AstraZeneca Plc (AZN.L, AZN), a prominent British pharmaceutical company, announced on Friday that its drug Imfinzi (durvalumab), in combination with chemotherapy, has received approval in the United States for treating adult patients with resectable non-small cell lung cancer (NSCLC) both before and after surgery.
The U.S. Food and Drug Administration (FDA) granted this approval based on strong evidence from the pivotal AEGEAN Phase III trial. The trial demonstrated that an Imfinzi-based regimen reduced the risk of recurrence, progression, or death by 32% compared to neoadjuvant chemotherapy alone.
These significant findings were published in The New England Journal of Medicine in October 2023.
The approved treatment is designated for adult patients with resectable early-stage or stage IIA-IIIB NSCLC, who do not have known epidermal growth factor receptor (EGFR) mutations or anaplastic lymphoma kinase (ALK) rearrangements.
In this treatment protocol, patients receive Imfinzi in combination with neoadjuvant chemotherapy before surgery and continue with Imfinzi as adjuvant monotherapy post-surgery.
The interim analysis of event-free survival (EFS) indicated a statistically significant and clinically meaningful 32% reduction in the risk of recurrence, progression, or death for patients treated with the Imfinzi-based regimen before and after surgery, compared to chemotherapy alone.
Furthermore, a final analysis of pathologic complete response (pCR) revealed that treatment with Imfinzi plus neoadjuvant chemotherapy before surgery achieved a pCR rate of 17.2%, compared to 4.3% for patients treated with neoadjuvant chemotherapy alone. Imfinzi has also been approved in the UK, Switzerland, and Taiwan (China) for this treatment setting, based on the AEGEAN trial results. Additional regulatory applications are under review in the EU, China, and several other countries for this indication.
AstraZeneca highlighted that Imfinzi is the only approved immunotherapy and is considered the global standard of care for unresectable, Stage III NSCLC patients whose disease has not progressed after chemoradiotherapy, based on the PACIFIC Phase III trial.
