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Phase III ATHENA-MONO trial of Rubraca meets primary endpoint in ovarian cancer.- Clovis Oncology

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Published:2nd Apr 2022

Clovis Oncology announced positive top-line data from the monotherapy arm of the phase III ATHENA (GOG 3020/ENGOT-ov45) trial (ATHENA-MONO) demonstrating that Rubraca (rucaparib) as maintenance treatment for ovarian cancer successfully achieved the primary endpoint of significantly improved investigator-assessed progression-free survival (PFS) compared with placebo.

Benefit was observed in both primary efficacy analyses of newly-diagnosed patients with advanced ovarian cancer following successful treatment with platinum-based chemotherapy: those who had homologous recombination deficiency (HRD-positive), including deleterious BRCA mutations, as well as all patients randomized in the trial (overall intent-to-treat population (ITT)). 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. Based on these results, the Company plans to submit a supplemental New Drug Application (sNDA) to the US FDA during the second quarter of 2022 followed by a Type II Variation to the EMA during the third quarter of 2022 for a first-line maintenance treatment indication for women with advanced ovarian cancer regardless of biomarker status who have responded to first-line platinum-based chemotherapy.

Condition: Ovarian Cancer
Type: drug

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