lung Cancer? What Every Patient Should Know
The Importance of Molecular Testing
Precision Medicines & Immunotherapy
Must Read Tips for Beating Lung Cancer
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References
Heymach JV, Harpole D, Mitsudomi T, et al. AEGEAN Investigators. Perioperative Durvalumab for Resectable Non-Small-Cell Lung Cancer. N Engl J Med. 2023 Nov 2;389(18):1672-1684.
Heymach, JV, et al. Perioperative Durvalumab for Resectable NSCLC: Updated Outcomes from the Phase 3 AEGEAN Trial. Presented at the 2024 World Conference on Lung Cancer, September 7-10, 20204. San Diego, CA. OA13.03
