PRESS RELEASE
For Immediate Release
Philadelphia, PA, USA, March 31, 2022 — The GOG Foundation, Inc., (GOG) GOG Partners (GOG-P) and the European Network of Gynaecological Oncology Trial Groups (ENGOT) are pleased to share that Clovis Oncology, Inc. announced positive top-line data from the monotherapy arm of A Multicenter, Randomized, Double-Blind, Placebo- Controlled Phase 3 Study in Ovarian Cancer Patients Evaluating Rucaparib and Nivolumab as Maintenance Treatment Following Response to Front-Line Platinum-Based Chemotherapy GOG 3020/ENGOT-ov45 (ATHENA) Trial. ATHENA-MONO results will serve as the basis of a supplemental NDA for US label expansion expected to be submitted during the second quarter of 2022; European submission is planned to follow during the third quarter of 2022.
Positive top-line data from the monotherapy arm of the ATHENA (GOG 3020/ENGOT-ov45) trial (ATHENA-MONO) that Rubraca as maintenance treatment 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)[1], 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[2] and BRCA mutant (BRCAm) tumors. The safety of Rubraca observed in the ATHENA-MONO study was consistent with both the US and European labels.
[1] HRD-positive may also be referred to as HR-deficient, HRD, HRD+, HRd, or biomarker positive
[2] HRD-negative may also be referred to as HR-proficient, HRD-, HRp, or biomarker negative
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