The European Union has approved the first-ever combination therapy consisting of an immunotherapy and a PARP inhibitor for the treatment of endometrial cancer, AstraZeneca announced Wednesday.
The European Commission on Wednesday signed off on AstraZeneca’s combination regimen of Imfinzi (durvalumab) and Lynparza (olaparib) for the treatment of certain endometrial cancer patients with advanced or recurrent disease.
The regulatory victory marks the “first-ever approval for a combination of an immunotherapy and PARP inhibitor in endometrial cancer,” Dave Fredrickson, executive vice president of AstraZeneca’s oncology business unit, said in a statement.
The approved treatment regimen consists of Imfinzi plus chemotherapy as a first-line treatment, followed by Lynparza and Imfinzi. The combo therapy can be given to patients with mismatch repair proficient (pMMR) tumors, who comprise 70% to 80% of endometrial cancer patients, according to AstraZeneca.
Also on Wednesday, the European Commission cleared the use of Imfinzi with chemotherapy, followed by Imfinzi alone, for the treatment of endometrial cancer patients with mismatch repair deficient (dMMR) disease. Around 20% to 30% of patients carry this mutation pattern.
Both approvals were backed by data from the Phase III DUO-E study. In October 2023, the pharma posted findings from the primary analysis of DUO-E, showing that in the overall trial population the combo regimen reduced the risk of disease progression or death by 45% versus chemotherapy alone. This effect was statistically significant, with a p-value less than 0.0001, AstraZeneca announced at the time.
When focusing on pMMR patients, treatment with Imfinzi and Lynparza cut the risk of disease progression or death by 43%.
DUO-E also demonstrated significant efficacy for the Imfinzi-alone regimen, which lowered the risk of disease progression or death by 29% in the overall trial population and by 58% in dMMR patients. Both treatment effects were statistically significant. The study continues to evaluate patients for overall survival, a key secondary endpoint.
Wednesday’s approval comes after a similar FDA decision in June 2024, which opened the use of Imfinzi plus chemotherapy followed by Imfinzi monotherapy in pMMR endometrial cancer patients with primary advanced or endometrial disease. However, the regulator at the time provided no feedback on the combination therapy.
Imfinzi is an intravenous PD-L1 blocking antibody that works by preventing the ligand’s interaction with its receptor, disrupting the cancer cells’ ability to evade and suppress the immune system. The mechanism of action also boosts the anti-cancer activity of T-cells. Imfinzi is indicated for various cancers including non-small cell lung cancer, biliary tract cancer and hepatocellular carcinoma.
Lynparza is an orally available PARP inhibitor that impairs DNA repair in cancer cells, leading to their death. The drug has been approved for ovarian, fallopian tube or primary peritoneal cancers, as well as malignancies of the breast, pancreas and prostate.
