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BOLT showed that sonidegib, a second hedgehog pathway pill, shrinks about four in ten locally advanced basal cell carcinomas at its lower dose, and that the higher dose adds side effects rather than responses.
BOLT randomised 230 patients with locally advanced or metastatic basal cell carcinoma to sonidegib 200 mg or 800 mg daily in a double-blind design with no placebo arm, the question being dose rather than efficacy against a comparator.
At the 200 mg dose the objective response rate by central review was 43 percent in locally advanced and 15 percent in metastatic disease (Lancet Oncology 2015), with more toxicity and no more responses at 800 mg. Long-term follow-up to 42 months showed durable responses and the same muscle spasm, hair loss and taste disturbance seen with vismodegib.
Sonidegib 200 mg was approved for locally advanced basal cell carcinoma in July 2015 and is used interchangeably with vismodegib; neither has been compared with the other head to head.
Numbers are from the trial as recorded here; see the source links in the table below. This is orientation, not medical advice: ask your team how closely the trial population matches you.
230 enrolled.
| Endpoint | Arm | n | Value | HR (95% CI) | p | Source |
|---|---|---|---|---|---|---|
| Objective response rate, 200 mg (locally advanced)primary | Sonidegib 200 mg | - | 43% | - | - | link |
A second publication from the BOLT trial, later than the first and described in its title as an update or longer-term analysis. Read it with the primary publication linked from the trial page; the record was linked automatically and its figures have not been checked by hand.
Sonidegib 200 mg is an approved option for locally advanced basal cell carcinoma with a side-effect profile similar to vismodegib.
Shares STEVIE (vismodegib in ordinary practice), Cemiplimab in basal cell carcinoma after a hedgehog inhibitor, Hedgehog pathway inhibitors, ERIVANCE BCC.
Shares STEVIE (vismodegib in ordinary practice), Hedgehog pathway inhibitors, ERIVANCE BCC, Why people stop taking hedgehog inhibitors.
Shares Hedgehog pathway inhibitors, Sonidegib, Basal cell carcinoma (KEGG map), Smoothened (hedgehog pathway).
Shares STEVIE (vismodegib in ordinary practice), Hedgehog pathway inhibitors, ERIVANCE BCC, Basal cell carcinoma (KEGG map).
Shares STEVIE (vismodegib in ordinary practice), Why people stop taking hedgehog inhibitors, Locally advanced and metastatic basal cell carcinoma, Basal cell carcinoma.
Shares Sonidegib, Why people stop taking hedgehog inhibitors, Smoothened (hedgehog pathway), Locally advanced and metastatic basal cell carcinoma.
Shares BOLT: two doses of sonidegib in locally advanced or metastatic basal cell carcinoma, Locally advanced and metastatic basal cell carcinoma, Skin cancer (all types).
Shares Hedgehog pathway inhibitors, Locally advanced and metastatic basal cell carcinoma, Basal cell carcinoma.