CHMP recommends EU approval for Roche's combination of Cotellic (cobimetinib) and Zelboraf (vemurafenib) in advanced melanoma

CHMP recommends EU approval for Roche's combination of Cotellic (cobimetinib) and Zelboraf (vemurafenib) in advanced melanoma

Basel, 25 September 2015

Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that the EU Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion for CotellicTM (cobimetinib), when used in combination with Zelboraf® (vemurafenib), for the treatment of BRAF V600 mutation-positive unresectable or metastatic melanoma. Approximately 50% of melanoma skin cancers are BRAF-positive, and more than 55,000 people worldwide die every year from melanoma.1

"Today's CHMP positive opinion is a substantial step forward for people with BRAF-positive skin cancer in Europe and around the world," said Sandra Horning, M.D., Chief Medical Officer and Global Head of Product Development. "The Cotellic and Zelboraf combination will provide physicians with a powerful therapeutic option that can help patients live significantly longer without their disease progressing compared to Zelboraf alone."

The CHMP's recommendation is based primarily on results of the pivotal Phase III coBRIM study. These data showed that people who received the combination of Cotellic and Zelboraf lived over a year without their disease worsening (median progression-free survival of 12.3 months, compared to 7.2 months with Zelboraf alone; hazard ratio=0.58, 95 percent confidence interval 0.46-0.72).2 The objective response rate was also higher for the combination arm compared to Zelboraf alone (70 vs. 50 percent; p<0.0001).2 The most common adverse events in the combination arm of the pivotal study were diarrhoea, rash, nausea, fever, sun sensitivity, liver lab abnormalities, elevated creatine phosphokinase (CPK, an enzyme released by muscles) and vomiting.

Supportive data early in development from the Phase Ib BRIM7 study indicated that the combination of Cotellic and Zelboraf helped people who had not been previously treated with a BRAF inhibitor live more than two years (median overall survival 28.5 months).3

Based on this CHMP recommendation, a final decision regarding the approval of the combination of Cotellic and Zelboraf is expected from the European Commission by the end of 2015.

Cotellic recently received approval in Switzerland for use in combination with Zelboraf as a treatment for patients with advanced melanoma, and the U.S. Food and Drug Administration (FDA) is expected to make a decision on Roche's new drug application for the combination before the end of the year.

About melanoma

Melanoma is less common, but more aggressive and deadlier than other forms of skin cancer.4,5 A V600 mutation of the BRAF protein occurs in approximately half of melanomas, and should therefore be tested to identify the best treatment option.6 When melanoma is diagnosed early, it is generally a curable disease,7,8 but most people with advanced melanoma have a poor prognosis.5 More than 232,000 people worldwide are currently diagnosed with melanoma each year.1 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.9

About Cotellic and Zelboraf in combination

Zelboraf was the first approved treatment for patients with unresectable or metastatic melanoma with BRAF V600 mutation as detected by a validated test, such as Roche's cobas 4800 BRAF Mutation Test. Zelboraf is not indicated for use in patients with wild-type BRAF melanoma. Cotellic (cobimetinib) is designed to selectively block the activity of MEK,10 one of a series of proteins inside cells that make up the MAPK signaling pathway that helps regulate cell division and survival.11 In the majority of patients, resistance to BRAF-inhibitor monotherapy will eventually occur through re-activation of the MAPK pathway via MEK.12 Cotellic was developed to overcome resistance to BRAF-inhibition and prevent re-activation of the pathway. Cotellic binds to MEK, while Zelboraf binds to mutant BRAF, to interrupt abnormal signalling that can cause tumours to grow.13,14

Cotellic is also being investigated in combination with several investigational medicines, including 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.

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, bringing about medical breakthroughs and setting new standards of care. Zelboraf and Erivedge, therapies for two of the most difficult-to-treat skin cancers, metastatic melanoma and basal cell carcinoma, have been used to treat more than 28,000 patients worldwide. Roche is continuing to study skin cancer medicines as monotherapies and in combination with other investigational medicines, such as cancer immunotherapies, in several cancer types and diseases.

About Roche

Headquartered in Basel, Switzerland, Roche is a leader in research-focused healthcare with combined strengths in pharmaceuticals and diagnostics. Roche is the world's largest biotech company, with truly differentiated medicines in oncology, immunology, infectious diseases, ophthalmology and neuroscience. Roche is also the world leader in in vitro diagnostics and tissue-based cancer diagnostics, and a frontrunner in diabetes management. Roche's personalised healthcare strategy aims at providing medicines and diagnostics that enable tangible improvements in the health, quality of life and survival of patients. Founded in 1896, Roche has been making important contributions to global health for more than a century. Twenty-nine medicines developed by Roche are included in the World Health Organization Model Lists of Essential Medicines, among them life-saving antibiotics, antimalarials and chemotherapy.

In 2014, the Roche Group employed 88,500 people worldwide, invested 8.9 billion Swiss francs in R&D and posted sales of 47.5 billion Swiss francs. Genentech, in the United States, is a wholly owned member of the Roche Group. Roche is the majority shareholder in Chugai Pharmaceutical, Japan. For more information, please visit

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Additional information

Roche in Oncology:

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