Cemiplimab demonstrated “clinically meaningful” activity and an “acceptable” safety profile in patients with locally advanced basal cell carcinoma (BCC) who had previously received hedgehog inhibitor (HHI) therapy, researchers reported in The Lancet Oncology.1

Cemiplimab was approved in the United States earlier this year to treat patients with locally advanced BCC (regular approval) or metastatic BCC (accelerated approval) who had previously received HHIs or could not receive HHIs.2

These approvals were supported by results from a phase 2 study (ClinicalTrials.gov Identifier: NCT03132636) of cemiplimab in patients with locally advanced or metastatic BCC who had progressed on or were intolerant to previous HHI therapy.

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The results published in The Lancet Oncology include only the 84 patients with locally advanced BCC. These patients received 350 mg of cemiplimab intravenously every 3 weeks for up to 93 weeks or until disease progression or unacceptable toxicity.

At a median follow-up of 15 months, the objective response rate was 31%, with 5 patients achieving a complete response and 21 having a partial response.

The median time to response was 4.3 months. The median duration of response was not reached at the data cutoff, but 91% of initial responders were still in response at 6 months, and 85% were still in response at 12 months.

The disease control rate was 80%. The rate of durable disease control (the proportion of patients without progressive disease for at least 182 days) was 60%.

The median progression-free survival was 19 months. The progression-free survival rate was 76% at 6 months and 57% at 12 months.

The median overall survival was not reached at the data cutoff. The estimated 2-year overall survival rate was 80%.

Grade 3-4 treatment-emergent adverse events (TEAEs) occurred in 48% of patients. The most common grade 3-4 TEAEs were hypertension (5%), colitis (5%), fatigue (4%), urinary tract infection (4%), and visual impairment (4%).

Serious TEAEs were observed in 35% of patients. There were no treatment-related deaths.

“Results from this study showed that cemiplimab is an active treatment option for patients with locally advanced basal cell carcinoma who had progressed on or are intolerant to HHI therapy,” the study authors wrote. “This is the first study to show activity of a systemic therapy in locally advanced basal cell carcinoma after HHI therapy, therefore addressing an unmet need in this patient population.”

Disclosures: This research was supported by Regeneron Pharmaceuticals and Sanofi. Some study authors declared affiliations with biotech, pharmaceutical, and/or device companies. Please see the original reference for a full list of disclosures.


  1. Stratigos AJ, Sekulic A, Peris K, et al. Cemiplimab in locally advanced basal cell carcinoma after hedgehog inhibitor therapy: an open-label, multi-centre, single-arm, phase 2 trial. Lancet Oncol. 2021;22(6):848-857. doi:10.1016/S1470-2045(21)00126-1
  2. FDA approves cemiplimab-rwlc for locally advanced and metastatic basal cell carcinoma. US Food and Drug Administration. Feb. 9, 2021. Accessed July 22, 2021. https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-cemiplimab-rwlc-locally-advanced-and-metastatic-basal-cell-carcinoma