Also known as: retifanlimab-dlwr, Zynyz
Retifanlimab-dlwr is marketed as ZYNYZ, a PD-1-blocking monoclonal antibody for specific anal canal squamous cell carcinoma settings and for Merkel cell carcinoma. The label describes blockade of PD-1 interaction with PD-L1/PD-L2 to potentiate T-cell activity. U.S. initial approval was in 2023, with 2025 label updates including SCAC indications.
Soft tissue sarcoma pipeline activity includes 70+ companies and 75+ therapies. A phase II ADI-PEG 20 trial with gemcitabine and docetaxel was designed for sarcomas, while other 2026 studies span synovial sarcoma and unresectable advanced disease.
Incyte received a Complete Response Letter from the FDA for Zynyz in lung cancer due to third-party manufacturing issues, while the EMA recommended approval for the drug in anal cancer treatment based on Phase 3 trial data.
New combination therapies demonstrate improved outcomes in advanced anal and colorectal cancers, with retifanlimab plus chemotherapy approved for anal cancer and onvansertib showing strong efficacy signals in RAS-mutated colorectal cancer.
Oncolytics Biotech received FDA Fast Track Designation for pelareorep in second-line KRAS-mutant microsatellite-stable metastatic colorectal cancer, based on clinical data showing a 33% response rate and median overall survival of 27 months versus 11.2 months with standard treatment.
| NCT ID | Title | Status | Phase |
|---|---|---|---|
| NCT07468136 |
Retifanlimab With or Without Difluoromethylornithine for the Treatment of Progressive High Grade Gliomas |
NOT_YET_RECRUITING | PHASE1/PHASE2 |
| NCT07425054 |
HPV ctDNA Response-Adapted Chemoradiation +/- Retifanlimab Treatment in Advanced-Stage Anal Cancer |
NOT_YET_RECRUITING | PHASE2 |
| NCT07219576 |
Retifanlimab and Ruxolitinib In Solid Malignancies |
RECRUITING | PHASE1/PHASE2 |
| NCT06959537 |
A Phase Ib 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) |
RECRUITING | PHASE1 |
| NCT06939036 |
Study of 225Ac-SS0110 in Subjects With ES-SCLC or MCC (SANTANA-225 ) |
TERMINATED | PHASE1/PHASE2 |
| NCT06910137 |
An Early Access Program Guideline to Provide Access to Retifanlimab (INCMGA00012) Together With Carboplatin and Paclitaxel for Squamous Carcinoma of the Anal Canal (SCAC) |
AVAILABLE | |
| NCT06896188 |
9-ING-41 Combined With Retifanlimab, Plus Modified FOLFIRINOX for Patients With Advanced Pancreatic Adenocarcinoma (RiLEY) |
RECRUITING | PHASE1 |
| NCT06873789 |
A Study to Evaluate INCB177054 in Participants With Select Advanced or Metastatic Solid Tumors |
ACTIVE_NOT_RECRUITING | PHASE1/PHASE2 |
| NCT06610682 |
A Trial to Evaluate CSF ctDNA and Safety of Plixorafenib Alone or With Retifanlimab in Patients With BRAF-altered Glioma |
RECRUITING | EARLY_PHASE1 |
| NCT06389799 |
A Phase 2, Open Label Study of PEmigatinib and REtifanlimab in Advanced Dedifferentiated LIposarcoma (PERELI) |
RECRUITING | PHASE2 |
