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BioMarin, Sarah Cannon Research UK Expand PARP Inhibitor Trial Outside US


NEW YORK (GenomeWeb) – Sarah Cannon Research UK is enrolling patients for BioMarin's Phase III EMBARCA trial investigating BMN 673 as a treatment for BRCA-mutation positive hereditary breast cancer.

In a statement, Sarah Cannon Research UK said it had enrolled the first patient in the EMBARCA study outside of the US, "expanding the trial internationally." The aim of the Phase III study is to evaluate the safety and efficacy of the PARP inhibitor BMN 673.

The EMBRACA trial launched in the US in the fall of 2013. BioMarin plans to enroll patients into the study from sites across the globe.

The 430-patient, open-label, randomized, parallel trial will compare BMN 673 against treatments of physicians' choosing. Study participants will have to have germline BRCA1/2 mutations and metastatic breast cancer for which they received no more than two chemotherapy treatments. Researchers will compare patients' progression-free survival, objective response rate, and overall survival with BMN 7673 against comparator treatments.

Patients with BRCA1/2 mutations have an impaired ability to repair DNA damage. BioMarin is using Myriad Genetics's BRACAnalysis test to identify best responders in the Phase III study.

However, clinical data suggests that patients with mutations in other genes involved in DNA repair may derive benefit from PARP inhibition. As such, BioMarin announced in November that it will also explore the use of Myriad's NGS-based Homologous Recombination Deficiency Test to try to identify best responders to BMN 673.

In addition to breast cancer, BMN 673 has also shown efficacy against ovarian cancer in BRCA mutated patients, as well as in small cell lung cancer patients.