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. Read more about the role of BRCA in cancer development here.

OlympiA study investigated LYNPARZA in gBRCA-mutated 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 gBRCA1/2-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<0.001; 9% difference LYNPARZA 86% vs. placebo 77%) and distant disease recurrence by 43% (0.57; 99.5% CI, 0.39 to 0.83; P<0.001; 8% difference LYNPARZA 88% vs. placebo 80%) compared with placebo, after a median 2.5 years of follow-up.^1,2
• 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=0.009) with a median follow-up of 3.5 years (Order a reprint of the original research here).^1,3

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, cough, dysgeusia, leukopenia, dizziness, dyspnea and dyspepsia.¹

Choose treatment based on BRCA testing

• The OlympiA study demonstrated that adjuvant LYNPARZA improves survival outcomes in HER-negative high-risk early BRCA-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

References

1. Lynparza summary of product characteristics, www.fass.se
2. Tutt ANJ, et al. N Engl J Med. 2021 Jun 24;384(25):2394-2405.
3. Geyer Jr CE, et al. Ann Oncol. 2022 Oct 10;S0923-7534(22)04165-5.