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11/5/2010 6:27:09 AM
SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)-- Genentech, Inc., a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), today 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.
“We are pleased by the RG7204 study results in advanced melanoma, one of the top causes of cancer deaths in young adults,” said Dr. Sosman. “We now have additional data that confirm promising clinical activity in previously treated patients with BRAF V600E mutation-positive metastatic melanoma.”
“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," explained Hal Barron, M.D., Head of Global Product Development and chief medical officer. "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.
BRIM2 is a single-arm, multi-center, open-label Phase II study that enrolled 132 patients with previously treated BRAF V600E mutation-positive advanced melanoma. Mutation status was determined by the cobas® 4800 BRAF V600 Mutation Test, a Roche Molecular Diagnostics companion diagnostic assay being co-developed with RG7204. Study participants received RG7204 twice daily until disease progression. The primary endpoint of the study was overall response rate as assessed by an independent review committee. Secondary endpoints of the study included duration of response, PFS, and overall survival. Of the 132 patients who received RG7204, results showed:
* 52 percent of patients had tumors decrease in size by 30 percent or more for at least two consecutive scans as assessed by an independent review committee.
* 82 percent of patients had either a response or stable disease (52 percent responders plus 30 percent stable disease)
* People who participated in the trial lived a median of 6.2 months without their disease getting worse (median PFS).
* Median duration of response was 6.8 months.
* Median overall survival has not yet been reached.
* The safety profile was generally consistent with previous RG7204 clinical studies. In the study, the most severe (Grade 3 or greater) adverse events were abnormal liver function (14 percent), joint pain/arthritis (11 percent) and gastrointestinal (dysphagia/pancreatitis) (10 percent). The most common adverse events were rash, photosensitivity, hair loss, and joint pain.
* Also reported was Grade 3 cutaneous squamous cell carcinoma (cSCC), a type of skin cancer in 26 percent (34/132) percent of patients. In cases of cSCC, the lesions were excised and the patients continued with treatment. The incidence of cSCC was consistent with that observed in a previous study of RG7204.
About Advanced Melanoma and BRAF
Advanced melanoma is the deadliest and most aggressive form of skin cancer. According to the American Cancer Society (ACS), approximately 15 percent of people with advanced melanoma (stage IV) will live for five years. The ACS estimates there are almost 70,000 new cases of melanoma and more than 8,000 melanoma deaths in 2010 in the United States.
The BRAF protein is a key component of the RAS-RAF pathway involved in normal cell growth and survival. Activating mutations in the BRAF gene cause this pathway to be overactive, which may lead to excessive growth and cancer. Mutations in the BRAF V600 protein are found in about 50 percent of melanomas and it is estimated that approximately eight percent of all solid tumors contain BRAF V600 mutations.
RG7204 is an investigational, oral, small molecule that is designed to selectively inhibit a cancer-causing mutated form of the BRAF protein. RG7204 is being co-developed under a 2006 license and collaboration agreement between Roche and Plexxikon. A polymerase chain reaction-based companion diagnostic, the cobas 4800 BRAF V600 Mutation Test, is being co-developed by Roche Molecular Diagnostics and Plexxikon in parallel to identify people whose tumors carry the BRAF V600E mutation.
A Phase III study (BRIM3) of RG7204 in previously untreated metastatic melanoma patients whose tumors test positive for the BRAF V600E mutation by the companion diagnostic test is currently ongoing. Additional information about the clinical trials is available at firstname.lastname@example.org, by visiting http://www.clinicaltrials.gov, or by contacting the Genentech clinical trial call center at 888-662-6728.
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.
The Society for Melanoma Research (SMR2010) is the most comprehensive melanoma conference of the decade. The combination of 4 independently structured and integrated meetings has allowed the evolution of concise programs, each oriented to a specific audience, providing great opportunities for cross specialty exchange of knowledge and ideas.
The overall Congress theme is ‘Pathways to Treatment’, which encompasses the ongoing translation of our basic knowledge of the cellular pathways underlying melanoma development to the design of new molecular therapies to treat this disease. A broad interdisciplinary program highlights cutting edge developments in primary and secondary prevention of melanoma.