Genentech, a member of the Roche Group, has released results from an open-label BRIM2 Phase II clinical study evaluating RG7204 (PLX4032), which showed that the BRAF inhibitor RG7204 shrank tumors in more than half of people with previously treated BRAF V600E mutation-positive metastatic melanoma.
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In the trial, people participated lived a median of 6.2 months without their disease getting worse (median progression-free survival or PFS).
Almost 52% of patients in the trial had tumors decrease in size by 30% or more for at least two consecutive scans as assessed by an independent review committee and 82% of patients had either a response or stable disease (52 percent responders plus 30 percent stable disease)
The safety profile was generally consistent with previous RG7204 clinical studies.
Genentech Global Product Development head and chief medical officer Hal Barron said that they are very encouraged by these data and based on the Phase II findings they 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," Barron said.
"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."
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