Phase III ATHENA-MONO trial of Rubraca meets primary endpoint in ovarian cancer.- Clovis Oncology
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.
150 mins
Learning Zones
The Learning Zones are an educational resource for healthcare professionals that provide medical information on the epidemiology, pathophysiology and burden of disease, as well as diagnostic techniques and treatment regimens.