Drugs / Retifanlimab
Retifanlimab
also known as
INCMGA00012 · MGA012 · retifanlimab-dlwr · AEX-1188 · INCMGA-0012 · MGA012 also known as INCMGA00012 · Ref · ZYNYZ
Monoclonal antibody targets PDCD1 via inhibition
Regulatory milestones approvals, filings & regulatory actions · 1 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Approved | EU (EMA) | Zynyz | — | 2024-04-19 | europa.eu ↗ |
Trials 63 · started per year
today
EU approved 2024
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| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 01 trial | ||||||
| Phase 0 | NCT06610682 | Apr 2025 → Jun 2027 expected | — | Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | Recruiting | No outcome recorded |
| Phase 116 trials | ||||||
| Phase 1 | NCT06896188 | Sep 2025 → Sep 2027 expected | pancreatic adenocarcinoma | Anwaar Saeed | Recruiting | No outcome recorded |
| Phase 1 | NCT06290622 | Aug 2024 → Jun 2026 | diffuse large B-cell lymphoma, follicular lymphoma | University of Alabama at Birmingham | Withdrawn | No outcome recorded |
| Phase 1 | NCT05743595 | Oct 2023 → Apr 2026 overdue | glioblastoma | Washington University School of Medicine | Active not recruiting | No outcome recorded |
| Phase 1 | NCT04799431 | May 2023 | colorectal cancer, pancreatic ductal adenocarcinoma | Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | Withdrawn | No outcome recorded |
| Phase 1 | NCT05440942 | Jan 2023 → May 2025 | pancreatic ductal adenocarcinoma | Peter Hosein, MD | Completed | No outcome recorded |
| Phase 1 | NCT05083754 | Aug 2022 → Jan 2028 expected | glioblastoma | Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | Recruiting | No outcome recorded |
| Phase 1 | NCT04989387 | Oct 2021 → Sep 2024 | digestive system cancer, head and neck squamous cell carcinoma | Incyte Corporation | Terminated | No outcome recorded |
| Phase 1 | NCT04470024 | Aug 2021 → Dec 2027 expected | head and neck cancer | Providence Health & Services | Recruiting | No outcome recorded |
| Phase 1 | NCT04580485 | Feb 2021 → Jan 2024 | anal canal squamous cell carcinoma, castration-resistant prostate carcinoma, gastroesophageal cancer, head and neck squamous cell carcinoma +6 | Incyte Corporation | Completed | No outcome recorded |
| Phase 1 | NCT03910530 | Jul 2019 → Dec 2021 | cancer, metastatic neoplasm | Incyte Biosciences Japan GK | Completed | No outcome recorded |
| Phase 1 | NCT03920839 | Jul → Nov 2019 | malignant pleural mesothelioma, non-small cell lung carcinoma | Incyte Corporation | Withdrawn | No outcome recorded |
| Phase 1 | NCT03522142 | Aug 2018 → Sep 2025 | cancer | Incyte Corporation | Terminated | No outcome recorded |
| Phase 1 | NCT03589651 | Aug 2018 → Nov 2022 | — | Incyte Corporation | Completed | No outcome recorded |
| Phase 1 | NCT03406949 | Feb 2018 → Apr 2022 | neoplasm | MacroGenics | Completed | No outcome recorded |
| Phase 1 | NCT03059823 | Nov 2016 → May 2024 | metastatic neoplasm | Incyte Corporation | Completed | No outcome recorded |
| Phase 1 | NCT02475213 | Jul 2015 → Aug 2021 | head and neck cancer, melanoma, non-small cell lung carcinoma, urothelial carcinoma | MacroGenics | Completed | No outcome recorded |
| Phase 1/212 trials | ||||||
| Phase 1/2 | NCT07472322 | Jul 2026 → May 2031 expected | cutaneous neuroendocrine carcinoma | University of Wisconsin, Madison | Not yet recruiting | No outcome recorded |
| Phase 1/2 | NCT07468136 | Jun 2026 → Oct 2030 expected | IDH-wildtype glioblastoma, anaplastic oligodendroglioma, astrocytoma, IDH-mutant, grade 3, astrocytoma, IDH-mutant, grade 4 +1 | Mayo Clinic | Recruiting | No outcome recorded |
| Phase 1/2 | NCT07219576 | Jan 2026 → Dec 2027 expected | non-small cell lung carcinoma, renal cell carcinoma | University of California, San Diego | Recruiting | No outcome recorded |
| Phase 1/2 | NCT06873789 | Jun 2025 → Jul 2026 overdue | cancer, metastatic neoplasm | Incyte Corporation | Active not recruiting | No outcome recorded |
| Phase 1/2 | NCT06320405 | May 2024 → Apr 2027 expected | cancer | OHSU Knight Cancer Institute | Recruiting | No outcome recorded |
| Phase 1/2 | NCT06149481 | Mar 2024 → Oct 2027 expected | colorectal cancer | National Cancer Institute (NCI) | Recruiting | No outcome recorded |
| Phase 1/2 | NCT05455697 | Jan 2023 → Oct 2026 expected | high grade B-cell lymphoma | University of Washington | Active not recruiting | No outcome recorded |
| Phase 1/2 | NCT04577014 | Sep 2020 → Sep 2026 expected | soft tissue sarcoma | Memorial Sloan Kettering Cancer Center | Recruiting | No outcome recorded |
| Phase 1/2 | NCT04370704 | Jul 2020 → Aug 2025 | melanoma | Incyte Corporation | Completed | No outcome recorded |
| Phase 1/2 | NCT03531632 | Jun 2018 → Feb 2020 | colorectal cancer | MacroGenics | Completed | No outcome recorded |
| Phase 1/2 | NCT03328026 | Mar 2018 → Mar 2026 | breast cancer | BriaCell Therapeutics Corporation | Completed | No outcome recorded |
| Phase 1/2 | NCT02393248 | Feb 2015 → Dec 2021 | breast cancer, cholangiocarcinoma, endometrial cancer, gastric cancer +4 | Incyte Corporation | Terminated | No outcome recorded |
| Phase 228 trials | ||||||
| Phase 2 | NCT07677579 | Aug 2026 → Aug 2028 expected | malignant colon neoplasm | Northwell Health | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT07425054 | Jun 2026 → Jan 2029 expected | anal squamous cell carcinoma, human papillomavirus-related squamous cell carcinoma | Jennifer Dorth | Recruiting | No outcome recorded |
| Phase 2 | NCT06160206 | Oct 2024 → Nov 2026 expected | glioblastoma | Academic and Community Cancer Research United | Recruiting | No outcome recorded |
| Phase 2 | NCT06389799 | Jun 2024 → Dec 2027 expected | dedifferentiated liposarcoma | Lund University Hospital | Recruiting | No outcome recorded |
| Phase 2 | NCT06056895 | Nov 2023 → Jan 2027 expected | cutaneous neuroendocrine carcinoma | University of Washington | Active not recruiting | No outcome recorded |
| Phase 2 | NCT05359692 | Mar 2023 → Apr 2024 | head and neck squamous cell carcinoma | Incyte Corporation | Withdrawn | No outcome recorded |
| Phase 2 | NCT04968106 | Dec 2022 → Aug 2025 overdue | sarcoma | Institut Bergonié | Active not recruiting | No outcome recorded |
| Phase 2 | NCT05594290 | Dec 2022 → Nov 2025 overdue | cutaneous neuroendocrine carcinoma | Gruppo Oncologico del Nord-Ovest | Active not recruiting | No outcome recorded |
| Phase 2 | NCT05345002 | Nov 2022 → Jun 2027 expected | astrocytoma (excluding glioblastoma), oligodendroglioma | Stephen Bagley, MD, MSCE | Recruiting | No outcome recorded |
| Phase 2 | NCT05287113 | Nov 2022 → Mar 2025 overdue | head and neck cancer | Incyte Corporation | Active not recruiting | No outcome recorded |
| Phase 2 | NCT05239182 | Jan → Dec 2022 | pancreatic adenocarcinoma | Anwaar Saeed | Terminated | No outcome recorded |
| Phase 2 | NCT04586244 | Jan 2022 → Jan 2024 | urothelial carcinoma | Incyte Corporation | Terminated | No outcome recorded |
| Phase 2 | NCT05177133 | Nov 2021 → May 2025 overdue | esophageal adenocarcinoma, gastric adenocarcinoma | Academic Medical Center - University of Amsterdam | Recruiting | No outcome recorded |
| Phase 2 | NCT04949191 | Jul 2021 → Apr 2024 | cancer | Incyte Corporation | Terminated | No outcome recorded |
| Phase 2 | NCT04634825 | Mar 2021 → Jul 2022 | head and neck squamous cell carcinoma | MacroGenics | Terminated | No outcome recorded |
| Phase 2 | NCT04776876 | Mar → Sep 2021 | carcinoid syndrome, neuroendocrine carcinoma | M.D. Anderson Cancer Center | Withdrawn | No outcome recorded |
| Phase 2 | NCT04463771 | Jan 2021 → May 2026 | endometrial cancer | Incyte Corporation | Completed | No outcome recorded |
| Phase 2 | NCT04494009 | Sep 2020 → Dec 2026 expected | esophageal cancer | Asan Medical Center | Active not recruiting | No outcome recorded |
| Phase 2 | NCT04445844 | Jul 2020 → Jun 2025 overdue | female breast carcinoma, triple-negative breast carcinoma | Mridula George, MD | Active not recruiting | No outcome recorded |
| Phase 2 | NCT04225039 | Jun 2020 → Sep 2022 overdue | glioblastoma | University of Pennsylvania | Active not recruiting | No outcome recorded |
| Phase 2 | NCT04374305 | Jun 2020 → Dec 2029 expected | NF2-related schwannomatosis, acoustic neuroma, ependymoma, meningioma | Scott R. Plotkin, MD, PhD | Recruiting | No outcome recorded |
| Phase 2 | NCT04438824 | Jun 2020 → Jun 2026 overdue | liposarcoma | Memorial Sloan Kettering Cancer Center | Active not recruiting | No outcome recorded |
| Phase 2 | NCT04231981 | Apr 2020 → Feb 2022 | squamous cell carcinoma of penis | MedSIR | Completed | No outcome recorded |
| Phase 2 | NCT03532295 | Apr 2020 → Jul 2024 | glioblastoma | Washington University School of Medicine | Completed | No outcome recorded |
| Phase 2 | NCT04116073 | Apr 2020 → Aug 2024 | malignant pancreatic neoplasm | Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | Completed | No outcome recorded |
| Phase 2 | NCT03599713 | Feb 2019 → Jan 2022 | cutaneous neuroendocrine carcinoma | Incyte Corporation | Completed | No outcome recorded |
| Phase 2 | NCT03679767 | Jan 2019 → Apr 2021 | clear cell renal carcinoma, metastatic melanoma, non-small cell lung carcinoma, urothelial neoplasm | Incyte Corporation | Completed | No outcome recorded |
| Phase 2 | NCT03597295 | Oct 2018 → Jun 2020 | anal canal squamous cell carcinoma | Incyte Corporation | Completed | No outcome recorded |
| Phase 2/32 trials | ||||||
| Phase 2/3 | NCT04129320 | Oct 2019 → Oct 2020 | head and neck squamous cell carcinoma | MacroGenics | Withdrawn | No outcome recorded |
| Phase 2/3 | NCT04082364 | Sep 2019 → Jan 2024 | gastric cancer, gastroesophageal junction adenocarcinoma | MacroGenics | Completed | No outcome recorded |
| Phase 34 trials | ||||||
| Phase 3 | NCT06072612 | Dec 2023 → Dec 2027 expected | breast cancer | BriaCell Therapeutics Corporation | Recruiting | No outcome recorded |
| Phase 3 | NCT04472429 | Jan 2021 → Apr 2024 | anal canal squamous cell carcinoma | Incyte Corporation | Completed | No outcome recorded |
| Phase 3 | NCT04205812 | Sep 2020 → Dec 2023 | non-small cell squamous lung carcinoma | Incyte Corporation | Completed | No outcome recorded |
| Phase 3 | NCT04203511 | Jul 2020 → Nov 2023 | non-small cell lung carcinoma | Incyte Corporation | Withdrawn | No outcome recorded |
Also used as a comparator or background therapy in 5 trials
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 13 trials | ||||||
| Phase 1 | NCT06959537 Background | Aug 2025 → Jan 2027 expected | breast cancer | M.D. Anderson Cancer Center | Recruiting | No outcome recorded |
| Phase 1 | NCT06179160 Background | Jan 2024 → Jan 2027 expected | cancer | Incyte Corporation | Recruiting | No outcome recorded |
| Phase 1 | NCT04387084 Background | Aug 2020 → Aug 2026 overdue | skin cancer | University of Southern California | Active not recruiting | No outcome recorded |
| Phase 1/21 trial | ||||||
| Phase 1/2 | NCT06939036 Background | Jul → Dec 2025 | cutaneous neuroendocrine carcinoma, small cell lung carcinoma | Ariceum Therapeutics GmbH | Terminated | No outcome recorded |
| Phase not stated1 trial | ||||||
| — | NCT06910137 Background | — | anal canal squamous cell carcinoma | Incyte Corporation | Available | No outcome recorded |
Press releases naming this drug 15 releases
| Date | Issuer | Release |
|---|---|---|
| 2026-03-06 | Incyte Corporation | Incyte Announces the European Commission Approval of Zynyz® (retifanlimab) for the First-Line Treatment of Advanced Squamous Cell Carcinoma of the Anal Canal (SCAC) incyte.com ↗ |
| 2026-01-30 | Incyte Corporation | Incyte Announces Positive CHMP Opinion for Zynyz® (retifanlimab) for First-Line Treatment of Advanced Squamous Cell Carcinoma of the Anal Canal (SCAC) incyte.com ↗ |
| 2025-12-22 | Incyte Corporation | Incyte Japan Announces Approval of Zynyz® (retifanlimab) for the First-Line Treatment of Advanced Anal Cancer incyte.com ↗ |
| 2025-06-12 | Incyte Corporation | Phase 3 Data for Incyte’s Retifanlimab (Zynyz®) in Patients with Squamous Cell Carcinoma of the Anal Canal (SCAC) Published in The Lancet incyte.com ↗ |
| 2025-05-15 | Incyte Corporation | Incyte Announces FDA Approval of Zynyz® (retifanlimab-dlwr) Making it the First and Only Approved First-Line Treatment for Advanced Anal Cancer Patients in the United States incyte.com ↗ |
| 2024-12-07 | Incyte Corporation | Incyte Announces Positive Results from Phase 3 Trial Evaluating Retifanlimab (Zynyz®) in Combination with Platinum-Based Chemotherapy in Patients with Non-Small Cell Lung Cancer incyte.com ↗ |
| 2024-09-14 | Incyte Corporation | Incyte’s Retifanlimab (Zynyz®) Extends Progression-Free Survival in Patients with Squamous Cell Anal Carcinoma (SCAC); Data Featured at ESMO 2024 Presidential Symposium incyte.com ↗ |
| 2024-08-21 | Incyte Corporation | Incyte to Present Late-Breaking Phase 3 Results for Retifanlimab (Zynyz®) and Initial Data from Phase 1 CDK2 Inhibitor Program at the European Society of Medical Oncology (ESMO) Congress 2024 incyte.com ↗ |
| 2023-03-22 | Incyte Corporation | Incyte Announces FDA Approval of Zynyz™ (retifanlimab-dlwr) for the Treatment of Metastatic or Recurrent Locally Advanced Merkel Cell Carcinoma (MCC) incyte.com ↗ |
| 2021-07-23 | Incyte Corporation | Incyte Provides Regulatory Update on Retifanlimab for the Treatment of Certain Patients with Squamous Cell Carcinoma of the Anal Canal (SCAC) incyte.com ↗ |
| 2021-06-24 | Incyte Corporation | Incyte Announces Outcome of FDA Oncologic Drugs Advisory Committee (ODAC) Meeting Reviewing Retifanlimab as a Treatment for Patients with Squamous Cell Carcinoma of the Anal Canal (SCAC) incyte.com ↗ |
| 2021-02-26 | Incyte Corporation | Incyte Announces the Validation by the European Medicines Agency of its Marketing Authorization Application for Retifanlimab as a Treatment for Patients with Squamous Cell Anal Carcinoma (SCAC) incyte.com ↗ |
| 2021-01-21 | Incyte Corporation | Incyte Announces Acceptance and Priority Review of BLA for Retifanlimab as a Potential Treatment for Patients with Squamous Cell Carcinoma of the Anal Canal (SCAC) incyte.com ↗ |
| 2020-09-18 | Incyte Corporation | Incyte Announces Encouraging Results From Phase 2 Trial of Retifanlimab (INCMGA0012) in Patients With Previously Treated, Advanced Squamous Cell Carcinoma of the Anal Canal incyte.com ↗ |
| 2017-10-25 | Incyte Corporation | Incyte and MacroGenics Announce Global Collaboration and Licensing Agreement for Anti-PD-1 Monoclonal Antibody MGA012 incyte.com ↗ |
Evidence & citations 13 cited values
Every value below carries the sentence it was read from. 70 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Retifanlimab | “Randomized Phase II Study of Neoadjuvant Chemotherapy Plus Retifanlimab (INCMGA00012) in Patients With Selected Sarcomas” NCT04968106 ↗57“A Trial to Evaluate CSF ctDNA and Safety of Plixorafenib Alone or With Retifanlimab in Patients With BRAF-altered Glioma” NCT06610682 ↗ |
| Known as | AEX-1188 | ChEMBL registry synonym — accepted as the source's own label CHEMBL4298037 ↗ |
| Known as | INCMGA-0012 | ChEMBL registry synonym — accepted as the source's own label CHEMBL4298037 ↗ |
| Known as | INCMGA00012 | “Retifanlimab (INCMGA00012)” NCT06910137 ↗ |
| Known as | MGA012 | “INCMGA00012 (also known as MGA012) is a humanized, hinge-stabilized IgG4 monoclonal antibody against human PD-1, which blocks the interaction of PD-1 with PD-L1 and PD-L2,...” NCT04494009 ↗ |
| Known as | MGA012 also known as INCMGA00012 | “MGA012 also known as INCMGA00012” NCT03531632 ↗ |
| Known as | Ref | “Retifanlimab (Ref) was administered once every 4 weeks on a 28-day cycle as an open-label product, at an initial dose of 500 mg over a 60-minute intravenous infusion.” NCT02393248 ↗ |
| Known as | retifanlimab-dlwr | “This study is being done to see if combining ASTX727 (decitabine/cedazuridine) with retifanlimab-dlwr is safe and confers clinical benefit in patients with advanced Merkel cell...” NCT07472322 ↗1“Retifanlimab-dlwr is a programmed death receptor-1 (PD-1)-blocking antibody.” NCT07677579 ↗ |
| Known as | ZYNYZ | “ZYNYZ (retifanlimab-dlwr) injection is a sterile, preservative-free, clear to slightly opalescent, colorless to pale yellow solution for intravenous use.” NCT07677579 ↗ |
| Action | Inhibit | “Combination therapy with retifanlimab (anti-PD-1)” NCT03328026 ↗ |
| Modality | Monoclonal antibody | “anti-PD-1 antibody” NCT03406949 ↗ |
| Route | Intravenous | “Retifanlimab (Ref) was administered once every 4 weeks on a 28-day cycle as an open-label product, at an initial dose of 500 mg over a 60-minute intravenous infusion” NCT02393248 ↗ |
| Target | PDCD1 | “Retifanlimab, a humanized IgG4 mAb, binds to PD-1 and blocks its interaction with PD-L1/2.” PMID 33263418 ↗ Dec 2020 |