WEEKLY IMPORTANT NEWS FROM MEDSCAPE AND OTHER SOURCES
Δευτέρα, 27 Φεβρουαρίου 2017
OLAPARIB FOR BRCA+ BREAST CANCER
On February 17, positive results were announced from the phase III OlympiAD trial comparing olaparib (Lynparza) tablets to physician’s choice of a standard-of-care chemotherapy in the treatment of patients with HER2-negative metastatic breast cancer harboring germline BRCA1 or BRCA2 mutations. Patients treated with olaparib showed a statistically significant and clinically meaningful improvement in progression-free survival compared with those who received chemotherapy (capecitabine, vinorelbine, or eribulin [Halaven]).
Sean Bohen, Executive Vice President, Global Medicines Development and Chief Medical Officer at AstraZeneca, said, “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 [poly ADP ribose polymerase (PARP)] inhibitor beyond ovarian cancer.”
Initial findings from the OlympiAD study indicate that the safety profile of olaparib was consistent with previous studies.
A full evaluation of the OlympiAD data is ongoing, and the results will be submitted for presentation at a forthcoming medical meeting.
OlympiAD is a randomized, multicenter phase III trial assessing the efficacy and safety of olaparib (300 mg twice daily) to “physician’s choice” chemotherapy (capecitabine, vinorelbine, or eribulin) in 302 patients with HER2-negative metastatic breast cancer with germline BRCA1 or BRCA2 mutations, which are predicted or suspected to be deleterious.
The international study was conducted in 19 countries from across Europe, Asia, North America, and South America.
The primary endpoint of the trial was progression-free survival, as measured by a blinded independent central review. Secondary endpoints included overall survival, time to second progression or death, objective response rate, and effect on health-related quality of life.
Olaparib tablets are an investigational formulation and are not approved by the U.S. Food and Drug Administration (FDA) for any use.
Olaparib capsules (400 mg twice daily) are currently approved in the United States as a monotherapy in patients with deleterious or suspected deleterious germline BRCA-mutated (as detected by an FDA-approved test) advanced ovarian cancer who have been treated with three or more prior lines of chemotherapy. The indication is approved under accelerated approval based on objective response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.