Results from the Phase III trial showed that AstraZeneca and MSD’s Lynparza demonstrated a statistically significant and clinically meaningful improvement in invasive disease-free survival versus placebo in the adjuvant treatment of patients with germline BRCA-mutated high-risk human epidermal growth factor receptor 2 (HER2)-negative early breast cancer.
“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,” says Dave Fredrickson, Executive Vice President, Oncology Business Unit, AstraZeneca.
In the overall trial population of patients who had completed local treatment and standard neoadjuvant or adjuvant chemotherapy, results showed Lynparza reduced the risk of invasive breast cancer recurrences, second cancers or death by 42% (based on a hazard ratio [HR] of 0.58; 99.5% confidence interval [CI] 0.41-0.82; p<0.0001). 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.
Lynparza also demonstrated a statistically significant and clinically meaningful improvement in the key secondary endpoint of distant disease-free survival (DDFS) in the overall trial population. Lynparza reduced the risk of distant disease recurrence or death by 43% (based on an HR of 0.57; 99.5% CI 0.39-0.83; p<0.0001). At the time of this initial data cut-off, fewer deaths had occurred in patients receiving Lynparza, but the difference in overall survival (OS) did not reach statistical significance. The trial will continue to assess OS as a secondary endpoint.
Lynparza is approved in the US, Japan, and a number of other countries for gBRCAm, HER2-negative, metastatic breast cancer previously treated with chemotherapy; in the EU, this includes locally advanced breast cancer.
Photo of Dave Fredrickson: AstraZeneca