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Impact of Sonidegib Dose Reductions and Interruptions in Patients With Advanced Basal Cell Carcinoma

By: Julia Fiederlein
Posted: Monday, December 13, 2021

In the randomized, double-blind, multicenter, phase II BOLT trial, the Hedgehog pathway inhibitor sonidegib demonstrated efficacy and continued tolerability after 42 months of treatment in patients with advanced basal cell carcinoma, according to Michael Migden, MD, of The University of Texas MD Anderson Cancer Center, Houston, and colleagues. The results of an analysis evaluating the impact of dose reductions and interruptions were published in the journal Dermatology and Therapy.  

“Dose reductions and interruptions were practical and did not impact the efficacy of sonidegib,” the investigators commented. “In patients with advanced basal cell carcinoma who necessitate long-term treatment, dose interruptions may be beneficial for continued treatment and disease control.”

A total of 230 Hedgehog pathway inhibitor–naive adults were randomly assigned in a 1:2 ratio to receive 200 or 800 mg of sonidegib daily. The incidence rates of dose interruptions appeared to be similar between the 200- and 800-mg groups (68.4% vs. 65.3%, respectively). Dose reductions were reported in 16.5% of patients treated with 200 mg and in 36.7% of those treated with 800 mg. In the population treated with 200 mg, the overall response rate was 48.1%; similar rates were reported in the subgroups of patients who underwent treatment with (46.2%) or without (48.5%) at least one dose reduction or interruption.

“While Hedgehog inhibitors provide a promising treatment option for patients with advanced basal cell carcinoma, adverse events can be difficult for patients to endure,” the investigators commented. “Preemptive management of adverse events through treatment interruptions may improve tolerability and optimize sonidegib treatment duration.”

Disclosure: For full disclosures of the study authors, visit

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