-=Clovis Oncology (CLVS) to seek FDA approval for ovarian cancer drug as a maintenance therapy

 

Clovis Oncology Rubraca significantly improves progression-free survival in first-line maintenance treatment in women with ovarian cancer regardless of their biomarker status in phase 3 athena-mono trial

• ATHENA study evaluating Rubraca monotherapy versus placebo (ATHENA-MONO) successfully achieved the primary endpoint of improved PFS in both populations in the primary efficacy analyses: HRD-positive and all patients randomized.
• Median PFS of 20.2 months for Rubraca vs 9.2 months for placebo in the ITT population.
• The exploratory PFS endpoints were also achieved in both HRD-negative and BRCA mutant subgroups of patients.
• Safety of Rubraca observed in ATHENA-MONO was consistent with both the current US and European labels.
• ATHENA-MONO results will serve as the basis of a supplemental NDA for US label expansion to be submitted during Q2 2022; European submission to follow during Q3 2022.
• These data, including additional analyses, have been submitted for presentation at the American Society of Clinical Oncology Annual Meeting in June 2022.