Plexxikon Inc. announced positive data from an interim analysis of the BRIM3 trial, a large multi-center Phase 3 clinical study of PLX4032 (RG7204) in patients with previously untreated metastatic melanoma with the BRAF mutation.
Patients treated with PLX4032 had an improved overall survival (OS) compared to patients treated with dacarbazine, the current standard of care.
In addition, these patientslived longer on average without their disease getting worse, as measured by progression-free survival (PFS). PLX4032 is an oral, novel kinase inhibitor that targets the oncogenic BRAF mutation.
The BRIM3 analysis showed that the study met the pre-specified criteria for co-primary endpoints of OS and PFS. The safety profile was generally consistent with the previous PLX4032 studies. Based on these results, patients on the dacarbazine arm of the study will have the option to crossover to receive PLX4032. Additionally, the Expanded Access Program also will now be opened to previously untreated melanoma patients with the BRAF mutation. Comprehensive clinical data from the BRIM3 trial are expected to be presented at a major medical meeting later this year.
“This positive effect on overall survival represents a significant development for melanoma patients,” said K. Peter Hirth, Ph.D., chief executive officer of Plexxikon.
Source: Plexxikon, USA