Roche has announced data for the phase III BRIM8 study, which was designed to investigate the efficacy and safety of Zelboraf (vemurafenib) in the adjuvant (after surgery) treatment of people with completely resected, BRAF V600 mutation-positive melanoma. The study assessed two cohorts; stage IIC-IIIB (cohort 1) and stage IIIC (cohort 2) melanoma patients. The study did not meet its primary endpoint of significantly reducing the risk of recurrence (disease-free survival; DFS) in patients with stage IIIC melanoma (cohort 2); however, a 46% reduction in recurrence risk was observed in stage IIC-IIIB patients (cohort 1). The safety profile was consistent with that seen in previous studies of Zelboraf in advanced melanoma.
People in cohort 2 had a median DFS of 23.1 months with Zelboraf vs. 15.4 months with placebo (HR=0.80; 95% CI 0.54-1.18, p=0.2598). For people in cohort 1, median DFS was not reached with Zelboraf compared with median DFS of 36.9 months with placebo, (HR=0.54; 95% CI 0.37-0.79). Due to the pre-specified statistical design of the study, the results for cohort 1 cannot be formally tested for significance.
“While results in people with stage IIIC melanoma were not what we had hoped, the reduction in the risk of recurrence in people with stage IIC-IIIB disease is encouraging and suggests Zelboraf may play a role in this earlier setting,” said Sandra Horning, MD, Roche’s chief medical officer and head of Global Product Development.