Journal article

Clinical features of serous retinopathy observed with cobimetinib in patients with BRAF-mutated melanoma treated in the randomized coBRIM study

Luis de la Cruz-Merino, Lorenza Di Guardo, Jean-Jacques Grob, Alfredo Venosa, James Larkin, Grant A McArthur, Antoni Ribas, Paolo A Ascierto, Jeffrey TR Evans, Antonio Gomez-Escobar, Giulio Barteselli, Susan Eng, Jessie J Hsu, Anne Uyei, Brigitte Dreno

JOURNAL OF TRANSLATIONAL MEDICINE | BMC | Published : 2017

Abstract

BACKGROUND: Serous chorioretinopathy has been associated with MEK inhibitors, including cobimetinib. We describe the clinical features of serous retinopathy observed with cobimetinib in patients with BRAF V600-mutated melanoma treated in the Phase III coBRIM study. METHODS: In the coBRIM study, 493 patients were treated in two randomly assigned treatment groups: cobimetinib and vemurafenib (n = 247) or vemurafenib (n = 246). All patients underwent prospective ophthalmic examinations at screening, at regular intervals during the study, and whenever ocular symptoms developed. Patients with serous retinopathy were identified in the study database using a group of relevant and synonymous adverse..

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University of Melbourne Researchers

Grants

Awarded by Larkin et al


Awarded by Cancer Research UK


Awarded by Versus Arthritis


Funding Acknowledgements

F. Hoffmann-La Roche/Genentech sponsored the study. The primary analysis of this study (NCT01689519) was previously published by Larkin et al. [6]. Authors and their research teams were involved in the collection of data. Representatives of the sponsor collated the data and confirmed the accuracy of the data and analysis. The analysis was performed in collaboration with the authors. All the authors had full access to the data and analyses presented in this report.