Rucaparib significantly improves PFS BRCA+ relapsed ovarian cancer
Rucaparib (Rubraca; Clovis Oncology) significantly improves progression-free survival (PFS) compared to standard-of-care chemotherapy in patients with advanced, relapsed ovarian cancer and a deleterious BRCA mutation who have received ≥2 prior lines of chemotherapy, according to data presented at Society of Gynecologic Oncology Virtual Annual Meeting.
In the randomized, Phase 3 ARIEL4 study, 220 patients were treated with rucaparib and 105 with standard-of-care chemotherapy. The primary efficacy population included patients with a deleterious tumor BRCA mutation and excluded those with a BRCA reversion mutation.The rucaparib group achieved statistical significance over the chemotherapy group for the primary endpoint of PFS. In the efficacy population, the median PFS was 7.4 months versus 5.7 months in patients treated with rucaparib and chemotherapy, respectively.
“Data from the ARIEL4 study meaningfully enhance our understanding about the role of Rubraca among women with BRCA mutation-positive relapsed ovarian cancer, as well as the clinical relevance of BRCA reversion mutations,” said Dr Rebecca Kristeleit, Co-Coordinating Investigator of ARIEL4 and Consultant Medical Oncologist, Guy’s and St Thomas’ NHS Foundation Trust, London, UK, in a press release. “This is important because women with more advanced disease have fewer treatment options, and it is increasingly important to understand how specific mutations affect treatment outcomes.”
Kristeleit R, et al. Rucaparib versus chemotherapy in patients with advanced, relapsed ovarian cancer and a deleterious BRCA mutation: efficacy and safety from ARIEL4, a randomized phase 3 study. Presented at: Society of Gynecologic Oncology Virtual Annual Meeting.