TRITON3 Phase 3 Trial of Rubraca® (rucaparib) Achieves Primary Endpoint in Men with Metastatic Castration-Resistant Prostate Cancer with BRCA or ATM Mutations
Clovis Oncology, Inc. (CLVS)
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Source: Business Wire
TRITON3 study evaluating Rubraca monotherapy versus chemotherapy or second-line androgen deprivation therapy in patients with metastatic castration-resistant prostate cancer (mCRPC) with mutations in BRCA or ATM achieved the primary endpoint of improved radiographic progression-free survival (rPFS) by independent radiology review (IRR)– Median rPFS of 11.2 months for Rubraca vs 6.4 months for control group in the BRCA subgroup– Median rPFS of 10.2 months for Rubraca vs 6.4 months for control group in the ITT population (inclusive of all patients with a BRCA or ATM mutation enrolled in TRITON3)Safety profile of Rubraca observed in TRITON3 was consistent with Rubraca labellingTRITON3 is the confirmatory study for Rubraca’s current US accelerated approval in mCRPC and will also serve as the basis of a supplemental New Drug Application (sNDA) for US label expansion to be submitted during Q1 2023TRITON3 data have been submitted for presentation at the Prostate Cancer Foundation Annual Scie
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