Retifanlimab (Zynyz)

Immunotherapy · Approved since 2023

US FDA Approved ES Not available IV 5 Clinical Trials
PD-1

Description

Retifanlimab is a humanized monoclonal antibody that functions as a PD-1 (programmed death-1) immune checkpoint inhibitor used in colorectal cancer treatment. In CRC, it is primarily utilized for patients with microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) tumors, as indicated by mutations in MLH1, MSH2, MSH6, or PMS2 genes. The drug works by blocking the PD-1 receptor on T-cells, thereby preventing cancer cells from evading immune system detection and destruction. Retifanlimab has also been explored in combination regimens with other immunotherapeutic agents for metastatic colorectal cancer.

Mechanism of Action

Retifanlimab binds to the PD-1 receptor on activated T-lymphocytes, blocking the interaction between PD-1 and its ligands PD-L1 and PD-L2. This blockade prevents the inhibitory signals that normally suppress T-cell activation, allowing the immune system to maintain its anti-tumor response. By removing this immune checkpoint brake, retifanlimab enables enhanced T-cell proliferation and cytotoxic activity against cancer cells.

Molecular Targets

Side Effects

Fatigue Skin rash Diarrhea Decreased appetite Nausea Pruritus Musculoskeletal pain Hypothyroidism

Not all side effects are listed. Side effects vary by individual. Always consult your oncologist.

Clinical Trials

NCT06149481 Phase 1
Recruiting
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)
United States
NCT07425054 Phase 2
Not yet recruiting
ctHPVDNA Response-Adapted Chemoradiation +/- Retifanlimab Treatment in Locally-Advanced Anal Cancer
United States
NCT04799431 Phase 1
Archived
Neoantigen-Targeted Vaccine Combined With Anti-PD-1 Antibody for Patients With Stage IV MMR-p Colon and Pancreatic Ductal Cancer
Multiple
NCT04989387 Phase 1
Terminated
Study of INCA 0186 in Subjects With Advanced Solid Tumors
United States, Austria, Belgium, Netherlands, Spain, United Kingdom
NCT04472429 Phase 3
Completed
Carboplatin-paclitaxel With Retifanlimab or Placebo in Participants With Locally Advanced or Metastatic Squamous Cell Anal Carcinoma (POD1UM-303/InterAACT 2).
United States, Australia, Belgium, Denmark, France, Germany, Italy, Japan, Norwa