FDA Approves AstraZeneca’s Imfinzi in Combination with Chemotherapy for Resectable Early-Stage Non-Small Cell Lung Cancer

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The FDA has approved AstraZeneca’s Imfinzi in combination with chemotherapy for treating adult patients with resectable early-stage (IIA-IIIB) non-small cell lung cancer (NSCLC) without epidermal growth factor receptor (EGFR) mutations or anaplastic lymphoma kinase (ALK) rearrangements. Administration of Imfinzi with neoadjuvant chemotherapy is performed before surgery and as monotherapy post-surgery. The approval is based on positive results from the AEGEAN trial.¹

“This approval brings an important new treatment option that should become a backbone combination approach for patients with resectable non-small cell lung cancer, who have historically faced high rates of recurrence even after chemotherapy and surgery. When added both before and after surgery, durvalumab delivered a significant and meaningful improvement in outcomes 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, TX, in a press release.

The randomized, double-blind, multi-center, placebo-controlled global Phase III AEGEAN trial evaluated Imfinzi as a perioperative treatment for patients with resectable Stage IIA-IIIB NSCLC, irrespective of PD-L1 expression. The trial included 820 patients, who 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 after surgery. Patients with known EGFR or ALK genomic tumor aberrations were excluded from the primary efficacy analyses.

The primary endpoints of the trial were pathologic complete response (pCR) and event-free survival (EFS). Secondary endpoints included 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 included patients from 264 centers in over 25 countries, including the United States, Canada, Europe, South America, and Asia.

Results demonstrated a 32% reduction in the risk of recurrence, progression, or death compared to chemotherapy alone, and a pCR rate of 17.2% compared to 4.3% for the placebo plus chemotherapy group. The treatment was reported to be well tolerated, with no new safety signals reported in the neoadjuvant and adjuvant settings. Additionally, Imfinzi did not compromise patients' ability to complete surgery versus chemotherapy alone.¹

According to the American Cancer Society, between 85% and 90% of all lung cancers are NSCLC. By the end of 2024, it is expected that approximately 234,580 new cases of lung cancer will be diagnosed in the United States, with 125,070 people dying as a result. Lung cancer is considered the leading cause of cancer deaths in the United States, accounting for an estimated one out of five cancer deaths overall.²

“[The] approval of Imfinzi in resectable early-stage lung cancer builds on its strong foundation of changing clinical practice in unresectable Stage III disease. We remain committed to bringing novel approaches like AEGEAN to early lung cancer settings where cure is the goal of treatment,” said Dave Fredrickson, EVP, oncology business unit, AstraZeneca, in the press release.

According to AstraZeneca, Imfinzi is currently the only approved immunotherapy in the curative-intent setting of unresectable, Stage III NSCLC in patients whose disease has not progressed after chemoradiotherapy. It has also received approval in the United Kingdom, Switzerland, and Taiwan based on results from the AEGEAN trial, with applications currently under review in the EU, China, and several other countries.¹

References

1. Imfinzi approved in the US for the treatment of resectable non-small cell lung cancer before and after surgery. AstraZeneca. August 16, 2024. Accessed August 19, 2024. https://www.astrazeneca.com/media-centre/press-releases/2024/imfinzi-approved-in-us-for-resectable-lung-cancer.html

2. Key Statistics for Lung Cancer. American Cancer Society. Accessed August 19, 2024. https://www.cancer.org/cancer/types/lung-cancer/about/key-statistics.html