ERIVANCE BCC
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.
Overview
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.
- 43 out of 100 people had their tumour shrink with Vismodegib.
- 30 out of 100 people had their tumour shrink with Vismodegib.
- There was no comparison group, so this number cannot tell you how much of the effect is due to the treatment.
- A response rate counts how many people had their tumours shrink by a set amount; shrinking is encouraging but does not by itself show that people live longer or feel better.
- These results apply to the people the trial enrolled: Locally advanced or metastatic basal cell carcinoma: vismodegib 150 mg daily. People in a different situation may not see the same effect.
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.
104 participants enrolled.
| Endpoint | Arm | n | Value | HR (95% CI) | p | Source |
|---|---|---|---|---|---|---|
| Objective response rate (locally advanced)primary | Vismodegib | 63 | 43% | - | - | link |
| Objective response rate (metastatic)primary | Vismodegib | 33 | 30% | - | - | link |
Similar pages
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