Plexxikon, Roche melanoma drug shows promise in trial

Data from a study showed the BRAF inhibitor RG7204 (PLX-4032), which was developed by 2010 Fierce 15 winner Plexxikon and being studied by Genentech ($DNA), 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. The data were presented at the seventh International Melanoma Research Congress of the Society for Melanoma Research in Sydney, Australia.

BRIM2 is a single-arm, multicenter, open-label Phase II study that enrolled 132 patients with previously treated BRAF V600E mutation-positive advanced melanoma. 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.

In the study, 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. And 82 percent of patients had either a response or stable disease, according to Genentech.

"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," explains Hal Barron, 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."

"This is not just encouraging--it's like never been seen before in melanoma," says Sondra Horning, senior VP and global head of hematology/oncology clinical development for Genentech, the San Francisco Business Times reports.

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