AstraZeneca has reported positive interim data from the Phase III DUO-O trial evaluating the combination of Lynparza (olaparib), Imfinzi (durvalumab), chemotherapy and bevacizumab to treat patients newly diagnosed with advanced high-grade epithelial ovarian cancer without tumour BRCA mutations.
The results showed that the combined therapy confirmed a statistically important and clinically meaningful improvement in progression-free survival (PFS) against a combination of chemotherapy and bevacizumab.
The safety and tolerability of these combinations were found to be mostly consistent with the results noticed in previous trials, as well as the known profiles of the individual therapies.
During the time of the interim assessment, the overall survival (OS) and other secondary endpoints of the trial were not mature. AstraZeneca plans to evaluate those in a following review.
As part of the randomised, double-blind, placebo-controlled, multi-centre trial, patients were given Imfinzi plus chemotherapy and bevacizumab followed by Imfinzi, Lynparza and bevacizumab as maintenance treatment.
Patients were randomised into a 1:1:1 ratio in three arms to receive the doses of the treatment.
The trial’s primary endpoint is PFS as assessed by investigator for Arm three in comparison with Arm one (control) in the overall subjects.
Major secondary endpoints are PFS as evaluated by investigator in Arm two against control, along with comparisons for OS.
The trial included more than 1200 patients across the treatment arms at 179 sites.
AstraZeneca Oncology R&D executive vice-president Susan Galbraith said: “While there has been significant progress for patients with advanced ovarian cancer, an unmet need still remains.
“These data from the DUO-O trial provide encouraging evidence for this Lynparza and Imfinzi combination in patients without tumour BRCA mutations and reinforce our continued commitment to finding new treatment approaches for these patients.
“It will be important to understand the key secondary endpoints as well as data for relevant subgroups.”