Phase III ARIEL4 study of Rubraca shows benefits in PFS for ovarian cancer.- Clovis Oncology

Clovis Oncology announced data from the randomized, Phase III ARIEL4 study of Rubraca (rucaparib) which demonstrates that Rubraca significantly improves progression-free survival (PFS) compared to standard-of-care chemotherapy, including platinum-based chemotherapy, among patients with advanced, relapsed ovarian cancer and a deleterious BRCA mutation who have received two or more prior lines of chemotherapy. The rucaparib arm in this population (n=220) achieved statistical significance over the chemotherapy arm (n=105) for the primary endpoint of PFS with a hazard ratio of 0.64 (p=0.001). The median PFS for the patients in the efficacy population treated with rucaparib was 7.4 months versus 5.7 months among those who received chemotherapy. Additionally, in the ITT population (n=349), the rucaparib arm (n=233) achieved statistical significance over the chemotherapy arm (n=116) for the primary endpoint of PFS with a hazard ratio of 0.67 (p=0.002). The median PFS for the patients in the ITT population treated with rucaparib was 7.4 months versus 5.7 months among those who received chemotherapy. Adverse events were consistent with the known safety profiles of Rubraca and chemotherapy. The most common (>5%) treatment-emergent at least grade 3 adverse events (TEAEs) among all patients treated with rucaparib (n=232) in the ARIEL4 study were anemia/decreased hemoglobin (22%), neutropenia /decreased absolute neutrophil count (10%), asthenia/fatigue (8%), thrombocytopenia/decreased platelets (8%), and increased ALT/AST (8%). Data will be presented at the Society of Gynecologic Oncology Virtual Annual Meeting on Women’s Cancer (SGO).