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Confirmed RECIST Response Rate of 50% in gBRCA Breast Cancer Patients Treated With 1mg/day Phase 3 Dose
Overall Benefit Response Rate With 1mg/day Phase 3 Dose of 86%
SAN RAFAEL, Calif., Sept. 29, 2013 (GLOBE NEWSWIRE) -- BioMarin Pharmaceutical Inc. (Nasdaq:BMRN) today announced an update on the ongoing Phase 1/2 study for its poly ADP-ribose polymerase (PARP) inhibitor, BMN 673, for the treatment of solid tumors. Dr. Ramesh Ramanathan, lead investigator of the study (Medical Director, Virginia G. Piper Cancer Center - Clinical Trials, Scottsdale Health Care, Scottsdale, AZ and Clinical Professor of Medicine, TGEN & College of Medicine, University of Arizona, Phoenix, AZ), presented the data at the Late Breaking Oral Session of the the 17th ECCO – 38th ESMO – 32nd ESTRO European Cancer Congress in Amsterdam, The Netherlands.
Data Presented Today
In the most currently available data presented today from the ongoing Phase 1/2 study, among 14 gBRCA breast cancer patients treated at the dose of 1mg/day selected for the Phase 3 study, the confirmed RECIST response rate was 50% (7 confirmed objective responses: 1 complete and 6 partial). In addition, there were 5 patients with stable disease lasting at least 24 weeks for an overall clinical benefit response rate at this dose of 86% (12/14). Responses presented in the oral presentation are all confirmed responses.
The median progression-free survival (PFS) has not yet been reached for the gBRCA breast cancer patients. It is anticipated that the median PFS will exceed 6 months in this heavily pre-treated patient population.
In the complete cohort of 18 gBRCA breast cancer patients, which included 6 patients from the dose escalation cohort at doses ranging from 900 µg to 1100 µg and 12 patients from the dose expansion cohort at a dose of 1.0 mg, the RECIST response rate was 44% or 8 of 18 patients with 1 complete and 7 partial responses. The clinical benefit rate was 72% or 13 of 18 patients with 5 patients having stable disease in excess of 24 weeks. Treatment is ongoing in 9 of the 18 breast cancer patients in the study.