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

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 event terms.

Results

Eighty-six serous retinopathy events were repor

SUBMITTER: de la Cruz-Merino L 

PROVIDER: S-EPMC5483259 | biostudies-literature | 2017 Jun

REPOSITORIES: biostudies-literature