AstraZeneca (AZN.US) and Merck (MRK.US) announced long-term results from the Phase 3 OlympiA trial.
As of today, AstraZeneca (AZN.US) and Merck (MRK.US) have announced the long-term results of the phase 3 OlympiA clinical trial. The study showed that Lynparza (olaparib, olaparib) continued to significantly improve overall survival (OS), invasive disease-free survival (IDFS), and distant disease-free survival (DDFS) in patients with high-risk early breast cancer who are HER2-negative and carry germline BRCA mutations (gBRCAm).
At a median follow-up of 6.1 years, Lynparza reduced the risk of death by 28% compared to placebo (HR=0.72; 95% CI: 0.56-0.93) in patients who had completed local therapy and standard neoadjuvant or adjuvant chemotherapy. In addition, 87.5% of patients treated with Lynparza were still alive, compared to 83.2% in the placebo group.
Lynparza is a "first-in-class" PARP inhibitor and the first synthetic lethality targeted therapy, designed to target cells/tumors with homologous recombination repair (HRR) defects (such as cells with BRCA1 and/or BRCA2 mutations). Based on the results of the OlympiA phase 3 clinical trial, Lynparza has been approved in the US, EU, Japan, and many other countries for the treatment of gBRCAm, HER2-negative high-risk early breast cancer. In addition, it has been approved in the US, EU, Japan, and many other countries for the treatment of gBRCAm, HER2-negative metastatic breast cancer.