Libtayo(cemiplimab)
Oncology· 128 cited findings· 1 source document
Company: Regeneron Pharmaceuticals, Inc. →
What the regulatory reviews say
Libtayo (cemiplimab) is a drug for which a Biologics License Application (BLA) was submitted on April 3, 2019 (BLA Application Number 761097) and approved on November 10, 2020. The recommended dosage is 350 mg.
In studies 1423 and 1540, 591 patients were exposed to Libtayo, including 131 patients with metastatic CSCC and 88 patients with locally advanced CSCC. For metastatic CSCC, the Confirmed Objective Response Rate (ORR) was 49% (complete response rate 17%, partial response rate 32%) with Libtayo 3 mg/kg every 2 weeks. For locally advanced CSCC, the Confirmed ORR was 44% (complete response rate 13%, partial response rate 31%) with Libtayo 3 mg/kg every 2 weeks. For combined CSCC, the Confirmed ORR was 46% (complete response rate 15%, partial response rate 31%) with Libtayo 3 mg/kg every 2 weeks. The Confirmed ORR for advanced CSCC with Libtayo 350 mg every 3 weeks was 41%.
Safety findings include a 1.9% permanent discontinuation rate due to pneumonitis, with a 59% pneumonitis resolution rate. Immune-mediated colitis incidence was 1.2%, with a 0.2% permanent discontinuation rate due to colitis and a 71% colitis resolution rate.
Key figures — cited to the source page
| Confirmed Objective Response Rate (ORR) for metastatic CSCC (LIBTAYO 3 mg/kg every 2 weeks) | 49 | Regeneron Pharmaceuticals, Inc. — Libtayo FDA Review (NDA/BL, p.24 |
| Confirmed Objective Response Rate (ORR) for locally advanced CSCC (LIBTAYO 3 mg/kg every 2 weeks) | 44 | Regeneron Pharmaceuticals, Inc. — Libtayo FDA Review (NDA/BL, p.24 |
| Confirmed ORR for advanced CSCC (LIBTAYO 350 mg every 3 weeks) | 41 | Regeneron Pharmaceuticals, Inc. — Libtayo FDA Review (NDA/BL, p.24 |
| Permanent discontinuation due to pneumonitis | 1.9 | Regeneron Pharmaceuticals, Inc. — Libtayo FDA Review (NDA/BL, p.13 |
| Pneumonitis resolution rate | 59 | Regeneron Pharmaceuticals, Inc. — Libtayo FDA Review (NDA/BL, p.13 |
| Immune-mediated colitis incidence | 1.2 | Regeneron Pharmaceuticals, Inc. — Libtayo FDA Review (NDA/BL, p.14 |
| Permanent discontinuation due to colitis | 0.2 | Regeneron Pharmaceuticals, Inc. — Libtayo FDA Review (NDA/BL, p.14 |
| Approval Date | November 10, 2020 | Regeneron Pharmaceuticals, Inc. — Libtayo FDA Review (NDA/BL, p.1 |
Source documents
Explore the full evidence
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Figures are as stated in the cited regulatory review documents (different drugs are studied in different trials — values are not head-to-head comparisons). Educational reference only — not medical or investment advice.