LIBTAYO

(Cemiplimab-Rwlc)

Phase 2Small molecule

Regeneron

LIBTAYO is one of 14 small molecule programs targeting Merkel Cell Carcinoma. It is currently in Phase 2.

Indications

Total Trials

Active Trials

Competitors

FDA Application

NDA/BLA/ANDA regulatory filings

Pipeline

Status by Indication[3][1]

Indication

Merkel Cell CarcinomaRecruiting

Non-Small Cell Lung Cancer Stage IIIRecruiting

Merkel Cell CarcinomaPhase 1

Recruiting

Non-Small Cell Lung Cancer Stage IIIPhase 2

Recruiting

Competition

Competitive Landscape

9 competitors in Merkel Cell Carcinoma

#DrugCompanyPhaseTrials

Keytruda

Merck & Co.

Phase 3

9 2

Opdivo

Bristol-Myers Squibb

Phase 2

3 3

Dostarlimab

Incyte

Phase 2

2 4

Lenvima

Eisai

Phase 2

1 5

Bavencio

EMD Serono

Phase 2

9 6

Platinol

MMcNeil Consumer & Specialty Pharmaceuticals, a Division of McNeil-PPC, Inc.

Phase 2

2 7

Vepesid

AAvyxa

Phase 2

1 8

Radiation Therapy

MM.D. Anderson Cancer Center

Phase 2

1 9

LIBTAYO

Regeneron

Phase 2

1 10

Ifx-Hu2.0

TTuHURA Biosciences, Inc.

Phase 3

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

Timeline

Expected Milestones

Q3 2027

Phase 2Recruiting

Non-Small Cell Lung Cancer

NCT04253964

Q1 2028

Phase 1Recruiting

Merkel Cell Carcinoma

NCT04975152

Q3 2032

Phase 2Recruiting

Non-Small Cell Lung Cancer Stage III

NCT06449313

Clinical

Trials by Indication[1]

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

Advanced1 trial

Cemiplimab/Peg-Interferon-α in Advanced CSCC

Withdrawn·BBaptist Health South Florida·Phase 1·NCT05729139

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

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Withdrawn·UUniversity of Miami·Phase 2·NCT04831450

Non-small Cell Lung Cancer Stage III1 trial

A Phase 2 Single-arm Study of Neoadjuvant Chemo-Immunotherapy and Surgical Resection in Locally Advanced Non-small Cell Lung Cancer With N3 Lymph Node Involvement or Other High Risk Features

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

2 more indications

Non-Small Cell Lung Cancer1 trial

Phase II Pilot Study of Performance Status 2 vs. Performance Status 0-1 Non-Small Cell Lung Cancer Patients Treated With Chemo/Immunotherapy

Recruiting·WWake Forest University Health Sciences·Phase 2·NCT04253964·105 enrolled

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 — 7 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

Q3 2027

Q1 2028

Q3 2032

Trials by Indication[1]

Glioblastoma1 trial

Advanced1 trial

Unresectable1 trial

Head and Neck Squamous Cell Carcinoma1 trial

Non-small Cell Lung Cancer Stage III1 trial

Non-Small Cell Lung Cancer1 trial

Merkel Cell Carcinoma1 trial

FDA Approval Timeline[4]

References

Drug Info

Quick Facts

Related News