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Genentech announced the result of Phase II clinical trail of RG7204

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Genentech, Inc., a member of the Roche Group announced results from a Phase II clinical study of RG7204 (PLX4032), an investigational first-in-class molecule designed to selectively inhibit a cancer-causing, mutated form of the BRAF protein found in approximately half of metastatic melanoma tumors.

The open-label study, known as BRIM2, showed that the BRAF inhibitor RG7204 shrank tumors in more than half of people with previously treated BRAF V600E mutation-positive metastatic melanoma. People who participated in the trial lived a median of 6.2 months without their disease getting worse (median progression-free survival or PFS). Typically, progression-free survival for these patients is approximately two months and median overall survival is six to nine months.

The data were presented at the seventh International Melanoma Research Congress of the Society for Melanoma Research in Sydney, Australia by Jeffrey Sosman, M.D. on Friday, November 5, 9:00 a.m. AEDT.

Dr. Sosman said, We are pleased by the RG7204 study results in advanced melanoma, one of the top causes of cancer deaths in young adults. We now have additional data that confirm promising clinical activity in previously treated patients with BRAF V600E mutation-positive metastatic melanoma.

Hal Barron, M.D., Head of Global Product Development and chief medical officer said, We are very encouraged by these data and based on the Phase II findings we are working to open an expanded access program. This would make RG7204 available to people with BRAF-mutation positive advanced melanoma who have had at least one prior medicine. People with advanced melanoma urgently need more options for treatment and we will continue to work with global health authorities to gather the necessary data to bring this medicine to people with this type of cancer.

RG7204 exemplifies Genentech's personalized healthcare approach using biomarkers and diagnostic tools to identify the right medicine for the right patient. RG7204 is being co-developed with a diagnostic test from Roche Molecular Diagnostics to identify patients whose tumors carry the mutated BRAF gene and are therefore most appropriate for treatment.

About Genentech

Founded more than 30 years ago, Genentech is a leading biotechnology company that discovers, develops, manufactures and commercializes medicines to treat patients with serious or life-threatening medical conditions. The company, a member of the Roche Group, has headquarters in South San Francisco, California. For additional information about the company, please visit http://www.gene.com.

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