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ERIVANCE showed that a pill blocking the hedgehog pathway shrinks most advanced basal cell carcinomas that surgery and radiotherapy can no longer control, and it produced the first approved drug for this cancer.
ERIVANCE BCC was a single-arm phase 2 trial of vismodegib, the first inhibitor of the hedgehog pathway receptor smoothened, in basal cell carcinoma that was metastatic or locally advanced and inappropriate for surgery or radiotherapy. Nearly all basal cell carcinomas depend on hedgehog signalling through loss of PTCH1 or activation of SMO, which made the pathway an obvious target.
By independent review the objective response rate was 43 percent in 63 patients with locally advanced disease and 30 percent in 33 with metastatic disease (NEJM 2012); with longer follow-up investigator-assessed responses were higher and lasted about two years in locally advanced disease. Muscle spasms, hair loss, taste loss and weight loss were nearly universal and led many patients to stop.
Vismodegib was approved in January 2012, the first hedgehog inhibitor and the first systemic drug for basal cell carcinoma; sonidegib followed on the BOLT trial and cemiplimab was later approved for disease that has failed hedgehog inhibitors.
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.
A second publication from the ERIVANCE BCC 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.
Vismodegib (and sonidegib) is the first-line systemic treatment for locally advanced or metastatic basal cell carcinoma, often given intermittently to manage side effects.
Shares Hedgehog pathway inhibitors, Basal cell carcinoma (KEGG map), Smoothened (hedgehog pathway), Vismodegib.
Shares Hedgehog pathway inhibitors, BOLT, Basal cell carcinoma (KEGG map), Why people stop taking hedgehog inhibitors.
Shares Patidegib gel in Gorlin syndrome (phase 2A), STEVIE (vismodegib in ordinary practice), Why people stop taking hedgehog inhibitors, Locally advanced and metastatic basal cell carcinoma.
Shares Patidegib gel in Gorlin syndrome (phase 2A), Why people stop taking hedgehog inhibitors, Smoothened (hedgehog pathway), Vismodegib.
Shares Hedgehog pathway inhibitors, Vismodegib, Locally advanced and metastatic basal cell carcinoma, Basal cell carcinoma.
Shares ERIVANCE BCC: efficacy and safety of vismodegib in advanced basal cell carcinoma, Locally advanced and metastatic basal cell carcinoma, Skin cancer (all types).
Shares Patidegib gel in Gorlin syndrome (phase 2A), Locally advanced and metastatic basal cell carcinoma, Basal cell carcinoma, Skin cancer (all types).
Shares Basal cell carcinoma (KEGG map), Hedgehog signalling, Skin cancer (all types).