Positive results from a planned interim analysis of the DUO-O Phase III trial showed that treatment with a combination of Lynparza (olaparib), Imfinzi (durvalumab), chemotherapy and bevacizumab demonstrated a statistically significant and clinically meaningful improvement in progression-free survival (PFS) versus chemotherapy plus bevacizumab (control arm) in newly diagnosed patients with advanced high-grade epithelial ovarian cancer without tumour BRCA mutations. Patients were treated with Imfinzi in combination with chemotherapy and bevacizumab followed by Imfinzi, Lynparza and bevacizumab as maintenance therapy.
These results will be presented today in an oral presentation at the 2023 American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago (Abstract #LBA5506).
The combination of Lynparza, Imfinzi, chemotherapy and bevacizumab reduced the relative risk of disease progression or death by 37% versus chemotherapy and bevacizumab (hazard ratio (HR) 0.63; 95% CI 0.52-0.76; pLynparza, Imfinzi, chemotherapy and bevacizumab reduced the relative risk of disease progression or death by 51% versus chemotherapy and bevacizumab alone (HR 0.49; 95% CI 0.34-0.69; p
Professor Philipp Harter, Director, Department of Gynaecology and Gynaecologic Oncology, Evangelische Kliniken Essen-Mitte, Germany, and principal investigator for the trial, said: "The primary aim of first-line treatment of patients with advanced ovarian cancer is long-term control over the disease, but still too many patients progress quickly and face poor clinical outcomes today. Data from the DUO-O trial interim progression-free survival analysis provide evidence for further improvement with olaparib and durvalumab combination versus chemotherapy and bevacizumab alone in patients without tumour BRCA mutations."
Susan Galbraith, Executive Vice President, Oncology R&D, AstraZeneca, said: "These results are an important milestone in our ongoing journey to address unmet need in ovarian cancer. The DUO-O trial demonstrates the potential of combining PARP inhibition with immunotherapy and we look forward to seeing more mature data and key secondary endpoints results."
At a pre-planned exploratory analysis of the HRD-negative subgroup of patients, Lynparza, Imfinzi, chemotherapy and bevacizumab reduced the relative risk of disease progression or death by 32% versus chemotherapy and bevacizumab (HR 0.68; 95% CI 0.54-0.86). Median PFS was 20.9 months versus 17.4.
At the time of this interim analysis, an additional arm evaluating the combination of Imfinzi, chemotherapy and bevacizumab demonstrated a numerical improvement in PFS which was not statistically significant (HR 0.87; 95% CI 0.73-1.04; p=0.13).
At the time of this planned interim analysis, the overall survival (OS) and other secondary endpoints were immature. OS will be formally assessed at a subsequent analysis.
Summary of results: DUO-O
