BioMarin Pharma announced an update on clinical studies of its poly ADP-ribose polymerase (PARP) inhibitor, a potential treatment for advanced and/or metastatic breast cancer. The ABRAZO Phase 2 trial has met the protocol-specified threshold for documented tumor reduction, which requires that that a minimum of five responses per cohort, of up to 35 patients, be observed in order to expand the study. Having met the minimum of five responses, study enrollment may double to 140 patients.
The ABRAZO study is the first study treating BRCA breast cancer patients with a PARP inhibitor monotherapy that has demonstrated activity in patients who are in a salvage setting, defined as having failed at least two prior chemotherapy regimens for metastatic disease.
“We are pleased to have met our protocol-specified criteria in the ABRAZO Phase 2 trial allowing us to expand enrollment and complete the study,” notes Hank Fuchs, M.D., Chief Medical Officer at BioMarin. “If successful, single agent efficacy in a salvage setting potentially could support registration, adoption and use by patients who have exhausted therapeutic options. We also are thrilled to have seen anti-tumor activity in patients previously treated with platinum regimens. This is an unprecedented finding in BRCA metastatic breast cancer, which may provide a further treatment option for these patients.”
For more information, visit the BioMarin website.