AstraZeneca and MSD's Lynparza (olaparib) has shown efficacy in preventing cancer recurrence in patients with germline BRCA-mutated (gBRCAm) high-risk human epidermal growth factor receptor 2 (HER2)-negative early breast cancer.

According to results from the OlympiA Phase III trial, published in The New England Journal of Medicine and in line for presentation at the 2021 American Society of Clinical Oncology (ASCO) Annual Meeting on June 6, the drug demonstrated a statistically significant and clinically meaningful improvement in invasive disease-free survival (iDFS) versus placebo in the adjuvant treatment setting.

In the overall trial population of patients who had completed local treatment and standard neoadjuvant or adjuvant chemotherapy, data showed Lynparza cut the risk of invasive breast cancer recurrences, second cancers or death by 42%.

At three years, 85.9% of patients treated with Lynparza remained alive and free of invasive breast cancer and second cancers versus 77.1% on placebo.

“While there have been great strides in the early treatment of breast cancer, the fear of cancer returning is still at the forefront of patients’ minds,” commented Sue Friedman, executive director, Facing Our Risk of Cancer Empowered (FORCE) and member of the OlympiA trial steering committee. “New targeted treatment approaches are needed in the adjuvant setting that can help keep cancer and that fear at bay.”

Dave Fredrickson, executive vice president, Oncology Business Unit, at AZ, said: “This is the first time that any medicine targeting a BRCA mutation has demonstrated the potential to change the course of early-stage breast cancer and offer hope for a cure. By providing a treatment which significantly reduces the risk of breast cancer returning in these high-risk patients, we hope Lynparza will set a new benchmark demonstrating sustained clinical benefit.

“We are working with regulatory authorities to bring Lynparza to these patients as quickly as possible.”

Roy Baynes, senior vice president and head of Global Clinical Development, chief medical officer, MSD Research Laboratories, also noted that the data “support the importance of testing at diagnosis for BRCA1/2 mutations, which are actionable biomarkers that can help identify patients with early breast cancer who may be eligible for adjuvant treatment with Lynparza.”

An estimated 2.3 million people were diagnosed with breast cancer worldwide in 2020 and BRCA mutations are found in approximately 5% of breast cancer patients.