Safety & tolerability in the OlympiA trial, including 6-year* follow-up data1

  • *Median follow-up time (exploratory analysis): 6.1 years. The analysis at 6 years is based on Kaplan–Meier estimates and is descriptive only; the OlympiA trial was not powered to assess a statistical difference between treatment groups at this time point.

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Study Design

Primary analysis†:

Adverse Reactions (ARs) in OlympiA (≥10% of patients with gBRCAm,‡ HER2-negative, high-risk§ early breast cancer who received LYNPARZA)1

  • LYNPARZA (n=911)
  • Placebo (n=904)
Adverse ReactionsII Grades 1–4 (%) Grades 3–4 (%)
Nausea
  • 57
  • 23
  • 0.8
  • 0
Vomiting
  • 23
  • 8
  • 0.7
  • 0
Diarrhea
  • 18
  • 14
  • 0.3
  • 0.3
Stomatitis
  • 10
  • 4.5
  • 0.1
  • 0
Fatigue (including asthenia)
  • 42
  • 28
  • 1.8
  • 0.7
Anemia#
  • 24
  • 3.9
  • 9
  • 0.3
Leukopenia**
  • 17
  • 6
  • 3
  • 0.3
Neutropenia††
  • 16
  • 7
  • 5
  • 0.8
Headache
  • 20
  • 17
  • 0.2
  • 0.1
Dysgeusia‡‡
  • 12
  • 4.8
  • 0
  • 0
Dizziness
  • 11
  • 7
  • 0.1
  • 0.1
Decreased appetite
  • 13
  • 6
  • 0.2
  • 0
  • †Data from the prespecified interim analysis at a median follow-up of 2.5 years.
  • ‡Select patients for therapy based on an FDA-approved companion diagnostic for LYNPARZA.1
  • §For patients who received prior neoadjuvant chemotherapy, high risk was defined as non-pCR in TNBC and as non-pCR with CPS&EG score ≥3 in HR-positive, HER2-negative disease. For patients who received prior adjuvant chemotherapy, high risk was defined as ≥pN1 or pN0 with ≥pT2 in TNBC and as ≥4 positive lymph nodes in HR-positive, HER2-negative disease.1
  • ||Graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), version 4.03.
  • Includes aphthous ulcer, mouth ulceration, stomatitis.
  • #Includes anemia, anemia macrocytic, erythropenia, hematocrit decreased, hemoglobin decreased, normochromic anemia, normochromic normocytic anemia, normocytic anemia, red blood cell count decreased.
  • **Includes leukopenia, white blood cell count decreased.
  • ††Includes agranulocytosis, febrile neutropenia, granulocyte count decreased, granulocytopenia, idiopathic neutropenia, neutropenia, neutropenic infection, neutropenic sepsis, neutrophil count decreased.
  • ‡‡Includes dysgeusia, taste disorder.

ARs in OlympiA were mostly Grades 1 and 2.1

In an exploratory analysis with a median follow-up of 6.1 years1,2:

No new safety signals were identified, and the safety profile remained generally consistent with the primary analysis

  • The incidence of MDS/AML was 0.4% in the LYNPARZA group and 0.7% in the placebo group
  • The incidence of new primary malignancies (excluding MDS/AML) was 4.9% in the LYNPARZA group and 7.5% in the placebo group
  • The incidence of pneumonitis was 1.0% in the LYNPARZA group and 1.4% in the placebo group

Learn more about AR data from clinical trials

Explore the data

Primary analysis*:

Laboratory abnormalities reported in ≥25% of patients in OlympiA1

  • LYNPARZA (n=911)†
  • Placebo (n=904)†
Laboratory Parameter‡ Grades 1–4 (%) Grades 3–4 (%)
Decrease in lymphocytes
  • 77
  • 59
  • 13
  • 3.7
Decrease in hemoglobin
  • 65
  • 31
  • 8
  • 0.9
Decrease in leukocytes
  • 64
  • 42
  • 5
  • 0.7
Increase in mean corpuscular volume§
  • 67
  • 4.8
  • 0
  • 0
Decrease in absolute neutrophil count
  • 39
  • 27
  • 7
  • 1.1
  • *Data from the prespecified interim analysis at a median follow-up of 2.5 years.
  • †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.
  • §Represents the proportion of subjects whose mean corpuscular volume was >ULN.

  • ULN=upper limit of normal.

Explore related content:

OlympiAEfficacy

Review the long-term efficacy data of LYNPARZA for patients with gBRCAm, HER2-negative, high-risk eBC. The OlympiA trial enrolled patients with HR+ or triple-negative breast cancer.

Explore the OlympiA data

LYNPARZA Adverse Reaction (AR) Management Guidance Website

Explore adverse reaction data from clinical trials, including median onset and duration of ARs, and view AR management strategies for certain ARs based on established medical protocols.

Learn more about AR data from clinical trials

IMPORTANT SAFETY INFORMATION