Plexxikon Inc. today 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 patients lived 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. “As a novel, first-in class, personalized medicine, together with its companion diagnostic, PLX4032 sets the stage for a strong foundation for Plexxikon’s commercial franchise in oncology. PLX4032, first tested in patients in 2006, demonstrates the potential to accelerate development when appropriate patients can be selected with a diagnostic and treated with a targeted medicine.”
Recently, Plexxikon announced its agreement to co-promote PLX4032 in the U.S. with Genentech, and is planning to begin building its commercial organization and sales force this year. PLX4032 is being co-developed with Roche, and now Genentech, a member of the Roche Group, under a 2006 license and collaboration agreement between Plexxikon and Roche. The companies plan to file for marketing approval with the health authorities in the U.S. and in Europe for PLX4032, and for its companion diagnostic, in 2011.
Combination trials with PLX4032, as well as trials in other BRAF-mutated cancers, are also planned.
In other recent news, the U.S. Patent and Trademark Office issued Plexxikon’s U.S. Patent No. 7,863,288, covering composition-of-matter claims for PLX4032 and providing a patent term until 2029. The accelerated development of a personalized medicine such as PLX4032 not only provides patient access to new medicines more quickly, but also maximizes patent life, thereby contributing substantive value to the program. The new U.S. patent further broadens Plexxikon’s intellectual property portfolio.