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

A Study of INCMGA00012, INCB001158, and the Combination in Japanese Participants With Advanced Solid Tumors

Phase 1

Completed

Conditions: Advanced Solid Tumors
Metastatic Solid Tumors

Interventions: Drug: INCB001158
Drug: Retifanlimab + INCB001158
Drug: Retifanlimab

First Posted Date: 2019-04-10

Last Posted Date: 2022-02-25

Lead Sponsor: Incyte Biosciences Japan GK

Target Recruit Count: 18

Registration Number: NCT03910530

Locations: 🇯🇵
National Cancer Center Hospital East, Kashiwa, Japan
🇯🇵
National Cancer Center Hospital, Chuo Ku, Japan

A Study of INCMGA00012 in Participants With Selected Solid Tumors (POD1UM-203)

Phase 2

Completed

Conditions: Metastatic Non-small Cell Lung Cancer
Metastatic Melanoma
Locally Advanced Renal Cell Carcinoma
Locally Advanced Urothelial Cancer
Metastatic Urothelial Cancer
Unresectable Melanoma
Metastatic Clear-Cell Renal Cell Carcinoma

Interventions: Drug: Retifanlimab

First Posted Date: 2018-09-20

Last Posted Date: 2023-07-21

Lead Sponsor: Incyte Corporation

Target Recruit Count: 121

Registration Number: NCT03679767

Locations: 🇺🇸
Texas Oncology - Waco, Waco, Texas, United States
🇦🇹
LKH Graz, Graz, Austria
🇺🇸
California Cancer Associates for Research and Excellence, Inc., San Marcos, California, United States

and more 48 locations

A Study of INCMGA00012 in Metastatic Merkel Cell Carcinoma (POD1UM-201)

Phase 2

Completed

Conditions: Metastatic Merkel Cell Carcinoma

Interventions: Drug: Retifanlimab

First Posted Date: 2018-07-26

Last Posted Date: 2024-10-15

Lead Sponsor: Incyte Corporation

Target Recruit Count: 107

Registration Number: NCT03599713

Locations: 🇺🇸
Stanford Cancer Institute, Palo Alto, California, United States
🇺🇸
Upmc Cancercenter, Pittsburgh, Pennsylvania, United States
🇺🇸
Roswell Park Cancer Institute, Buffalo, New York, United States

and more 62 locations

A Study of INCMGA00012 in Squamous Carcinoma of the Anal Canal Following Platinum-Based Chemotherapy (POD1UM-202)

Phase 2

Completed

Conditions: Squamous Cell Carcinoma of Anal Canal

Interventions: Drug: Retifanlimab

First Posted Date: 2018-07-24

Last Posted Date: 2022-11-17

Lead Sponsor: Incyte Corporation

Target Recruit Count: 94

Registration Number: NCT03597295

Locations: 🇩🇰
Vejle Hospital, Vejle, Denmark
🇫🇷
Centre Hospitalier Universitaire de Besancon, Besancon, France
🇺🇸
Maryland Oncology Hematology P.A., Rockville, Maryland, United States

and more 43 locations

INCMGA00012 in Combination With Other Therapies in Patients With Advanced Solid Tumors

Phase 1

Completed

Conditions: Unresectable or Metastatic Solid Tumors

Interventions: Drug: Retifanlimab
Drug: Epacadostat
Drug: INCB050465

First Posted Date: 2018-07-18

Last Posted Date: 2023-02-21

Lead Sponsor: Incyte Corporation

Target Recruit Count: 83

Registration Number: NCT03589651

Locations: 🇺🇸
Rutgers Cancer Institute of Nj, New Brunswick, New Jersey, United States
🇺🇸
Upmc Cancercenter, Pittsburgh, Pennsylvania, United States
🇺🇸
Roswell Park Cancer Institute, Buffalo, New York, United States

and more 6 locations

Retifanlimab and Epacadostat in Combination With Radiation and Bevacizumab in Patients With Recurrent Gliomas

Phase 2

Active, not recruiting

Conditions: Glioma
Glioblastoma

Interventions: Drug: Bevacizumab
Drug: Epacadostat
Radiation: Radiation therapy
Procedure: Peripheral blood draw
Drug: Retifanlimab

First Posted Date: 2018-05-22

Last Posted Date: 2024-08-05

Lead Sponsor: Washington University School of Medicine

Target Recruit Count: 51

Registration Number: NCT03532295

Locations: 🇺🇸
Washington University School of Medicine, Saint Louis, Missouri, United States
🇺🇸
Mayo Clinic, Rochester, Minnesota, United States
🇺🇸
Wake Forest Baptist Medical Center, Winston-Salem, North Carolina, United States

A Study Exploring the Safety and Tolerability of INCB081776 in Participants With Advanced Malignancies

Phase 1

Active, not recruiting

Conditions: Advanced Solid Tumors

Interventions: Drug: INCB081776
Drug: INCMGA00012

First Posted Date: 2018-05-11

Last Posted Date: 2024-12-19

Lead Sponsor: Incyte Corporation

Target Recruit Count: 84

Registration Number: NCT03522142

Locations: 🇺🇸
Hackensack University Medical Center, Hackensack, New Jersey, United States
🇺🇸
University of Pennsylvania Abramson Cancer Center, Philadelphia, Pennsylvania, United States
🇺🇸
Dana Farber Cancer Institute, Boston, Massachusetts, United States

and more 15 locations

Combination Study of SV-BR-1-GM With Retifanlimab

Phase 1

Conditions: Breast Cancer
Breast Cancer Metastatic
Breast Neoplasm
Metastatic Breast Cancer

Interventions: Biological: SV-BR-1-GM
Drug: Low dose cyclophosphamide
Drug: Interferon Inoculation
Drug: retifanlimab

First Posted Date: 2017-11-01

Last Posted Date: 2025-02-04

Lead Sponsor: BriaCell Therapeutics Corporation

Target Recruit Count: 36

Registration Number: NCT03328026

Locations: 🇺🇸
Nebraska Cancer Specialists, Omaha, Nebraska, United States
🇺🇸
St. Joseph Heritage Healthcare, Santa Rosa, California, United States
🇺🇸
St Vincent-Frontier Cancer Center, Billings, Montana, United States

and more 11 locations

A Phase 1 Study of INCMGA00012 in Patients With Advanced Solid Tumors

Phase 1

Completed

Conditions: Locally Advanced Solid Tumors
Metastatic Solid Tumors

Interventions: Drug: retifanlimab

First Posted Date: 2017-02-23

Last Posted Date: 2024-06-13

Lead Sponsor: Incyte Corporation

Target Recruit Count: 325

Registration Number: NCT03059823

Locations: 🇵🇱
Szpital Kliniczny Przemienienia Panskiego, Poznan, Poland
🇵🇱
Medical University of Warsaw - 2Nd Department Obstetric and Gynecology, Warsaw, Poland
🇵🇱
Centrum Onkologii - Instytut Im. Marii Sklodowskiej - Curie, Warsaw, Poland

and more 76 locations

Open-Label, Dose-Escalation Study of Pemigatinib in Subjects With Advanced Malignancies - (FIGHT-101)

Phase 1

Terminated

Conditions: UC
MPN
Lung Cancer
Solid Tumor
Gastric Cancer
Urothelial Cancer
Endometrial Cancer
Multiple Myeloma
Myeloproliferative Neoplasms
Breast Cancer

Interventions: Drug: Pemigatinib
Drug: Docetaxel
Drug: Pembrolizumab
Drug: Gemcitabine
Drug: Trastuzumab
Drug: Retifanlimab
Drug: Cisplatin

First Posted Date: 2015-03-19

Last Posted Date: 2023-01-06

Lead Sponsor: Incyte Corporation

Target Recruit Count: 201

Registration Number: NCT02393248

Locations: 🇺🇸
Ohio State University - Wexner Medical Center, Columbus, Ohio, United States
🇺🇸
South Texas Accelerated Research Therapeutics, San Antonio, Texas, United States
🇺🇸
University of Michigan Health System, Ann Arbor, Michigan, United States

and more 17 locations

Drug Development Updates

Stay informed with timely notifications on clinical trials, regulatory changes, and research advancements related to this medication.

Home Terms & Conditions Privacy Policy