Long-term efficacy and safety of sonidegib in patients with advanced basal cell carcinoma: 42-month analysis of the phase II randomized, double-blind BOLT study
British Journal of Dermatology Dec 15, 2019
Dummer R, Guminksi A, Gutzmer R, et al. - In this 42-month analysis of phase II randomized, double-blind BOLT study, researchers tested the safety and effectiveness of sonidegib, a hedgehog pathway inhibitor approved for the treatment of locally advanced BCC (laBCC) and metastatic BCC (mBCC) based on primary outcomes of the BOLT study. For this investigation, they randomized adults with no prior hedgehog pathway inhibitor therapy in a 1 : 2 ratio to sonidegib 200 mg or 800 mg once daily. Participants in the study were 230 patients, with 79 randomized to sonidegib 200 mg and 151 randomized to sonidegib 800 mg. In the 200-mg group, the ORRs by central review were 56% for laBCC and 8% for mBCC and in the 800-mg group, were 46·1% for laBCC and 17% for mBCC. According to findings, sonidegib showed sustained effectiveness as well as a manageable safety profile. As a viable treatment option for laBCC and mBCC, the final BOLT results support sonidegib.
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