Long-term efficacy and safety of sonidegib in patients with advanced basal cell carcinoma: 42-month analysis of the phase 2 randomised, double-blind BOLT study
British Journal of Dermatology Sep 30, 2019
Dummer R, Guminksi A, Gutzmer R, et al. - Since sonidegib is an approved hedgehog pathway inhibitor for the treatment of locally advanced basal cell carcinoma (laBCC) and metastatic BCC (mBCC) based on primary results of the BOLT (Basal Cell Carcinoma Outcomes with LDE225 [sonidegib] Treatment) study, researchers tested the long-term effectiveness and safety of sonidegib in advanced BCC patients (n = 230). For this investigation, they randomized adults without previous hedgehog pathway inhibitor therapy in a 1:2 ratio to sonidegib 200 mg or 800 mg once daily. Treatment persisted for up to 42 months or until progression of the disease, unacceptable toxicity, death, termination of the research, or withdrawal of consent. According to this 42-month analysis of the phase 2 randomised, double-blind BOLT study, sonidegib showed sustained effectiveness and a manageable safety profile. Final BOLT results support sonidegib as a feasible laBCC and mBCC treatment option. There have been no new safety concerns.
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