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Dostarlimab

(Retifanlimab)

Phase 3Monoclonal antibody

It is used to treat certain cancers, particularly mismatch repair deficient endometrial cancer and other solid tumors. It works by helping the body's immune system recognize and fight cancer cells.[1] Dostarlimab is currently being investigated across 39 indications[3], with its most advanced program in Phase 3.[1]

Dostarlimab is one of 684 biologic programs targeting Glioma. It is currently in Phase 3.

39

Indications

61

Total Trials

33

Active Trials

683

Competitors

Pipeline

Status by Indication[3][1]

Indication

GliomaActive, not recruiting

Merkel Cell Skin CancerUnknown

Esophageal CancerActive, not recruiting

Anal CarcinomaActive, not recruiting

Dedifferentiated LiposarcomaActive, not recruiting

Carcinoid SyndromeActive, not recruiting

Triple-Negative Breast CancerActive, not recruiting

Anaplastic OligodendrogliomaRecruiting

Neuroendocrine CarcinomaUnknown

Pancreatic Ductal AdenocarcinomaActive, not recruiting

GliomaPhase 2

Active, not recruiting

Merkel Cell Skin CancerPreclinical

Unknown

Esophageal CancerPhase 2

Active, not recruiting

Anal CarcinomaPhase 3

Active, not recruiting

Dedifferentiated LiposarcomaPhase 2

Active, not recruiting

Carcinoid SyndromePhase 2

Active, not recruiting

Triple-Negative Breast CancerPhase 2

Active, not recruiting

Anaplastic OligodendrogliomaPreclinical

Recruiting

Neuroendocrine CarcinomaPreclinical

Unknown

Pancreatic Ductal AdenocarcinomaPhase 1

Active, not recruiting

Showing 10 of 39 indications

Competition

Competitive Landscape

2828 competitors in Breast Cancer

#DrugCompanyPhaseTrials

Dostarlimab

Cymbalta

Alnylam Pharmaceuticals

Nubain

AAultman Health Foundation

Chirocaine

PPurdue Pharma LP

Chantix

PPrism Pharmaceuticals

Vfend

PPrism Pharmaceuticals

QS21

MMemorial Sloan Kettering Cancer Center

Beta Blocker

WWeill Medical College of Cornell University

Neoadjuvant Treatment

SShanghai Zhongshan Hospital

Conventional Chemotherapy

SShanghai Jiao Tong University School of Medicine

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Q3 2026

Phase 1/2Recruiting

Soft Tissue Sarcoma

NCT04577014

Q4 2026

Phase 2Active, not recruiting

Merkel Cell Carcinoma

NCT05594290

Q1 2027

Phase 1Recruiting

Advanced or Metastatic Solid Tumors

NCT06179160

PreclinicalActive, not recruiting

Diffuse Large B-Cell Lymphoma

NCT05455697

Phase 2Recruiting

Endometrial Cancer

NCT04774419

PreclinicalActive, not recruiting

Lung Cancer (non-Small Cell)

NCT04655976

Clinical

Trials by Indication[1]

Glioblastoma3 trials

Neoantigen-based Personalized DNA Vaccine With Retifanlimab PD-1 Blockade Therapy in Patients With Newly Diagnosed, Unmethylated Glioblastoma

Active, not recruiting·WWashington University School of Medicine·Phase 1·NCT05743595·27 enrolled

Carmustine Wafer in Combination With Retifanlimab and Radiation With/Without Temozolomide in Subjects With Glioblastoma

Recruiting·SSidney Kimmel Comprehensive Cancer Center at Johns Hopkins·Phase 1·NCT05083754·50 enrolled

Retifanlimab with Bevacizumab and Hypofractionated Radiotherapy for the Treatment of Recurrent Glioblastoma

Recruiting·—·Phase 2·NCT06160206·134 enrolled

Breast Cancer3 trials

INCMGA00012 and Pelareorep for the Treatment of Metastatic Triple Negative Breast Cancer, IRENE Study

Active, not recruiting·MMridula George, MD·Phase 2·NCT04445844·25 enrolled

Study of the Bria-IMT Regimen and CPI vs Physicians' Choice in Advanced Metastatic Breast Cancer.

Recruiting·BBriaCell Therapeutics Corporation·Phase 3·NCT06072612·404 enrolled

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·MM.D. Anderson Cancer Center·Phase 1·NCT06959537·24 enrolled

Advanced Solid Tumors3 trials

INCMGA00012 Plus Chemotherapy in Participants With Advanced Solid Tumors (POD1UM-105)

Withdrawn· Incyte logo

Incyte·Phase 1·NCT03920839

A Study of INCMGA00012, INCB001158, and the Combination in Japanese Participants With Advanced Solid Tumors

Completed·IIncyte Biosciences Japan GK·Phase 1·NCT03910530·18 enrolled

Study of INCA 0186 in Subjects With Advanced Solid Tumors

Terminated· Incyte logo

Incyte·Phase 1·NCT04989387·57 enrolled

Merkel Cell Carcinoma3 trials

A Study of INCMGA00012 in Metastatic Merkel Cell Carcinoma (POD1UM-201)

Completed· Incyte logo

Incyte·Phase 2·NCT03599713·107 enrolled

Chemo-immunotherapy in Patients With Resectable Merkel Cell Carcinoma Prior to Surgery

Active, not recruiting·GGruppo Oncologico del Nord-Ovest·Phase 2·NCT05594290·36 enrolled

Triple Immune Checkpoint Inhibition for Advanced or Metastatic PD-(L)1 Refractory Merkel Cell Carcinoma

Active, not recruiting·UUniversity of Washington·Phase 2·NCT06056895·12 enrolled

Advanced or Metastatic Solid Tumors2 trials

A Study to Evaluate INCB177054 in Participants With Select Advanced or Metastatic Solid Tumors

Active, not recruiting· Incyte logo

Incyte·Phase 1/2·NCT06873789·9 enrolled

A Study to Evaluate INCB161734 in Participants With Advanced or Metastatic Solid Tumors With KRAS G12D Mutation

Recruiting· Incyte logo

Incyte·Phase 1·NCT06179160·710 enrolled

40 more indications

Pancreatic Adenocarcinoma2 trials

9-ING-41 Plus Retifanlimab and Gemcitabine/Nab-Paclitaxel in Patients With Advanced Pancreatic Adenocarcinoma

Terminated·AAnwaar Saeed·Phase 2·NCT05239182·7 enrolled

9-ING-41 Combined With Retifanlimab, Plus Modified FOLFIRINOX for Patients With Advanced Pancreatic Adenocarcinoma (RiLEY)

Recruiting·AAnwaar Saeed·Phase 1·NCT06896188·12 enrolled

Squamous Carcinoma2 trials

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· Incyte logo

Incyte··NCT06910137

A Study of INCMGA00012 in Squamous Carcinoma of the Anal Canal Following Platinum-Based Chemotherapy (POD1UM-202)

Completed· Incyte logo

Incyte·Phase 2·NCT03597295·94 enrolled

Advanced Malignancies2 trials

The Purpose of the Study is to Continue to Provide Pemigatinib to Patients With Advanced Malignancies.

Terminated· Incyte logo

Incyte·Phase 2·NCT04949191·10 enrolled

Open-Label, Dose-Escalation Study of Pemigatinib in Subjects With Advanced Malignancies - (FIGHT-101)

Terminated· Incyte logo

Incyte·Phase 1/2·NCT02393248·201 enrolled

Patients With Advanced Solid Tumors2 trials

A Phase 1 Study of INCMGA00012 in Patients With Advanced Solid Tumors

Completed· Incyte logo

Incyte·Phase 1·NCT03059823·325 enrolled

INCMGA00012 in Combination With Other Therapies in Patients With Advanced Solid Tumors

Completed· Incyte logo

Incyte·Phase 1·NCT03589651·83 enrolled

Endometrial Cancer2 trials

Safety and Efficacy of Retifanlimab (INCMGA00012) Alone or in Combination With Other Therapies in Participants With Advanced or Metastatic Endometrial Cancer Who Have Progressed on or After Platinum-based Chemotherapy.

Active, not recruiting· Incyte logo

Incyte·Phase 2·NCT04463771·206 enrolled

Adjuvant Checkpoint Blockade Plus Radiation In Locally Advanced, Mismatch Repair Deficient/Microsatellite Instability-High (MMR-D/MSI-H) Endometrial Cancer

Recruiting·MMemorial Sloan Kettering Cancer Center·Phase 2·NCT04774419·62 enrolled

Squamous Cell Carcinoma2 trials

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

Active, not recruiting·IIncyte Biosciences International Sàrl·Phase 2·NCT05287113·176 enrolled

Efficacy of INCMGA00012 in Penile Squamous Cell Carcinoma (ORPHEUS)

Completed·MMedSIR·Phase 2·NCT04231981·18 enrolled

Glioma2 trials

Retifanlimab and Epacadostat in Combination With Radiation and Bevacizumab in Patients With Recurrent Gliomas

Completed·WWashington University School of Medicine·Phase 2·NCT03532295·51 enrolled

All-Trans Retinoic Acid (ATRA) Plus PD-1 Inhibition in Recurrent IDH-Mutant Glioma

Recruiting·SStephen Bagley, MD, MSCE·Phase 2·NCT05345002·55 enrolled

Relapsed/Refractory1 trial

MGD009/MGA012 Combination in Relapsed/Refractory Cancer

Completed·MMacroGenics·Phase 1·NCT03406949·25 enrolled

Head and Neck Cancer1 trial

Enoblituzumab Plus Retifanlimab or Tebotelimab in Head and Neck Cancer

Terminated·MMacroGenics·Phase 2·NCT04634825·62 enrolled

Carcinoid Syndrome1 trial

Retifanlimab (INCMGA00012) and Telotristat Ethyl for the Treatment of Advanced Neuroendocrine Tumors and Carcinoid Syndrome

Withdrawn·MM.D. Anderson Cancer Center·Phase 2·NCT04776876

Dedifferentiated Liposarcoma1 trial

A Phase 2, Open Label Study of PEmigatinib and REtifanlimab in Advanced Dedifferentiated LIposarcoma (PERELI)

Recruiting·LLund University Hospital·Phase 2·NCT06389799·33 enrolled

Urothelial Carcinoma1 trial

An Umbrella Study to Determine the Safety and Efficacy of Various Monotherapy or Combination Therapies in Neoadjuvant Urothelial Carcinoma

Terminated· Incyte logo

Incyte·Phase 2·NCT04586244·30 enrolled

Gastric Cancer1 trial

Anti-PD-1 and CapOx for the First-line Treatment of dMMR Esophagogastric Cancer (AuspiCiOus)

Recruiting·—·Phase 2·NCT05177133·25 enrolled

Refractory Cancer1 trial

Safety Study of Enoblituzumab (MGA271) in Combination With Pembrolizumab or MGA012 in Refractory Cancer

Completed·MMacroGenics·Phase 1·NCT02475213·146 enrolled

Anti-PD-1 Antibody1 trial

Neoantigen-Targeted Vaccine Combined With Anti-PD-1 Antibody for Patients With Stage IV MMR-p Colon and Pancreatic Ductal Cancer

Withdrawn·SSidney Kimmel Comprehensive Cancer Center at Johns Hopkins·Phase 1·NCT04799431

Pancreatic Ductal Adenocarcinoma1 trial

Combined MEK, STAT3 and PD-1 Inhibition in Metastatic Pancreatic Ductal Adenocarcinoma

Completed·PPeter Hosein, MD·Phase 1·NCT05440942·28 enrolled

Soft Tissue Sarcoma1 trial

Retifanlimab (Anti-PD-1 Antibody) With Gemcitabine and Docetaxel in Patients With Advanced Soft Tissue Sarcoma

Recruiting·MMemorial Sloan Kettering Cancer Center·Phase 1/2·NCT04577014·98 enrolled

Solid Tumors1 trial

A Study of INCMGA00012 in Participants With Selected Solid Tumors (POD1UM-203)

Completed· Incyte logo

Incyte·Phase 2·NCT03679767·121 enrolled

Metastatic1 trial

Short-term Fasting Prior to PD-1/PD-L1 Inhibitor Therapy for of Advanced or Metastatic Skin Malignancy

Active, not recruiting·UUniversity of Southern California·Phase 1·NCT04387084·10 enrolled

Non-Small Cell Lung Cancer1 trial

INCMGA00012 in Combination With Chemoradiation in Participants With Stage III Non-Small Cell Lung Cancer (POD1UM-301)

Withdrawn· Incyte logo

Incyte·Phase 3·NCT04203511

Chemotherapy1 trial

Combination Margetuximab, Retifanlimab, Tebotelimab, and Chemotherapy Phase 2/3 Trial in HER2+ Gastric/GEJ Cancer

Completed·MMacroGenics·Phase 2/3·NCT04082364·82 enrolled

Solid Malignancies1 trial

Retifanlimab and Ruxolitinib In Solid Malignancies

Recruiting·UUniversity of California, San Diego·Phase 1/2·NCT07219576·40 enrolled

Anal Carcinoma1 trial

Carboplatin-paclitaxel With Retifanlimab or Placebo in Participants With Locally Advanced or Metastatic Squamous Cell Anal Carcinoma (POD1UM-303/InterAACT 2).

Completed· Incyte logo

Incyte·Phase 3·NCT04472429·308 enrolled

ES-SCLC1 trial

Study of 225Ac-SS0110 in Subjects With ES-SCLC or MCC (SANTANA-225 )

Terminated·AAriceum Therapeutics GmbH·Phase 1/2·NCT06939036·2 enrolled

Head and Neck Squamous Cell Carcinoma1 trial

INCAGN01876 in Combination With Immunotherapy in Participants With Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma

Withdrawn·IIncyte Biosciences International Sàrl·Phase 2·NCT05359692

Metastatic Colorectal Cancer1 trial

Phase I/II Study of the Combination Immunotherapy Regimen: SX-682, TriAdeno Vaccine, Retifanlimab and IL-15 Agonist N-803 (STAR15) for Metastatic Colorectal Cancer (mCRC)

Recruiting·NNational Cancer Institute (NCI)·Preclinical·NCT06149481·60 enrolled

Advanced Malignant Solid Neoplasm1 trial

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

Recruiting·OOHSU Knight Cancer Institute·Preclinical·NCT06320405·38 enrolled

Tumours, Gynecological1 trial

A Phase 1/2 Randomized Multi-Cohort Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Clinical Activity of Mocertatug Rezetecan in Combination With Anti-Cancer Agents in Participants With Advanced Solid Tumors

Recruiting· GSK logo

GSK·Preclinical·NCT06796907·305 enrolled

Neoplasms, Endometrial1 trial

A Randomized, Open-label, Multicenter, Phase 3 Study to Investigate GSK5733584 in Combination With Immune Checkpoint Inhibition for Maintenance Treatment of Participants With Mismatch Repair Proficient (MMRp) Endometrial Cancer

Not yet recruiting· GSK logo

GSK·Phase 3·NCT07684599·610 enrolled

Non-Small Cell Lung Carcinoma1 trial

A Randomized, Double Blind, Phase 3 Study of Platinum-Based Chemotherapy With or Without INCMGA00012 in First-Line Metastatic Squamous and Nonsquamous Non-Small Cell Lung Cancer (POD1UM-304)

Completed· Incyte logo

Incyte·Phase 3·NCT04205812·583 enrolled

Colon Cancer Metastatic1 trial

NIMBLE-CRC: NeoImmunoModulation Before Leveraging Excision in Colorectal Rectal Cancer

Not yet recruiting·NNorthwell Health·Phase 2·NCT07677579·26 enrolled

Lung Cancer (Non-Small Cell)1 trial

A Randomized, Open Label Phase 2/3 Study Comparing Cobolimab + Dostarlimab + Docetaxel To Dostarlimab + Docetaxel To Docetaxel Alone In Participants With Advanced Non-small Cell Lung Cancer Who Have Progressed On Prior Anti-PD-(L)1 Therapy And Chemotherapy (COSTAR Lung)

Active, not recruiting· GSK logo

GSK·Preclinical·NCT04655976·758 enrolled

Rectal Neoplasms1 trial

A Phase 1b/2 Trial of Preoperative Niraparib, Dostarlimab, and Hypofractionated Radiotherapy for the Treatment of Locally-advanced Rectal Cancers.

Terminated·UUniversity of Iowa·Phase 1·NCT04926324·3 enrolled

Anal Cancer1 trial

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

Recruiting·JJennifer Dorth·Phase 2·NCT07425054·33 enrolled

Neoplasms1 trial

A Phase 1 First-Time-in-Human, Open-Label Study of GSK4381562 Administered as Monotherapy and in Combination With Anticancer Agents in Participants With Selected Advanced Solid Tumors

Active, not recruiting· GSK logo

GSK·Phase 1·NCT05277051·152 enrolled

Neoplasms, Head and Neck1 trial

A Phase 2, Randomized, Open-label, Platform Study Using a Master Protocol to Evaluate Novel Immunotherapy Combinations as First-Line Treatment in Participants With Recurrent/Metastatic PD-L1 Positive Squamous Cell Carcinoma of the Head and Neck

Active, not recruiting· GSK logo

GSK·Phase 2·NCT06062420·316 enrolled

Anaplastic Oligodendroglioma1 trial

Phase I/IIa Trial of Retifanlimab and Difluoromethylornithine (DFMO) in Patients With Progressive High-Grade Glioma

Recruiting·MMayo Clinic·Preclinical·NCT07468136·33 enrolled

Ovarian Clear Cell Carcinoma1 trial

Safety and Efficacy of Targeting PP2A in Ovarian Clear Cell Carcinoma Using Dostarlimab and LB-100

Recruiting·MM.D. Anderson Cancer Center·Preclinical·NCT06065462·21 enrolled

Diffuse Large B-Cell Lymphoma1 trial

Immunostart: Prephase Tafasitamab, Retifanlimab, and Rituximab (TRR), Followed by TRR With Standard Therapy for Previously Untreated Diffuse Large B-Cell Lymphoma

Active, not recruiting·UUniversity of Washington·Preclinical·NCT05455697·33 enrolled

Unspecified1 trial

Combination Study of SV-BR-1-GM With Retifanlimab

Enrolling by invitation·BBriaCell Therapeutics Corporation·Phase 1/2·NCT03328026·36 enrolled

Sources

References

[1]
ClinicalTrials.gov — 61 trial records for Retifanlimab. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — Retifanlimab compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for Retifanlimab. EMBL-EBI & Wellcome Sanger Institute.
[4]
SEC EDGAR — Incyte company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Mechanism of Action: Programmed Cell Death Protein 1 Antagonist[2]
Modality: Monoclonal antibody[2]
Highest Phase: Phase 3[1]
Company: Incyte

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