Melanoma drug shows promise

January 26, 2011

Genentech, maker of an investigational oral drug targeting a mutated BRAF kinase protein, says the drug boosted overall survival in patients with metastatic melanoma, though the extent to which this occurred was not disclosed, MedPage Today reports.

South San Francisco, Calif. - Genentech, maker of an investigational oral drug targeting a mutated BRAF kinase protein, says the drug boosted overall survival in patients with metastatic melanoma, though the extent to which this occurred was not disclosed, MedPage Today reports.

According to Genentech, based here, overall and progression-free survival were longer in patients receiving RG7204 than in those treated with dacarbazine, a drug commonly used to treat metastatic melanoma.

The RG7204 trial involved 675 patients who were selected for enrollment based on genomic testing for the so-called V600 mutation in BRAF. According to Genentech, the BRAF kinase protein is a component of the RAS-RAF pathway involved in normal cell growth and survival. Some mutations in the BRAF gene, such as V600, keep the pathway open, leading to proliferation of malignant cells.

Genentech parent company Hoffmann-La Roche says it plans to market the genomic test for the V600 mutation along with the drug as a companion diagnostic, if both win regulatory approval.

In the trial, RG7204 was administered orally twice daily until disease progression was seen or toxicity became unacceptable. Genentech officials say serious adverse effects were noted primarily in the skin and included cutaneous squamous cell carcinoma.

According to MedPage Today, Genentech has promised to present full data at an unspecified medical meeting later this year, and the company did not say whether or when it would seek regulatory approval.