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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