Health-related quality of life impact of cobimetinib in combination with vemurafenib in patients with advanced or metastatic BRAFV600 mutation–positive melanoma

Abstract

Background: In the coBRIM study, cobimetinib plus vemurafenib (C þ V) significantly improved survival outcomes vs placebo and vemurafenib (P þ V) in patients with advanced/metastatic BRAFV600-mutated melanoma. An analysis of health-related quality of life (HRQOL) from coBRIM is reported. Methods: Patients completing the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (QLQ-C30) at baseline and X1 time point thereafter constituted the analysis population. Change from baseline X10 points was considered clinically meaningful. Results: Mean baseline scores for all QLQ-C30 domains were similar between arms. Most on-treatment scores for QLQ-C30 domains were also comparable between arms. A transient deterioration in role function in cycle 1 day 15 (C1D15; -14.7 points) in the Pþ V arm and improvement in insomnia in the Cþ V arm at C2D15 (-12.4 points) was observed. Among patients who experienced a X10-point change from baseline (responders), between-group differences were greatest for insomnia (16%), social functioning (10%), fatigue (9%) and pain (7%), all favouring C þ V. Diarrhoea, photosensitivity reaction, pyrexia, and rash did not meaningfully affect global health status (GHS). Serous retinopathy was associated with a transient decrease in GHS at C1D15 assessment. Conclusions: In patients with advanced/metastatic BRAFV600-mutated melanoma, treatment with C þ V maintained HRQOL compared with P þ V, with superior efficacy.