Pharma Focus Asia

Imfinzi, in Combination With Chemotherapy, Has Received Approval in the US for Treating Advanced or Recurrent Endometrial Cancer With Mismatch Repair Deficiency

Monday, June 17, 2024

AstraZeneca's Imfinzi (durvalumab) has received FDA approval in the United States for the treatment of adult patients with primary advanced or recurrent endometrial cancer that is mismatch repair deficient (dMMR). This decision was based on data from the DUO-E Phase III trial, which included a specific subgroup analysis by MMR status. Published in the Journal of Clinical Oncology, the trial showed that combining Imfinzi with carboplatin and paclitaxel followed by Imfinzi alone reduced the risk of disease progression or death by 58% compared to chemotherapy alone, with a hazard ratio of 0.42 and a 95% confidence interval of 0.22-0.80.

Endometrial cancer is the fourth most common cancer among women in the US, with more than 66,000 new cases and almost 12,000 deaths reported in 2022. Early-stage diagnosis offers a five-year survival rate of about 80-90%, whereas survival rates for advanced disease drop to less than 20%, highlighting the critical need for new treatment options.

Dr. Shannon N. Westin, a Professor of Gynecologic Oncology and Reproductive Medicine at The University of Texas MD Anderson Cancer Center, stressed the importance of this approval, noting the expected rise in incidence and mortality rates of endometrial cancer. Dave Fredrickson, Executive Vice President of AstraZeneca's Oncology Business Unit, emphasized that combining immunotherapy with chemotherapy is becoming the standard approach for treating advanced endometrial cancer, particularly in patients with dMMR disease.

The safety and tolerability profile of the Imfinzi and chemotherapy regimen were generally manageable and consistent with prior clinical trials, with no new safety concerns identified. The DUO-E trial continues to evaluate overall survival as a key secondary endpoint for both treatment strategies.

The multicenter Phase III DUO-E trial (GOG 3041/ENGOT-EN10) involved 699 patients and compared Imfinzi plus platinum-based chemotherapy (carboplatin and paclitaxel) followed by either Imfinzi alone or Imfinzi plus Lynparza (olaparib) as maintenance therapy against standard chemotherapy alone.

Imfinzi functions by binding to the PD-L1 protein, thereby blocking its interaction with PD-1 and CD80 proteins, which helps counteract the tumor's immune evasion tactics and potentially enhance immune responses against the tumor.

This approval expands Imfinzi's uses beyond its existing applications in treating various cancers, including non-small cell lung cancer (NSCLC) and hepatocellular carcinoma, highlighting its broad potential in cancer immunotherapy.



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