AstraZeneca said that the combination of Lynparza (olaparib), Imfinzi (durvalumab), bevacizumab, and chemotherapy showed positive results in the DUO-O phase 3 trial in certain ovarian cancer patients.
The trial featured 1,200 patients who are newly diagnosed with advanced high-grade epithelial ovarian cancer without BRCA mutations tumour.
As per the interim analysis, the investigational combination demonstrated a statistically significant and clinically meaningful improvement in progression-free survival (PFS) compared to chemotherapy plus bevacizumab used in the control arm.
The patients were randomised equally in three treatment arms.
The first patient group or control arm was subjected to induction therapy with the combination of platinum-based chemotherapy and bevacizumab and placebo. This was followed by maintenance treatment with bevacizumab plus placebo.
In the second arm, the patients were dosed with induction therapy with the combination of platinum-based chemotherapy and bevacizumab and Imfinzi. This was followed by Imfinzi and bevacizumab as maintenance plus placebo.
The third arm was given induction therapy and platinum-based chemotherapy in combination with bevacizumab and Imfinzi. It was followed by maintenance Imfinzi and bevacizumab plus Lynparza.
PFS is the primary endpoint of the DUO-O phase 3 clinical trial as evaluated by investigator for Arm 3 in comparison to the first patient group in the overall trial population which included patients without tumour BRCA mutations and in the subset of these patients with HRD positive disease.
AstraZeneca Oncology R&D EVP 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.”
According to AstraZeneca, the key secondary endpoints consist of PFS as assessed by investigator in Arm 2 compared to the control arm and overall survival (OS).
The OS and other secondary endpoints were found to be immature, said AstraZeneca which plans to assess them in subsequent analysis.
The safety and tolerability of the investigational combination were similar with the findings from prior clinical trials and known profiles of the individual drugs.
In November last year, Imfinzi, in combination with Imjudo plus platinum-based chemotherapy was approved by the US Food and Drug Administration (FDA) to treat a type of lung cancer.
