Making some mayhem for melanoma

Drug from Roche and Daiichi Sankyo shows death reduction of 63 percent among advanced melanoma patients

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CHICAGO—With the annual meeting of the American Society of Clinical Oncology (ASCO) this month in Chicago as the backdrop, Swiss company Roche and Plexxicon, a subsidiary of Tokyo-based Daiichi Sankyo Co., announced results of a study showing that advanced melanoma patients treated with vemurafenib were 63 percent less likely to die than patients given chemotherapy. This announcement coincided, interestingly enough, with new data release at ASCO about Bristol-Myers Squibb Co.'s Yervoy, approved in March, with which vemurafenib will compete if and when it is approved.

Vemurafenib is designed for use in patients with tumors that exhibit BRAF gene mutation, a major selling point for the drug given that roughly half of all melanomas, which are the deadliest form of skin cancer, possess that genetic aberration. The impressive death reduction of 63 percent from the Phase III BRIM3 study also served as a way for Roche to tout its personalized healthcare abilities, as the study also employed the company's investigational companion diagnostic, the cobas 4800 BRAF V600 Mutation Test. Moreover, vemurafenib patients also had a 74 percent reduction in the risk of cancer progression compared to dacarbazine.

"We are greatly encouraged by the results of BRIM3, which showed that vemurafenib not only extended life and reduced the risk of disease worsening, but also led to significant tumor shrinkage, an important result for this devastating cancer," said Dr. Hal Barron chief medical officer and head of global product development at Roche. "We will continue to work closely with regulatory authorities to seek approval for vemurafenib and its companion diagnostic test to provide patients with BRAF-mutated metastatic melanoma a personalized option as soon as possible."

Vemurafenib has been granted priority review by the U.S. Food and Drug Administration (FDA). Roche recently announced the submission of new drug applications for vemurafenib in the United States and European Union. As Roche waits for what it expects to be regulatory approval of vemurafenib, a global "expanded access program" is available for people with previously treated or untreated BRAF V600 mutation-positive metastatic melanoma. Roche also is planning to initiate a global, multicentre Phase II study exploring the efficacy and safety profile of vemurafenib in people with BRAF V600 mutation-positive metastatic melanoma that has spread to the brain.

"We are very enthusiastic about the potential benefits seen with vemurafenib treatment in BRAF mutation‐positive melanoma patients," says K. Peter Hirth, Plexxikon's CEO. "The consistency and statistical significance of the data generated to date from BRIM3, BRIM2 and even seen early on in the Phase I trial, underscores the power of a personalized medicine approach for patients. Not only have we been able to detect an efficacy signal early on in the clinic, but we have been able to accelerate development of this molecularly targeted treatment, in combination with a companion diagnostic, ultimately for the benefit of patients."

"The data presented from studies conducted with vemurafenib treatment provide new hope to patients who currently have limited treatment options," adds Glenn Gormley, chief science officer of Daiichi Sankyo. "We remain committed to bringing innovative solutions, like vemurafenib, to patients by combining potent therapies with diagnostic tools to provide better outcomes."

Additional clinical trials will further evaluate vemurafenib in combination with other approved drugs and investigational agents targeting melanoma, and will also evaluate vemurafenib as a single agent in thyroid patients with the BRAF mutation.

Looking to the potential competition, which already has several months' head start with its March approval (Roche and Daiichi expect approval for their drug before year's end), Bristol Myers Squibb's Yervoy, or ipilimumb, was shown in a recent study to, in combination with dacarbazine, markedly improve survival in newly diagnosed metastatic melanoma patients.

Right now, the frontrunner in the market is predicted to be Yervoy, with many analysts thinking it may reach $1.5 billion in sales by 2015. But vemurafenib isn't expected to be a slouch either, with current predictions saying it may generate $796 million.

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