AstraZeneca’s (AZ) anti-PDL1 antibody Imfinzi (durvalumab) and PARP inhibitor Lynparza (olaparib) have been approved by the European Commission (EC) to treat certain cases of endometrial cancer.
The EU regulator has approved Imfinzi plus chemotherapy as a first-line treatment, followed by Lynparza and Imfinzi, for use in patients with mismatch repair proficient (pMMR) primary advanced or recurrent endometrial cancer.
Imfinzi plus chemotherapy, followed by Imfinzi alone, has also been authorised to treat those with mismatch repair deficient (dMMR) disease.
The EC’s decision follows a recent recommendation from the European Medicines Agency’s human medicines committee and was based on positive results from the late-stage DUO-E trial.
A pre-specified exploratory subgroup analysis of the study demonstrated a 43% reduction in the risk of disease progression or death for pMMR patients receiving the Lynparza/Imfinzi combination compared to the control arm, while the Imfinzi regimen reduced the risk of disease progression or death in the dMMR cohort by 58% versus control.
The safety profiles of both regimens were generally manageable, well tolerated and broadly consistent with the known profiles of the individual agents, AZ said.
Endometrial cancer is the fourth most common cancer in women in Europe, with nearly 125,000 diagnoses made in 2022.
The majority of patients with endometrial cancer are diagnosed at an early stage, at which point the five-year survival rate is as high as 90%. However, this falls to less than 20% for those with advanced disease.
DUO-E trial investigator Els Van Nieuwenhuysen, UZ Leuven, said: “This approval is welcome news for patients with advanced or recurrent endometrial cancer in Europe, especially those with pMMR disease who have limited options.
“The [Lynparza] and [Imfinzi] as well as the [Imfinzi] regimens now have the potential to improve outcomes for all patients in this setting in Europe, regardless of mismatch repair status.”
Regulatory submissions for Imfinzi and Lynparza are currently under review in several other countries based on the DUO-E study, AZ said.
The EU approval came in the same week that an Imfinzi/chemotherapy regimen was approved by the US Food and Drug Administration to treat a subset of adults with resectable non-small cell lung cancer.