OREANDA-NEWS. November 25, 2015. Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced data from the pivotal coBRIM study, which showed that Cotellic (cobimetinib) in combination with Zelboraf (vemurafenib) helped people with BRAF V600E and V600K mutation-positive unresectable or metastatic melanoma live significantly longer (overall survival; OS) than with Zelboraf alone.1 Cotellic plus Zelboraf reduced the risk of death by 30 percent compared to Zelboraf alone and helped people live a median of nearly two years (median OS 22.3 months vs. 17.4 months, hazard ratio [HR]=0.70, 95 percent CI: 0.55–0.90, p=0.005).1 Ongoing study monitoring did not identify any new safety signals. The final coBRIM OS results were presented during the 12th International Congress of the Society for Melanoma Research (SMR) held in San Francisco, California from 18 – 21 November.

“With about half of the people taking Cotellic and Zelboraf alive after two years, these data underscore the progress being made in cancer research towards better patient outcomes.” said Sandra Horning, M.D., Chief Medical Officer and Head of Global Product Development. “Five years ago, the survival rate for BRAF mutation-positive advanced melanoma was measured in months, and now we are measuring it in years.”

This final analysis of the OS data from coBRIM showed that with the combination of Cotellic and Zelboraf, 74.5 percent of people with BRAF V600 mutation-positive advanced melanoma in the study were alive at one year and 48.3 percent were alive at two years.

The data were presented in an oral session presentation by Dr. Victoria Atkinson, Medical Oncologist at Princess Alexandra Hospital, Queensland, Australia on 21 November.

The announcement follows the U.S. Food and Drug Administration (FDA) approval of Cotellic for the treatment of people with BRAF V600E or V600K mutation-positive unresectable or metastatic melanoma in combination with Zelboraf.  A decision from the European Commission is expected before the end of 2015. The final OS results are being submitted to both of these health authorities for consideration.

About the coBRIM study

CoBRIM is an international, randomised, double-blind, placebo-controlled Phase III study evaluating the safety and efficacy of 60 mg once daily of Cotellic plus 960 mg twice daily of Zelboraf compared to 960 mg twice daily of Zelboraf alone. In the study, 495 patients with BRAF V600 mutation-positive unresectable locally advanced or metastatic melanoma (detected by the cobas 4800 BRAF Mutation Test) and previously untreated for advanced disease were randomised to receive Zelboraf every day on a 28-day cycle plus either Cotellic or placebo on days 1-21. Treatment was continued until disease progression, unacceptable toxicity or withdrawal of consent. Investigator-assessed PFS is the primary endpoint. Secondary endpoints include PFS by independent review committee, objective response rate, overall survival, duration of response and other safety, pharmacokinetic and quality of life measures.2

About Cotellic plus Zelboraf

Cotellic and Zelboraf are prescription medicines used in combination to treat melanoma that has spread to other parts of the body or cannot be removed by surgery, and that has a certain type of abnormal “BRAF” gene. Found in approximately half of melanomas3, mutated BRAF causes abnormal signaling inside cancer cells leading to tumor growth4,5. Zelboraf is designed to inhibit some mutated forms of BRAF and Cotellic is designed to inhibit some forms of MEK6. Both BRAF and MEK are proteins in a cell signaling pathway that help control cell growth and survivals7. When used in combination, Cotellic and Zelboraf are thought to reduce cancer cell growth longer than with Zelboraf alone. A patient’s healthcare provider will perform a test to make sure Cotellic and Zelboraf are right for the patient. Cotellic and Zelboraf are not used to treat melanoma with a normal BRAF gene. It is not known if Cotellic and Zelboraf are safe and effective in children under 18 years of age.

Cotellic is also being investigated in combination with several investigational medicines, including an immunotherapy, in several tumour types such as non-small cell lung cancer and colorectal cancer. Cotellic was discovered by Exelixis Inc. and is being developed by Roche in collaboration with Exelixis.

About melanoma

Melanoma is less common, but more aggressive and deadlier than other forms of skin cancer.8,9  When melanoma is diagnosed early, it is generally a curable disease,10,11 but most people with advanced melanoma have a poor prognosis.8 More than 232,000 people worldwide are currently diagnosed with melanoma each year12 In recent years, there have been significant advances in treatment for metastatic melanoma and people with the disease have more options. However, it continues to be a serious health issue with a high unmet need and a steadily increasing incidence over the past 30 years.13

Roche in skin cancer

The Roche Group is the world’s leading provider of cancer care products, including anti-cancer treatments, supportive care products and diagnostics. In the area of skin cancer, Roche scientists have been studying treatments for nearly 20 years. More than 28,000 patients having been treated worldwide, bringing about medical breakthroughs and new standards of care that include Zelboraf and Erivedge, treatments for two of the most difficult-to-treat skin cancers, metastatic melanoma and basal cell carcinoma. Roche is continuing to study our skin cancer medicines as monotherapies and in combination with other investigational medicines, such as cancer immunotherapies, in several cancer types and diseases.