Patients taking RG7204 lived longer and also lived longer without their disease getting worse compared to participants who received dacarbazine, the current standard of care.
Roche claims that RG7204 is a potential first-in-class medicine designed to selectively inhibit the mutated BRAF protein found in about half of all cases of metastatic melanoma, which is considered as the most aggressive and deadliest form of skin cancer.
BRAF protein is involved in sending signals in cells and cell growth and mutations in the BRAF gene could cause cancer.
For the first time, a personalized investigational medicine, RG7204, has shown a significant survival benefit in metastatic melanoma. This is an important advance for people with the BRAF V600 mutation-positive form of the disease who have had extremely limited treatment options, Hal Barron, Chief Medical Officer and Head, Global Product Development, said in a statement.
Roche is now working closely with global health authorities to expand the recently announced RG7204 Early Access Program (EAP). The global EAP will be extended to include people with previously untreated melanoma patients with the BRAF mutation.
RG7204, which is also known as PLX4032, is being co-developed under a 2006 license and collaboration deal between Genentech, Roche and Plexxikon. In March 2009, Genentech was fully acquired by Roche in $46.8 billion deal.
Full data of the study, which is named as BRIM3, will be presented at a medical meeting later this year, Roche said.
The BRIM3 study, which was started in the first quarter of 2010, was carried out at more than 100 sites worldwide including the United States, United Kingdom, France, Germany, Australia, New Zealand, Italy and Spain.
Melanoma is the most serious type of skin cancer and is growing at a rate of about five to six percent annually. A person with metastatic melanoma typically has a short life expectancy that is measured in months.
More than 70,000 people in the U.S. and 160,000 people worldwide are diagnosed with melanoma each year. It is one of the deadliest cancers, with a five-year survival rate of 15 percent for people with advanced (Stage IV) melanoma, according to the American Cancer Society.
Shares of Roche, based in Basel, Switzerland, were down 0.57 percent at 141.30 Swiss francs on Zurich Stock Exchange, while the ADR's of the company closed at $36.57 Tuesday.