Summary

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• This summary is based on the review of three randomized controlled trial(s). ^[1-3]
• For patients with locally advanced basal cell carcinoma (laBCC) taking sonidegib 200 mg daily, the overall objective response rate (ORR) was 71.2% at 42 months by investigator review, with a median duration of response (DOR) of 15.7 months. For patients using select concomitant medications, the ORR was 73.0%, though DOR was not estimable for this group.
• In assessments by central review using mRECIST (modified Response Evaluation Criteria in Solid Tumors) criteria, the ORR for laBCC patients was 56.1%, while under ERIVANCE-like criteria, the ORR increased to 60.6% (CR (complete response) at 21.2% and PR (partial response) at 39.4%), with a consistent DOR of 26.1 months across criteria.
• In comparative analyses, the ORR for laBCC was 56% for those on a 200 mg dose of sonidegib and 46.1% on the 800 mg dose. For metastatic BCC (mBCC), the ORR was notably lower, with 8% for 200 mg and 17% for 800 mg, reflecting differential efficacy based on dose and disease extent.
• Sonidegib demonstrated a manageable safety profile over a 42-month follow-up period, with no new safety concerns reported for patients with locally advanced or metastatic basal cell carcinoma (BCC). Specific adverse events were not detailed, and there were no significant safety concerns or adverse effects noted for specific population types or subgroups in the reviewed studies.
• There is no population types or subgroups information available in the reviewed studies.