BOLT: two doses of sonidegib in locally advanced or metastatic basal cell carcinoma
Sonidegib, a second hedgehog inhibitor, shrank tumours in about 40 percent of patients with locally advanced basal cell carcinoma at the lower 200 mg dose with fewer side effects than the higher dose, and was approved as an alternative to vismodegib.
Overview
Randomised phase 2 trial of 230 patients with locally advanced or metastatic basal cell carcinoma randomised to sonidegib 200 mg or 800 mg daily.
Objective response by central review was 36 percent (200 mg) and 34 percent (800 mg) in locally advanced disease, with lower toxicity and discontinuation at 200 mg; the metastatic cohort response was lower, and later analyses reported higher responses with longer follow-up.
- Objective response 36 percent (200 mg) vs 34 percent (800 mg) in locally advanced disease.
- Fewer grade 3 to 4 adverse events at 200 mg.
Sonidegib 200 mg is an approved option for locally advanced basal cell carcinoma with a side-effect profile similar to vismodegib.
- Randomised between doses only; no comparison with vismodegib or placebo.
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