Individuals treated with the drugs from AstraZeneca demonstrate clinically meaningful and statistically significant improvement.
A combination of bevacizumab, chemotherapy, durvalumab (Imfinzi; AstraZeneca), and olaparib demonstrated clinically meaningful and statistically significant improvement in progression-free survival (PFS) compared with just bevacizumab and chemotherapy in newly diagnosed individuals with advanced high-grade epithelial ovarian cancer without tumor BRCA mutations, according to the results of a planned interim analysis of the DUO-O (NCT03737643) phase 3 trial.
“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 [olaparib] and [durvalumab] combination in patients without tumor BRCA mutations and reinforce our continued commitment to finding new treatment approaches for these patients,” Susan Galbraith, PhD, executive vice president of oncology research and development at AstraZeneca, said in a statement.
“It will be important to understand the key secondary endpoints, as well as data for relevant subgroups,” she said.
In the study, individuals were treated with durvalumab in combination with bevacizumab and chemotherapy, followed by bevacizumab, durvalumab, and olaparib as a maintenance therapy.
In an additional arm of the study, durvalumab and bevacizumab plus chemotherapy demonstrated numerical improvements in PFS compared with the bevacizumab and chemotherapy control arm.
However, investigators reported that statistical significance was not reached at the interim analysis.
At the time of this analysis, the overall survival and other secondary endpoints were immature and will be formally assessed at a subsequent analysis, according to investigators.
Patients were randomized 1:1:1 to the control arm; induction therapy with platinum-based chemotherapy in combination with bevacizumab and durvalumab, followed by maintenance durvalumab and bevacizumab, plus the placebo; or induction therapy with platinum-based chemotherapy in combination with bevacizumab and durvalumab, followed by maintenance durvalumab and bevacizumab, plus olaparib.
In all arms of the study, the platinum-based chemotherapy was administered every 3 weeks for up to 6 cycles, bevacizumab was administered every 3 weeks for up to 15 months, durvalumab or the placebo were administered every 3 weeks for up to 24 months, and olaparib or the placebo were administered twice daily for up to 24 months.
Investigators enrolled more than 1200 individuals across all treatment arms at 179 study locations.
“DUO-O showcases the power of academia and industry collaboration in advancing new treatment combinations for patients with ovarian cancer. I’m grateful for the academic cooperative study groups and patients around the world that made this trial possible and look forward to sharing the results with the clinical community,” Philipp Harter, MD, PhD, director of the department of gynecology and gynecologic oncology at Kliniken Essen-Mitte in Germany, said in the statement.
The safety and tolerability of the combinations are broadly consistent with those observed in other clinical trials and with the known profiles of the individual drugs. The data will be presented at upcoming medical meetings and be shared with health authorities.
Lynparza and Imfinzi combination improved progression-free survival in newly diagnosed patients with advanced ovarian cancer without tumor BRCA mutations in DUO-O phase III trial. News release. AstraZeneca. April 5, 2023. Accessed April 5, 2023. https://www.astrazeneca.com/media-centre/press-releases/2023/lynparza-imfinzi-met-endpoint-in-ovarian-cancer.html