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Date: 2010-01-08
Phase: III
Anouncement: Launch
Biotech: Plexxikon (USA)
Pharma: Roche (Switzerland)
Product: PLX4032 (RG7204 - oral and highly targeted drug designed to inhibit the BRAF cancer-causing mutation) The product has been discovered by Plexxikon. It is co-developed under a 2006 license and collaboration agreement with Roche. In parallel, Plexxikon and Roche Molecular Systems are also co-developing a DNA-based companion diagnostic to identify patients whose tumors carry the BRAF mutation.
Disease: metastatic melanoma
Country: USA, Australia, Europe and Canada
Other: Enrollment has been initiated and the first patient has been dosed in a pivotal Phase 3 trial of PLX4032 (RG7204) in patients with metastatic melanoma. The randomized, controlled, Phase 3 “BRAFInhibitor in Melanoma” (BRIM3) trial in previously untreated patients is part of the planned registration program for PLX4032.
BRIM3 is a Phase 3 trial expected to enroll approximately 700 previously untreated melanoma patients who will be randomized one-to-one with PLX4032 at a dose of 960 mg BID or dacarbazine (DTIC). Patients will be monitored throughout the study for safety and efficacy endpoints.
The primary endpoint of this trial is overall survival. Secondary endpoints include duration of response, progression-free survival and best overall response rate (BORR).
This multicenter study is being conducted at approximately 100 sites, including sites in the United States, Australia, Europe and Canada, with sites continuing to open through Q2 2010.
A Phase 2 trial (BRIM2) in previously treated melanoma patients was initiated in September 2009, with enrollment ongoing. This trial expected to enroll approximately 100 patients and is a single-arm study in previously treated melanoma patients. This trial is enrolling patients at 13 sites in the U.S. and Australia.

Patients enrolling in both BRIM3 and BRIM2 are being selected using an investigational companion diagnostic test that detects the BRAF mutation. This diagnostic is being co-developed in parallel with PLX4032 by Roche Molecular Systems, Inc. and Plexxikon.

The initiation of the phase III trial has also triggered a milestone payment to Plexxikon from Roche, its co-development partner, under their 2006 collaboration agreement.