In the full study population

Combination therapy: Safety and tolerability in the PROpel trial

Adverse reactions reported in ≥10% of patients who received LYNPARZA (with a difference of ≥5% vs placebo)

  • LYNPARZA + abi/pred (n=398)
  • placebo + abi/pred (n=396)
Adverse Reactions* Grades 1–4 (%) Grades 3–4 (%)
Blood and lymphatic disorders
Anemia†
  • 48
     
  • 18
     
  •  
    16
  •  
    3.3
Lymphopenia‡
  • 14
     
  • 6
     
  •  
    5
  •  
    1.8
General disorders and administration site conditions
Fatigue (including asthenia)
  • 38
     
  • 30
     
  •  
    2.3
  •  
    1.5
Gastrointestinal disorders
Nausea
  • 30
     
  • 14
     
  •  
    0.3
  •  
    0.3
Diarrhea
  • 19
     
  • 10
     
  •  
    1
  •  
    0.3
Abdominal pain§
  • 13
     
  • 7
     
  •  
    0
  •  
    0.5
Metabolism and nutrition disorders
Decreased appetite
  • 16
     
  • 7
     
  •  
    1
  •  
    0
Nervous system disorders
Dizziness||
  • 14
     
  • 7
     
  •  
    0.3
  •  
    0

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

†Includes anemia, anemia macrocytic, and red blood cell count decreased.

‡Includes lymphocyte count decreased and lymphopenia.

§Includes abdominal discomfort, abdominal pain, abdominal pain upper, and abdominal pain lower.

||Includes dizziness and vertigo.

  • Fatal adverse reactions occurred in 6% of patients, including COVID-19 (3%) and pneumonias (0.5%)
  • Serious adverse reactions occurred in 39% of patients. Serious adverse reactions reported in >2% of patients included anemia (6%), COVID-19 (6%), pneumonia (4.5%), pulmonary embolism (3.5%), and urinary tract infection (3%)
  • 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 PROpel (full study population)

Changes due to adverse reactions LYNPARZA + abi/pred
(n=398)
Dose interruptions 48%
Dose reductions 21%
Discontinuations 16%

The most common (>2%) adverse reactions requiring dosage interruption of LYNPARZA were anemia (16%), COVID-19 (6%), fatigue (3.5%), nausea (2.8%), pulmonary embolism (2.3%), and diarrhea (2.3%). The most common (>2%) adverse reactions requiring dosage reductions of LYNPARZA were anemia (11%) and fatigue (2.5%). The most common adverse reactions that resulted in permanent discontinuation of LYNPARZA were anemia (4.3%) and pneumonia (1.5%).

In PROpel, 84% of patients remained on LYNPARZA without discontinuing due to adverse reactions

Select laboratory abnormalities reported in ≥20% of patients in PROpel1

  • LYNPARZA + abi/pred (n=398)*
  • placebo + abi/pred (n=396)*
Laboratory Parameter Grades 1–4 (%) Grades 3–4 (%)
Decrease in hemoglobin
  • 97
     
  • 81
     
  •  
    12
  •  
    1.3
Decrease in lymphocytes
  • 70
     
  • 49
     
  •  
    23
  •  
    11
Decrease in platelets
  • 23
     
  • 20
     
  •  
    1.2
  •  
    0.3
Decrease in absolute neutrophil count
  • 23
     
  • 6
     
  •  
    5
  •  
    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.