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Cemiplimab Shows Strong Activity in Pivotal Basal Cell Carcinoma Trial

Jason M. Broderick @jasoncology
Published: Tuesday, May 05, 2020

Cemiplimab (Libtayo) induced clinically meaningful and durable responses in patients with advanced basal cell carcinoma who had progressed on or were intolerant to prior hedgehog pathway inhibitor therapy, according to topline phase 2 data announced by Regeneron Pharmaceuticals, Inc., and Sanofi, the codevelopers of the PD-1 inhibitor.1

Among 75 patients with metastatic CSCC, the ORR was 47% (95% CI, 35-59). The CR rate was 5% and the PR rate was 41%. The duration of response ranged from 3 months to over 15 months. Sixty percent of patients had a duration of response ≥6 months. In the 33 patients with locally advanced disease, the ORR was 49% (95% CI, 31-67), comprising all PRs. The duration of response ranged from 1 month to over 13 months. Sixty-three percent of patients had a duration of response ≥6 months.


  1. Libtayo® (cemiplimab) Shows Clinically-Meaningful and Durable Responses in Second-line Advanced Basal Cell Carcinoma. Published May 5, 2020. Accessed May 5, 2020.
  2. FDA approves cemiplimab-rwlc for metastatic or locally advanced cutaneous squamous cell carcinoma. Published Sept. 28, 2018. Accessed May 5, 2020.

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