BioMarin Pharmaceutical Inc. has dosed the first patient in its phase III programme to evaluate BMN 673, its poly ADP-ribose polymerase (PARP) inhibitor, in the treatment of metastatic germline BRCA mutated breast cancer.
"It has been very exciting to work with this novel molecule in the preclinical laboratory where we saw it to be best in class. It is equally exciting to now be involved in the clinical translation of this drug in this genetically defined population of breast cancer patients who may benefit from a treatment option specifically designed for them," said Dennis Slamon, Ph.D., M.D., chief, Division Hematology/Oncology and director of Clinical/Translational Research, Jonsson Comprehensive Cancer Centre, David Geffen School of Medicine at the University of California, Los Angeles. "Oncology therapy is moving towards a personalized and targeted model with the goal of establishing more effective treatments based on an individual's genetic profile, and BMN 673 could be an important step toward tailoring cancer treatments by tumor type."
"Enrolling the first patient is an important milestone in the clinical trial process. We are excited to be part of a trial that not only offers the potential to eliminate the use of chemotherapy, but also the possibility of improving the length and quality of life for patients already diagnosed with hereditary breast cancer," said Fran Visco, president of the National Breast Cancer Coalition.
The phase III study is an open-label, randomized, parallel, two-arm, multi-center study of BMN 673 versus physician's choice in approximately 430 germline BRCA mutation patients with locally advanced and/or metastatic breast cancer, who have received no more than two prior chemotherapy regimens for metastatic disease. The primary objective of the study is to measure progression free survival (PFS). Secondary objectives include evaluating the objective response rate (ORR) and the overall survival (OS).
"We are eager to fully enroll this important trial for breast cancer patients with hereditary breast cancer to better understand the role of BMN 673 in this defined population," said Hank Fuchs, MD, chief medical officer of BioMarin. "We are looking forward to gaining a better understanding of the safety and efficacy of our compound."
BRCA1 and BRCA2 are human genes that belong to a class of genes known as tumour suppressors. Mutation of these genes has been linked to hereditary breast and ovarian cancer. A woman's risk of developing breast and/or ovarian cancer is greatly increased if she inherits a deleterious (harmful) BRCA1 or BRCA2 mutation. Men with these mutations also have an increased risk of breast cancer. Both men and women who have harmful BRCA1 or BRCA2 mutations may also be at increased risk of other cancers.
BioMarin develops and commercializes innovative biopharmaceuticals for serious diseases and medical conditions.