Clovis soars on Rubraca ovarian cancer data

Clovis Oncology Inc. (NASDAQ:CLVS) jumped $27.91 (47%) to $87.88 on Monday after Rubraca rucaparib met the primary endpoint of progression-free survival (PFS) in all three molecularly defined subgroups of the Phase III ARIEL3 trial as maintenance therapy to treat platinum-sensitive ovarian cancer. The company said that within four months, it plans to submit an sNDA to FDA for Rubraca as second-line or later maintenance therapy for patients who have responded to platinum therapy.

The oral PARP-1 and PARP-2 inhibitor improved PFS by investigator review vs. placebo among 196 tumor BRCA-mutant patients (16.6 vs. 5.4 months, HR=0.23, p<0.0001), 354 homologous recombination deficiency-positive patients (13.6 vs. 5.4 months, HR=0.32, p<0.0001), and the study'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 germline and somatic mutations. The HRD-positive group enrolled BRCA-mutant and BRCA wild-type patients with high loss of heterozygosity. Clovis said Rubraca also led to further reductions in tumor burden, including complete responses, in patients with residual disease at baseline...