In patients with platinum-resistant recurrent ovarian cancer (OC) who did not have a genetic BRCA mutation, an investigation was conducted to determine the efficacy, safety, and tolerability of the combination drug cediranib with olaparib (cedi/ola). In this single-arm, multicenter, Phase IIb trial, PARP inhibitor-naive women aged more than or equal to 18 years with platinum-resistant non-gBRCAm OC, an ECOG performance status of 0–2, and more than or equal to 3 prior lines of therapy were given cediranib 30 mg once daily in addition to olaparib 200 mg twice daily. The trial was conducted in a multicenter setting. The objective response rate (ORR) was the primary endpoint, and it was determined by an independent central review (ICR) using RECIST 1.1. Additionally, progression-free survival (PFS), overall survival (OS), and safety and tolerability were investigated and analyzed. About 60 patients were treated with cedi/ola, and all had a non-gBRCAm status that could be verified. Patients had gone through a median of 4 lines of chemotherapy, and the vast majority of them (88.3%) had been given bevacizumab in the past. The ORR determined by ICR was 15.3%, the median progression-free survival was 5.1 months, and the median overall survival was 13.2 months. One patient experienced a grade 5 adverse event (sepsis) unrelated to the study medication. Around 44 individuals, or 73.3%, reported suffering a grade more than or equal to 3 adverse events (AE), while another patient experienced a grade 5 AE. About 55.0% of patients experienced dose interruptions, whereas 18.3% of patients saw dose reductions, and 18.3% discontinued treatment altogether due to adverse events. Patients who had a high global loss of heterozygosity (gLOH) had an ORR of 26.7% (4/15; 95% CI: 7.8–55.1%), while patients in the low gLOH group had an ORR of 12.5% (4/32; 95% CI: 3.5–29.0%). Despite falling short of the desired ORR of 20%, clinical activity was demonstrated for the cedi/ola combination in extensively pretreated, non-gBRCAm, platinum-resistant patients with OC. It highlighted the need for future biomarker research.
