Plexxikon updates Zelboraf Phase 1 data on BRAF V600E mutation-positive melanoma

Published on November 8, 2012 at 11:39 PM · No Comments

Plexxikon today announced that updated Phase 1 clinical data of Zelboraf® (vemurafenib) were presented at the Society for Melanoma Research (SMR) 2012 Congress, held November 8-11 in Los Angeles, CA. These data represent the longest follow-up of any cohort of patients treated with any BRAF inhibitor. The data show that 26 percent of patients were alive at three years suggesting that long-term survival with Zelboraf can be achieved in a subset of metastatic melanoma patients with the BRAF V600E mutation.

The Phase 1 extension study, which was conducted by Plexxikon and Plexxikon's partner Roche, included 32 patients with BRAF V600E mutation-positive melanoma. As of July 17, 2012, the date of the analysis, the data showed:

• Long-term overall survival:

55% of patients were alive at 1 year
36% of patients were alive at 2 years
26% of patients were alive at 3 years

• Progression-free survival (PFS) benefit:

Median PFS of 7.7 months

Five patients remain on vemurafenib to date, three of whom continue to have complete responses with no evidence of disease and one of whom continues to have a partial response.

Data also suggest a potential benefit of vemurafenib's use in conjunction with post-progression surgery, as well as continued drug administration in some patients with isolated melanoma metastases. Fourteen of the 32 patients received vemurafenib post-progression.

The most common drug-related adverse events in this Phase 1 study were joint pain, rash, nausea, sun sensitivity, fatigue, cutaneous squamous cell carcinoma, itching and hand-foot syndrome.

"Plexxikon is pleased to report the results from this study, which demonstrate that long term survival was achieved in a subset of patients," said K. Peter Hirth, Ph.D., chief executive officer of Plexxikon. "Since initiating the first clinical trial in 2006, our primary goal has been to provide a new treatment option for metastatic melanoma patients with the BRAF V600E mutation who historically have had very limited treatment options."

Other Zelboraf Clinical Trial Results Continue to Mature

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