VIEW THE FULL TRITON3 STUDY DESIGN AND BASELINE PATIENT CHARACTERISTICS
TRITON3 was an international, multicenter, randomized, open-label Phase 3 trial enrolling 405 chemotherapy-naïve patients with BRCA-mutated mCRPC who progressed on prior ARPI therapy.1
Patients were randomized 2:1 to receive RUBRACA 600 mg orally twice daily or physician’s choice of docetaxel or a second-generation ARPI (abiraterone or enzalutamide). Randomization was stratified by ECOG PS (0 vs 1), hepatic metastases (yes vs no), and gene alteration (BRCA1 vs BRCA2 vs ATM). The primary endpoint was rPFS by IRR and key secondary endpoints included OS and ORR by IRR. Patients continued treatment until progression, with crossover to RUBRACA allowed at physician’s discretion. Patients also received a concomitant GnRH analog or had a prior bilateral orchiectomy.1
SUPERIOR TO CHEMOTHERAPY IN A HEAD-TO-HEAD TRIAL1,2
RUBRACA significantly improves rPFS vs docetaxel in chemotherapy-naïve patients with BRCA-mutated mCRPC
RUBRACA significantly improves median rPFS vs second-generation ARPI (abiraterone or enzalutamide)2
OF ELIGIBLE PATIENTS FROM THE PHYSICIAN’S CHOICE ARM CROSSED OVER TO RUBRACA, CONTRIBUTING TO SIMILAR TREATMENT OUTCOMES4
RUBRACA® (rucaparib) is indicated for the treatment of adult patients with a deleterious BRCA mutation (germline and/
or somatic)-associated metastatic castration-resistant prostate cancer (mCRPC) who have been treated with androgen receptor-directed therapy. Select patients for therapy based on an FDA-approved companion diagnostic for RUBRACA.
The duration of RUBRACA treatment prior to the diagnosis of MDS/AML ranged from < 2 months to approximately 72 months. The cases were typical of secondary MDS/
cancer therapy-related AML; in all cases, patients had received previous platinum-containing chemotherapy regimens and/
or other DNA damaging agents.
In TRITON3, MDS/AML occurred in 2 out of 201 patients (1%) with a BRCA mutation treated with RUBRACA. The duration of therapy with RUBRACA in patients who developed secondary MDS/cancer therapy-related AML varied from 1.4 to 2.3 years.
If MDS/AML is confirmed, discontinue RUBRACA.
Most common adverse reactions of patients with BRCA-mutated mCRPC treated with RUBRACA in TRITON3 (≥10%, Grade 1-4) were fatigue/asthenia (61%), musculoskeletal pain (53%), nausea (51%), decreased appetite (34%), diarrhea (31%), constipation (31%), vomiting (25%), dyspnea (19%), dysgeusia (18%), edema (18%), abdominal pain (17%), dizziness (16%), weight decreased (16%), rash (13%), headache (12%), peripheral neuropathy (12%), photosensitivity reaction (12%), and urinary tract infection (10%).
Most common adverse reactions of patients with BRCA-mutated mCRPC treated with RUBRACA in TRITON2 (≥ 20%; Grade 1-4) were fatigue/asthenia (62%), nausea (52%), decreased appetite (28%), rash (27%), constipation (27%), vomiting (22%), and diarrhea (20%).
Most common laboratory abnormalities of patients with BRCA-mutated mCRPC treated with RUBRACA in TRITON2 (≥ 35%; Grade 1-4) were increased ALT (69%), decreased leukocytes (69%), decreased phosphate (68%), decreased absolute neutrophil count (62%), decreased hemoglobin (59%), increased alkaline phosphatase (44%), increased creatinine (43%), decreased lymphocytes (42%), increased triglycerides (42%), decreased platelets (40%), and decreased sodium (38%).
If concomitant administration with warfarin (a CYP2C9 substrate) cannot be avoided, consider increasing the frequency of international normalized ratio (INR) monitoring.
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You may report adverse events to the FDA at 1-800-FDA-1088 or www.fda.gov/
medwatch.
Alternatively, to report an adverse event or reaction, contact pharma& at pv@pharmaand.com.
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for the treatment of BRCA-mutated mCRPC1
Learn more about the updated indication in the full Prescribing Information
ARPI, androgen receptor pathway inhibitor; BRCA, BReast CAncer gene; mCRPC, metastatic castration-resistant prostate cancer;
PARPi, poly (adenosine diphosphate-ribose) polymerase inhibitor.
