Roche and Plexxikon's PLX4032 shows 81% response in metastatic melanoma patients in Ph I trial

Data from the Phase I clinical trial of PLX4032 (RG7204), has confirmed that treatment of metastatic melanoma patients with the BRAF V600E mutation resulted in significant tumor shrinkage in the majority of patients, says the drug's discoverer privately-held California, USA-based biotechnology firm Plexxikon.

The drug's development is partnered with Swiss drug major Roche (SIX: ROG.VX), which acquired exclusive worldwide rights in a $335 million deal early last year (The Pharma Letter January 19, 2009).

Specifically, in the melanoma extension cohort of the study, nearly all patients showed some response; 81% of subjects had tumor shrinkage of at least 30%. 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 II (BRIM2) and Phase III (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.