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AstraZeneca Imfinzi Combo Gets EU Nod for Uterine Cancer

AstraZeneca (NASDAQ: AZN) announced that the combination therapy of its PD-L1 inhibitor, Imfinzi (durvalumab), and PARP inhibitor, Lynparza (olaparib), has been approved in the EU to treat certain patients with primary advanced or recurrent endometrial cancer, also known as uterine cancer. The eligible patient population for receiving Imfinzi plus chemotherapy as a first-line treatment followed by Lynparza and Imfinzi are patients with mismatch repair proficient (pMMR) disease. For those who suffer from mismatch repair deficient (dMMR) advanced or recurrent endometrial cancer, Imfinzi plus chemotherapy followed by Imfinzi monotherapy has also been approved in the EU. The final decision in the EU follows the positive opinion adopted by the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency in July 2024, recommending the approval for the Lynparza and Imfinzi combination to treat patients with pMMR advanced or recurrent endometrial cancer. The CHMP had also recommended Imfinzi plus chemotherapy followed by Imfinzi alone for patients with dMMR advanced or recurrent endometrial cancer. The approval of both regimens in the EU was based on data from a prespecified exploratory subgroup analysis by MMR status in the phase III DUO-E study. Data from the DUO-E study showed that the Lynparza plus Imfinzi combo reduced the risk of disease progression or death by 43% in pMMR patients compared with the control arm. Meanwhile, the ...