Characterization of Serous Retinopathy Associated with Cobimetinib: Integrated Safety Analysis of Four Studies

Giulio Barteselli, Grant R. Goodman, Yogesh Patel, Ivor Caro, Cloris Xue and Samuel McCallum ()
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Giulio Barteselli: Genentech, Inc. (a Member of the Roche Group)
Grant R. Goodman: Genentech, Inc. (a Member of the Roche Group)
Yogesh Patel: F. Hoffmann-La Roche Ltd
Ivor Caro: Genentech, Inc. (a Member of the Roche Group)
Cloris Xue: Hoffmann-La Roche Ltd
Samuel McCallum: Genentech, Inc. (a Member of the Roche Group)

Drug Safety, 2022, vol. 45, issue 12, No 5, 1499 pages

Abstract: Abstract Introduction and Objective Serous retinopathy can be associated with MEK inhibitors, including cobimetinib. We present results of an integrated safety analysis to further characterize ocular functional and structural changes due to serous retinopathy. Methods Four studies evaluating cobimetinib at the approved dose and schedule in combination with other oncology drugs were included. Study CO39721 incorporated standardized ophthalmologic assessments to fully characterize serous retinopathy events over time and was the primary study for analysis. Supporting information was provided by studies GO28141, WO29479, and GO30182. Results In total, 655 patients received one or more doses of cobimetinib and comprised the safety-evaluable population. Overall, 117 patients (17.9%) had one or more serous retinopathy events, 24 (3.7%) had two or more events, and four (0.6%) had three or more events. Grade 3 events occurred in

Date: 2022
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DOI: 10.1007/s40264-022-01248-2

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