Complete Story
06/20/2017
Phase 3 ARIEL3 Maintenance Treatment Trial
Phase 3 ARIEL3 Maintenance Treatment Trial
- The ARIEL3 study successfully achieved its primary endpoint of improved PFS by investigator review in all three primary efficacy analyses: tumor BRCA-mutant, HRD-positive and overall intent-to-treat populations
- The ARIEL3 study successfully achieved the key secondary endpoint of improved PFS by blinded, independent central review (BICR) in each of the tumor BRCA-mutant, HRD-positive and overall intent-to-treat populations
- The exploratory PFS endpoints were achieved by both investigator and independent review in the HRD-positive and HRD-negative subgroups of patients without a BRCA mutation
- ARIEL3 patients with residual disease at study entry who were treated with rucaparib showed further reduction in tumor burden, including complete responses
- The safety of rucaparib observed in ARIEL3 was highly consistent with the U.S. treatment label for Rubraca®
- The Company plans to submit a supplemental NDA within the next four months
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