Lynparza Demonstrates 42% Reduction in Breast Cancer Recurrence Risk in Phase III OlympiA Trial

Today, AstraZeneca and MSD jointly announced that olaparib (brand name Lynparza), a PARP inhibitor co-developed by the two companies, achieved positive results in a Phase 3 clinical trial for the treatment of high-risk, HER2-negative early breast cancer with germline BRCA mutations (gBRCAm). Olaparib reduced the risk of disease recurrence, new primary tumors, or death by 42% (HR=0.58; 99.5% CI: 0.41–0.82; p<0.0001).

The Phase III OlympiA clinical trial is a double-blind, placebo-controlled, multicenter trial. Patients with high-risk HER2-negative early breast cancer harboring germline BRCA mutations (gBRCAm) were randomized to receive olaparib or placebo after completing local therapy and neoadjuvant or adjuvant chemotherapy. The primary endpoint of the trial was invasive disease-free survival (iDFS), defined as the time from randomization to the first occurrence of locoregional or distant disease recurrence, a new primary cancer, or death.

The trial results showed that after 3 years of treatment, 85.9% of patients in the olaparib group remained free of cancer recurrence or new primary cancers, compared with 77.1% in the control group. Olaparib also met the key secondary endpoint of distant disease-free survival (DDFS), reducing the risk of distant disease recurrence or death by 43%.

▲ Efficacy results of olaparib in the Phase 3 OlympiA clinical trial (Image source: Reference [1])

In 2020, approximately 2.3 million women worldwide were diagnosed with breast cancer. BRCA mutations are found in approximately 5% of breast cancer patients. Between 55% and 65% of women with a BRCA1 gene mutation, and 45% of those with a BRCA2 gene mutation, will develop breast cancer by the age of 70. Given that 90% of breast cancer patients are still at an early disease stage upon diagnosis, preventing disease recurrence following early surgical treatment is critically important.

Note: The original text has been abridged.

References:

[1] Lynparza reduced the risk of cancer recurrence by 42% in the adjuvant treatment of patients with germline BRCA-mutated high-risk early breast cancer in OlympiA Phase III trial. Retrieved June 3, 2021, from https://www.astrazeneca.com/content/astraz/media-centre/press-releases/2021/lynparza-reduced-the-risk-of-cancer-recurrence-by-42-in-the-adjuvant-treatment-of-patients-with-germline-brca-mutated-high-risk-early-breast-cancer-in-olympia-phase-iii-trial.html

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