The phase 3 OLYMPIAD clinical trial met its primary endpoint of progression-free survival in breast cancer.
AstraZeneca recently announced that Lynparza (olaparib) performed well in a phase 3 clinical trial of BRCA-mutated HER2-negative metastatic breast cancer. This is the first study to investigate the safety and efficacy of a PARP inhibitor in other cancer types than ovarian.
The investigators found that patients treated with Lynparza had statistically significant and clinically meaningful improvements in progression-free survival, compared with those treated with chemotherapy, according to a press release.
In the study, 302 patients with HER2-negative breast cancer with BRCA 1/2 mutations were randomized to receive treatment with Lynparza 300-mg twice per day or the physician’s choice of chemotherapy, which included capecitabine, vinorelbine, or eribulin.
The primary endpoint of the clinical trial was progression-free survival, as assessed by independent reviewers. Secondary endpoints included overall survival, time to progression or death, objective response rate, and health-related quality of life, AstraZeneca reported.
While the full evaluation of data from the OLYMPIAD study is ongoing, the preliminary results have been positive. Thus far, their findings indicate that the safety profile of the drug was consistent with previously conducted studies.
Lynparza is an oral poly ADP-ribose polymerase inhibitor that may selectively kill cancer cells through exploiting the tumor DNA damage response pathway, according to the press release.
The drug was previously approved in the European Union as a monotherapy for maintenance treatment of patients with replaced BRCA-mutated epithelial ovarian, fallopian tube, or primary peritoneal cancer.
In the United States, Lynparza received FDA approval for the treatment of patients with deleterious or suspected deleterious germline BRCA-mutated advanced ovarian cancer administered 3 or more lines of chemotherapy, according to AstraZeneca.
Lynparza is being explored in another phase 3 clinical trial for the treatment of patients with non-metastatic breast cancer.
“These results are positive news for patients with BRCA-mutated metastatic breast cancer, a disease with a high unmet need, and are the first positive Phase III data for a PARP inhibitor beyond ovarian cancer,” said Sean Bohen, executive vice president, Global Medicines Development and chief medical officer at AstraZeneca. “This is highly encouraging for the development of our broad portfolio which aims to treat multiple cancers by targeting DNA damage response pathways.”