EU Approves Imfinzi, Lynparza for Endometrial Cancer

The European Commission has granted approval for two treatment regimens involving AstraZeneca’s PD-L1 inhibitor, Imfinzi (durvalumab), and its PARP inhibitor, Lynparza (olaparib). These drugs, co-developed with Merck & Co., are now authorized for use in patients with primary advanced or recurrent endometrial cancer. This marks a significant milestone as it is the first approval of a combination therapy involving both an immunotherapy and a PARP inhibitor for this type of cancer, according to Dave Fredrickson, Executive Vice President of AstraZeneca’s oncology business unit.

The first approved regimen consists of Imfinzi combined with chemotherapy, followed by a combination of Lynparza and Imfinzi for patients with mismatch repair proficient (pMMR) disease. The second regimen includes Imfinzi plus chemotherapy, followed by Imfinzi alone for patients with mismatch repair deficient (dMMR) disease.

This European Union approval follows a positive recommendation from the European Medicines Agency’s drug advisory body, which was based on data from a prespecified exploratory subgroup analysis of the Phase III DUO-E study. The study's findings revealed that the combination of Imfinzi and Lynparza reduced the risk of disease progression or death by 43% in patients with pMMR disease. For those with dMMR disease, the Imfinzi regimen alone decreased this risk by 58%.

Previously, in June, the U.S. Food and Drug Administration (FDA) also approved the use of Imfinzi with chemotherapy, followed by Imfinzi monotherapy for patients with dMMR disease. However, the FDA did not include Lynparza in the maintenance regimen at that time. Discussions about the data on Lynparza at last year’s European Society for Medical Oncology (ESMO) congress revealed some skepticism among analysts regarding the additional benefits provided by Lynparza.

These two regimens are also currently under regulatory review in Japan and several other countries.

Earlier this year, the FDA expanded the labels for Merck’s Keytruda (pembrolizumab) and GSK’s Jemperli (dostarlimab-gxly), making them approved front-line treatment options for endometrial cancer irrespective of mismatch repair status.