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 · 7 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed anal canal squamous cell carcinoma 5 milestones | |||||
| Filed | Japan (PMDA) | Zynyz | anal canal squamous cell carcinoma | 2025-07-29 | “in March 2025 submitted and received acceptance of a Japanese New Drug Application (J-NDA) by the Pharmaceuticals and Medical Devices Agency (PMDA) for retifanlimab in advanced SCAC.” incyte.com ↗ “a Japanese New Drug Application (J-NDA) which was accepted by the Pharmaceuticals and Medical Devices Agency (PMDA) for retifanlimab in advanced SCAC.” incyte.com ↗ “a Japanese New Drug Application (J-NDA) for retifanlimab in advanced SCAC.” incyte.com ↗ |
| Filed | EU (EMA) | Zynyz | anal canal squamous cell carcinoma | 2025-05-15 | “In addition to the sBLA in the U.S., Incyte submitted a Type II variation Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) for retifanlimab in...” incyte.com ↗ |
| Rejected (CRL) | US (FDA) | — | anal canal squamous cell carcinoma | 2021-07-23 | “FDA has issued a Complete Response Letter (CRL) regarding its Biologics License Application (BLA) for retifanlimab” incyte.com ↗ |
| Filed | EU (EMA) | — | anal canal squamous cell carcinoma | 2021-02-26 | “In March, the Marketing Authorization Application (MAA) seeking approval of retifanlimab in squamous cell carcinoma of the anal canal (SCAC) was validated by the European...” incyte.com ↗ “today announced the validation of the Company’s Marketing Authorization Application (MAA) for retifanlimab” incyte.com ↗ |
| Filed | US (FDA) | Zynyz | anal canal squamous cell carcinoma | 2021-01-21 | “In December 2024, the supplemental Biologics License Application (sBLA) submission for retifanlimab (Zynyz®) in advanced/metastatic squamous cell anal carcinoma was filed with the FDA” incyte.com ↗ “FDA has accepted for Priority Review its Biologics License Application (BLA) for retifanlimab” incyte.com ↗ |
| Approved Indication not stated 2 milestones | |||||
| Filed | EU (EMA) | — | advanced squamous cell carcinoma of the anal canal | 2025-07-29 | “submitted a Type II variation Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) for retifanlimab in advanced SCAC.” incyte.com ↗ |
| Approved | EU (EMA) | Zynyz | — | 2024-04-19 | europa.eu ↗ |
Trials 63 · started per year
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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 → Mar 2028 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 Stop: Business |
| Phase 1 | NCT04470024 | Aug 2021 → Dec 2027 expected | head and neck cancer | Providence Health & Services | Active not 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 | Oct 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 | cancer, metastatic neoplasm | Incyte Corporation | Terminated | No outcome recorded Stop: Business |
| 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 2027 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 · 2 missed | ||||||
| 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 Stop: Business |
| 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 | head and neck cancer | Incyte Corporation | Completed | Missed primary |
| 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 | Missed primary Stop: Business |
| 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 Stop: Business |
| 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 2027 expected | 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 · 2 met primary | ||||||
| Phase 3 | NCT06072612 | Dec 2023 → Dec 2027 expected | breast cancer | BriaCell Therapeutics Corporation | Recruiting | No outcome recorded |
| Phase 3 | NCT04472429 | Nov 2020 → Apr 2024 | anal canal squamous cell carcinoma | Incyte Corporation | Completed | Met primary |
| Phase 3 | NCT04205812 | Sep 2020 → Dec 2023 | non-small cell squamous lung carcinoma | Incyte Corporation | Completed | Met primary |
| Phase 3 | NCT04203511 | Jul 2020 → Nov 2023 | non-small cell lung carcinoma | Incyte Corporation | Withdrawn | No outcome recorded Stop: Business |
| Comparator or background therapy5 trials | ||||||
| Phase 1 | NCT06959537 Background | Aug 2025 → Jan 2027 | breast cancer | M.D. Anderson Cancer Center | Suspended | 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 → Mar 2027 expected | skin cancer | University of Southern California | Active not recruiting | No outcome recorded |
| Phase 1/2 | NCT06939036 Background | Jul → Dec 2025 | cutaneous neuroendocrine carcinoma, small cell lung carcinoma | Ariceum Therapeutics GmbH | Terminated | No outcome recorded Stop: Business |
| — | NCT06910137 Background | — | anal canal squamous cell carcinoma | Incyte Corporation | Available | No outcome recorded |
News releases announcing trial results or a regulatory action · 32
| Date | Issuer | Release |
|---|---|---|
| 2026-03-06 | Incyte Corporation | Regulatory 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 ↗
“The EC approval of Zynyz marks an important step forward for patients with advanced SCAC, a rare cancer for which meaningful treatment advances have not occurred in several decades,” said Bill Meury, President and Chief Executive Officer, Incyte. |
| 2026-01-30 | Incyte Corporation | Regulatory 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 | Regulatory Incyte Japan Announces Approval of Zynyz® (retifanlimab) for the First-Line Treatment of Advanced Anal Cancer incyte.com ↗ |
| 2025-06-12 | Incyte Corporation | Results 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 ↗
The trial met its primary endpoint; treatment with retifanlimab in combination with platinum-based chemotherapy (carboplatin-paclitaxel) resulted in clinically meaningful improvements in progression-free survival and overall survival |
| 2025-05-23 | BriaCell Therapeutics Corporation | Results BriaCell Abstracts Showcase Positive Survival and Clinical Benefit Data at ASCO 2025 briacell.com ↗
Phase 2 survival and clinical benefit data meet or exceed outcomes of FDA-approved therapies in comparable metastatic breast cancer patients, with no treatment-related discontinuations |
| 2025-05-15 | Incyte Corporation | Regulatory 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 ↗
Zynyz® (retifanlimab-dlwr), a PD-1 inhibitor, is now approved for the treatment of advanced squamous cell carcinoma of the anal canal (SCAC) in combination with chemotherapy and as a monotherapy |
| 2024-12-11 | BriaCell Therapeutics Corporation | Results BriaCell Presents Unprecedented Overall Survival Data in Metastatic Breast Cancer in Spotlight Poster at 2024 SABCS® briacell.com ↗
Significantly lowered levels of circulating tumor cells (CTCs) and cancer associated macrophage-like cells (CAMLs) in 40% of heavily pre-treated MBC patients |
| 2024-12-07 | Incyte Corporation | Results 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 ↗
The POD1UM-304 trial results show a clinically meaningful and statistically significant improvement over chemotherapy alone. |
| 2024-11-26 | BriaCell Therapeutics Corporation | Results BriaCell 2024 SABCS® Spotlight Poster to Showcase Positive Overall Survival Data Across All Patient Subtypes in Metastatic Breast Cancer briacell.com ↗
Patients receiving the pivotal Phase 3 Bria-IMT™ combination regimen (n=37) showed significantly higher median overall survival (OS) (13.4), an objective response rate (ORR) of 9.5% and a clinical benefit rate (CBR) of 55%. |
| 2024-09-14 | Incyte Corporation | Results 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 ↗
These data were featured today in a Presidential Symposium (LBA 2) at the European Society for Medical Oncology (ESMO) Congress 2024, held in Barcelona and virtually. |
| 2024-07-30 | Incyte Corporation | Results Incyte Reports 2024 Second Quarter Financial Results and Provides Updates on Key Clinical Programs incyte.com ↗
Incyte announces positive topline results from two Phase 3 clinical studies evaluating retifanlimab (Zynyz®), a humanized monoclonal antibody targeting programmed cell death receptor-1 (PD-1), in squamous cell anal carcinoma (SCAC) and non-small cell lung cancer (NSCLC). |
| 2024-06-03 | BriaCell Therapeutics Corporation | Results BriaCell Presents Clinical Efficacy Data at ASCO 2024 briacell.com ↗
This presentation details the results of BriaCell’s randomized Phase 2 study of Bria-IMT™ in combination with retifanlimab, an immune checkpoint inhibitor (CPI). |
| 2023-12-06 | BriaCell Therapeutics Corporation | Results BriaCell Highlights Outstanding Topline Survival and Clinical Benefit Data in Advanced Metastatic Breast Cancer at the 2023 SABCS briacell.com ↗
Interim analysis using Kaplan-Meier curve method, measuring the probability of patients’ survival in time, showed median overall survival (OS) of 13.4 months for 54 patients. |
| 2023-09-08 | BriaCell Therapeutics Corporation | Results BriaCell Reports Benchmark-Beating Patient Survival and Clinical Benefit in Advanced Metastatic Breast Cancer briacell.com ↗
21 out of 29 patients that have received treatment since 2022 remain alive suggesting tolerability and survival efficacy. |
| 2023-04-17 | BriaCell Therapeutics Corporation | Results BriaCell Presents Positive Data Demonstrating Survival and Clinical Benefits in Advanced Metastatic Breast Cancer at the 2023 AACR briacell.com ↗
15 of 18 patients remain alive of those recruited since the study reopened in 2021. |
| 2023-03-22 | MacroGenics | Regulatory MacroGenics Earns $15 Million Milestone Following U.S. FDA Approval of ZYNYZ™ (retifanlimab-dlwr) macrogenics.com ↗
MacroGenics, Inc. (NASDAQ: MGNX), a biopharmaceutical company focused on developing and commercializing innovative antibody-based therapeutics for the treatment of cancer, today reported that following the U.S. Food and Drug Administration’s (FDA) approval of Incyte’s Biologics License Application (BLA) for ZYNYZ™ (retifanlimab-dlwr), the Company will receive a $15 million milestone payment from Incyte. |
| 2023-03-22 | Incyte Corporation | Regulatory Incyte Announces FDA Approval of Zynyz™ (retifanlimab-dlwr) for the Treatment of Metastatic or Recurrent Locally Advanced Merkel Cell Carcinoma (MCC) incyte.com ↗
Incyte (Nasdaq:INCY) today announced that the U.S. Food and Drug Administration (FDA) has approved Zynyz™ (retifanlimab-dlwr), a humanized monoclonal antibody targeting programmed death receptor-1 (PD-1), for the treatment of adults with metastatic or recurrent locally advanced Merkel cell carcinoma (MCC). |
| 2023-02-23 | BriaCell Therapeutics Corporation | Results BriaCell Reports Positive Survival Data in Advanced Metastatic Breast Cancer briacell.com ↗
9 of 11 (82%) patients remain alive from 2021/2022 dosing, suggesting strong survival benefits. |
| 2022-12-08 | BriaCell Therapeutics Corporation | Results BriaCell Announces Positive Clinical and Quality of Life Data in Advanced Metastatic Breast Cancer at 2022 San Antonio Breast Cancer Symposium® briacell.com ↗
As previously disclosed , clinical benefits were observed across multiple subtypes of advanced metastatic breast cancer patients, especially in patients with hormone receptor positive (“HR+”) cancer, a very large segment of the patient population. |
| 2022-11-10 | BriaCell Therapeutics Corporation | Results BriaCell Reports Positive Breast Cancer Efficacy Data with Bria-IMT(TM) Immunotherapy Treatment at SITC Annual Meeting briacell.com ↗
Disease control, tumor shrinkage, and potential survival benefit were observed amongst 12 patients in the Phase I/IIa clinical study of Bria-IMT™ in combination with Incyte’s retifanlimab. |
| 2022-10-21 | BriaCell Therapeutics Corporation | Results BriaCell Announces Successful Completion of Phase I Portion of Clinical Study in Advanced Breast Cancer; Randomized Phase II Efficacy Evaluation Progressing briacell.com ↗
The combination treatment showed a favorable safety profile in 12 patients. |
| 2022-07-08 | MacroGenics | Results MacroGenics Announces Closure of CP-MGA271-06 Study Evaluating Enoblituzumab plus Checkpoint Inhibition in Head and Neck Cancer macrogenics.com ↗
The decision to discontinue the study was based on an internal review of safety data, which included the occurrence of seven fatalities potentially associated with hemorrhagic events in both arms of the study (of 62 total patients treated). |
| 2021-12-10 | Oncolytics Biotech | Results Oncolytics Biotech® Presents Positive Interim Safety Update from Phase 2 Triple-Negative Breast Cancer Trial at the 2021 San Antonio Breast Cancer Symposium oncolyticsbiotech.com ↗
Safety data from the trial show that the combination has been well-tolerated, as no safety concerns have been noted in any of the five patients enrolled in the trial at the time of reporting. |
| 2021-09-16 | MacroGenics | Results MacroGenics Announces Clinical Results from Cohort A Part 1 of Phase 2/3 MAHOGANY Study of Margetuximab in Combination with Retifanlimab in Gastroesophageal Adenocarcinoma at ESMO 2021 macrogenics.com ↗
21 of 40 patients (53%) achieved confirmed responses by independent review, exceeding prespecified futility boundary for trial; enrollment proceeding to Part 2 of Cohort A |
| 2021-07-23 | Incyte Corporation | Regulatory Incyte Provides Regulatory Update on Retifanlimab for the Treatment of Certain Patients with Squamous Cell Carcinoma of the Anal Canal (SCAC) incyte.com ↗
The complete response letter states that the FDA cannot approve the application in its present form. |
| 2021-06-24 | Incyte Corporation | Regulatory 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 | Regulatory 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 ↗
The European Medicines Agency’s (EMA) validation of the MAA confirms that the submission is sufficiently complete to begin the formal review process. |
| 2021-01-21 | Incyte Corporation | Regulatory 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 | Results 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 ↗
Incyte (Nasdaq:INCY) today announced results from its Phase 2 POD1UM-202 trial evaluating retifanlimab, a PD-1 inhibitor, in previously treated patients with advanced squamous cell carcinoma of the anal canal (SCAC) who have progressed following standard platinum-based chemotherapy. |
| 2019-04-03 | MacroGenics | Results MacroGenics Reports Presentation of Data at the AACR Annual Meeting 2019 macrogenics.com ↗
Data from the following two posters presented by Incyte suggest that MGA012 is biologically active and leads to an increase in circulating T cell activation and support the use of a flat dosing regimen in later phase clinical trials: |
| 2018-12-07 | MacroGenics | Regulatory MacroGenics Announces Partial Clinical Hold on MGD009 Phase 1 Studies macrogenics.com ↗ |
| 2018-11-09 | MacroGenics | Results MacroGenics Reports Presentation of Clinical Data at 33rd Annual SITC Meeting macrogenics.com ↗ |
All press releases naming this drug 42 releases
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 |