Select adverse reactions in PROfound (Cohort A+B)1

Adverse reactions reported in ≥10% of patients who received LYNPARZA

  • LYNPARZA (n=256)
  • Investigator’s choice of enzalutamide or abiraterone (n=130)
Adverse Reactions* Grades 1–4 (%) Grades 3–4 (%)
Blood and lymphatic disorders
Anemia†
  • 46
     
  • 15
     
  •  
    21
  •  
    5
Thrombocytopenia‡
  • 12
     
  • 3
     
  •  
    4
  •  
    0
Gastrointestinal disorders
Nausea
  • 41
     
  • 19
     
  •  
    1
  •  
    0
Diarrhea
  • 21
     
  • 7
     
  •  
    1
  •  
    0
Vomiting
  • 18
     
  • 12
     
  •  
    2
  •  
    1
General disorders and administration site conditions
Fatigue (including asthenia)
  • 41
     
  • 32
     
  •  
    3
  •  
    5
Metabolism and nutrition disorders
Decreased appetite
  • 30
     
  • 18
     
  •  
    1
  •  
    1
Respiratory, thoracic, and mediastinal disorders
Cough
  • 11
     
  • 2
     
  •  
    0
  •  
    0
Dyspnea
  • 10
     
  • 3
     
  •  
    2
  •  
    0

*Graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), version 4.03.

†Includes anemia and hemoglobin decreased.

‡Includes platelet count decreased and thrombocytopenia.

  • Fatal adverse reactions occurred in 4% of patients treated with LYNPARZA. These included pneumonia (1.2%), cardiopulmonary failure (0.4%), aspiration pneumonia (0.4%), intestinal diverticulum (0.4%), septic shock (0.4%), Budd-Chiari Syndrome (0.4%), sudden death (0.4%), and acute cardiac failure (0.4%)
  • Serious adverse reactions occurred in 36% of patients receiving LYNPARZA. The most frequent serious adverse reactions (≥2%) were anemia (9%), pneumonia (4%), pulmonary embolism (2%), fatigue/asthenia (2%), and urinary tract infection (2%)
  • Venous thromboembolism (VTE), including severe or fatal pulmonary embolism (PE), occurred in patients treated with LYNPARZA. In the combined data of two randomized, placebo-controlled clinical studies (PROfound and PROpel) in patients with metastatic castration-resistant prostate cancer (N=1180), VTE occurred in 8% of patients who received LYNPARZA, including pulmonary embolism in 6%. In the control arms, VTE occurred in 2.5% including pulmonary embolism in 1.5%

Dose modifications in PROfound1

Changes due to adverse reactions LYNPARZA (n=256)
Dose interruptions 45%
Dose reductions 22%
Discontinuations 18%

The most frequent adverse reactions leading to dose interruption of LYNPARZA were anemia (25%) and thrombocytopenia (6%), and the most frequent adverse reaction leading to reduction was anemia (16%). The adverse reaction that most frequently led to discontinuation of LYNPARZA was anemia (7%).

In PROfound, 82% of patients remained on LYNPARZA without discontinuing due to adverse reactions

Laboratory abnormalities reported in ≥25% of patients in PROfound (Cohorts A+B)1

  • LYNPARZA (n=256)*
  • Investigator’s choice of enzalutamide or abiraterone (n=130)*
Laboratory Parameter† Grades 1–4 (%) Grades 3–4 (%)
Decrease in hemoglobin
  • 98
     
  • 73
     
  •  
    13
  •  
    4
Decrease in lymphocytes
  • 62
     
  • 34
     
  •  
    23
  •  
    13
Decrease in leukocytes
  • 53
     
  • 21
     
  •  
    4
  •  
    0
Decrease in absolute neutrophil count
  • 34
     
  • 9
     
  •  
    3
  •  
    0

*This number represents the safety population. The derived values in the table are based on the total number of evaluable patients for each laboratory parameter.

†Patients were allowed to enter clinical studies with laboratory values of CTCAE Grade 1.