Roche Posts Positive Results For Two-Pill Combo In Melanoma
Roche’s subsidiary Genentech reported positive results from its Phase 3 trial investigating its combination treatment cobimetinib plus Zelboraf (vemurafenib) in patients with advanced melanoma.
Cobimetinib works to block the activity of the protein MEK — a member of a series of proteins inside cells that make up a signaling pathway that regulates cell division and survival. Zelboraf is an approved treatment indicated for unresectable or metastatic melanoma with BRAF V600 mutation, as verified by a valid test. Roche collaborated with Plexxikon, which now belongs to the Daiichi Sankyo Group, for the development of Zelboraf, and the company is currently working with Exelixis for the development of cobimetinib.
The combination works through cobimetinib’s binding to MEK while Zelboraf targets and binds to mutant BRAF, another protein in the series pathway. The combo therapy’s mechanism of action interrupts the abnormal signaling in cell division that can cause tumors to grow and survive.
The international, double blind, randomized, placebo-controlled Phase 3 study CoBRIM investigated the safety and efficacy of cobimetinib plus Zelboraf compared to Zelboraf alone. Results showed that the combination reduced the risk of disease progression or death by half. Those who took the combination treatment had significantly longer progression-free survival (PFS) of 9.9 months compared to 6.2 months with Zelboraf alone. The company reported that the safety profile of the combination treatment was consistent with a previous study of the combo therapy.
“We combined cobimetinib and Zelboraf in this study to better inhibit a major cancer growth pathway and hopefully improve clinical outcomes. The coBRIM results are exciting because they support the potential of the combination as a new treatment option for people with BRAF mutation-positive advanced melanoma,” said Sandra Horning, CMO and Head of Global Product Development. Roche said it has filed an EU marketing application for the combination therapy as treatment for BRAF V600 mutation-positive advanced melanoma.
The company said it will present results from the coBRIM study at the European Society of Medical Oncology (ESMO) 2014 Congress and will later publish them in the New England Journal of Medicine.
According to Reuters, Roche’s investigational combo therapy is set to compete for its share of the market with an already commercialized combination treatment from rival, GlaxoSmithKline. Due to the treatments’ high similarity, doctors will likely base their choice on the drugs’ side effect profiles. GSK’s Tafinlar is associated with a higher rate of fever while Roche’s Zelboraf is linked to photosensitivity, which can lead to sunburn.