Retifanlimab

Generic Name: Retifanlimab

Brand Names: Zynyz

Drug Type: Biotech

CAS Number: 2079108-44-2

Unique Ingredient Identifier: 2Y3T5IF01Z

Background: Retifanlimab is a humanized IgG4 kappa monoclonal antibody that binds to the programmed death receptor-1 (PD-1), blocking PD-1 interaction with its ligands, programmed death-ligand 1 (PD-L1) and programmed death-ligand 2 (PD-L2). By blocking the PD-1/PD-L1/2 pathway, retifanlimab potentiates T-cell activity and boosts the immune response against cancer cells. Other monoclonal antibodies that block PD-1 include pembrolizumab, nivolumab and cemiplimab.

On October 2021, Incyte Biosciences withdrew its application for a marketing authorization of retifanlimab for the treatment of squamous carcinoma of the anal canal. On March 2023, the FDA granted accelerated approval to retifanlimab for a different indication, the treatment of metastatic or recurrent locally advanced Merkel cell carcinoma (MCC). The use of retifanlimab in combination with other oncology drugs for the treatment of metastatic gastroesophageal adenocarcinoma has also been evaluated.

Indication: Retifanlimab is indicated for the treatment of adult patients with metastatic or recurrent locally advanced Merkel cell carcinoma.

Associated Conditions: Metastatic Locally Advanced Merkel Cell Carcinoma, Recurrent, locally advanced Merkel Cell Carcinoma

Clinical Trials

Carmustine Wafer in Combination With Retifanlimab and Radiation With/Without Temozolomide in Subjects With Glioblastoma

Phase 1

Recruiting

Conditions: Glioblastoma Multiforme

Interventions: Drug: Retifanlimab
Radiation: Radiation Therapy
Drug: Temozolomide

First Posted Date: 2021-10-19

Last Posted Date: 2025-02-24

Lead Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Target Recruit Count: 50

Registration Number: NCT05083754

Locations: 🇺🇸
Johns Hopkins Medical Institution, Baltimore, Maryland, United States

Study of INCA 0186 in Subjects With Advanced Solid Tumors

Phase 1

Active, not recruiting

Conditions: Squamous Cell Carcinoma of the Head and Neck (SCCHN)
Advanced Solid Tumors
Gastrointestinal (GI) Malignancies

Interventions: Drug: INCA00186
Drug: INCB106385
Drug: Retifanlimab

First Posted Date: 2021-08-04

Last Posted Date: 2025-05-04

Lead Sponsor: Incyte Corporation

Target Recruit Count: 57

Registration Number: NCT04989387

Locations: 🇺🇸
Emory University, Atlanta, Georgia, United States
🇧🇪
Universitair Ziekenhuis Antwerpen (Uza), Edegem, Belgium
🇳🇱
University Medical Center Groningen, Groningen, Netherlands

and more 29 locations

Neoadjuvant Chemotherapy and Retifanlimab in Patients With Selected Sarcomas (TORNADO)

Phase 2

Recruiting

Conditions: Resectable Sarcoma

Interventions: Drug: Doxorubicin
Drug: Ifosfamide
Drug: INCMGA00012

First Posted Date: 2021-07-20

Last Posted Date: 2023-03-03

Lead Sponsor: Institut Bergonié

Target Recruit Count: 66

Registration Number: NCT04968106

Locations: 🇫🇷
Institut Bergonié, Bordeaux, France
🇫🇷
Centre Léon Bérard, Lyon, France
🇫🇷
Institut Curie, Paris, France

and more 1 locations

The Purpose of the Study is to Continue to Provide Pemigatinib to Patients With Advanced Malignancies.

Phase 2

Terminated

Conditions: Advanced Malignancies

Interventions: Drug: Pemigatinib
Drug: Retifanlimab
Drug: Pembrolizumab

First Posted Date: 2021-07-02

Last Posted Date: 2024-05-03

Lead Sponsor: Incyte Corporation

Target Recruit Count: 10

Registration Number: NCT04949191

Locations: 🇺🇸
Virginia Cancer Specialists, Pc, Fairfax, Virginia, United States
🇺🇸
Oncology Specialists of Charlotte, Charlotte, North Carolina, United States
🇮🇹
Istituto Nazionale Tumori Regina Elena Irccs, Rome, Italy

and more 7 locations

Neoantigen-Targeted Vaccine Combined With Anti-PD-1 Antibody for Patients With Stage IV MMR-p Colon and Pancreatic Ductal Cancer

Phase 1

Withdrawn

Conditions: Pancreatic Cancer Metastatic
Colorectal Cancer Metastatic

Interventions: Drug: Neoantigen Vaccine with Poly-ICLC adjuvant
Drug: Retifanlimab

First Posted Date: 2021-03-16

Last Posted Date: 2023-05-09

Lead Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Registration Number: NCT04799431

An Umbrella Study to Determine the Safety and Efficacy of Various Monotherapy or Combination Therapies in Neoadjuvant Urothelial Carcinoma

Phase 2

Terminated

Conditions: Urothelial Carcinoma

Interventions: Drug: retifanlimab
Drug: epacadostat
Drug: INCAGN02385
Drug: INCAGN02390

First Posted Date: 2020-10-14

Last Posted Date: 2025-03-10

Lead Sponsor: Incyte Corporation

Target Recruit Count: 30

Registration Number: NCT04586244

Locations: 🇮🇹
Istituto Tumori Giovanni Paolo Ii Irccs Ospedale Oncologico Bari, Bari, Italy
🇺🇸
Oregon Health & Science University, Portland, Oregon, United States
🇫🇷
Institut Gustave Roussy, Villejuif Cedex, France

and more 9 locations

INCB106385 Alone or in Combination With Immunotherapy in Advanced Solid Tumors

Phase 1

Completed

Conditions: Non Small Cell Lung Cancer
Castration Resistant Prostate Cancer
Colorectal Cancer
Triple Negative Breast Cancer
Gastric/ Gastroesophageal Junction
Squamous Carcinoma of the Anal Canal
Squamous Cell Carcinoma of Head and Neck
Pancreatic Ductal Adenocarcinoma
Ovarian Cancer
Bladder Cancer

Interventions: Drug: INCB106385
Drug: INCMGA00012

First Posted Date: 2020-10-08

Last Posted Date: 2025-02-18

Lead Sponsor: Incyte Corporation

Target Recruit Count: 54

Registration Number: NCT04580485

Locations: 🇧🇪
Cliniques Universitaires Ucl Saint-Luc, Brussels, Belgium
🇺🇸
Cedars-Sinai Medical Center, West Hollywood, California, United States
🇺🇸
University of Maryland-Greenebaum Cancer Center, Baltimore, Maryland, United States

and more 24 locations

Retifanlimab (Anti-PD-1 Antibody) With Gemcitabine and Docetaxel in Patients With Advanced Soft Tissue Sarcoma

Phase 1

Recruiting

Conditions: Sarcoma,Soft Tissue
Sarcoma
Soft Tissue Sarcoma
Soft Tissue Sarcoma Adult

Interventions: Drug: Retifanlimab
Drug: Gemcitabine
Drug: Docetaxel

First Posted Date: 2020-10-06

Last Posted Date: 2025-04-23

Lead Sponsor: Memorial Sloan Kettering Cancer Center

Target Recruit Count: 98

Registration Number: NCT04577014

Locations: 🇺🇸
Memorial Sloan Kettering Cancer Center, New York, New York, United States
🇺🇸
Memorial Sloan Kettering Cancer Center, New York, New York, United States

PD-1 Inhibitor INCMGA00012 as Consolidation Therapy After Definitive Concurrent Chemoradiotherapy

Phase 2

Active, not recruiting

Conditions: Esophageal Cancer

Interventions: Drug: INCMGA00012

First Posted Date: 2020-07-31

Last Posted Date: 2025-04-20

Lead Sponsor: Asan Medical Center

Target Recruit Count: 110

Registration Number: NCT04494009

Locations: 🇰🇷
Asan Medical Center, Seoul, Korea, Republic of

Carboplatin-paclitaxel With Retifanlimab or Placebo in Participants With Locally Advanced or Metastatic Squamous Cell Anal Carcinoma (POD1UM-303/InterAACT 2).

Phase 3

Active, not recruiting

Conditions: Squamous Cell Carcinoma of the Anal Canal

Interventions: Drug: carboplatin
Drug: paclitaxel
Drug: retifanlimab

First Posted Date: 2020-07-15

Last Posted Date: 2024-12-20

Lead Sponsor: Incyte Corporation

Target Recruit Count: 308

Registration Number: NCT04472429

Locations: 🇺🇸
Sansum Clinic, Santa Barbara, California, United States
🇫🇷
Chu Besancon Hospital Jean Minjoz, Besançon, France
🇺🇸
Texas Oncology-Wichita Falls Texoma Cancer Center, Wichita Falls, Texas, United States

and more 80 locations

Drug Development Updates

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