OlympiA

LYNPARZA (olaparib) is a PARP inhibitor, which provokes tumor cell death by inducing DNA double-strand breaks in the cells with homologous recombination deficiency caused e.g., by deleterious mutations in BRCA1 or BRCA2 genes^1,2

OlympiA study investigated LYNPARZA in BRCA-mutated HER2-negative early breast cancer

• The phase III OlympiA study investigated the efficacy of LYNPARZA versus placebo as adjuvant therapy in high-risk early breast cancer.
• A total of 1,836 patients with BRCA1/2-mutated HER2-negative early breast cancer and high-risk clinical features were included in the study.^1,2 The patients had received prior local treatment and neoadjuvant or adjuvant chemotherapy.
• The patients were randomized 1:1 for 1 year of treatment with oral LYNPARZA (300 mg twice daily) or placebo.^1,2
• The primary end-point was invasive disease-free survival and secondary endpoints included distant disease-free survival and overall survival.^1,2

OlympiA demonstrated significantly improved survival outcomes in patients treated with LYNPARZA versus placebo

• In the OlympiA study, adjuvant LYNPARZA reduced the risk of invasive disease recurrence by 42% (HR 0.58; 99.5% CI, 0.41 to 0.82; P=0.0000073; 9% difference LYNPARZA 86% vs. placebo 77%).¹

• A descriptive analysis showed that the IDFS benefit was sustained with ~1 year of additional median follow up (HR 0.63; 95% Cl, 0.50-0.78;7.3% difference LYNPARZA 82.7% vs. placebo 75.4%).³

• In the second pre-specified interim analysis, LYNPARZA was also shown to significantly improve the overall survival by reducing the risk of death by 32% (HR 0.68; 98.5% CI, 0.47–0.97; P=0.0091; 4% difference LYNPARZA 90% vs 86% vs. placebo) with a median follow-up of 3.5 years (Order a reprint of the original research here).¹

_{Kaplan-Meier estimate of overall survival (OS). The P value threshold for significance in this prespecified event-driven interim analysis was 0.015 (adapted from Geyer et al. 2022).}

Adverse events associated with LYNPARZA

• The adverse events associated with LYNPARZA in clinical trials are generally of mild or moderate severity (grade 1 or 2) and do not generally require treatment discontinuation.¹
• The most frequent adverse reactions in patients (≥ 10%) on LYNPARZA monotherapy include nausea, fatigue, anemia, vomiting, diarrhea, decreased appetite, headache, neutropenia, dysgeusia, cough, leukopenia, dizziness, dyspnea and dyspepsia.¹

Important safety information¹

• CONTRAINDICATIONS: Breast‑feeding during treatment and for 1 month after the last dose (see section 4.6).
• SPECIAL WARNINGS AND PRECAUTIONS FOR USE: Haematological toxicity: Baseline testing, followed by monthly monitoring, of complete blood counts is recommended for the first 12 months of treatment and periodically after this time to monitor for clinically significant changes in any parameter during treatment. Myelodysplastic syndrome/Acute myeloid leukaemia: If patient is diagnosed with MDS/AML is confirmed during Lynparza treatment, Lynparza should be discontinued and the patient treated appropriately. Venous Thromboembolic Events: Monitor patients for clinical signs and symptoms of venous thrombosis and pulmonary embolism and treat as medically appropriate. Pneumonitis: If patients present with new or worsening respiratory symptoms such as dyspnoea, cough and fever, or an abnormal chest radiologic finding is observed, Lynparza treatment should be interrupted and prompt investigation initiated. Hepatotoxicity: If clinical symptoms or signs suggestive of hepatotoxicity develop, prompt clinical evaluation of the patient and measurement of liver function tests should be performed. In case of suspected drug-induced liver injury (DILI), treatment should be interrupted.
• IMPORTANT INTERACTIONS: Lynparza co administration with strong or moderate CYP3A inhibitors is not recommended. If a strong or moderate CYP3A inhibitor must be co administered, the dose of Lynparza should be reduced (see sections 4.2 and 4.5 in SPC). See section 4.5 in SPC for more information on other types of interactions.

Choose treatment based on gBRCA testing

• The OlympiA study demonstrated that adjuvant LYNPARZA improves survival outcomes in HER-negative high-risk early gBRCA-mutated breast cancer.^1-3
• Approximately 5% of all breast cancer patients carry pathogenic or likely pathogenic germline BRCA1 or BRCA2 mutation.²
• Test patients for BRCA mutations at diagnosis to identify those who may benefit from treatment with adjuvant LYNPARZA.¹