AstraZeneca’s IMFINZI Plus Chemotherapy Approved in the US for Mismatch Repair Deficient Endometrial Cancer

1. FDA Approval: The US Food and Drug Administration (FDA) has approved AstraZeneca's IMFINZI (durvalumab) plus chemotherapy for the treatment of adult patients with mismatch repair deficient (dMMR) advanced or recurrent endometrial cancer.
2. DUO-E Trial Results: The approval is based on the results of the DUO-E Phase III trial, which showed that IMFINZI reduced the risk of disease progression or death by 58% compared to chemotherapy alone.
3. Safety Profile: The safety and tolerability profile of the IMFINZI plus chemotherapy regimen was generally manageable and well tolerated, with no new safety signals.
4. Endometrial Cancer Statistics: Endometrial cancer is the fourth most common cancer in women in the US, with over 66,000 new cases and almost 12,000 deaths in 2022. The five-year survival rate for early-stage disease is approximately 80-90%, but falls to less than 20% for advanced disease.
5. AstraZeneca's Immuno-Oncology Portfolio: AstraZeneca is a pioneer in immuno-oncology, with a comprehensive and diverse portfolio and pipeline focused on overcoming evasion of the anti-tumor immune response and stimulating the body's immune system to attack tumors.