- Clovis Oncology Inc (NASDAQ:CLVS) announced positive topline data from the monotherapy arm of Phase 3 ATHENA-MONO trial of Rubraca (Rucaparib) as first-line maintenance treatment in ovarian cancer.
- Rubraca achieved the primary endpoint of significantly improved progression-free survival (PFS) compared with placebo (20.2 months vs. 9.2 months).
- The median PFS for the HRD-positive patient population treated with rucaparib was 28.7 months vs. 11.3 months among those who received a placebo.
- The median PFS in an exploratory subgroup of HRD-negative demonstrated a hazard ratio of 0.65, with a PFS of 12.1 months vs. 9.1 months.
- PFS benefit was also seen in the exploratory subgroups of patients with HRD-negative2 and BRCA mutant (BRCAm) tumors.
- The median PFS for these patients treated with rucaparib (n=91) was Not Reached vs. 14.7 months.
- The Company plans to submit a supplemental marketing application to the FDA during Q2 of 2022, followed by a Type II Variation to the EMA during Q3 of 2022.
- Results from the ATHENA-COMBO part (rucaparib+nivolumab vs. rucaparib) are expected in Q1 2023 based on a slower than anticipated event count.
- ATHENA-MONO enrolled 538 women.
- Price Action: CLVS shares are up 46.1% at $2.41 during the premarket session on the last check Thursday.
