OlympiA Phase III trial of Lynparza shows improvement in OS in HER2- breast cancer.- AstraZeneca
Further positive results from the OlympiA Phase III trial showed Lynparza (olaparib), from AstraZeneca and MSD, demonstrated a statistically significant and clinically meaningful improvement in overall survival (OS) versus placebo in the adjuvant treatment of patients with germline BRCA-mutated (gBRCAm) high-risk human epidermal growth factor receptor 2 (HER2)-negative early breast cancer who had completed local treatment and standard neoadjuvant or adjuvant chemotherapy.
Further positive results from the OlympiA Phase III trial showed Lynparza (olaparib), from AstraZeneca and MSD, demonstrated a statistically significant and clinically meaningful improvement in overall survival (OS) versus placebo in the adjuvant treatment of patients with germline BRCA-mutated (gBRCAm) high-risk human epidermal growth factor receptor 2 (HER2)-negative early breast cancer who had completed local treatment and standard neoadjuvant or adjuvant chemotherapy.
In the key secondary endpoint of OS, Lynparza reduced the risk of death by 32% versus placebo (based on a HR of 0.68; 98.5% CI 0.47-0.97; p=0.009). Lynparza improved the three-year survival rate to 92.8% versus 89.1% for those on placebo.
At four years, the survival benefit was maintained with 89.8% of patients treated with Lynparza alive versus 86.4% of those on placebo. The safety and tolerability profile of Lynparza in this trial was in line with that observed in prior clinical trials. Primary results from the OlympiA Phase III trial were first presented during the 2021 American Society of Clinical Oncology Annual Meeting and are published in The New England Journal of Medicine.
The OS data and the primary results formed the basis for the recent approval by the FDA of Lynparza in this setting.
These results were presented at a European Society for Medical Oncology Virtual Plenary. The OlympiA trial is led by the Breast International Group (BIG) in partnership with the Frontier Science & Technology Research Foundation (FSTRF), NRG Oncology, AstraZeneca and MSD.
See- "Adjuvant Olaparib for Patients with BRCA1- or BRCA2-Mutated Breast Cancer":Andrew N.J. Tutt, M.B., Ch.B., Ph.D., Judy E. Garber, M.D., M.P.H., Bella Kaufman, M.D., et al., for the OlympiA Clinical Trial Steering Committee and Investigators: June 24, 2021. N Engl J Med 2021; 384:2394-2405 . DOI: 10.1056/NEJMoa2105215.
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