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

Phase Ib Trial of Multivalent Autophagosome Vaccine With or Without GITR Agonist, With Anti-PD-1 Immunotherapy in HNSCC

Phase 1

Recruiting

Conditions: Cancer of the Head and Neck

Interventions: Drug: INCMGA00012
Drug: INCAGN01876
Biological: DPV-001

First Posted Date: 2020-07-14

Last Posted Date: 2024-06-21

Lead Sponsor: Providence Health & Services

Target Recruit Count: 56

Registration Number: NCT04470024

Locations: 🇺🇸
Portland Providence Medical Center, Portland, Oregon, United States

Safety and Efficacy of Retifanlimab (INCMGA00012) Alone or in Combination With Other Therapies in Participants With Advanced or Metastatic Endometrial Cancer Who Have Progressed on or After Platinum-based Chemotherapy.

Phase 2

Active, not recruiting

Conditions: Endometrial Cancer

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

First Posted Date: 2020-07-09

Last Posted Date: 2025-04-24

Lead Sponsor: Incyte Corporation

Target Recruit Count: 300

Registration Number: NCT04463771

Locations: 🇺🇸
Advent Health Medical Group-Orlando 2501, Orlando, Florida, United States
🇺🇸
H. Lee Moffitt Cancer Center and Research Institute Hospital, Tampa, Florida, United States
🇺🇸
Alaska Womens Cancer Care Akwcc, Anchorage, Alaska, United States

and more 62 locations

INCMGA00012 and Pelareorep for the Treatment of Metastatic Triple Negative Breast Cancer, IRENE Study

Phase 2

Active, not recruiting

Conditions: Prognostic Stage IV Breast Cancer AJCC v8
Triple-negative Breast Cancer
Locally Advanced Breast Carcinoma
Anatomic Stage IV Breast Cancer AJCC v8
Metastatic Triple-Negative Breast Carcinoma

Interventions: Biological: Pelareorep
Other: Quality-of-Life Assessment
Other: Questionnaire Administration
Biological: Retifanlimab

First Posted Date: 2020-06-24

Last Posted Date: 2025-04-04

Lead Sponsor: Mridula George, MD

Target Recruit Count: 25

Registration Number: NCT04445844

Locations: 🇺🇸
Rutgers Cancer Institute of New Jersey, New Brunswick, New Jersey, United States
🇺🇸
The Ohio State University Stefanie Spielman Comprehensive Breast Center, Columbus, Ohio, United States

Palbociclib and INCMGA00012 in People With Advanced Liposarcoma

Phase 2

Active, not recruiting

Conditions: Well-differentiated/Dedifferentiated Liposarcoma

Interventions: Drug: INCMGA00012
Drug: Palbociclib

First Posted Date: 2020-06-19

Last Posted Date: 2024-08-21

Lead Sponsor: Memorial Sloan Kettering Cancer Center

Target Recruit Count: 42

Registration Number: NCT04438824

Locations: 🇺🇸
Memorial Sloan Kettering Bergen (Limited Protocol Activities), Montvale, New Jersey, United States
🇺🇸
Memorial Sloan Kettering Monmouth (Limited Protocol Activities), Middletown, New Jersey, United States
🇺🇸
Memorial Sloan Kettering at Basking Ridge (Limited Protocol Activities), Basking Ridge, New Jersey, United States

and more 4 locations

Efficacy of INCMGA00012 in Penile Squamous Cell Carcinoma (ORPHEUS)

Phase 2

Conditions: Penile Cancer

Interventions: Drug: INCMGA0012

First Posted Date: 2020-01-18

Last Posted Date: 2023-01-19

Lead Sponsor: MedSIR

Target Recruit Count: 18

Registration Number: NCT04231981

Locations: 🇮🇹
IRCCS Ospedale San Raffaele, Milano, Italy
🇮🇹
Fondazione IRCCS Istituto Nazionale dei Tumori, Milano., Milan, Italy
🇪🇸
Hospital de la Santa Creu i Sant Pau, Barcelona, Spain

and more 10 locations

Anti-GITR/Anti-PD1/Stereotactic Radiosurgery, in Recurrent Glioblastoma

Phase 2

Active, not recruiting

Conditions: Glioblastoma

Interventions: Drug: INCMGA00012
Drug: INCAGN01876
Drug: SRS
Procedure: Brain surgery

First Posted Date: 2020-01-13

Last Posted Date: 2025-02-25

Lead Sponsor: University of Pennsylvania

Target Recruit Count: 39

Registration Number: NCT04225039

Locations: 🇺🇸
Hospital of the University of Pennsylvania, Philadelphia, Pennsylvania, United States

Platinum-Based Chemotherapy With/Without INCMGA00012, an Anti-PD-1 Antibody, in Non-Small Cell Lung Cancer

Phase 3

Active, not recruiting

Conditions: Metastatic Squamous Non-Small Cell Lung Cancer
Metastatic Nonsquamous Non-Small Cell Lung Cancer

Interventions: Drug: Retifanlimab
Drug: Placebo
Drug: Pemetrexed
Drug: Cisplatin
Drug: Paclitaxel
Drug: Carboplatin
Drug: nab-Paclitaxel

First Posted Date: 2019-12-19

Last Posted Date: 2025-05-13

Lead Sponsor: Incyte Corporation

Target Recruit Count: 583

Registration Number: NCT04205812

Locations: 🇹🇷
Trakya Universitesi Tip Fakultesi, Edirne, Turkey
🇿🇦
Wits Clinical Research, Johannesburg, South Africa
🇺🇦
Kherson Regional Oncologic Dispensary, Kherson, Ukraine

and more 135 locations

INCMGA00012 in Combination With Chemoradiation in Participants With Stage III Non-Small Cell Lung Cancer (POD1UM-301)

Phase 3

Withdrawn

Conditions: Non-small Cell Lung Cancer

Interventions: Drug: Retifanlimab
Drug: Placebo
Drug: Pemetrexed
Drug: Cisplatin
Drug: Carboplatin
Drug: Paclitaxel
Drug: Etoposide
Radiation: Radiotherapy

First Posted Date: 2019-12-18

Last Posted Date: 2020-06-09

Lead Sponsor: Incyte Corporation

Registration Number: NCT04203511

Combination Margetuximab, Retifanlimab, Tebotelimab, and Chemotherapy Phase 2/3 Trial in HER2+ Gastric/GEJ Cancer

Phase 2

Completed

Conditions: Gastric Cancer
Gastroesophageal Junction Cancer
HER2-positive Gastric Cancer

Interventions: Biological: margetuximab
Biological: Trastuzumab
Biological: Retifanlimab
Other: Chemotherapy
Biological: Tebotelimab

First Posted Date: 2019-09-09

Last Posted Date: 2025-04-22

Lead Sponsor: MacroGenics

Target Recruit Count: 82

Registration Number: NCT04082364

Locations: 🇺🇸
Rutgers Cancer Institute of New Jersey, New Brunswick, New Jersey, United States
🇺🇸
Mayo Clinic - Scottsdale, Scottsdale, Arizona, United States
🇺🇸
City of Hope Comprehensive Cancer Center - Duarte, Duarte, California, United States

and more 70 locations

INCMGA00012 Plus Chemotherapy in Participants With Advanced Solid Tumors (POD1UM-105)

Phase 1

Withdrawn

Conditions: Advanced and/or Metastatic Solid Tumors
Stage IIIB Not Amenable to Curative Therapy to Stage IV Non-small Cell Lung Cancer
Advanced/Metastatic Unresectable Malignant Pleural Mesothelioma

Interventions: Drug: Retifanlimab
Drug: Gemcitabine
Drug: Cisplatin
Drug: Pemetrexed
Drug: Carboplatin
Drug: Paclitaxel

First Posted Date: 2019-04-19

Last Posted Date: 2020-04-24

Lead Sponsor: Incyte Corporation

Registration Number: NCT03920839

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