Novartis AG's Tafinlar combined with chemotherapy treatment trametinib was shown to double relapse-free survival in patients with late stage melanoma, results from the COMBI-AD trial presented at the European Society for Medical Oncology 2017 Congress in Madrid showed.
After an average follow-up of 2.8 years, data showed that the combination therapy reduced the risk of disease recurring by 53% in high-risk patients with skin cancer when administered following surgery, compared with placebo.
COMBI-AD is the first clinical trial of targeted therapies for the treatment of stage 3 melanoma after surgery.
"There is no standard of care for the adjuvant treatment of stage 3 melanoma," said Axel Hauschild, professor of dermatology at the University of Kiel in Germany and presenter of the trial at ESMO.
"These are the best results ever shown."
All of the 870 patients treated over a 12-month period had a BRAF mutation, and while 97% suffered side effects, around a quarter had to stop the combination treatment of Tafinlar, also known as dabrafenib, and trametinib, due to the severity of the side effects.
BRAF is a human gene, and its mutation can be found in some types of cancer, including melanoma and colorectal cancer. Checking for this BRAF mutation in tumor tissue may help to plan cancer treatment.
Trametinib is a chemotherapy made by GlaxoSmithKline plc and marketed as Mekinist.
Hauschild said the number of people stopping treatment was a little higher than in trials on stage IV melanoma, which he attributed to the fact that 90% of patients were treated for the full year. Still, no new toxicities were discovered and the treatment was well tolerated overall, he added.
"The improvements in progression-free survival and overall survival are both very significant, making this new treatment an attractive option for patients with BRAF mutations, who constitute about half of the melanoma population," commented Olivier Michielin, a doctor and head of Personalised Analytical Oncology in Lausanne, Switzerland.
At the same presentation, however, Roche Holding AG's Zelboraf, also known as vemurafenib, did not meet its target of disease-free survival for melanoma patients after surgery but was effective and well tolerated in those patients with BRAF-mutant melanoma. Data was from the Phase 3 BRIM8 study.
Roche's shares were down 1.20% from the previous close in early morning trade at 9:32 a.m. CEST on the news.
"While results in people with stage 3c melanoma were not what we had hoped, the reduction in the risk of recurrence in people with stage 2c-2b disease is encouraging and suggests Zelboraf may play a role in this earlier setting," said Sandra Horning, chief medical officer and head of global product development at Roche.