FDA Approves AstraZeneca's Imfinzi for Endometrial Cancer

The FDA has granted approval for AstraZeneca’s Imfinzi (durvalumab) in a new treatment regimen for adults with mismatch repair deficient (dMMR) primary advanced or recurrent endometrial cancer. This regimen involves an initial combination of Imfinzi with chemotherapy, followed by Imfinzi monotherapy. Dave Fredrickson, AstraZeneca's executive vice president of the oncology business unit, emphasized the significance of this approval, highlighting the limited advancements in endometrial cancer treatment to date. He underscored that the emerging use of immunotherapy in combination with chemotherapy is becoming a new standard of care, and the approval of Imfinzi presents an important new option for patients.

The FDA's decision was influenced by data from a pre-specified exploratory subgroup analysis of the Phase III DUO-E trial. The trial's findings, released last year, demonstrated that the combination of Imfinzi with carboplatin and paclitaxel, followed by Imfinzi monotherapy, reduced the risk of disease progression or death by 58% in patients with dMMR endometrial cancer compared to chemotherapy alone.

The DUO-E trial also included another treatment arm that investigated the combination of Imfinzi with chemotherapy, followed by Imfinzi in conjunction with AstraZeneca’s PARP inhibitor Lynparza (olaparib) as maintenance therapy. This regimen also met the primary endpoint of progression-free survival (PFS). The trial is ongoing and aims to evaluate overall survival as a key secondary endpoint for both treatment arms.

In addition to the FDA approval, marketing applications for Imfinzi, as well as the combined regimen of Imfinzi and Lynparza, are under review in the European Union and Japan based on the results from the DUO-E trial. This international review process signifies the global importance of the findings and the potential for these treatment regimens to benefit a broader population of patients with endometrial cancer.

Fredrickson’s comments reflect a growing optimism in the oncology community about the potential of immunotherapy to improve patient outcomes significantly. The introduction of Imfinzi as a new treatment option is seen as a critical development, given the historical challenges and limited progress in treating endometrial cancer. As the global review continues, there is hope that more patients will soon have access to these new therapeutic options.

The approval of Imfinzi marks a pivotal moment in endometrial cancer treatment, offering a beacon of hope for patients and healthcare providers alike. The continued efforts to explore and validate new treatment combinations and strategies underscore the commitment to advancing cancer care and improving survival rates for patients with this challenging diagnosis.