Clovis Oncology reports data from Phase III ARIEL 3 trial of rucaparib for ovarian cancer and plans sNDA for second line and maintenance treatment.

Clovis Oncology, Inc. announced topline data from the confirmatory phase III ARIEL3 trial of rucaparib, which successfully achieved the primary endpoint of improved progression-free survival (PFS) by investigator review in each of the three populations studied. PFS was also improved in the rucaparib group compared with placebo by blinded independent central review (BICR), a key secondary endpoint.

Based on these findings, the Company plans to submit a supplemental New Drug Application (sNDA) within the next four months for a second-line and later maintenance treatment indication for all women with platinum-sensitive ovarian cancer who have responded to their most recent platinum therapy.

The most robust clinical outcomes were observed among ARIEL3 patients with a germline or somatic BRCA mutation (n=196). By investigator review, the rucaparib arm successfully achieved statistical significance over the placebo arm for the primary endpoint of PFS with a hazard ratio of 0.23 (p<0.0001). the median pfs for the tbrcamut patients treated with rucaparib was 16.6 months vs. 5.4 months among those who received placebo.>

Comment: The new positive data for Clovis Oncology's ovarian cancer treatment Rubraca (rucaparib) could position the company to secure an expanded label for the PARP inhibitor, potentially improving its competitive standing versus rival drugs from AstraZeneca and Tesaro, Inc.