Late-stage trial data showed that Roche's skin cancer drug, RG7204, helps patients with BRAF V600 mutation-positive metastatic Melanoma survive for longer without their cancer progressing. The company said the Phase III clinical study met its co-primary endpoing, showing "a significant survival benefit in people with previously untreated BRAF V600 mutation-positive metastatic melanoma."
Participants were given either RG7204 960 mg orally twice daily, or dacarbazine (the current standard of care) 1000 mg/m2 intravenously every 3 weeks. Those on RG7204 not only had better overall survival (lived longer), but progression-free survival was also superior. Progression-free survival means living longer without the illness getting worse.
Participants received these therapies until either their disease progressed or toxicity levels became unacceptable. They were treated in over 100 sites around the world, including the USA, Spain, UK, Italy, New Zealand, Australia, France and Germany.
Roche believes RG7204 will become a first-in-class medication which was created to selectively inhibit the BRAF protein. This protein exists in approximately half of all metastatic melanoma cases, the most aggressive and fatal type of skin cancer. The company added that its safety profile was consistent with other studies of the same medication.
Hal Barron M.D., Chief Medical Officer and Head, Global Product Development, Roche, said:
"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."
Patients on the current standard therapy - dacarbazine - will be given the choice to switch over to RG7204.
In a communiqué, Roche informed:
"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, BRAF V600 mutation-positive metastatic melanoma (first line)."
RG7204 is being developed alongside the cobas 4800 BRAF V600 Mutation Test, an investigational diagnostic test, to pick out individuals whose cancers carry the BRAF V600 gene.
Patients with metastatic melanoma usually have a life expectancy which is measured in months, wrote Roche. It is the deadliest and most aggressive form of skin cancer. The majority of individuals do not survive more than a year after diagnosis. Metastatic melanoma is thought to cause 40,000 deaths annually worldwide. Experts believe the number of people with this type of cancer will double over the next ten years in developed nations to 227,000 new cases, from the current 138,000.
Written by Christian Nordqvist