For the treatment of patients with gBRCAm,* HER2-negative, high-risk^† early breast cancer who have been treated with neoadjuvant or adjuvant chemotherapy

The OlympiA trial demonstrated significant invasive disease-free survival (IDFS) and overall survival (OS) in patients with gBRCAm, HER2-negative, high-risk eBC with LYNPARZA vs placebo¹

Primary (prespecified interim) analysis

Primary endpoint: IDFS¹

42^%

REDUCTION IN RISK OF INVASIVE DISEASE RECURRENCE, NEW CANCERS, OR DEATH VS PLACEBO

Key secondary endpoint: OS¹

32^%

REDUCTION IN RISK OF DEATH VS PLACEBO

See below for IDFS and OS results from 6-year exploratory analysis^‡

*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

^‡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.

SELECT FROM TOPICS ON THE PAGE

REVIEW IMPORTANT SAFETY INFORMATION BELOW

PRIMARY (prespecified interim) ANALYSIS

Adjuvant LYNPARZA demonstrated a statistically significant improvement in IDFS* vs placebo in gBRCAm, HER2-negative, high-risk early breast cancer^1,2

IDFS event rates at 1, 2, and 3 years are based on Kaplan–Meier estimates and are descriptive only; the OlympiA trial was not powered to assess a statistical difference between treatment groups at these time points.

The threshold for statistical significance was 0.005¹
The number of IDFS events observed was 106 with LYNPARZA (N=921) vs 178 with placebo (N=915)¹
Data from the prespecified interim analysis (86% of the number of events for the planned final analysis) at a median follow-up of 2.5 years^1,2

*IDFS was defined as time to first invasive breast cancer recurrence (loco-regional or distant), second primary cancer, or death from any cause.¹

^†LYNPARZA was administered for up to 12 months or until disease recurrence or unacceptable toxicity.¹

EXPLORATORY (prespecified third) ANALYSIS*

In an exploratory analysis,* ~80% of patients in the LYNPARZA arm and ~70% of patients in the placebo arm were living without an IDFS event at 6 years^3†

The IDFS event rates at 6 years are based on Kaplan–Meier estimates and are descriptive only; the OlympiA trial was not powered to assess a statistical difference between treatment groups at this time point.

The number of IDFS events observed was 178 (19%) in the LYNPARZA arm and 258 (28%) in the placebo arm; HR=0.65 (95% CI: 0.53–0.78)³
Median IDFS follow-up time (exploratory analysis): 6.1 years³

*Efficacy and safety were assessed with follow-up at 10 years from First Patient In; DCO3: June 2024.³

^†Invasive disease-free survival was defined as the time to first invasive breast cancer recurrence (loco-regional or distant), second primary cancer, or death from any cause.¹

^‡LYNPARZA was administered for up to 12 months or until disease recurrence or unacceptable toxicity.¹

NEW 6-year exploratory follow-up data publication

Read the NEW Publication

PRIMARY (prespecified second interim) ANALYSIS: SIGNIFICANTLY IMPROVED OS VS PLACEBO

LYNPARZA is the ONLY targeted adjuvant therapy to achieve OS benefit vs placebo specifically in patients with gBRCAm, HER2-negative, high-risk eBC^1,4-9

OS rates at 1, 2, 3, and 4 years are based on Kaplan–Meier estimates and are descriptive only; the OlympiA trial was not powered to assess a statistical difference between treatment groups at these time points.

OS was controlled for Type 1 error within a hierarchical statistical analysis in OlympiA¹⁰
The threshold for statistical significance was 0.015¹
The number of deaths was 75 with LYNPARZA (N=921) vs 109 with placebo (N=915)¹
Data from the prespecified second interim analysis of OS (at ~330 IDFS events) at a median follow-up of 3.5 years^1,7

Adjuvant treatment with LYNPARZA may give your eligible patients the opportunity to live longer¹

*LYNPARZA was administered for up to 12 months or until disease recurrence or unacceptable toxicity.¹

EXPLORATORY (prespecified third) ANALYSIS*

In an exploratory analysis,* ~88% of patients in the LYNPARZA arm and ~83% of patients in the placebo arm were alive at 6 years³

OS event rates at 6 years are based on Kaplan–Meier estimates and are descriptive only; the OlympiA trial was not powered to assess a statistical difference between treatment groups at this time point.

The number of deaths in the LYNPARZA arm was 107 (11.6%) and 143 in the placebo arm (15.6%); HR=0.72 (95% CI: 0.56–0.93)³
Median OS follow-up time (exploratory analysis): 6.1 years³

*Efficacy and safety were assessed with follow-up at 10 years from First Patient In; DCO3: June 2024.³

^†LYNPARZA was administered for up to 12 months or until disease recurrence or unacceptable toxicity.¹

OlympiA Study Design

OlympiA was designed to evaluate LYNPARZA as adjuvant therapy in certain patients with gBRCAm,* HER2-negative, high-risk early breast cancer¹

OlympiA was a phase 3, randomized, double-blind, placebo-controlled, international clinical trial^1,2

The CPS&EG scoring system estimates relapse probability on the basis of pre-treatment clinical and post-treatment pathologic stage (CPS), estrogen receptor (ER) status, and histologic grade.^1,2

*Select patients for therapy based on an FDA-approved companion diagnostic for LYNPARZA.¹

^†At least 6 cycles of neoadjuvant or adjuvant chemotherapy containing anthracyclines, taxanes, or both agents. Platinum-based chemotherapy was allowed.¹

^‡Radiation therapy was given when appropriate.^2,10

^§OS and DDFS were controlled for Type 1 error within a hierarchical statistical analysis in OlympiA.²

Explore related content:

LYNPARZA eBC Data Brochure

Download a resource for complete summaries of efficacy and safety data from the OlympiA trial, a clinical trial for gBRCAm, HER2-negative early BC, including exploratory 6-year follow-up data.

Download

Dosing and Administration Considerations

LYNPARZA dosing can be modified to help manage adverse reactions.

Review the dosing information and dose modification data from the OlympiA trial.

View LYNPARZA dosing for BC

NEW Publication

See the publication for a 6-year exploratory analysis from the OlympiA trial.

You are now leaving LYNPARZAhcp.com

This reprint discusses some information about LYNPARZA^® (olaparib) that is not contained in or is inconsistent with its FDA-approved Prescribing Information. This information is intended for educational purposes only. AstraZeneca provided sponsorship/funding and supplies for the study discussed in this reprint. Some authors may have a financial interest in either LYNPARZA or AstraZeneca and/or may have received compensation from AstraZeneca in connection with this study or other engagements. AstraZeneca recommends use of LYNPARZA only in accordance with its approved Prescribing Information. Prescription drugs used outside of an approved indication may not be eligible for reimbursement by third-party payors, including Medicare or Medicaid.

Please see www.LYNPARZAhcp.com for Important Safety Information and complete Prescribing Information, including Medication Guide.

Please note: AstraZeneca does not control, review, or endorse third-party content and is not responsible for the content you are about to access. We provide links to external Web sites as a convenience and for educational purposes only.

Would you like to continue to an external link?

IMPORTANT SAFETY INFORMATION

The OlympiA trial demonstrated significant invasive disease-free survival (IDFS) and overall survival (OS) in patients with gBRCAm, HER2-negative, high-risk eBC with LYNPARZA vs placebo¹

Adjuvant LYNPARZA demonstrated a statistically significant improvement in IDFS* vs placebo in gBRCAm, HER2-negative, high-risk early breast cancer^1,2

In an exploratory analysis,* ~80% of patients in the LYNPARZA arm and ~70% of patients in the placebo arm were living without an IDFS event at 6 years^3†

LYNPARZA is the ONLY targeted adjuvant therapy to achieve OS benefit vs placebo specifically in patients with gBRCAm, HER2-negative, high-risk eBC^1,4-9

In an exploratory analysis,* ~88% of patients in the LYNPARZA arm and ~83% of patients in the placebo arm were alive at 6 years³

You are now leaving LYNPARZAhcp.com

IMPORTANT SAFETY INFORMATION

INDICATIONS

Adjuvant Treatment of gBRCAm, HER2-Negative, High-Risk Early Breast Cancer

gBRCAm, HER2-Negative Metastatic Breast Cancer

First-Line Maintenance BRCAm Advanced Ovarian Cancer

First-Line Maintenance HRD-Positive Advanced Ovarian Cancer in Combination with Bevacizumab

Maintenance BRCA-mutated Recurrent Ovarian Cancer

First-Line Maintenance gBRCAm Metastatic Pancreatic Cancer

HRR Gene-mutated Metastatic Castration-Resistant Prostate Cancer

BRCAm Metastatic Castration-Resistant Prostate Cancer in Combination with Abiraterone and Prednisone or Prednisolone

IMPORTANT SAFETY INFORMATION

CONTRAINDICATIONS

WARNINGS AND PRECAUTIONS

ADVERSE REACTIONS—First-Line Maintenance BRCAm Advanced Ovarian Cancer

ADVERSE REACTIONS—First-Line Maintenance Advanced Ovarian Cancer in Combination with Bevacizumab

ADVERSE REACTIONS—Maintenance gBRCAm Recurrent Ovarian Cancer

ADVERSE REACTIONS—Adjuvant Treatment of gBRCAm, HER2-Negative, High-Risk Early Breast Cancer

ADVERSE REACTIONS—gBRCAm, HER2-Negative Metastatic Breast Cancer

ADVERSE REACTIONS—First-Line Maintenance gBRCAm Metastatic Pancreatic Adenocarcinoma

ADVERSE REACTIONS—HRR Gene-mutated Metastatic Castration-Resistant Prostate Cancer

ADVERSE REACTIONS—Metastatic Castration-Resistant Prostate Cancer in Combination with Abiraterone and Prednisone or Prednisolone

DRUG INTERACTIONS

USE IN SPECIFIC POPULATIONS

EXPAND FOR INDICATIONS

IMPORTANT SAFETY INFORMATION

See Important Safety Information, including Warnings and Precautions for MDS/AML, pneumonitis, venous thromboembolism, hepatotoxicity, including drug-induced liver injury, and embryo-fetal toxicity below.

IMPORTANT SAFETY INFORMATION

See Important Safety Information, including Warnings and Precautions for MDS/AML, pneumonitis, venous thromboembolism, hepatotoxicity, including drug-induced liver injury, and embryo-fetal toxicity below.

The OlympiA trial demonstrated significant invasive disease-free survival (IDFS) and overall survival (OS) in patients with gBRCAm, HER2-negative, high-risk eBC with LYNPARZA vs placebo1

Adjuvant LYNPARZA demonstrated a statistically significant improvement in IDFS* vs placebo in gBRCAm, HER2-negative, high-risk early breast cancer1,2

In an exploratory analysis,* ~80% of patients in the LYNPARZA arm and ~70% of patients in the placebo arm were living without an IDFS event at 6 years3†

LYNPARZA is the ONLY targeted adjuvant therapy to achieve OS benefit vs placebo specifically in patients with gBRCAm, HER2-negative, high-risk eBC1,4-9

In an exploratory analysis,* ~88% of patients in the LYNPARZA arm and ~83% of patients in the placebo arm were alive at 6 years3

You are now leaving LYNPARZAhcp.com

IMPORTANT SAFETY INFORMATION

INDICATIONS

Adjuvant Treatment of gBRCAm, HER2-Negative, High-Risk Early Breast Cancer

gBRCAm, HER2-Negative Metastatic Breast Cancer

First-Line Maintenance BRCAm Advanced Ovarian Cancer

First-Line Maintenance HRD-Positive Advanced Ovarian Cancer in Combination with Bevacizumab

Maintenance BRCA-mutated Recurrent Ovarian Cancer

First-Line Maintenance gBRCAm Metastatic Pancreatic Cancer

HRR Gene-mutated Metastatic Castration-Resistant Prostate Cancer

BRCAm Metastatic Castration-Resistant Prostate Cancer in Combination with Abiraterone and Prednisone or Prednisolone

IMPORTANT SAFETY INFORMATION

CONTRAINDICATIONS

WARNINGS AND PRECAUTIONS

ADVERSE REACTIONS—First-Line Maintenance BRCAm Advanced Ovarian Cancer

ADVERSE REACTIONS—First-Line Maintenance Advanced Ovarian Cancer in Combination with Bevacizumab

ADVERSE REACTIONS—Maintenance gBRCAm Recurrent Ovarian Cancer

ADVERSE REACTIONS—Adjuvant Treatment of gBRCAm, HER2-Negative, High-Risk Early Breast Cancer

ADVERSE REACTIONS—gBRCAm, HER2-Negative Metastatic Breast Cancer

ADVERSE REACTIONS—First-Line Maintenance gBRCAm Metastatic Pancreatic Adenocarcinoma

ADVERSE REACTIONS—HRR Gene-mutated Metastatic Castration-Resistant Prostate Cancer

ADVERSE REACTIONS—Metastatic Castration-Resistant Prostate Cancer in Combination with Abiraterone and Prednisone or Prednisolone

DRUG INTERACTIONS

USE IN SPECIFIC POPULATIONS

EXPAND FOR INDICATIONS

IMPORTANT SAFETY INFORMATION

See Important Safety Information, including Warnings and Precautions for MDS/AML, pneumonitis, venous thromboembolism, hepatotoxicity, including drug-induced liver injury, and embryo-fetal toxicity below.

IMPORTANT SAFETY INFORMATION

See Important Safety Information, including Warnings and Precautions for MDS/AML, pneumonitis, venous thromboembolism, hepatotoxicity, including drug-induced liver injury, and embryo-fetal toxicity below.

The OlympiA trial demonstrated significant invasive disease-free survival (IDFS) and overall survival (OS) in patients with gBRCAm, HER2-negative, high-risk eBC with LYNPARZA vs placebo¹

Adjuvant LYNPARZA demonstrated a statistically significant improvement in IDFS* vs placebo in gBRCAm, HER2-negative, high-risk early breast cancer^1,2

In an exploratory analysis,* ~80% of patients in the LYNPARZA arm and ~70% of patients in the placebo arm were living without an IDFS event at 6 years^3†

LYNPARZA is the ONLY targeted adjuvant therapy to achieve OS benefit vs placebo specifically in patients with gBRCAm, HER2-negative, high-risk eBC^1,4-9

In an exploratory analysis,* ~88% of patients in the LYNPARZA arm and ~83% of patients in the placebo arm were alive at 6 years³