Data from PLX4032 Phase 1 clinical trial in melanoma patients with BRAF mutation published

Plexxikon today announced publication of data from the Phase 1 clinical trial of PLX4032 (RG7204), confirming that treatment of metastatic melanoma patients with the BRAF ^V600E mutation resulted in significant tumor shrinkage in the majority of patients. Specifically, in the melanoma extension cohort of the study, nearly all patients showed some response; 81 percent of patients had tumor shrinkage of at least 30 percent. The data were published in the August 26, 2010 issue of the New England Journal of Medicine, based on an analysis as of January 31, 2010. These results further support the current PLX4032 development strategy, which includes parallel and ongoing Phase 2 (BRIM2) and Phase 3 (BRIM3) studies to support registration. PLX4032 is a novel, orally administered, targeted agent that is selective for a key oncogenic driver in melanoma and other cancers.

“This PLX4032 trial represents the first evidence that a treatment that targets activating BRAF mutations can induce significant tumor regressions in patients”

The data published in the New England Journal of Medicine focused on the Phase 1 dose-escalation trial of PLX4032 (RG7204), and a subsequent melanoma extension cohort at the established maximum tolerated dose (MTD). Primary objectives of the melanoma extension cohort were to establish further safety and pharmacokinetics (PK) data beyond the dose-escalation phase, as well as demonstrate proof-of-concept in the target patient population at the MTD of 960 mg twice daily.

Source Plexxikon