Combination of cobimetinib and vemurafenib can halt progression of metastatic melanoma for one year

Jun 2 2015

Cobimetinib and Zelboraf^® (vemurafenib) target MEK and BRAF cell signals respectively to prevent disease progression in most aggressive form of skin cancer

Data from the pivotal coBRIM Phase III study, presented by Lead Investigator Dr James Larkin today at the American Society of Clinical Oncology (ASCO) annual meeting, demonstrate that Roche’s investigational MEK inhibitor cobimetinib, used in combination with BRAF inhibitor vemurafenib, typically offers people with previously untreated advanced metastatic melanoma (BRAF^V600 mutation-positive unresectable or metastatic) one full year (median 12.3 months) without their disease worsening. These results show that experimental combination treatment with the oral, targeted therapies can halt disease progression longer than the current standard treatment with a BRAF inhibitor alone.

Dr James Larkin, Consultant Medical Oncologist at The Royal Marsden and Lead Investigator of the coBRIM study said:

The results of the coBRIM study reinforce that our continued attention and focus on this disease is providing the clinical advances we need to improve the quality of life and survival for people with melanoma across the UK. Targeting two parts of this cellular pathway, by adding cobimetinib in combination with vemurafenib, sees patients live on average for over a year without their disease progressing - an important advance in melanoma, a significantly life-limiting cancer.

The updated results from coBRIM also demonstrated higher response rates with cobimetinib and vemurafenib compared to vemurafenib alone, a current treatment option for patients with BRAF mutated melanoma. The objective response rate (ORR) with the combination was 70 per cent (16 per cent complete response [CR], 54 per cent partial response [PR]) compared to 50 per cent (11 per cent CR, 40 per cent PR) in the vemurafenib arm (p<0.0001). Importantly, complete response in some patients was not achieved until after more than one year of combination treatment. The safety profile of cobimetinib and vemurafenib was consistent with safety data previously reported. The most common adverse events in the combination arm were diarrhoea, rash, nausea, fever, sun sensitivity, liver laboratory abnormalities, elevated creatine phosphokinase (CPK, an enzyme released by muscles) and vomiting. Overall survival (OS) figures for the coBRIM study will be available later this year.

Another study presented today, follow-up data from the Phase Ib BRIM7 study, showed cobimetinib plus vemurafenib helped people who had not been previously treated with a BRAF inhibitor live a median of more than two years (28.5 months). In addition, extended follow-up showed 61 per cent of patients who had not been previously treated with a BRAF inhibitor were alive after two years. The safety profile was consistent with the previous analyses. The incidence of serous retinopathy, cardiomyopathy and skin squamous carcinoma were similar to those previously reported.

The European Medicines Agency is expected to make a decision on Roche’s marketing authorisation application for cobimetinib in combination with vemurafenib, for BRAF^V600 mutation-positive unresectable or metastatic melanoma, before the end of 2015. A new drug application for cobimetinib was granted priority review by the US Food and Drug Administration and a decision is expected in August 2015.

Source: https://www.roche.co.uk/