The combination therapy was added to standard chemotherapy and lowered the risk of progression or death by 37% in newly diagnosed patients with advanced ovarian cancer without BRCA mutations.
Pictured: AstraZeneca sign on building/Courtesy of Getty Images
Interim data released at the American Society of Clinical Oncology annual meeting on Saturday showed the addition of AstraZeneca’‘s Imfinzi (durvalumab) and Lynparza (olaparib) to the treatment regimen for patients with advanced ovarian cancer without BRCA mutations extended progression-free survival by five months.
Data from the Phase III DUO-O trial reported at ASCO indicated that when the Imfinzi-Lynparza combination was added to standard chemotherapy, the treatment lowered the risk of progression or death by 37% in newly diagnosed patients with advanced ovarian cancer without BRCA mutations.
Ovarian cancer poses a challenge due to the lack of early detection methods, often leading to late-stage diagnoses and recurring disease.
The study included 1,130 patients with stage III or IV high-grade epithelial tumors (without BRCA mutations). Participants had either completed or were scheduled for ovarian cancer debulking surgery, which removes cancerous tumors from the pelvis.
Randomized into three arms, all patients received the standard of care: upfront paclitaxel/carboplatin chemotherapy plus bevacizumab, followed by maintenance bevacizumab.
In arms 2 and 3, durvalumab was added to the upfront and maintenance regimens. Arm 3 also included olaparib in the maintenance treatment.
In the intent-to-treat population, progression-free survival (PFS) was 24.2 months in the olaparib arm, surpassing the 19.3 months in the standard-of-care arm.
Patients with HRD-positive tumors and those in the intent-to-treat group who received durvalumab and olaparib exhibited a 51% and 37% lower risk of disease progression compared to the standard-of-care arm.
All subsets of patients, including both HRD-positive and negative patients, demonstrated a 32% lower risk of disease progression when treated with the combination therapy relative to the standard-of-care arm.
Approximately 90% of the patients completed the trial regimens, and serious adverse events were reported in 34% of patients in the standard-of-care arm, 43% in the durvalumab arm, and 39% in the olaparib arm.
Despite the growing number of approved therapies for ovarian cancer in recent years, relapse rates remain high, with an average recurrence period of approximately two years. The improved PFS and reduced risk of disease progression demonstrated in this trial may portend better outcomes among these patients.
Dr. Philipp Harter, director of the Department of Gynecology and Gynecologic Oncology at the Evangelische Kliniken Essen-Mitte hospital in Germany, expressed optimism about the trial results.
“While there has been significant progress for patients with advanced ovarian cancer, an unmet need remains. Our trial results provide encouraging evidence that we can find new treatment approaches for patients with advanced disease,” Harter said in a news release published by ASCO.
However, more research is needed to determine the specific role of durvalumab in combination therapy.
“Despite this being an incredibly well-executed trial, it does not, unfortunately, clarify the role of immune checkpoint inhibitors in frontline ovarian cancer,” Kathleen Moore, a professor of gynecologic oncology at the University of Oklahoma, told Endpoints News.
Moore is the principal investigator in a GSK trial testing a similar combo in ovarian cancer. She also sits on advisory boards and steering committees for GSK and AstraZeneca.
Lisa Munger is a senior editor at BioSpace. You can reach her at lisa.munger@biospace.com. Follow her on LinkedIn.
