AstraZeneca’s IMFINZI® (durvalumab) Approved in the US for Comprehensive Treatment of Resectable Non-Small Cell Lung Cancer
AstraZeneca has announced that IMFINZI® (durvalumab), in combination with chemotherapy, has received approval from the US Food and Drug Administration (FDA) for the treatment of adult patients with resectable early-stage non-small cell lung cancer (NSCLC), specifically stages IIA to IIIB, who do not have known epidermal growth factor receptor (EGFR) mutations or anaplastic lymphoma kinase (ALK) rearrangements. The regimen involves administering IMFINZI with neoadjuvant chemotherapy before surgery and continuing with adjuvant monotherapy post-surgery.
This FDA approval is based on the pivotal AEGEAN trial’s positive outcomes, detailed in The New England Journal of Medicine in October 2023. The interim analysis revealed a statistically significant 32% reduction in the risk of recurrence, progression, or death with the IMFINZI-based regimen compared to chemotherapy alone (32% data maturity; EFS hazard ratio of 0.68; 95% confidence interval [CI] 0.53-0.88; P=0.003902).
The final analysis showed that IMFINZI combined with neoadjuvant chemotherapy before surgery resulted in a pathologic complete response (pCR) rate of 17.2%, significantly higher than the 4.3% pCR rate seen with neoadjuvant chemotherapy alone (difference in pCR 13.0%; 95% CI 8.7-17.6).
Lung cancer remains a major global health challenge, with around 2.4 million new cases diagnosed each year and approximately 235,000 expected in the US in 2024. About 25-30% of NSCLC patients are diagnosed early enough for curative surgery, but the majority experience recurrence. Survival rates are approximately 36-46% for Stage II, 24% for Stage IIIA, and 9% for Stage IIIB, underscoring a significant need for effective treatments.
Dr. John V. Heymach from The University of Texas MD Anderson Cancer Center commented, “This approval introduces a crucial new treatment option for patients with resectable NSCLC, addressing high recurrence rates even after chemotherapy and surgery. IMFINZI’s addition before and after surgery has significantly improved outcomes in this setting.”
Dave Fredrickson, Executive Vice President of AstraZeneca’s Oncology Business Unit, added, “The approval of IMFINZI for early-stage lung cancer enhances our commitment to advancing treatment options. We are dedicated to applying novel approaches like AEGEAN to improve outcomes in lung cancer.”
IMFINZI was well tolerated with no new safety signals identified in the neoadjuvant and adjuvant settings. It is also approved in the UK, Switzerland, and Taiwan based on the AEGEAN results, with regulatory reviews ongoing in the EU, China, and other countries.
IMFINZI remains the only approved immunotherapy for unresectable Stage III NSCLC in the curative-intent setting, following chemoradiotherapy, based on the PACIFIC Phase III trial.
IMPORTANT SAFETY INFORMATION
IMFINZI® (durvalumab) does not have any contraindications. However, it can cause immune-mediated adverse reactions in various organ systems, which may be severe or fatal. Regular monitoring for symptoms and signs of immune-mediated reactions is essential. Treatment may involve systemic corticosteroids or other immunosuppressants.
Immune-Mediated Reactions:
- Pneumonitis: Higher incidence in patients with prior thoracic radiation.
- Colitis: Can lead to diarrhea; may require corticosteroids or infectious workup.
- Hepatitis: Can cause liver inflammation.
- Endocrinopathies: Includes adrenal insufficiency, hypophysitis, thyroid disorders, and Type 1 diabetes mellitus.
For more detailed safety information, including specific adverse reaction rates and management guidelines, refer to the US Prescribing Information for IMFINZI.
