# Cemiplimab in basal cell carcinoma after a hedgehog inhibitor

Source: https://onco.cc/trials/cemiplimab-advanced-bcc/  
OnCo record `cemiplimab-advanced-bcc` (Trial). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

Before this trial there was nothing to offer someone whose basal cell carcinoma had outgrown or outlasted the hedgehog pill. Immunotherapy shrank the tumour in about a third of them, and it is now the standard second treatment.

## Summary

Until February 2021 there was no standard treatment for locally advanced basal cell carcinoma after a hedgehog inhibitor, and since most people either progress or stop the pill because of its side effects, that gap covered the majority of patients who ever start one. This open-label single-arm trial at 38 centres in Canada, Europe and the United States enrolled patients who had progressed on, could not tolerate, or had no better than stable disease after nine months of hedgehog inhibitor therapy, and gave cemiplimab 350 mg every three weeks for up to 93 weeks.

Eighty-four patients were treated between November 2017 and January 2019. At a median follow-up of 15 months, objective response by independent central review was seen in 26 of 84 (31 per cent, 95 per cent confidence interval 21 to 42), with five complete responses (6 per cent) and 21 partial responses (25 per cent).

Toxicity was that of PD-1 blockade and it was not trivial in this elderly population: grade 3 or 4 treatment-emergent adverse events in 40 of 84 (48 per cent), most commonly hypertension and colitis at 5 per cent each, and serious treatment-emergent events in 29 (35 per cent). There were no treatment-related deaths.

A response rate of 31 per cent is lower than the 43 to 68 per cent reported for first-line hedgehog inhibitors, but the comparison is unfair: this is a population selected for hedgehog failure. What the trial establishes is a second line where there was none. Basal cell carcinoma, long thought a cold tumour because it rarely spreads, turns out to respond to checkpoint blockade, which fits its very high ultraviolet mutational burden.

## Fields

- Kind: Trial
- Status: positive
- Last checked: 2026-09-25
- Also known as: Study 1620; cemiplimab in locally advanced basal cell carcinoma
- Registry id: NCT03132636
- Phase: 2
- Setting: Locally advanced basal cell carcinoma in patients who had progressed on, were intolerant of, or had no better than stable disease after nine months of hedgehog inhibitor therapy: cemiplimab 350 mg intravenously every three weeks for up to 93 weeks, with objective response by independent central review as the primary endpoint
- Sponsor: Regeneron Pharmaceuticals and Sanofi
- Enrolled: 84
- Result: Objective response by independent central review in 26 of 84 patients (31 per cent, 95 per cent confidence interval 21 to 42) with five complete responses; grade 3 or 4 treatment-emergent adverse events in 48 per cent.
- Outcomes: Objective response by independent central review: Cemiplimab 350 mg every 3 weeks 31%; Grade 3 or 4 treatment-emergent adverse events: Cemiplimab 350 mg every 3 weeks 48%
- Replication: No randomised comparison exists. Cemiplimab was approved in this setting in February 2021 on this single-arm evidence, and there is no NICE technology appraisal of it for basal cell carcinoma.

## Sources

- ClinicalTrials.gov NCT03132636: https://clinicaltrials.gov/study/NCT03132636
- Primary analysis (Lancet Oncology 2021): https://doi.org/10.1016/S1470-2045(21)00126-1
- Primary analysis on PubMed: https://pubmed.ncbi.nlm.nih.gov/34000246/

## Connected records

- cancers: [Basal cell carcinoma](https://onco.cc/cancers/basal-cell-carcinoma/), [Locally advanced and metastatic basal cell carcinoma](https://onco.cc/cancers/locally-advanced-bcc/), [Skin cancer (all types)](https://onco.cc/cancers/skin-cancer/)
- technologies: [Immune checkpoint inhibitors](https://onco.cc/technologies/checkpoint-inhibitor/)
- targets: [PD-1](https://onco.cc/targets/pd1/)
- drugs: [Cemiplimab](https://onco.cc/drugs/cemiplimab/)
- companies: [Regeneron](https://onco.cc/companies/regeneron/), [Sanofi](https://onco.cc/companies/sanofi/)
- terms: [Immune-related adverse events (irAEs)](https://onco.cc/terms/irae/), [Tumour mutational burden (TMB)](https://onco.cc/terms/tmb/), [Why people stop taking hedgehog inhibitors](https://onco.cc/terms/hedgehog-inhibitor-tolerability/)
- trials: [BOLT](https://onco.cc/trials/bolt/), [ERIVANCE BCC](https://onco.cc/trials/erivance/), [STEVIE (vismodegib in ordinary practice)](https://onco.cc/trials/stevie/), [VISMONEO (vismodegib before surgery for locally advanced basal cell carcinoma)](https://onco.cc/trials/vismoneo/)
- key papers: [Cemiplimab in locally advanced basal cell carcinoma after hedgehog inhibitor therapy](https://onco.cc/key-papers/paper-cemiplimab-bcc-stratigos-lancet-oncol-2021/)

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