Cotellic®/Zelboraf® Combo: New Standard of Care for Melanoma

Cotellic®/Zelboraf® Combo: New Standard of Care for Melanoma.

The treatment combination consisting of Cotellic® (cobimetinib) plus Zelboraf® (vemurafenib) improves overall survival for patients with advanced, BRAF (V600) mutation-positive melanoma. These confirmatory results have led to this treatment combination being considered as a new standard of care for patients with this disease. These results were recently published in the Lancet Oncology.

Melanoma is a type of skin cancer that typically starts in the form of a mole. It is the most deadly type of skin cancer, since the cancer cells spread aggressively to different sites in the body.

Historically, melanoma did not respond well to available therapies such as chemotherapy and radiation. However, with the rapid advancements of more targeted and immune-stimulating agents for treatment of cancer, overall outcomes for patients with melanoma continues to improve.

The BRAF V600 kinase is a pathway in cells that is active in cellular replication and spread. BRAF V600 mutations (either V600K or V600E) result in unchecked cellular replication and spread, resulting in the growth of cancer cells.

Both Cotellic and Zelboraf block different cellular mechanisms to disrupt the over activity of BRAF V600 mutations. Zelboraf is already FDA approved as a single agent for the treatment of advanced or unresectable (not able to be surgically removed) melanoma that has a BRAF V600 mutation, and Cotellic is approved for the same indication, with the exception that it has to be used in combination with Zelboraf.

Researchers recently conducted a clinical trial to directly compare the effectiveness of the combination of Cotellic/Zelboraf to placebo (inactive substitute)/Zelboraf in 495 patients with advanced melanoma that is BRAF V600 mutation-positive.

  • Median progression-free survival was 12.3 months for patients treated with Cotellic/Zelboraf, compared to only 7.2 months for those treated with placebo/Zelboraf.
  • Medial overall survival was 22.2 months for patients treated with Cotellic/Zelboraf, compared to only 17.4 months for those treated with placebo/Zelboraf.
  • No unexpected side effects were observed in the group of patients treated with Cotellic/Zelboraf.

The researchers concluded that “These data confirm the clinical benefit of [Cotellic] combined with [Zelboraf] and support the use of the combination as a standard first-line approach to improve survival in patients with advanced BRAFV600-mutant melanoma.”

Reference: Ascierto P, McArthur G, Dreno B, et al. Cobimetinib combined with vemurafenib in advanced BRAF V600-mutant melanoma (coBRIM): updated efficacy results from a randomised, double-blind, phase 3 trial. The Lancet Oncology. 2016;17 (9): 1248-1260.

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