TRITON2 Safety
& Tolerability

Rubraca Has an Established 
and Manageable Safety Profile1,2

The majority of adverse reactions and lab abnormalities
were Grades 1 or 21,3

Adverse reactions reported in ≥20% of patients with BRCAmut+ mCRPC (N=115)a,1

Laboratory abnormalities in ≥35% (Grades 1-4) and ≥2% (Grades 3-4) worsening from baseline in
patients with BRCAmut+ mCRPCd,e,1

92% of Patients Were Able to Stay on Rubraca Without Discontinuing Therapy Due to Adverse Reactions2,3

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Discontinuation rate due to adverse reactions (N=115)

Dose interruptions and dose reductions (N=115)

  • Adverse reactions most frequently leading to dose interruption of Rubraca were anemia (21.7%), thrombocytopenia (13.9%), asthenia/fatigue (9.6%), nausea (7.0%), vomiting (6.1%), neutropenia (6.1%)
  • Adverse reactions most frequently leading to dose reduction of Rubraca were anemia (14%), asthenia/fatigue (10%), thrombocytopenia (7%), nausea (6%)
  • None of the adverse reactions leading to discontinuation of Rubraca occured in more than one patientg

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  • aNational Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.03.
  • bIncludes blister, blood blister, dermatitis, dermatitis contact, eczema, genital rash, palmar-plantar erythrodysaesthesia syndrome, photosensitivity reaction, psoriasis, rash, rash maculo-papular, rash pruritic, skin exfoliation, skin lesion, urticaria.
  • cIncludes platelet count decreased.
  • dDenominator for each laboratory parameter is based on the number of patients with a baseline and post-treatment laboratory value available for 111 to 115 patients.
  • eNCI CTCAE version 5.0; decrease in phosphate is graded using NCI CTCAE Version 4.03.
  • fGrade 3-4 ALT or AST elevation led to drug interruption in 4 patients, of which 1 had dose reduction upon rechallenge.
  • gECG QT prolonged, acute respiratory distress syndrome, anemia, balance disorder, cardiac failure, decreased appetite/fatigue/weight decreased, leukopenia/neutropenia, ALT/AST increased, and pneumonia.
  • ALT, alanine aminotransferase; AST, aspartate aminotransferase; BRCAmut+ mCRPC, breast cancer susceptibility gene-positive metastatic castration-resistant prostate cancer; ECG, electrocardiogram; QT, electrocardiogram representation of ventricular depolarization and repolarization.

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