Lynparza Tablets Show Promise for BRCA-Mutated Metastatic Breast Cancer

Compared with standard chemotherapy, Lynparza (olaparib; AstraZeneca) provided statistically significant improvement in progression-free survival of patients with HER2-negative metastatic breast cancer with germline BRCA1 or BRCA2 mutations, AstraZeneca recently announced.

The positive results stemmed from a phase 3 trial, which compared Lynparza 300-mg tablets twice daily with physician’s choice of a standard of care chemotherapy (, vinorelbine, or eribulin). 

Lynparza is an inhibitor of poly ADP-ribose polymerase (PARP) and is already approved for the treatment of certain patients with advanced ovarian cancer. In the randomized, multicenter, phase 3 OlympiAD trial involving 302 patients with BRCA-mutated metastatic breast cancer, Lynparza met its primary endpoint of clinically meaningful improvement in progression-free survival. The trial took place in 19 countries in Europe, Asia, North America, and South America. 

“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 3 data for a PARP inhibitor beyond ovarian cancer,” said Sean Bohen, executive vice president of 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.”

A complete evaluation of data from the company’s OlympiAD study is underway. Results are expected to be presented at an upcoming medical conference. Initial trial findings indicate a safety profile consistent with previous Lynparza studies, AstraZeneca reported.

Lynparza tablets are investigational and not approved by the US Food and Drug Administration (FDA) for any use. Lynparza capsules (400 mg twice daily), however, are approved for patients with deleterious or suspected deleterious germline BRCA-mutated (as detected by an FDA-approved test) advanced ovarian cancer treated with at least 3 prior lines of chemotherapy. 

The most common adverse reactions to Lynparza in clinical studies were nausea, fatigue, abdominal pain or discomfort, vomiting, pharyngitis, and upper respiratory tract infection. Common lab abnormalities included anemia, mean corpuscular volume elevation, and lymphopenia.

Lynparza is also being studied in a separate phase 3 trial called OlympiA. That investigation is focusing on patients with nonmetastatic
breast cancer. —Jolynn Tumolo