Clovis' Rubraca meets primary PFS endpoint in Phase III ovarian cancer trial

Clovis Oncology Inc. (NASDAQ:CLVS) reported top-line data from the Phase III ARIEL3 trial in 564 patients with platinum-sensitive, high-grade epithelial ovarian, fallopian tube or primary peritoneal cancer showing that maintenance treatment with twice-daily 600 mg oral Rubraca rucaparib (CO-338) met the primary endpoint of improving progression-free survival (PFS) in all 3 molecularly defined subgroups vs. placebo. Specifically, Rubraca improved median PFS by investigator review vs. placebo in 196 tumor breast cancer early onset (BRCA)-mutant patients (16.6 vs. 5.4 months, HR=0.23, p<0.0001), 354 homologous recombination deficiency (HRD)-positive patients (13.6 vs. 5.4 months, HR=0.32, p<0.0001), and the trial's overall 564-patient intent-to-treat (ITT) population (10.8 vs. 5.4 months, HR=0.36, p<0.0001). The BRCA-mutant cohort included patients with germline and somatic mutations and the HRD-positive cohort included BRCA-mutant and BRCA wild-type patients with high loss of heterozygosity.

Rubraca also met the secondary endpoints of improving blinded independent central review (BICR)-assessed PFS in the BRCA-mutant (26.8 vs. 5.4 months, HR=0.2, p<0.0001), HRD-positive (22.9 vs. 5.5 months, HR=0.34, p<0.0001) and ITT (13.7 vs. 5.4, HR=0.35, p<0.0001) populations vs. placebo...