AstraZeneca has reported positive high-level results from the DUO-E trial (GOG 3041/ENGOT-EN10) of Imfinzi (durvalumab) and platinum-based chemotherapy combination followed by Imfinzi with Lynparza (olaparib) or Imfinzi alone as maintenance therapy in advanced or recurrent endometrial cancer patients.
The three-arm, double-blind, randomised, multicentre, placebo-controlled trial enrolled 699 patients with newly diagnosed or recurrent stage III or IV epithelial endometrial carcinoma (excluding sarcomas).
The study was conducted in 253 locations across 22 countries including the US, South America, Europe and Asia.
Patients were randomised to receive either 1120mg of Imfinzi or placebo, every three weeks along with standard-of-care platinum-based chemotherapy.
Following cessation of chemotherapy, patients received either 1500mg of Imfinzi or placebo every four weeks as maintenance, either along with 300mg BID (2x150mg tablets, twice a day) of Lynparza or placebo until progressive disease for a period of 24 months.
Progression-free survival (PFS) was the study’s dual primary endpoint.
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Overall survival, duration of response, objective response rate, safety and tolerability were the key secondary endpoints of the study.
AstraZeneca Oncology research and development executive vice-president Susan Galbraith said: “These DUO-E data demonstrate for the first time the power of combining immunotherapy and a PARP inhibitor to provide meaningful clinical improvements for patients with endometrial cancer.
“These results underscore our ambition to redefine cancer care and we hope to bring this innovative Imfinzi and Lynparza combination to endometrial cancer patients as soon as possible.”