Women with an advanced epithelial ovarian, fallopian tube or primary peritoneal cancers could be benefited from olaparib bevacizumab combination as first-line maintenance treatment got FDA approval. This combination can be used by females who attained complete or partial response to first-line platinum-based chemotherapy, and whose cancer is linked with homologous recombination deficiency-positive status in accordance with either detrimental or suspected detrimental BRCA mutation and/or genomic instability. A laboratory test was also approved which is only FDA-approved tumour test as a diagnostic for olaparib (poly(ADP-ribose) polymerase (PARP) inhibitor).

The approvals were based on the outcomes of the PAOLA-1 trial comprising 806 women in total, with advanced high-grade epithelial ovarian cancer, fallopian tube or primary peritoneal cancers. They were given first-line platinum-based chemotherapy and bevacizumab.

Out of total women, 537 women were randomly assigned to maintenance therapy with olaparib 300 mg twice daily along with bevacizumab 15 mg/kg every 3 weeks. After the final chemotherapy dose, treatment using olaparib was initiated from 3 weeks to 9 weeks. Treatment sustained for about 2 years or till disease progression or intolerable toxicity. As for the other 269 women, they were given maintenance therapy with placebo along with bevacizumab. The study investigators distinguished women via first-line treatment outcome and BRCA mutation status. The primary endpoint was the investigator-evaluated PFS. OS was also regarded as an efficacy endpoint.

In the olaparib group, significantly longer median PFS was found as compared with the placebo group. Median PFS was observed as 37.2 months in the olaparib group than 21.7 months in the patients with BRCA-mutated tumours. On the other hand, the median PFS was 18.9 months in the olaparib group versus 16 months in the placebo group as observed in patients without BRCA mutations.

Patients with homologous recombination deficiency (HRD)-positive disease resulted in almost doubled median PFS while using olaparib therapy as compared to with placebo. 

The median PFS of the patients with HRD-positive status without BRCA mutations and HRD-negative or unknown status was 28.1 months with olaparib and 16.6 months with placebo; and 16.9 months with olaparib and 16 months with placebo, respectively.