Sonidegib (1) – Odomzo®

• Clinical trials
  • For sonidegib, the pharmaceutical manufacturer includes the BOLT trial in the comparison.
  • The BOLT trial is the pivotal registration trial for Sonidegib, in which two different dosages (800 mg and 200 mg daily, respectively) are compared.
  • For vismodegib, the pharmaceutical manufacturer refers to the single-arm ERIVANCE trial.

a) Adult patients with locally advanced basal cell carcinoma (BCC) who are not eligible for curative surgery or radiotherapy

• The additional benefit is not proven.
• There are no direct comparative studies between sonidegib and vismodegib.
• To demonstrate additional benefit, the pharmaceutical manufacturer presents a comparison of individual arms from different studies without adjustment via a bridging comparator.
• Due to the lack of a suitable comparator, no adjusted indirect comparison could be carried out.
• Furthermore, as conclusions regarding additional benefit based on historical controls are only possible, at best, where there are very large effects with regard to patient-relevant endpoints, the effect estimated from the available data would have to be so large that it can be ruled out that it is due solely to systematic bias arising from the historical control.
• Consequently, there are no suitable data available that would allow a comparison with the appropriate comparator therapy.

Courtesy translation only, please refer to the German original.