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Fabhalta

(Fianlimab)

Phase 3Monoclonal antibody

Fianlimab is used to treat a rare autoimmune skin condition called pemphigus vulgaris, where the body's immune system attacks the skin causing blistering and sores.[1] Fabhalta is currently being investigated across 14 indications[3], with its most advanced program in Phase 3.[1]

Fabhalta is one of 315 biologic programs targeting Basal Cell Carcinoma. It is currently in Phase 3.

14

Indications

27

Total Trials

25

Active Trials

314

Competitors

5

FDA Applications

NDA/BLA/ANDA regulatory filings

Pipeline

Status by Indication[3][1]

Indication

Basal Cell CarcinomaRecruiting

Metastatic MelanomaActive, not recruiting

Non-Small Cell Lung CancerRecruiting

Colorectal CancerRecruiting

MelanomaActive, not recruiting

Renal Cell CarcinomaRecruiting

Multiple MyelomaRecruiting

Advanced Non-Small Cell Lung CancerActive, not recruiting

Resectable NSCLCActive, not recruiting

Advanced MalignanciesActive, not recruiting

Basal Cell CarcinomaPhase 2

Recruiting

Metastatic MelanomaPhase 3

Active, not recruiting

Non-Small Cell Lung CancerPhase 2

Recruiting

Colorectal CancerPhase 2

Recruiting

MelanomaPhase 3

Active, not recruiting

Renal Cell CarcinomaPhase 2

Recruiting

Multiple MyelomaPhase 1

Recruiting

Advanced Non-Small Cell Lung CancerPreclinical

Active, not recruiting

Resectable NSCLCPhase 2

Active, not recruiting

Advanced MalignanciesPhase 1

Active, not recruiting

Showing 10 of 14 indications

Competition

Competitive Landscape

414 competitors in Non-Small Cell Lung Cancer

#DrugCompanyPhaseTrials

Opdivo

Bristol-Myers Squibb

DATROWAY

Fabhalta

Gotistobart

Remeron

OOrganon and Co

Aqupla

Jiangsu Simcere Pharmaceutical Co., Ltd.

Ftorafur

TThe First Affiliated Hospital with Nanjing Medical University

Vibramycin

PPfizer's Upjohn has merged with Mylan to form Viatris Inc.

Treatment

PD-1 Inhibitors

BBioNTech US Inc.

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

Timeline

Expected Milestones

Q3 2027

Phase 2Recruiting

Non-Small Cell Lung Cancer

NCT06865339

Phase 2Recruiting

Advanced Melanoma

NCT06594991

PreclinicalActive, not recruiting

Advanced Non-Small Cell Lung Cancer

NCT05785767

Phase 1Active, not recruiting

Advanced Malignancies

NCT03233139

Q1 2028

Phase 2Recruiting

Renal Cell Carcinoma

NCT06699602

Q2 2028

Phase 2Recruiting

Colorectal Cancer

NCT06205836

Clinical

Trials by Indication[1]

Renal Cell Carcinoma2 trials

A Study of Cemiplimab and Fianlimab in People With Clear Cell Renal Cell Carcinoma

Recruiting·MMemorial Sloan Kettering Cancer Center·Phase 2·NCT06699602·10 enrolled

Cemiplimab or Cemiplimab and Fianlimab After Stereotactic Body Radiotherapy in Clear Cell Renal Cell Carcinoma

Recruiting·UUniversity of Oklahoma·Phase 2·NCT07223541·72 enrolled

Colorectal Cancer2 trials

Cemiplimab With or Without Fianlimab to Treat Older Patients With Localized or Locally Advanced MSI-H Colorectal Cancer

Recruiting·SSidney Kimmel Comprehensive Cancer Center at Johns Hopkins·Phase 2·NCT06205836·44 enrolled

Combining Capecitabine/Oxaliplatin Chemotherapy With Cemiplimab Alone or in Combination With Fianlimab or REGN7075 for the Neoadjuvant Treatment of Locally Advanced Rectal Cancer

Recruiting·SSidney Kimmel Comprehensive Cancer Center at Johns Hopkins·Phase 2·NCT07281768·66 enrolled

Non-Small Cell Lung Cancer2 trials

Thoracic Radiotherapy and Inhibition of PD-1 and LAG-3 for Locally Advanced Non-Small Cell Lung Cancer

Recruiting·NNitin Ohri·Phase 2·NCT06865339·76 enrolled

A Randomized, Double-Blind Phase 2/3 Study of Fianlimab (Anti-LAG-3 Antibody), Cemiplimab (Anti-PD-1 Antibody), and Chemotherapy Versus Cemiplimab and Chemotherapy in First-Line Treatment of Patients With Advanced Non-Small Cell Lung Cancer (NSCLC) Irrespective of PD-L1 Expression Levels

Active, not recruiting· Regeneron logo

Regeneron·Preclinical·NCT05800015·160 enrolled

Melanoma2 trials

A Phase 3 Study of Fixed Dose Combinations of Fianlimab and Cemiplimab Versus Relatlimab and Nivolumab in Participants With Unresectable or Metastatic Melanoma

Recruiting· Regeneron logo

Regeneron·Phase 3·NCT06246916·560 enrolled

A Phase 3 Trial of Fianlimab (Anti-LAG-3) and Cemiplimab Versus Pembrolizumab in the Adjuvant Setting in Patients With Completely Resected High-risk Melanoma

Active, not recruiting· Regeneron logo

Regeneron·Phase 3·NCT05608291·1,564 enrolled

Advanced Malignancies1 trial

Safety and Pharmacokinetics of Cemiplimab Anti-programmed Death-ligand 1 (Anti-PD-1) and Other Agents in Japanese Adult Patients With Advanced Malignancies

Active, not recruiting· Regeneron logo

Regeneron·Phase 1·NCT03233139·146 enrolled

18 more indications

Resectable NSCLC1 trial

Neoadjuvant Cemiplimab for the Treatment of Resectable NSCLC, HCC, and HNSCC in Adult Patients

Active, not recruiting· Regeneron logo

Regeneron·Phase 2·NCT03916627·65 enrolled

Cutaneous Squamous Cell Carcinoma1 trial

Study of Cemiplimab Alone or in Combination With Fianlimab and/or Other Experimental Agents in Adult Participants With Peri-operative Stage III/IV Cutaneous Squamous Cell Carcinoma (CSCC)

Withdrawn· Regeneron logo

Regeneron·Phase 2·NCT06384820

Basal Cell Carcinoma1 trial

Cemiplimab Plus Fianlimab for the Treatment of Locally Advanced Head and Neck Basal Cell Carcinoma Before Surgery

Recruiting·TThomas Jefferson University·Phase 2·NCT05929664·70 enrolled

Metastatic Melanoma1 trial

Clinical Study of Fianlimab in Combination With Cemiplimab Versus Pembrolizumab in Adolescent and Adult Patients With Previously Untreated Unresectable Locally Advanced or Metastatic Melanoma

Active, not recruiting· Regeneron logo

Regeneron·Phase 3·NCT05352672·1,546 enrolled

Squamous Cell Carcinoma1 trial

A Trial of Locoregionally Advanced Squamous Cell Carcinoma of The Head and Neck

Not yet recruiting·UUniversity of Chicago·Phase 2·NCT07346196·90 enrolled

Nasopharyngeal Carcinoma1 trial

A Pilot Randomized Trial of Induction Cemiplimab With or Without Fianlimab in De-escalated Chemoradiation for Locoregionally Advanced Non-Metastatic Nasopharyngeal Carcinoma

Not yet recruiting·MMemorial Sloan Kettering Cancer Center·Phase 1·NCT07650266·60 enrolled

Bladder Cancer1 trial

A Phase 2, Randomized, Open-label Study of Gemcitabine/Cisplatin Plus Cemiplimab (REGN2810, Anti-PD-1) With or Without Fianlimab (REGN3767, Anti-LAG-3) for Organ Preservation in Patients With Localized Muscle-invasive Bladder Cancer (NeoSTOP-IT)

Terminated·CColumbia University·Phase 2·NCT06571708·1 enrolled

Locally Advanced Basal Cell Carcinoma1 trial

Phase 2 Platform Trial of Combination Therapies for Participants With Locally Advanced Basal Cell Carcinoma: Master Protocol With Cemiplimab Monotherapy as Comparator Arm

Not yet recruiting· Regeneron logo

Regeneron·Phase 2·NCT07808515·135 enrolled

Lung Non-Small Cell Carcinoma1 trial

Phase II Single Arm Study of Neoadjuvant Dual Checkpoint Blockade With Programmed Death-ligand 1 (PD1) and Lymphocyte Activation Gene 3 (LAG-3) Inhibition in Resectable Non-Small Cell Lung Cancer (N-PLANC)

Recruiting·MMayo Clinic·Phase 2·NCT06918132·60 enrolled

Advanced Melanoma1 trial

A Phase 2 Study of Fianlimab, Cemiplimab, and Ipilimumab in Anti-PD-1 Refractory Melanoma

Recruiting·MMemorial Sloan Kettering Cancer Center·Phase 2·NCT06594991·88 enrolled

Prostate Cancer1 trial

Phase I/II Trial of Androgen Deprivation, With or Without pTVG-AR, and With or Without T-Cell Checkpoint Blockade, in Patients With Newly Diagnosed, High-Risk Prostate Cancer

Active, not recruiting·UUniversity of Wisconsin, Madison·Preclinical·NCT04989946·57 enrolled

Ovarian Cancer1 trial

Multi-Arm Phase 2 Platform Study of Ubamatamab (REGN4018; MUC16×CD3 Bispecific Antibody) With or Without Additional Agents in Platinum-Resistant Ovarian Cancer

Recruiting· Regeneron logo

Regeneron·Phase 2·NCT06787612·297 enrolled

Melanoma (Skin)1 trial

Fianlimab and Cemiplimab as Total Neoadjuvant Therapy (TNT) For Melanoma

Not yet recruiting·UUniversity of California, Irvine·Phase 2·NCT07527325·35 enrolled

Advanced Renal Cell Carcinoma (aRCC)1 trial

A Randomized Phase 2 Trial of Fianlimab and Cemiplimab +/- Ipilimumab or Ipilimumab Plus Nivolumab in First-line Advanced Renal Cell Carcinoma (RCC)

Recruiting·BBrian Rini·Phase 2·NCT07188896·120 enrolled

Pleural Mesotheliomas1 trial

A Non-Comparative Phase IIR Trial Assessing Fianlimab Plus Cemiplimab Plus Pemetrexed-Platinum Chemotherapy or Cemiplimab Plus Pemetrexed-Platinum Chemotherapy for Treatment-Naive Pleural Mesothelioma (PM) Patients

Recruiting·IIntergroupe Francophone de Cancerologie Thoracique·Phase 2·NCT07234058·126 enrolled

Resectable Non-small Cell Lung Cancer1 trial

A Phase 2 Peri-Operative Trial of Fianlimab and Cemiplimab in Combination With Chemotherapy Versus Cemiplimab in Combination With Chemotherapy in Patients With Resectable Early Stage (Stage II to IIIB [N2]) NSCLC

Active, not recruiting· Regeneron logo

Regeneron·Phase 2·NCT06161441·195 enrolled

Multiple Myeloma1 trial

Phase 1b Study of REGN5458 (Anti-BCMA x Anti-CD3 Bispecific Antibody) Plus Other Cancer Treatments for Patients With Relapsed/Refractory Multiple Myeloma

Recruiting· Regeneron logo

Regeneron·Phase 1·NCT05137054·317 enrolled

Advanced Non-Small Cell Lung Cancer1 trial

A Randomized, Double-Blind Phase 2/3 Study of Fianlimab (Anti-LAG-3 Antibody) in Combination With Cemiplimab (Anti-PD-1 Antibody) Versus Cemiplimab Monotherapy in First-Line Treatment of Patients With Advanced Non-Small Cell Lung Cancer (NSCLC) With Tumors Expressing PD-L1 ≥50%

Active, not recruiting· Regeneron logo

Regeneron·Preclinical·NCT05785767·149 enrolled

Regulatory

FDA Approval Timeline[4]

Dec 5, 2023

FABHALTA

NDA NDA218276

Mar 26, 2024

FABHALTA

NDA NDA218276

May 24, 2024

FABHALTA

NDA NDA218276

Mar 20, 2025

FABHALTA

NDA NDA218276

Jul 16, 2026

FABHALTA

NDA NDA218276

Sources

References

[1]
ClinicalTrials.gov — 27 trial records for Fianlimab. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — Fianlimab compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for Fianlimab. EMBL-EBI & Wellcome Sanger Institute.
[4]
OpenFDA — FDA approval records (NDA NDA218276). U.S. Food & Drug Administration.
[5]
SEC EDGAR — Regeneron company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Mechanism of Action: Lymphocyte Activation Gene 3 Protein Inhibitor[2]
Modality: Monoclonal antibody[2]
Highest Phase: Phase 3[1]
Company: Regeneron

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