Long‐term efficacy and safety of sonidegib in patients with locally advanced and metastatic basal cell carcinoma: 30‐month analysis of the randomized phase 2 BOLT study

Long‐term efficacy and safety of sonidegib in patients with locally advanced and metastatic... IntroductionPatients with locally advanced basal cell carcinoma (laBCC) or metastatic BCC (mBCC) have historically had limited treatment options. Surgery, the primary course of treatment for most BCCs, and radiotherapy are often not viable options in advanced BCC. In recent years, hedgehog (Hh) pathway inhibitors (HPIs) were developed to block aberrant Hh signalling that is found in most sporadic BCCs; HPIs have demonstrated efficacy in patients with laBCC and those with mBCC.Sonidegib (LDE225), which inhibits Hh signalling by targeting the Hh pathway component smoothened, was approved (200 mg once daily) in the United States and Europe for the treatment of laBCC, in Australia for the treatment of laBCC and mBCC and in Switzerland for the treatment of advanced BCC that cannot be treated with curative surgery or radiotherapy. These approvals were based on results from the pivotal phase 2 Basal Cell Carcinoma Outcomes With LDE225 Treatment (BOLT) study (NCT01327053), in which the primary analysis was performed using data based on 6 months of follow‐up. Here, we report long‐term efficacy and safety results from BOLT, with up to 30 months of follow‐up after the last patient was randomized.Materials and methodsBOLT study design and patientsBOLT is a randomized, double‐blind, phase 2 study conducted in 58 http://www.deepdyve.com/assets/images/DeepDyve-Logo-lg.png Journal of the European Academy of Dermatology & Venereology Wiley

Long‐term efficacy and safety of sonidegib in patients with locally advanced and metastatic basal cell carcinoma: 30‐month analysis of the randomized phase 2 BOLT study

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Publisher
Wiley
Copyright
Copyright © 2018 European Academy of Dermatology and Venereology
ISSN
0926-9959
eISSN
1468-3083
D.O.I.
10.1111/jdv.14542
Publisher site
See Article on Publisher Site

Abstract

IntroductionPatients with locally advanced basal cell carcinoma (laBCC) or metastatic BCC (mBCC) have historically had limited treatment options. Surgery, the primary course of treatment for most BCCs, and radiotherapy are often not viable options in advanced BCC. In recent years, hedgehog (Hh) pathway inhibitors (HPIs) were developed to block aberrant Hh signalling that is found in most sporadic BCCs; HPIs have demonstrated efficacy in patients with laBCC and those with mBCC.Sonidegib (LDE225), which inhibits Hh signalling by targeting the Hh pathway component smoothened, was approved (200 mg once daily) in the United States and Europe for the treatment of laBCC, in Australia for the treatment of laBCC and mBCC and in Switzerland for the treatment of advanced BCC that cannot be treated with curative surgery or radiotherapy. These approvals were based on results from the pivotal phase 2 Basal Cell Carcinoma Outcomes With LDE225 Treatment (BOLT) study (NCT01327053), in which the primary analysis was performed using data based on 6 months of follow‐up. Here, we report long‐term efficacy and safety results from BOLT, with up to 30 months of follow‐up after the last patient was randomized.Materials and methodsBOLT study design and patientsBOLT is a randomized, double‐blind, phase 2 study conducted in 58

Journal

Journal of the European Academy of Dermatology & VenereologyWiley

Published: Jan 1, 2018

References

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