Two of AstraZeneca’s top cancer treatments have been approved in combination to treat a subgroup of endometrial cancer patients in the European Union, the drugmaker announced Wednesday morning.
The approval of Imfinzi and Lynparza in the first-line setting “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.
PD-L1 inhibitor Imfinzi and PARP inhibitor Lynparza are cleared for patients with mismatch repair proficient (pMMR) disease, meaning their cancer cells don’t carry genetic mutations that make them vulnerable to certain treatments. Up to 70% to 80% of patients have this form of disease, according to AstraZeneca.
In a subgroup analysis of a Phase 3 trial, Lynparza plus Imfinzi lowered the risk of disease progression or death by 43% among patients with pMMR disease compared to the control arm, who got chemotherapy only. Median PFS on the combo arm was 15 months, versus 9.7 months on control.
The trial, dubbed DUO-E, also featured an Imfinzi-only arm that showed a benefit. AstraZeneca said a regimen featuring Imfinzi and chemotherapy has also been approved for patients with mismatch repair deficient (dMMR) disease.
In June, the FDA similarly approved Imfinzi for this type of primary advanced or recurrent endometrial cancer, but there was no word on the Lynparza/Imfinzi combo, with AstraZeneca saying the study is continuing to assess overall survival.