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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 33 indications[3], with its most advanced program in Phase 3.[1]

Dostarlimab is one of 506 biologic programs targeting Glioma. It is currently in Phase 3.

33

Indications

73

Total Trials

41

Active Trials

505

Competitors

Pipeline

Status by Indication[3][1]

Indication

GliomaCompleted

Merkel Cell Skin CancerUnknown

Neuroendocrine CarcinomaUnknown

Squamous Cell CarcinomaCompleted

Ovarian Clear Cell CarcinomaRecruiting

Anaplastic OligodendrogliomaRecruiting

Neoplasms, Head and NeckActive, not recruiting

Anal CancerRecruiting

Lung Cancer (non-Small Cell)Active, not recruiting

Colon Cancer MetastaticNot yet recruiting

GliomaPhase 2

Completed

Merkel Cell Skin CancerPreclinical

Unknown

Neuroendocrine CarcinomaPreclinical

Unknown

Squamous Cell CarcinomaPhase 3

Completed

Ovarian Clear Cell CarcinomaPreclinical

Recruiting

Anaplastic OligodendrogliomaPreclinical

Recruiting

Neoplasms, Head and NeckPhase 2

Active, not recruiting

Anal CancerPhase 2

Recruiting

Lung Cancer (non-Small Cell)Phase 3

Active, not recruiting

Colon Cancer MetastaticPhase 2

Not yet recruiting

Showing 10 of 33 indications

Competition

Competitive Landscape

744 competitors in Breast Cancer

#DrugCompanyPhaseTrials

Dostarlimab

Voltaren

Lexiscan

Zolymbus

Blenoxane

Bristol-Myers Squibb

MS Contin

HHikma Pharmaceuticals LLC

Methylthioninium Chloride

PProvepharm SAS

Duragesic-100

MS Contin

HHikma Pharmaceuticals LLC

Spravato

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

Timeline

Expected Milestones

Q4 2026

Phase 2Active, not recruiting

Merkel Cell Carcinoma

NCT05594290

Q1 2027

Phase 1Recruiting

Solid Tumor

NCT06179160

PreclinicalActive, not recruiting

Diffuse Large B-Cell Lymphoma

NCT05455697

Phase 2Recruiting

Endometrial Cancer

NCT04774419

PreclinicalActive, not recruiting

Lung Cancer (non-Small Cell)

NCT04655976

Q2 2027

Phase 2Active, not recruiting

Clinical Stage III Merkel Cell Carcinoma AJCC V8

NCT06056895

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

Squamous Cell Carcinoma3 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

A Phase 3 Global, Multicenter, Double-Blind Randomized Study of Carboplatin-Paclitaxel With INCMGA00012 or Placebo in Participants With Inoperable Locally Recurrent or Metastatic Squamous Cell Carcinoma of the Anal Canal Not Previously Treated With Systemic Chemotherapy (POD1UM-303/InterAACT 2)

Completed· Incyte logo

Incyte·Phase 3·NCT04472429·308 enrolled

Advanced Solid Tumors3 trials

Study of INCA 0186 in Subjects With Advanced Solid Tumors

Terminated· Incyte logo

Incyte·Phase 1·NCT04989387·57 enrolled

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

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

Randomized, Open-Label Study of the Bria-IMT Regimen and Check Point Inhibitor 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

Lung Cancer (Non-Small Cell)3 trials

A Pilot/Exploratory Translational Study to Evaluate Response to Dostarlimab and Pembrolizumab in Extracellular Vesicles (EVs) or Patient-derived Organoids (PDOs) and by Zirconium-89 Labelled Programmed Death Ligand 1 Positron Emission Tomography in Participants With Recurrent Non-small Cell Lung Cancer

Terminated· GSK logo

GSK·Preclinical·NCT06405230·2 enrolled

A Randomized, Multicenter, Double-blind, Phase 3 Study to Investigate the Safety and Efficacy of Belrestotug in Combination With Dostarlimab Compared With Placebo in Combination With Pembrolizumab in Participants With Previously Untreated, Unresectable, Locally Advanced or Metastatic PD-L1 Selected Non-small Cell Lung Cancer (GALAXIES Lung-301)

Active, not recruiting· GSK logo

GSK·Phase 3·NCT06472076·88 enrolled

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

48 more indications

Neoplasms3 trials

A Phase 1 Dose Escalation and Cohort Expansion Study of TSR-042, an Anti-PD-1 Monoclonal Antibody, in Patients With Advanced Solid Tumors

Active, not recruiting·TTesaro, Inc.·Phase 1·NCT02715284·729 enrolled

A Phase I First Time in Human Open Label Study of GSK3745417 Administered With and Without Anticancer Agents in Participants With Advanced Solid Tumors

Terminated· GSK logo

GSK·Phase 1·NCT03843359·97 enrolled

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

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

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

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

Merkel Cell Carcinoma2 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

Advanced Malignancies2 trials

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

Terminated· Incyte logo

Incyte·Phase 1/2·NCT02393248·201 enrolled

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

Glioma2 trials

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

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

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

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

Solid Tumor2 trials

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

Terminated· Incyte logo

Incyte·Preclinical·NCT06873789·9 enrolled

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

Recruiting· Incyte logo

Incyte·Phase 1·NCT06179160·710 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

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

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

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

Head and Neck Cancer1 trial

Enoblituzumab Plus Retifanlimab or Tebotelimab in Head and Neck Cancer

Terminated·MMacroGenics·Phase 2·NCT04634825·62 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

Relapsed/Refractory1 trial

MGD009/MGA012 Combination in Relapsed/Refractory Cancer

Completed·MMacroGenics·Phase 1·NCT03406949·25 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

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

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

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

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

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

Soft Tissue Sarcoma1 trial

A Multi-cohort Study of Retifanlimab With or Without Gemcitabine and Docetaxel in Patients With Advanced Sarcoma

Recruiting·MMemorial Sloan Kettering Cancer Center·Preclinical·NCT04577014·98 enrolled

Metastatic Pancreatic Ductal Adenocarcinoma1 trial

Phase II Study of Niraparib and TSR-042 in Patients With Germline or Somatic BRCA1/2 and PALB2-Related Pancreatic Cancer

Completed·MMayo Clinic·Phase 2·NCT04493060·22 enrolled

Neurofibromatosis Type 21 trial

Innovative Trial for Understanding the Impact of Targeted Therapies in NF2-Related Schwannomatosis (INTUITT-NF2)

Recruiting·SScott R. Plotkin, MD, PhD·Phase 2·NCT04374305·109 enrolled

Neoplasms, Endometrial1 trial

A Randomized, Open-label, Multicenter, Phase 3 Study to Investigate Mocertatug Rezetecan 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

Dedifferentiated Liposarcoma1 trial

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

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

Adenocarcinoma1 trial

Watch-and-wait Strategy to Initiate Dostarlimab-based Immunotherapy in Localized Deficient Mismatch Repair (dMMR) and/or Microsatellite Instability High (MSI-H) oEso-gastric Junction and Gastric Adenocarcinoma: An Open-label GERCOR Phase II Study

Recruiting·GGERCOR - Multidisciplinary Oncology Cooperative Group·Phase 2·NCT06059495·89 enrolled

Anatomic Stage III Breast Cancer AJCC v81 trial

Phase IB Trial of Niraparib and Dostarlimab (TSR-042) in Patients With BRCA-Mutated Breast, Pancreas or Ovary Cancer

Active, not recruiting·UUniversity of Washington·Phase 1·NCT04673448·18 enrolled

Breast Carcinoma1 trial

Phase II Trial of Retifanlimab With Trastuzumab and Pertuzumab Combination in HER2-Addicted Breast Cancer

Not yet recruiting·PPolly A. Niravath, MD·Phase 2·NCT07772245·30 enrolled

Female1 trial

Dostarlimab, Cisplatin and Etoposide in Combination With Radiotherapy in Sandwich Sequence for Small Cell Neuroendocrine Cervical Carcinoma (DICER Trial): Taiwanese Gynecologic Oncology Group (TGOG) 1012

Recruiting·CChang Gung Memorial Hospital·Phase 2·NCT07336147·45 enrolled

Pancreatic Cancer Metastatic1 trial

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)

Not yet recruiting·MMassachusetts General Hospital·Phase 2·NCT07765836·40 enrolled

Anal Cancer1 trial

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

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

Clinical Stage III Merkel Cell Carcinoma AJCC v81 trial

A Proof-of-Concept Study of Combination Therapy With INCMGA00012 (Anti-PD-1), INCAGN02385 (Anti-LAG-3), and INCAGN02390 (Anti-TIM-3) in Participants With Advanced or Metastatic PD-(L)1 Refractory Merkel Cell Carcinoma

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

Neoplasms, Rectal1 trial

A Phase 3b, Open-label Study Investigating the Duration of Neoadjuvant Dostarlimab Monotherapy in Participants With Untreated Stage II/III dMMR/MSI-H Locally Advanced Rectal Cancer

Not yet recruiting· GSK logo

GSK·Phase 3·NCT07740720·90 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

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

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

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 — 73 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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