EC Approves AstraZeneca's Imfinzi/Lynparza for Endometrial Cancer

AstraZeneca’s (AZ) anti-PDL1 antibody, Imfinzi (durvalumab), and PARP inhibitor, Lynparza (olaparib), have received approval from the European Commission (EC) for treating specific cases of endometrial cancer. The EC has given the green light for Imfinzi combined with chemotherapy as a first-line treatment, to be followed by a combination of Lynparza and Imfinzi, targeting patients with mismatch repair proficient (pMMR) primary advanced or recurrent endometrial cancer. Furthermore, Imfinzi combined with chemotherapy, followed by Imfinzi alone, has been approved for treating patients with mismatch repair deficient (dMMR) disease.

This regulatory decision by the EC was preceded by a positive recommendation from the European Medicines Agency’s human medicines committee. The approval was largely based on encouraging outcomes from the late-stage DUO-E trial. In a pre-specified exploratory subgroup analysis, the study revealed that pMMR patients receiving the Lynparza and Imfinzi combination experienced a 43% reduction in the risk of disease progression or death compared to the control group. Meanwhile, the Imfinzi regimen alone reduced the risk of disease progression or death by 58% in the dMMR cohort compared to the control.

AstraZeneca reported that the safety profiles of both treatment regimens were generally manageable, well-tolerated, and aligned with the known safety profiles of the individual drugs. Endometrial cancer ranks as the fourth most common cancer among women in Europe, with nearly 125,000 new cases diagnosed in 2022. Most endometrial cancer patients are diagnosed at an early stage, which boasts a five-year survival rate of up to 90%. However, for patients with advanced disease, the five-year survival rate drops to less than 20%.

Els Van Nieuwenhuysen, an investigator in the DUO-E trial from UZ Leuven, expressed optimism about the approval, stating it is promising news for patients with advanced or recurrent endometrial cancer in Europe, particularly those with pMMR disease who have limited treatment options. She highlighted the potential of the Lynparza and Imfinzi combination, as well as the Imfinzi regimen alone, to improve outcomes for patients across different mismatch repair statuses.

AstraZeneca noted that regulatory submissions for Imfinzi and Lynparza are currently under review in several other countries, based on the results of the DUO-E study. The European approval coincided with the US Food and Drug Administration's approval of an Imfinzi and chemotherapy regimen for treating a specific group of adults with resectable non-small cell lung cancer.