# Retifanlimab

Source: https://onco.cc/drugs/retifanlimab/  
OnCo record `retifanlimab` (Treatment). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

Retifanlimab is a PD-1 antibody approved for Merkel cell carcinoma and, with chemotherapy, as the first immunotherapy standard for advanced anal cancer.

## Summary

Retifanlimab is an IgG4 monoclonal antibody that blocks PD-1 binding to PD-L1 and PD-L2, restoring T-cell activity against tumours. It is used in metastatic or recurrent locally advanced Merkel cell carcinoma and in advanced anal squamous cell carcinoma. POD1UM-201 showed a 52% response rate in chemotherapy-naive metastatic Merkel cell carcinoma, supporting accelerated US approval in 2023 and EU approval in 2024. POD1UM-303/InterAACT-2 (Lancet 2025) randomised patients with first-line advanced anal SCC to carboplatin-paclitaxel with or without retifanlimab, and adding the antibody improved both progression-free and overall survival, leading to approval in 2025 for the combination and for monotherapy after platinum. It is the first immunotherapy standard for anal cancer. Retifanlimab shows that adding checkpoint blockade to chemotherapy can lengthen survival in a virus-driven cancer.

## Fields

- Kind: Treatment
- Status: approved
- Last checked: 2026-09-08
- Tags: gap-fill
- Brand: Zynyz
- Modality: Anti-PD-1 monoclonal antibody (IgG4)
- Mechanism: Blocks PD-1 binding to PD-L1/PD-L2, restoring T-cell activity.
- Approvals: US 2023: Metastatic or recurrent locally advanced Merkel cell carcinoma; US 2025: Locally recurrent or metastatic anal SCC with carboplatin-paclitaxel; monotherapy after platinum; EU 2024: Merkel cell carcinoma

## Sources

- Wikipedia: https://en.wikipedia.org/wiki/Retifanlimab
- POD1UM-303 (Lancet 2025): https://doi.org/10.1016/S0140-6736(25)00631-2
- Label (DailyMed): https://dailymed.nlm.nih.gov/dailymed/search.cfm?labeltype=all&query=retifanlimab

## Connected records

- cancers: [Anal cancer (squamous cell carcinoma)](https://onco.cc/cancers/anal/), [Merkel cell carcinoma](https://onco.cc/cancers/merkel-cell-carcinoma/), [Metastatic and recurrent anal squamous cell carcinoma](https://onco.cc/cancers/metastatic-anal-cancer/), [Skin cancer (all types)](https://onco.cc/cancers/skin-cancer/)
- technologies: [Immune checkpoint inhibitors](https://onco.cc/technologies/checkpoint-inhibitor/)
- targets: [PD-1](https://onco.cc/targets/pd1/), [PDCD1LG2](https://onco.cc/targets/pdcd1lg2/)
- companies: [Incyte](https://onco.cc/companies/incyte/)
- pathways: [Oncogenic viruses](https://onco.cc/pathways/oncogenic-viruses/), [PD-1 / PD-L1 immune checkpoint & T-cell activation](https://onco.cc/pathways/pd1-checkpoint/)
- trials: [Combination Margetuximab, Retifanlimab, Tebotelimab, and Chemotherapy Phase 2/3 Trial in HER2+ Gastric/GEJ Cancer](https://onco.cc/trials/nct04082364/), [INTUITT-NF2](https://onco.cc/trials/intuitt-nf2/), [NIMBLE-CRC: NeoImmunoModulation Before Leveraging Excision in Colorectal Rectal Cancer](https://onco.cc/trials/nct07677579/), [Phase I/II Study of the Combination Immunotherapy Regimen: SX-682, TriAdeno Vaccine, Retifanlimab and IL-15 Agonist N-803 (STAR15) for Metastatic Colorectal Can](https://onco.cc/trials/nct06149481/), [POD1UM-201 (retifanlimab in advanced Merkel cell carcinoma)](https://onco.cc/trials/pod1um-201/), [POD1UM-303/InterAACT-2](https://onco.cc/trials/pod1um-303/), [Retifanlimab and Ruxolitinib In Solid Malignancies](https://onco.cc/trials/nct07219576/), [Study of Retinfanlimab in Combination With INCAGN02385 and INCAGN02390 as First-Line Treatment in Participants With PD-L1-Positive (CPS ≥ 1) Recurrent/Metastatic Squamous Cell Carcinoma of the Head and Neck](https://onco.cc/trials/nct05287113/), [Study of the Bria-IMT Regimen and CPI vs Physicians' Choice in Advanced Metastatic Breast Cancer.](https://onco.cc/trials/nct06072612/), [Vilastobart+Retifanlimab in BRCA or PALB2 Deficient PC](https://onco.cc/trials/nct07765836/)
- terms: [Merkel cell polyomavirus (MCPyV) status](https://onco.cc/terms/mcpyv-status/)
- key papers: [POD1UM-303/InterAACT-2: retifanlimab with carboplatin and paclitaxel for locally recurrent or metastatic anal squamous cell carcinoma](https://onco.cc/key-papers/paper-pod1um-303-retifanlimab-anal-cancer-rao-lancet-2025/)

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