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Genentech’s Melanoma Drug Shows Promise

Genentech achieved positive results from a Phase II study of RG7204, an investigational molecule designed to selectively inhibit a cancer-causing, mutated form of the BRAF protein found in approximately half of metastatic melanoma tumors.

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By: Tim Wright

Editor-in-Chief, Contract Pharma

Genentech, Inc., a member of the Roche Group, achieved positive results from a Phase II 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, 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 had median progression-free survival of 6.2 months. Typically, progression-free survival for these patients is approximately two months and median overall survival is six to nine months.

“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 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.

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