Clovis announces updated data from Phase 2 TRITON2 trial
Clovis Oncology announced updated data from the Phase 2 TRITON2 trial at the European Society for Medical Oncology Congress 2019, reinforcing the potential of Rubraca for the treatment of patients with metastatic castration-resistant prostate cancer with a BRCA1/2 mutation. The data show a 43.9% confirmed objective response rate by investigator assessment in 57 RECIST/PCWG3 response-evaluable patients with a BRCA1/2 mutation. When assessed by independent radiological review, the response rate was similar. In addition, a 52.0% confirmed prostate-specific antigen response rate was observed in 98 response-evaluable patients with a BRCA1/2 mutation. Confirmed radiographic responses were durable, with 60% lasting 24 weeks or longer. The TRITON2 data will be used to support the filing of Clovis Oncology's planned supplemental NDA to the Food and Drug Administration for Rubraca in BRCA1/2-mutant advanced prostate cancer. Confirmed investigator-assessed RECIST and PSA responses were also observed in patients with alterations in other DDR genes, including ATM, CDK12, CHEK2, PALB2, BRIP1, FANCA, and RAD51B. The median duration of follow-up for patients in TRITON2 was 13.1 months with the safety profile consistent with prior reports. Clovis Oncology is further evaluating the potential of Rubraca to treat advanced prostate cancer in the TRITON3 clinical trial - a multicenter, randomized, open-label Phase 3 study of Rubraca versus physician's choice of therapy - for patients with mCRPC. TRITON3 is currently enrolling patients with BRCA1/2-mutant and ATM-mutant tumors with a primary objective of assessing radiographic progression-free survival in these patients.