Rubraca significantly improves PFS in 1st-line maintenance of ovarian cancer
US biotech Clovis Oncology (Nasdaq: CLVS) saw its shares roar up 55% to $2.55 pre-market, as it unveiled positive top-line results from the monotherapy portion of the ATHENA (GOG 3020/ENGOT-ov45) trial (ATHENA-MONO) demonstrating Rubraca (rucaparib) as first-line maintenance treatment successfully achieved the primary endpoint of significantly improved investigator-assessed progression-free survival (PFS) in both populations in the primary efficacy analyses: HRD-positive and all patients randomized (ITT) compared to placebo.
- Median PFS of 20.2 months for Rubraca versus 9.2 months for placebo in the ITT population
Benefit in PFS was also seen in the exploratory subgroups of patients with HRD-negative and BRCA mutant (BRCAm) tumors. The safety of Rubraca observed in the ATHENA-MONO study was consistent with both the US and European labels for the approved product.
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