LIBTAYO

(Cemiplimab-Rwlc)

Phase 2Small molecule

Regeneron

LIBTAYO is one of 164 small molecule programs targeting Cutaneous Squamous Cell Carcinoma. It is currently in Phase 2.

Indications

Total Trials

Active Trials

163

Competitors

FDA Application

NDA/BLA/ANDA regulatory filings

Pipeline

Status by Indication[3][1]

Indication

Cutaneous Squamous Cell CarcinomaActive, not recruiting

Non-Small Cell Lung CancerActive, not recruiting

Head and Neck Squamous Cell CarcinomaActive, not recruiting

GlioblastomaActive, not recruiting

Merkel Cell CarcinomaRecruiting

Cutaneous Squamous Cell CarcinomaPhase 1

Active, not recruiting

Non-Small Cell Lung CancerPhase 2

Active, not recruiting

Head and Neck Squamous Cell CarcinomaPhase 2

Active, not recruiting

GlioblastomaPhase 2

Active, not recruiting

Merkel Cell CarcinomaPhase 1

Recruiting

Competition

Competitive Landscape

1639 competitors in Non-Small Cell Lung Cancer

#DrugCompanyPhaseTrials

LIBTAYO

Regeneron

Phase 2

1 2

PORTRAZZA

Eli Lilly

Preclinical

8 3

Lenvima

Eisai

Preclinical

6 4

Imjudo

AstraZeneca

Preclinical

5 5

Vizimpro

Pfizer

Preclinical

4 6

Gilotrif

Boehringer Ingelheim

Preclinical

12 7

Ofev

Boehringer Ingelheim

Preclinical

7 8

Immunotherapy

Bristol-Myers Squibb

Preclinical

12 9

Tyrosine Kinase Inhibitor

Pfizer

Preclinical

2 10

Vidaza

Bristol-Myers Squibb

Preclinical

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Q1 2028

Phase 1Recruiting

Merkel Cell Carcinoma

NCT04975152

Q3 2032

Phase 2Recruiting

Non-Small Cell Lung Cancer

NCT06449313

Clinical

Trials by Indication[1]

Head and Neck Squamous Cell Carcinoma1 trial

Phase 2 Trial of Maintenance Cemiplimab for Head and Neck Squamous Cell Carcinoma (HNSCC)

Withdrawn·UUniversity of Miami·Phase 2·NCT04831450

Unresectable1 trial

Cemiplimab-rwlc for Unresectable Locally Recurrent and/or Metastatic CSCC

Terminated·HH. Lee Moffitt Cancer Center and Research Institute·Phase 2·NCT04242173·3 enrolled

Non-Small Cell Lung Cancer1 trial

Neoadjuvant Chemo-Immunotherapy and Surgical Resection in Locally Advanced Non-small Cell Lung Cancer With N3 Lymph Node Involvement

Recruiting·GGeorgetown University·Phase 2·NCT06449313·21 enrolled

Advanced1 trial

Cemiplimab/Peg-Interferon-α in Advanced CSCC

Withdrawn·BBaptist Health South Florida·Phase 1·NCT05729139

Glioblastoma1 trial

Study of Ad-RTS-hIL-12 + Veledimex in Combination With Cemiplimab in Subjects With Recurrent or Progressive Glioblastoma

Terminated·AAlaunos Therapeutics·Phase 2·NCT04006119·40 enrolled

1 more indication

Merkel Cell Carcinoma1 trial

Neoadjuvant Cemiplimab in Newly Diagnosed or Recurrent Stage I-II Merkel Cell Carcinoma and Locoregionally Advanced Cutaneous Squamous Cell Carcinoma: Safety and Biomarker Analysis

Recruiting·HH. Lee Moffitt Cancer Center and Research Institute·Phase 1·NCT04975152·36 enrolled

Regulatory

FDA Approval Timeline[4]

Sep 28, 2018

LIBTAYO

BLA BLA761097

Sources

References

[1]
ClinicalTrials.gov — 6 trial records for Cemiplimab-Rwlc. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — Cemiplimab-Rwlc compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for Cemiplimab-Rwlc. EMBL-EBI & Wellcome Sanger Institute.
[4]
OpenFDA — FDA approval records (BLA BLA761097). U.S. Food & Drug Administration.
[5]
SEC EDGAR — Regeneron company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Modality: Small molecule[2]
Highest Phase: Phase 2[1]
Company: Regeneron

LIBTAYO

Status by Indication[3][1]

Competitive Landscape

Expected Milestones

Q1 2028

Q3 2032

Trials by Indication[1]

Head and Neck Squamous Cell Carcinoma1 trial

Unresectable1 trial

Non-Small Cell Lung Cancer1 trial

Advanced1 trial

Glioblastoma1 trial

Merkel Cell Carcinoma1 trial

FDA Approval Timeline[4]

References

Drug Info

Quick Facts

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