fianlimab/cemiplimab FDC (REGN3767/REGN2810 FDC) / Regeneron - LARVOL DELTA

Fianlimab, a human lymphocyte activation gene-3 monoclonal antibody, in combination with cemiplimab: Tumor-specific expansion cohorts in advanced malignancies. (PubMed, Cancer) - P1 | "Fianlimab plus cemiplimab demonstrated modest clinical efficacy with an acceptable safety profile in patients with advanced malignancies across several tumor types mostly in treatment-naive patients. Further investigation is warranted."

First-in-human • Journal • Clear Cell Renal Cell Carcinoma • Dermatology • Endocrine Disorders • Fatigue • Genito-urinary Cancer • Head and Neck Cancer • Lung Cancer • Nephrology • Non Small Cell Lung Cancer • Non-melanoma Skin Cancer • Oncology • Pruritus • Renal Disease • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck • Squamous Cell Skin Cancer • LAG3

A Trial to Learn if the Combination of Fianlimab, Cemiplimab, and Chemotherapy is Safe and Works Better Than the Combination of Cemiplimab and Chemotherapy in Adult Patients With Non-Small Cell Lung Cancer That Can be Treated With Surgery (clinicaltrials.gov) - P2 | N=195 | Active, not recruiting | Sponsor: Regeneron Pharmaceuticals | Trial primary completion date: Apr 2026 ➔ Aug 2026

Trial primary completion date • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • PD-L1

PROSECCO: A Phase 2, Single Arm, Neoadjuvant Study Evaluating Combination Cemiplimab, Fianlimab, And Ipilimumab In Patients With Surgically Resectable Melanoma (clinicaltrials.gov) - P2 | N=20 | Not yet recruiting | Sponsor: M.D. Anderson Cancer Center

New P2 trial • Cutaneous Melanoma • Melanoma • Mucosal Melanoma • Oncology • Solid Tumor

A Phase II Platform Study to Evaluate Treatment With Cemiplimab Monotherapy or Cemiplimab Plus Fianlimab or Other Novel Combinations in Patients With Colorectal Cancer With Minimal Residual Disease Following Definitive Surgery and Chemotherapy (EMPIRE) (clinicaltrials.gov) - P2 | N=79 | Recruiting | Sponsor: NSABP Foundation Inc | Trial primary completion date: Jun 2028 ➔ Apr 2029 | Not yet recruiting ➔ Recruiting

Enrollment open • Minimal residual disease • Monotherapy • Trial primary completion date • Colon Cancer • Colorectal Cancer • Oncology • Solid Tumor

A Trial to Learn if the Combination of Fianlimab, Cemiplimab, and Chemotherapy is Safe and Works Better Than the Combination of Cemiplimab and Chemotherapy in Adult Patients With Non-Small Cell Lung Cancer That Can be Treated With Surgery (clinicaltrials.gov) - P2 | N=195 | Recruiting | Sponsor: Regeneron Pharmaceuticals | Active, not recruiting ➔ Recruiting

Enrollment open • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • PD-L1

A Safety and Efficacy Study of Combined Fianlimab + Cemiplimab in Children and Young Adults With Recurrent or Progressive High-Grade Glioma or Posterior Fossa-A Ependymoma (clinicaltrials.gov) - P1/2 | N=120 | Not yet recruiting | Sponsor: Regeneron Pharmaceuticals

New P1/2 trial • Brain Cancer • Ependymoma • Glioma • High Grade Glioma • Oncology • Pediatrics • Solid Tumor

Key Pipeline Progress (The Manila Times) - "The Company remains on track to report results from the Phase 3 study of fianlimab in combination with cemiplimab versus pembrolizumab in first-line metastatic melanoma in the second quarter of 2026....A second interim analysis as well as the study's final analysis, if necessary, are anticipated in the second half of 2026. Regeneron remains blinded to these data; The Company determined that Phase 2 data evaluating fianlimab in combination with cemiplimab in first-line advanced non-small cell lung cancer (NSCLC) did not support advancement to Phase 3 development."

P3 data • Trial status • Melanoma • Non Small Cell Lung Cancer

A Study to See if Giving Fianlimab and Cemiplimab Together is Better Than Cemiplimab Alone at Treating Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma (clinicaltrials.gov) - P2 | N=120 | Recruiting | Sponsor: Regeneron Pharmaceuticals | Not yet recruiting ➔ Recruiting

Enrollment open • IO biomarker • Head and Neck Cancer • Oncology • Oropharyngeal Cancer • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck • PD-L1

A Study Comparing Two Immunotherapy Options for Human Papillomavirus Positive HPV-Positive Head and Neck Cancer After Treatment (clinicaltrials.gov) - P2 | N=68 | Not yet recruiting | Sponsor: University of Chicago | Initiation date: Jan 2026 ➔ Dec 2026

Minimal residual disease • Trial initiation date • Head and Neck Cancer • Oncology • Oropharyngeal Cancer • Solid Tumor • Squamous Cell Carcinoma of Head and Neck • PD-L1

R3767-ONC-2208: A Trial to Learn if Fianlimab and Cemiplimab Are Safe and Work Better Than Anti-PD1 Alone in Adult Participants With Resectable Stage 3 or 4 Melanoma (clinicaltrials.gov) - P2 | N=151 | Active, not recruiting | Sponsor: Regeneron Pharmaceuticals | Recruiting ➔ Active, not recruiting | Trial completion date: Apr 2031 ➔ Dec 2030 | Trial primary completion date: Mar 2027 ➔ Nov 2026

Enrollment closed • Trial completion date • Trial primary completion date • Cutaneous Melanoma • Melanoma • Oncology • Solid Tumor

A Trial of Locoregionally Advanced Squamous Cell Carcinoma of The Head and Neck (clinicaltrials.gov) - P2 | N=90 | Not yet recruiting | Sponsor: University of Chicago

New P2 trial • Head and Neck Cancer • Oncology • Oropharyngeal Cancer • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck

A Trial to Learn if the Combination of Fianlimab, Cemiplimab, and Chemotherapy is Safe and Works Better Than the Combination of Cemiplimab and Chemotherapy in Adult Patients With Non-Small Cell Lung Cancer That Can be Treated With Surgery (clinicaltrials.gov) - P2 | N=195 | Active, not recruiting | Sponsor: Regeneron Pharmaceuticals | Recruiting ➔ Active, not recruiting

Enrollment closed • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • PD-L1

A Study to See if Giving Fianlimab and Cemiplimab Together is Better Than Cemiplimab Alone at Treating Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma (clinicaltrials.gov) - P2 | N=120 | Not yet recruiting | Sponsor: Regeneron Pharmaceuticals | Trial completion date: Nov 2029 ➔ Dec 2030 | Initiation date: Mar 2025 ➔ Mar 2026 | Trial primary completion date: Apr 2027 ➔ Jun 2028

IO biomarker • Trial completion date • Trial initiation date • Trial primary completion date • Head and Neck Cancer • Oncology • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck • PD-L1

Opdualag vs. Cemiplimab/Fianlimab in Relation to the Immunological Response in Tumor and Peripheral Blood in Unresectable or Metastatic Melanoma (clinicaltrials.gov) - P=N/A | N=20 | Recruiting | Sponsor: John Kirkwood | Not yet recruiting ➔ Recruiting

Enrollment open • Hepatocellular Cancer • Melanoma • Oncology • Solid Tumor

A Trial to Learn if the Combination of Fianlimab, Cemiplimab, and Chemotherapy is Safe and Works Better Than the Combination of Cemiplimab and Chemotherapy in Adult Patients With Non-Small Cell Lung Cancer That Can be Treated With Surgery (clinicaltrials.gov) - P2 | N=180 | Recruiting | Sponsor: Regeneron Pharmaceuticals | Trial completion date: Apr 2029 ➔ Nov 2029 | Trial primary completion date: Sep 2025 ➔ May 2026

Trial completion date • Trial primary completion date • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

Opdualag vs. Cemiplimab/Fianlimab in Relation to the Immunological Response in Tumor and Peripheral Blood in Unresectable or Metastatic Melanoma (clinicaltrials.gov) - P=N/A | N=20 | Not yet recruiting | Sponsor: John Kirkwood

New trial • Hepatocellular Cancer • Melanoma • Oncology • Solid Tumor

A Study Comparing Two Immunotherapy Options for Human Papillomavirus Positive HPV-Positive Head and Neck Cancer After Treatment (clinicaltrials.gov) - P2 | N=68 | Not yet recruiting | Sponsor: University of Chicago

Minimal residual disease • New P2 trial • Head and Neck Cancer • Oncology • Solid Tumor

A Phase II Platform Study to Evaluate Treatment With Cemiplimab Monotherapy or Cemiplimab Plus Fianlimab or Other Novel Combinations in Patients With Colorectal Cancer With Minimal Residual Disease Following Definitive Surgery and Chemotherapy (EMPIRE) (clinicaltrials.gov) - P2 | N=79 | Not yet recruiting | Sponsor: NSABP Foundation Inc

Minimal residual disease • Monotherapy • New P2 trial • Colorectal Cancer • Oncology • Solid Tumor

TRIPL: Thoracic Radiotherapy and Inhibition of PD-1 and LAG-3 for Locally Advanced Non-Small Cell Lung Cancer (clinicaltrials.gov) - P2 | N=76 | Recruiting | Sponsor: Albert Einstein College of Medicine | Not yet recruiting ➔ Recruiting

Enrollment open • Lung Cancer • Lung Non-Squamous Non-Small Cell Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

ENCEFALO: Encorafenib and biNimetinib Followed by CEmiplimab and FiAnLimab in Patients With BRAF Mutant melanOma and Symptomatic Brain Metastases (clinicaltrials.gov) - P2 | N=33 | Recruiting | Sponsor: Grupo Español Multidisciplinar de Melanoma | Not yet recruiting ➔ Recruiting

Enrollment open • Melanoma • Oncology • Solid Tumor

R3767-ONC-2208: A Trial to Learn if Fianlimab and Cemiplimab Are Safe and Work Better Than Anti-PD1 Alone in Adult Participants With Resectable Stage 3 or 4 Melanoma (clinicaltrials.gov) - P2 | N=150 | Recruiting | Sponsor: Regeneron Pharmaceuticals | Phase classification: P2/3 ➔ P2 | N=520 ➔ 150 | Trial completion date: Jun 2033 ➔ Apr 2031 | Trial primary completion date: Sep 2028 ➔ Mar 2027

Enrollment change • Phase classification • Trial completion date • Trial primary completion date • Melanoma • Oncology • Solid Tumor

A Study to Learn About the Long-Term Health of Adult Participants From a Previous Study of a New Melanoma Treatment (clinicaltrials.gov) - P2 | N=48 | Enrolling by invitation | Sponsor: Regeneron Pharmaceuticals | Not yet recruiting ➔ Enrolling by invitation | N=98 ➔ 48

Enrollment change • Enrollment open • Melanoma • Oncology • Solid Tumor

ENCEFALO: Encorafenib and BiNimetinib Followed by CEmiplimab and FiAnLimab in Patients with BRAF Mutant MelanOma and Symptomatic Brain Metastases (clinicaltrials.gov) - P2 | N=33 | Not yet recruiting | Sponsor: Grupo Español Multidisciplinar de Melanoma

New P2 trial • Melanoma • Oncology • Solid Tumor

TRIPL: Thoracic Radiotherapy and Inhibition of PD-1 and LAG-3 for Locally Advanced Non-Small Cell Lung Cancer (clinicaltrials.gov) - P2 | N=76 | Not yet recruiting | Sponsor: Albert Einstein College of Medicine

New P2 trial • Lung Cancer • Lung Non-Squamous Non-Small Cell Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

A Study to Learn About the Long-Term Health of Adult Participants From a Previous Study of a New Melanoma Treatment (clinicaltrials.gov) - P2 | N=98 | Not yet recruiting | Sponsor: Regeneron Pharmaceuticals

New P2 trial • Melanoma • Oncology • Solid Tumor