The US Food and Drug Administration’s (FDA) Oncologic Drugs Advisory Committee (ODAC) recently reviewed AstraZeneca’s Imfinzi (durvalumab) for the treatment of resectable non-small cell lung cancer (NSCLC). The review was based on results from the AEGEAN Phase III trial, which demonstrated that Imfinzi met the primary endpoint of event-free survival (EFS). The trial involved adult patients with resectable early-stage (IIA-IIIB) non-small cell lung cancer who did not have known epidermal growth factor receptor (EGFR) mutations or anaplastic lymphoma kinase (ALK) rearrangements. These patients were treated with Imfinzi in combination with neoadjuvant chemotherapy before surgery and as adjuvant monotherapy after surgery.
The AEGEAN Phase III trial results were pivotal in the FDA’s review. The trial showed a statistically significant and clinically meaningful 32% reduction in the risk of recurrence, progression events, or death compared to chemotherapy alone. The trial’s data indicated an EFS hazard ratio of 0.68, with a 95% confidence interval (CI) of 0.53-0.88 and a p-value of 0.003902. Additionally, in a final analysis of pathologic complete response (pCR), treatment with Imfinzi plus neoadjuvant chemotherapy resulted in a pCR rate of 17.2% compared to 4.3% for patients treated with neoadjuvant chemotherapy alone.
Regulatory and Market Implications
Imfinzi was generally well tolerated, with no new safety signals observed in both neoadjuvant and adjuvant settings. The combination of Imfinzi and neoadjuvant chemotherapy did not compromise patients’ ability to complete surgery. The ODAC provides the FDA with independent, expert advice and recommendations on marketed and investigational medicines for cancer treatment. Although the FDA is not bound by the Committee’s recommendation, it will consider the feedback during its review.
Imfinzi is already approved in Switzerland and the UK for treating adults with resectable non-small cell lung cancer in Stage II and III without known EGFR mutations or ALK rearrangements, based on the AEGEAN results. Regulatory applications for Imfinzi in this setting are also currently under review in the EU, China, and several other countries.
Global Standard of Lung Cancer Care
Imfinzi is the only approved immunotherapy and the global standard of care for unresectable, Stage III NSCLC in patients whose disease has not progressed after chemoradiotherapy, based on the PACIFIC Phase III trial. Additionally, Imfinzi is approved for the treatment of extensive-stage small cell lung cancer (SCLC) and in combination with Imjudo (tremelimumab) and chemotherapy for metastatic non-small cell lung cancer.
In limited-stage SCLC, Imfinzi demonstrated significant improvements in overall survival (OS) and progression-free survival (PFS) compared to placebo in the ADRIATIC Phase III trial. Beyond lung cancer, Imfinzi is approved for biliary tract cancer, unresectable hepatocellular carcinoma (HCC), and primary advanced or recurrent endometrial cancer in specific regions.
Leading Innovations in Lung Cancer Care
AstraZeneca is dedicated to revolutionizing cancer care through innovative treatments and early-stage disease detection. The company’s comprehensive lung cancer portfolio includes leading medicines like Tagrisso (osimertinib), Iressa (gefitinib), and collaborations on Enhertu (trastuzumab deruxtecan) and datopotamab deruxtecan with Daiichi Sankyo. AstraZeneca also partners with HUTCHMED on Orpathys (savolitinib) and pursues new medicines and combination therapies across various cancer types.
AstraZeneca’s focus on immuno-oncology (IO) aims to overcome immune evasion and stimulate the body’s immune response against tumors. The company’s IO pipeline includes bispecific antibodies, cell therapy, and T cell engagers, pushing the boundaries of cancer treatment.
AstraZeneca is committed to bringing long-term survival benefits to patients through novel IO-based therapies. The company is exploring combination approaches to prevent treatment resistance and drive sustained immune responses. AstraZeneca champions the use of IO treatments in early disease stages, where the potential for cure is greatest. By continuously innovating and redefining cancer care, AstraZeneca aims to eliminate cancer as a cause of death. The company leverages its scientific expertise to discover, develop, and deliver life-changing medicines, transforming the patient experience and setting new standards in oncology.
Resource: Astrazeneca, July 25, 2024

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