The ovarian cancer drug Lynparza (olaparib) may be a promising treatment approach for patients with HER2-negative metastatic breast cancer who have BRCA1 and BRCA2 mutations, according to recent data from AstraZeneca‘s Phase 3 OlympiAD trial.
The trial revealed significant and clinically meaningful improvements in progression-free survival when patients received Lynparza compared to physician’s choice of standard of care chemotherapy.
“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. This is highly encouraging for the development of our broad portfolio which aims to treat multiple cancers by targeting DNA damage response pathways,” Sean Bohen, executive vice president, Global Medicines Development, and chief medical officer at AstraZeneca, said in a news release.
Currently, Lynparza capsules are approved in the U.S. as a monotherapy to treat patients with BRCA-mutated advanced ovarian cancer who have received three or more prior lines of therapy.
Now, AstraZeneca is evaluating the safety and effectiveness of Lynparza tablets — an investigational formulation not yet approved by the U.S. Food and Drug Administration for any use — for patients with advanced breast cancer who also harbor inherited BRCA mutations.
The randomized, open-label, multi-center OlympiAD study (NCT02000622) was designed to evaluate the safety and effectiveness of Lynparza as a monotherapy vs. physician’s choice of standard of care chemotherapy — Xeloda (capecitabine), Navelbine (vinorelbine), or Halaven (eribulin) — in up to 2,128 patients with HER2-negative BRCA-mutated metastatic breast cancer.
The study’s primary endpoint was progression-free survival, and secondary measures included overall survival, time to progression or death, and objective response rate, as well as quality of life and safety measures.
Results showed that patients treated with Lynparza showed a significant and clinically meaningful improvement in progression-free survival compared to those receiving chemotherapy. Researchers also reported an initial safety profile that was consistent with that seen in prior Lynparza studies.
The company is currently analyzing the full data from OlympiAD, which will be submitted for presentation at an upcoming medical meeting.
AstraZeneca will be working with regulatory authorities to obtain approval of Lynparza for patients with this type of breast cancer.