The European Commission on Wednesday logged out To AstraZenecaCombination therapy of Imfinzi (durvalumab) and Lynparza (olaparib) for the treatment of certain patients with advanced cervical cancer or with recurrent disease.
The approval marks the “first approval of a combination of immunotherapy and PARP inhibitor for the treatment of uterine cancer,” said Dave Fredrickson, executive vice president of AstraZeneca’s oncology business unit, in a statement.
The approved treatment regimen consists of Imfinzi plus chemotherapy as first-line treatment, followed by Lynparza and Imfinzi. The combination therapy can be given to patients with mismatch repair-competent (pMMR) tumors, which AstraZeneca says account for 70 to 80 percent of patients with endometrial cancer.
Also on Wednesday, the European Commission approved the use of Imfinzi in combination with chemotherapy, followed by Imfinzi alone, to treat patients with uterine cancer and mismatch repair deficiency (dMMR). About 20 to 30 percent of patients carry this mutation pattern.
Both approvals were supported by data from the Phase III DUO-E study. In October 2023 published results from the primary analysis of DUO-E, which showed that the combination therapy reduced the risk of disease progression or death by 45% in the entire trial population compared with chemotherapy alone. This effect was statistically significant, with a p-value of less than 0.0001, AstraZeneca announced at the time.
When treating pMMR patients, treatment with Imfinzi and Lynparza reduced the risk of disease progression or death by 43%.
DUO-E also demonstrated significant efficacy for Imfinzi monotherapy, reducing the risk of disease progression or death by 29% in the overall study 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 follows a similar decision by the FDA in June 2024 that allowed the use of Imfinzi plus chemotherapy followed by Imfinzi monotherapy in patients with pMMR endometrial cancer and primary advanced or endometrial disease. However, the regulator did not provide feedback on the combination therapy at the time.
Imfinzi is an intravenously administered PD-L1 blocking antibody that prevents the ligand from interacting with its receptor, thereby interrupting the ability of cancer cells to evade and suppress the immune system. The mechanism of action also increases the anti-cancer activity of T cells. Imfinzi is indicated for several types of cancer, including non-small cell lung cancer, bile duct cancer and hepatocellular carcinoma.
Lynparza is an orally available PARP inhibitor that impairs DNA repair in cancer cells, causing them to die. The drug is approved for ovarian cancer, fallopian tube cancer or primary peritoneal cancer, as well as for malignant diseases of the breast, pancreas and prostate.
