Phase 3 trial in relapsed ovarian cancer misses primary endpoint
Click Here to Manage Email Alerts
The combination of cediranib and olaparib failed to extend PFS compared with platinum-based chemotherapy for a subset of women with ovarian cancer, according to topline results of a randomized phase 3 trial.
Cediranib (AstraZeneca) is an oral VEGF receptor tyrosine kinase inhibitor.
Olaparib (Lynparza; AstraZeneca, Merck) — a poly(ADP-ribose) polymerase (PARP) inhibitor — is approved in the United States for maintenance treatment of women with platinum-sensitive relapsed ovarian cancer, as well as first-line maintenance treatment of women with BRCA-mutated advanced ovarian cancer after response to platinum-based chemotherapy. The agent also is approved for treatment of specific patients with breast or pancreatic cancers.
The open-label, multicenter GY004 trial included women with recurrent platinum-sensitive ovarian, fallopian tube or primary peritoneal cancer regardless of BRCA mutation status.
The trial assessed the efficacy and safety of three regimens: cediranib plus olaparib, olaparib alone, and standard platinum-based chemotherapy.
PFS among women in the intention-to-treat population assigned the cediranib-olaparib combination compared with those assigned chemotherapy served as the study’s primary endpoint. Results showed no statistically significant benefit.
“Despite these disappointing results, we remain committed to expanding on the benefits already demonstrated with Lynparza for patients with advanced ovarian cancer,” Jose Baselga, MD, PhD, executive vice president for oncology research and development with AstraZeneca, said in a company-issued press release.
The safety and tolerability profiles of the agents evaluated in GY004 appeared generally consistent with those observed in prior studies.
Complete data from the trial will be submitted for presentation at a medical meeting.