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
A Phase Ib/II Study of Novel Combination (New) of Low Dose Oral CyclophoSphamide (s) to Potentiate Axatilimab (A) + Retifanlimab (R) in Treating Metastatic Triple Negative Breast Cancer (TNBC)
- Conditions
- Breast Cancer
- Interventions
- First Posted Date
- 2025-05-06
- Last Posted Date
- 2025-05-06
- Lead Sponsor
- M.D. Anderson Cancer Center
- Target Recruit Count
- 24
- Registration Number
- NCT06959537
- Locations
- 🇺🇸
The University of Texas M. D. Anderson Cancer Center, Houston, Texas, United States
Study of 225Ac-SS0110 in Subjects With ES-SCLC or MCC (SANTANA-225 )
- Conditions
- Small Cell Lung Cancer Extensive StageMerkel Cell Carcinoma
- Interventions
- Drug: 225Ac-SSO110 + SoC
- First Posted Date
- 2025-04-22
- Last Posted Date
- 2025-04-22
- Lead Sponsor
- Ariceum Therapeutics GmbH
- Target Recruit Count
- 50
- Registration Number
- NCT06939036
- Locations
- 🇺🇸
Biogenix Molecular, Miami, Florida, United States
An Early Access Program Guideline to Provide Access to Retifanlimab (INCMGA00012) Together With Carboplatin and Paclitaxel for Squamous Carcinoma of the Anal Canal (SCAC)
- Conditions
- Squamous Cell Carcinoma of the Anal Canal
- First Posted Date
- 2025-04-04
- Last Posted Date
- 2025-04-16
- Lead Sponsor
- Incyte Corporation
- Registration Number
- NCT06910137
9-ING-41 Combined with Retifanlimab, Plus Modified FOLFIRINOX for Patients with Advanced Pancreatic Adenocarcinoma (RiLEY)
- Conditions
- Pancreatic Adenocarcinoma
- Interventions
- First Posted Date
- 2025-03-26
- Last Posted Date
- 2025-03-26
- Lead Sponsor
- Anwaar Saeed
- Target Recruit Count
- 12
- Registration Number
- NCT06896188
- Locations
- 🇺🇸
UPMC Hillman Cancer Center, Pittsburgh, Pennsylvania, United States
A Study to Evaluate INCB177054 in Participants With Select Advanced or Metastatic Solid Tumors
- Conditions
- Solid TumorsAdvanced Solid TumorsMetastatic Solid Tumors
- Interventions
- Drug: INCB177054
- First Posted Date
- 2025-03-13
- Last Posted Date
- 2025-03-18
- Lead Sponsor
- Incyte Corporation
- Target Recruit Count
- 322
- Registration Number
- NCT06873789
A Phase 2, Open Label Study of PEmigatinib and REtifanlimab in Advanced Dedifferentiated LIposarcoma (PERELI)
- Conditions
- Dedifferentiated Liposarcoma
- Interventions
- First Posted Date
- 2024-04-29
- Last Posted Date
- 2024-10-08
- Lead Sponsor
- Lund University Hospital
- Target Recruit Count
- 33
- Registration Number
- NCT06389799
- Locations
- 🇳🇴
Oslo University Hospital HF, Oslo, Norway
🇸🇪Sahlgrenska University Hospital, Göteborg, Sweden
🇸🇪Skåne University Hospital, Lund, Sweden
Axatilimab in Combination With Retifanlimab and Paclitaxel for the Treatment of Patients With Advanced or Metastatic Solid Tumors
- Conditions
- Advanced Malignant Solid NeoplasmMetastatic Malignant Solid NeoplasmRecurrent Malignant Solid NeoplasmRefractory Malignant Solid Neoplasm
- Interventions
- Procedure: BiopsyProcedure: Biospecimen CollectionProcedure: Computed TomographyProcedure: Magnetic Resonance ImagingProcedure: Positron Emission Tomography
- First Posted Date
- 2024-03-20
- Last Posted Date
- 2024-12-16
- Lead Sponsor
- OHSU Knight Cancer Institute
- Target Recruit Count
- 38
- Registration Number
- NCT06320405
- Locations
- 🇺🇸
OHSU Knight Cancer Institute, Portland, Oregon, United States
A Study to Evaluate INCB161734 in Participants With Advanced or Metastatic Solid Tumors With KRAS G12D Mutation
- Conditions
- Solid Tumors
- Interventions
- First Posted Date
- 2023-12-21
- Last Posted Date
- 2025-05-09
- Lead Sponsor
- Incyte Corporation
- Target Recruit Count
- 466
- Registration Number
- NCT06179160
- Locations
- 🇪🇸
Fundacion Jimenez Diaz, Madrid, Spain
🇺🇸Scri Oncology Partners, Nashville, Tennessee, United States
🇺🇸Mayo Clinic Hospital, Phoenix, Arizona, United States
Retifanlimab with Bevacizumab and Hypofractionated Radiotherapy for the Treatment of Recurrent Glioblastoma
- Conditions
- Recurrent WHO Grade 4 GliomaRecurrent Glioblastoma
- Interventions
- Procedure: Biospecimen CollectionProcedure: Computed TomographyOther: Electronic Health Record ReviewRadiation: Hypofractionated Radiation TherapyProcedure: Magnetic Resonance Imaging
- First Posted Date
- 2023-12-07
- Last Posted Date
- 2024-11-19
- Lead Sponsor
- Academic and Community Cancer Research United
- Target Recruit Count
- 134
- Registration Number
- NCT06160206
- Locations
- 🇺🇸
Mayo Clinic in Arizona, Scottsdale, Arizona, United States
🇺🇸Mayo Clinic in Florida, Jacksonville, Florida, United States
🇺🇸Mayo Clinic, Rochester, Minnesota, United States
Phase I/II Study of the Combination Immunotherapy Regimen: SX-682, TriAdeno Vaccine, Retifanlimab and IL-15 Agonist N-803 (STAR15) for Metastatic Colorectal Cancer (mCRC)
- Conditions
- Metastatic Colorectal Cancer
- Interventions
- Biological: Therapeutic CEA, Brachyury and MUC1 TriAdeno Vaccine Platform
- First Posted Date
- 2023-11-29
- Last Posted Date
- 2025-05-20
- Lead Sponsor
- National Cancer Institute (NCI)
- Target Recruit Count
- 60
- Registration Number
- NCT06149481
- Locations
- 🇺🇸
National Institutes of Health Clinical Center, Bethesda, Maryland, United States
Drug Development Updates
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