Lynparza and Imfinzi combination approved in the EU for patients with mismatch repair proficient advanced or recurrent endometrial cancer . AstraZeneca

AstraZeneca’s Imfinzi (durvalumab) and Lynparza (olaparib) have been approved in the European Union (EU) as treatment for certain patients with primary advanced or recurrent endometrial cancer.

Imfinzi plus chemotherapy as 1st-line treatment followed by Lynparza and Imfinzi has been approved for patients with mismatch repair proficient (pMMR) disease. Imfinzi plus chemotherapy followed by Imfinzi alone has been approved for patients with mismatch repair deficient (dMMR) disease. The approval by the European Commission follows the positive opinion of the Committee for Medicinal Products for Human Use and is based on a prespecified exploratory subgroup analysis by mismatch repair (MMR) status from the DUO-E Phase III trial, which was published in the Journal of Clinical Oncology.

In the trial, the Lynparza and Imfinzi regimen reduced the risk of disease progression or death for patients with pMMR disease by 43% (median 15.0 months versus 9.7 months, hazard ratio [HR] 0.57; 95% confidence interval [CI] 0.44-0.73) versus the control arm.1 The Imfinzi regimen reduced the risk of disease progression or death among patients with dMMR disease by 58% (median not reached versus 7.0 months, HR 0.42; 95% CI 0.22-0.80) versus the control arm.

Els Van Nieuwenhuysen, Gynaecological Oncologist at the UZ Leuven, Belgium and DUO-E trial investigator, said: “This approval is welcome news for patients with advanced or recurrent endometrial cancer in Europe, especially those with mismatch repair proficient disease who have limited options. The olaparib and durvalumab as well as the durvalumab regimens now have the potential to improve outcomes for all patients in this setting in Europe, regardless of mismatch repair status.”