- 43.9% confirmed objective response rate (ORR) in 57 RECIST*-evaluable patients with metastatic castration-resistant prostate cancer (mCRPC) and a BRCA1/2 mutation
- 52.0% confirmed prostate-specific antigen (PSA) response in 98 PSA-evaluable patients with mCRPC and a BRCA1/2 mutation
- The safety profile of Rubraca was consistent with prior reports from TRITON2 and for those patients with ovarian cancer and other solid tumors
- Supplemental new drug application (NDA) for Rubraca in BRCA1/2-mutant advanced prostate cancer on track for Q4 2019
- Clovis Oncology also highlights efficacy and safety of Rubraca in recurrent ovarian cancer
“The updated data from the TRITON2 trial confirm the potential role of rucaparib in treating metastatic castration-resistant prostate cancer,” said Wassim Abida, M.D., Medical Oncologist, Memorial Sloan Kettering Cancer Center, and principal investigator for the TRITON2 study. “These data specifically demonstrate the efficacy of rucaparib in eligible mCRPC patients with a BRCA1/2 mutation and reinforce the known safety profile in this treatment setting, showing it has the potential to offer clinical benefit to eligible patients.”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 (as of July 2, 2019) for patients in TRITON2 was 13.1 months (range 4.1–28.5 months) with the safety profile consistent with prior reports. The most common any-grade treatment-emergent adverse events (TEAE) >20% in the TRITON2 trial were asthenia/fatigue (55.3%), nausea (49.5%), anemia/decreased hemoglobin (37.9%), decreased appetite (27.9%), transient increased aspartate transaminase/alanine aminotransferase (ALT/AST) (24.7%), constipation (24.7%), vomiting (22.1%) and diarrhea (21.1%).
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 (both inclusive of germline and somatic) tumors with a primary objective of assessing radiographic progression-free survival (PFS) in these patients.
The Company will present greater detail about its planned sNDA filing and regulatory strategy in mCRPC at its Investor/Analyst event Sunday at 6:30pm CEST, which will be webcast live and available via replay.
About Rubraca® (rucaparib) Rubraca is an oral, small molecule inhibitor of PARP1, PARP2 and PARP3 that is being developed in multiple tumor types, including ovarian and mCRPC, as monotherapy, and in combination with other anti-cancer agents. Exploratory studies in other tumor types are also underway. Rubraca U.S. FDA approved indications Rubraca is indicated as monotherapy for the maintenance treatment of adult patients with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in CR or PR to platinum-based chemotherapy.
Rubraca is indicated as monotherapy for the treatment of adult patients with deleterious BRCA mutations (germline and/or somatic) associated epithelial ovarian, fallopian tube, or primary peritoneal cancer who have been treated with ≥2 chemotherapies and selected for therapy based on an FDA-approved companion diagnostic for Rubraca.
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* Response Evaluation Criteria in Solid Tumors (RECIST) is a standardized methodology for determining therapeutic response to anticancer using changes in lesion appearance on imaging studies
** Prostate Cancer Working Group (PCWG3) is an international expert committee of prostate cancer clinical investigators who have recommended modifications to RECIST for use in the conduct of trials in metastatic castration-resistant prostate cancer (mCRPC), which were adopted in the TRITON2 protocol.
Source: WIRE, BUSINESS. 2019. "Clovis Oncology Highlights Rubraca® (rucaparib) Updated Data from the Ongoing TRITON2 Clinical Trial in Patients with mCRPC and Exploratory and Integrated Analyses in Recurrent Ovarian Cancer at the ESMO Congress 2019". Businesswire.com. https://www.businesswire.com/news/home/20190928005026/en/Clovis-Oncology-Highlights-Rubraca%C2%AE-rucaparib-Updated-Data.