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retifanlimab

Generic: retifanlimab·Brand: Zynyz

retifanlimab: developed by 1 company · 35 clinical trials tracked · 1 FDA decision.

retifanlimab evidence translation

What we can confirm

1 FDA record · 35 tracked trials

What it means

Source-backed records connect retifanlimab to INCY; that link alone does not prove the drug works.

What to watch

Watch active trials and any change in FDA or trial status.
BioSniper AIPage evidence connected

Prepared research question

How could retifanlimab → INCY affect its developer, and what evidence supports the link?

Run cited research

Traceable citations · Unknowns marked

See linked entities and source evidence8 indications · 2 study sponsors
Development Pipeline (1)
CompanyPhase
Incyte Corp. (INCY)Approved
Clinical Trials (35)showing 10 most recent

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
Expanded AccessIncyte Corporation

A Phase 2 Study of Fc Enhanced checKpoint bLockade With CTLA4 Antibody Vilastobart in Combination With PD-1 antibodY RetifAnlimab in BRCA or PALB2 Deficient Pancreatic Adenocarcinoma (EKLAVYA-HRD)

NCT07765836·Phase 2
Not yet recruiting

Primary endpoint: Objective response rate (ORR)

Interventionalopen40 targetStarted 2027-01Completion 2030-121 site · United StatesMassachusetts General Hospital

ctHPVDNA Adapted ChemoRadiation +/- Retifanlimab Treatment in Locally-Advanced Anal Cancer (CHART-AC)

NCT07425054·Phase 2
Recruiting

Primary endpoint: 1-year Disease-free survival (DFS) by response subgroup

Interventionalopen33 targetStarted 2026-06Completion 2029-012 sites · United StatesJennifer Dorth

PRISM: Phase 1b of Retifanlimab and Ruxolitinib In Solid Malignancies Progressing on Prior Checkpoint Inhibition

NCT07219576·Phase 1/Phase 2
Recruiting

Primary endpoint: Recommended phase 2 dose

Interventionalopen40 targetStarted 2026-01Completion 2029-121 site · United StatesUniversity of California, San Diego

A Phase Ib Study of 9-ING-41 (Elraglusib), a Glycogen Synthase Kinase 3-beta (GSK-3β) Inhibitor, Combined With Retifanlimab, a PD-1 Inhibitor, Plus Modified FOLFIRINOX as Frontline Therapy for Patients With Advanced Pancreatic Adenocarcinoma (RiLEY)

NCT06896188·Phase 1
Recruiting

Primary endpoint: Dose Limiting Toxicities (DLTs)

Interventionalopen12 targetStarted 2025-09Completion 2028-121 site · United StatesAnwaar Saeed

A Phase 1/2, Open-Label, Multicenter Study of INCB177054 in Participants With Select Advanced or Metastatic Solid Tumors

NCT06873789·Phase 1/Phase 2·INCY
Active, not recruiting

Primary endpoint: Number of participants with Dose Limiting Toxicities (DLTs)

Interventionalopen9 targetStarted 2025-06Completion 2026-079 sites · United StatesIncyte Corporation

A Trial to Evaluate Deoxyribonucleic) in BRAF (V-raf Murine Sarcoma Viral Oncogene Homolog B1)-Altered Glioma During Treatment With Plixorafenib Alone or With Retifanlimab

NCT06610682·Early Phase 1
Recruiting

Primary endpoint: Detection rate of BRAF-V600E ctDNA in CSF and/or plasma

Interventionalopen24 targetStarted 2025-04Completion 2028-061 site · United StatesSidney Kimmel Comprehensive Cancer Center at Johns Hopkins

A Phase Ib/II Study of Axatilimab in Combination With Retifanlimab and Paclitaxel for the Treatment of Patients With Advanced Solid Tumors

NCT06320405·Phase 1/Phase 2
Recruiting

Primary endpoint: Incidence of dose limiting toxicities (phase Ib)

Interventionalopen38 targetStarted 2024-05Completion 2029-041 site · United StatesOHSU Knight Cancer Institute

A Phase 1, Open-Label, Multicenter Study of INCB161734 in Participants With Advanced or Metastatic Solid Tumors With KRAS G12D Mutation

NCT06179160·Phase 1·INCY
Recruiting

Primary endpoint: Number of participants with Dose Limiting Toxicities (DLTs)

Interventionalopen710 targetStarted 2024-01Completion 2027-0134 sites · Australia, Belgium, Canada, France…Incyte Corporation

Randomized, Open-Label Study of the Bria-IMT Regimen and Check Point Inhibitor vs Physicians' Choice in Advanced Metastatic Breast Cancer.

NCT06072612·Phase 3·BCTX
Recruiting

Primary endpoint: Overall Survival

InterventionalRandomizedopen404 targetStarted 2023-12Completion 2028-0650 sites · United StatesBriaCell Therapeutics Corporation
FDA Decisions1 records
Approval1 INDICATIONS AND USAGE ZYNYZ is a programmed death receptor-1 (PD-1)–blocking antibody indicated: Squamous Cell Carcinoma of the Anal Canal (SCAC) in combination with carboplatin and paclitaxel for the first-line treatment of adult patients with inoperable locally recurrent or metastatic squamous cell carcinoma of the anal canal (SCAC). ( 1.1 ) as a single agent for the treatment of adult patients with locally recurrent or metastatic SCAC with disease progression on or intolerance to platinum-b(INCY)FDA ↗
BLA761334Type 1 - New Molecular EntityOrphan DrugPriorityIntravenousInjectable

Frequently asked questions

Who is developing retifanlimab?

retifanlimab is being developed by Incyte Corp..

How many clinical trials involve retifanlimab?

BioSniper tracks 35 clinical trials involving retifanlimab.

What is retifanlimab's latest FDA decision?

The most recent tracked FDA decision for retifanlimab is Approval for 1 INDICATIONS AND USAGE ZYNYZ is a programmed death receptor-1 (PD-1)–blocking antibody indicated: Squamous Cell Carcinoma of the Anal Canal (SCAC) in combination with carboplatin and paclitaxel for the first-line treatment of adult patients with inoperable locally recurrent or metastatic squamous cell carcinoma of the anal canal (SCAC). ( 1.1 ) as a single agent for the treatment of adult patients with locally recurrent or metastatic SCAC with disease progression on or intolerance to platinum-b, dated March 22, 2023.