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Epacadostat

Phase 3Small molecule

Epacadostat is an experimental cancer drug that works by blocking an enzyme called indoleamine 2,3-dioxygenase (IDO), which helps tumors hide from the immune system. It's being studied to help the body's immune system recognize and fight cancer cells more effectively.[1] Epacadostat is currently being investigated across 24 indications[3], with its most advanced program in Phase 3.[1]

Epacadostat is one of 625 small molecule programs targeting Glioma. It is currently in Phase 3.

24

Indications

50

Total Trials

3

Active Trials

624

Competitors

Pipeline

Status by Indication[3][1]

Indication

GliomaActive, not recruiting

Esophageal CancerActive, not recruiting

LymphomaActive, not recruiting

Head and Neck Malignant NeoplasiaActive, not recruiting

Thymic CarcinomaActive, not recruiting

Urogenital NeoplasmActive, not recruiting

Metastatic MelanomaActive, not recruiting

Metastatic Colorectal CancerActive, not recruiting

Hematopoietic and Lymphoid Cell NeoplasmActive, not recruiting

Endometrial CarcinomaActive, not recruiting

GliomaPhase 2

Active, not recruiting

Esophageal CancerPhase 2

Active, not recruiting

LymphomaPhase 1/Phase 2

Active, not recruiting

Head and Neck Malignant NeoplasiaPhase 3

Active, not recruiting

Thymic CarcinomaPhase 2

Active, not recruiting

Urogenital NeoplasmPhase 3

Active, not recruiting

Metastatic MelanomaPhase 1/Phase 2

Active, not recruiting

Metastatic Colorectal CancerPhase 1

Active, not recruiting

Hematopoietic and Lymphoid Cell NeoplasmPhase 1

Active, not recruiting

Endometrial CarcinomaPhase 2

Active, not recruiting

Showing 10 of 24 indications

Competition

Competitive Landscape

1774 competitors in Lymphoma

#DrugCompanyPhaseTrials

Epacadostat

Norvir

Nuvigil

NNuvo Research GmbH

Emend

CCidara Therapeutics Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)

Kenalog

BBausch Health Americas, Inc.

Systemic Therapy

Bristol-Myers Squibb

PEG-Intron

Elitek

AAzienda U.S.L. 1 di Massa e Carrara

Decadron

QQuince Therapeutics S.p.A.

Solu-Medrol

MMassachusetts Eye and Ear Infirmary

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

Timeline

Expected Milestones

Q3 2030

Phase 1/2Recruiting

Patients With Locally Advanced Rectal Cancer

NCT03516708

Clinical

Trials by Indication[1]

Advanced Solid Tumors4 trials

A Study to Evaluate the Safety, Tolerability, and Antitumor Activity of INCB001158 Plus Epacadostat, With or Without Pembrolizumab, in Advanced Solid Tumors

Terminated· Incyte logo

Incyte·Phase 1/2·NCT03361228·5 enrolled

Study of Epacadostat (INCB024360) Alone and In Combination With Pembrolizumab (MK-3475) With Chemotherapy and Pembrolizumab Without Chemotherapy in Participants With Advanced Solid Tumors (MK-3475-434)

Completed· Merck & Co. logo

Merck & Co.·Phase 1·NCT02862457·34 enrolled

Azacitidine Combined With Pembrolizumab and Epacadostat in Subjects With Advanced Solid Tumors (ECHO-206)

Terminated· Incyte logo

Incyte·Phase 1/2·NCT02959437·70 enrolled

Show 1 more trial

Itacitinib Combined With INCB024360 and/or Itacitinib Combined With INCB050465 in Advanced Solid Tumors

Terminated· Incyte logo

Incyte·Phase 1·NCT02559492·142 enrolled

Non-Small Cell Lung Cancer4 trials

A Study of Pembrolizumab Plus Epacadostat With Platinum-based Chemotherapy Versus Pembrolizumab Plus Platinum-based Chemotherapy Plus Placebo in Metastatic Non-Small Cell Lung Cancer (KEYNOTE-715-06/ECHO-306-06)

Completed· Incyte logo

Incyte·Phase 2·NCT03322566·233 enrolled

Nivolumab and Epacadostat With Platinum Doublet Chemotherapy Versus Platinum Doublet Chemotherapy in Non-Small Cell Lung Cancer

Terminated· Incyte logo

Incyte·Phase 3·NCT03348904·2 enrolled

A Study of Atezolizumab (MPDL3280A) in Combination With Epacadostat (INCB024360) in Subjects With Previously Treated Stage IIIB or Stage IV Non-Small Cell Lung Cancer and Previously Treated Stage IV Urothelial Carcinoma (ECHO-110)

Terminated· Incyte logo

Incyte·Phase 1·NCT02298153·29 enrolled

Show 1 more trial

Pembrolizumab Plus Epacadostat vs Pembrolizumab Plus Placebo in Metastatic Non-Small Cell Lung Cancer (KEYNOTE-654-05/ECHO-305-05)

Completed· Incyte logo

Incyte·Phase 2·NCT03322540·154 enrolled

Pembrolizumab3 trials

Optimizing Antitumor Immunity Using Plasmid Electroporation, Pembrolizumab, and Epacadostat

Terminated·—·Phase 2·NCT03823131·14 enrolled

Epacadostat and Pembrolizumab in Patients With GIST

Terminated·—·Phase 2·NCT03291054·1 enrolled

Pembrolizumab (MK-3475) Plus Epacadostat vs Standard of Care in mRCC (KEYNOTE-679/ECHO-302)

Completed· Incyte logo

Incyte·Phase 3·NCT03260894·129 enrolled

Urothelial Carcinoma3 trials

Pembrolizumab in Combination With Epacadostat or Placebo in Cisplatin-ineligible Urothelial Carcinoma (KEYNOTE-672/ECHO-307)

Completed· Incyte logo

Incyte·Phase 3·NCT03361865·93 enrolled

Pembrolizumab + Epacadostat vs Pembrolizumab + Placebo in Recurrent or Progressive Metastatic Urothelial Carcinoma

Completed· Incyte logo

Incyte·Phase 3·NCT03374488·84 enrolled

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

Primary Peritoneal Cancer2 trials

Epacadostat Before Surgery in Treating Patients With Newly Diagnosed Stage III-IV Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cancer

Completed·NNational Cancer Institute (NCI)·Phase 1·NCT02042430·17 enrolled

DEC-205/NY-ESO-1 Fusion Protein CDX-1401, Poly ICLC, and IDO1 Inhibitor INCB024360 in Treating Patients With Ovarian, Fallopian Tube, or Primary Peritoneal Cancer in Remission

Completed·RRoswell Park Cancer Institute·Phase 1/2·NCT02166905·40 enrolled

29 more indications

AML2 trials

Epacadostat, Cladribine and Cytarabine (ECC) in AML

Withdrawn·IInsel Gruppe AG, University Hospital Bern·Phase 1·NCT03491579

Epacadostat, Idarubicin and Cytarabine (EIC) in AML

Withdrawn·IInsel Gruppe AG, University Hospital Bern·Phase 1·NCT03444649

Head and Neck Cancer2 trials

Epacadostat and Pembrolizumab in Patients With Head and Neck Cancer That Have Failed Prior Immunotherapy

Terminated·UUniversity of Chicago·Phase 2·NCT03463161·2 enrolled

A Study of Epacadostat + Pembrolizumab in Head and Neck Cancer Patients, Who Failed Prior PD-1/PD-L1 Therapy

Withdrawn·UUniversity of Chicago·Phase 2·NCT03238638

Ovarian Cancer2 trials

Testing Whether the Combination of Two Immunotherapy Drugs Have Activity in Recurrent or Persistent Clear Cell Ovarian Cancer

Completed·NNational Cancer Institute (NCI)·Phase 2·NCT03602586·14 enrolled

Study of DPX-Survivac Therapy in Patients With Recurrent Ovarian Cancer

Unknown status·IImmunoVaccine Technologies, Inc. (IMV Inc.)·Phase 1/2·NCT02785250·85 enrolled

Malignancies2 trials

A Study of Epacadostat and Nivolumab in Combination With Immune Therapies in Participants With Advanced or Metastatic Malignancies (ECHO-208)

Terminated· Incyte logo

Incyte·Phase 1/2·NCT03347123·11 enrolled

INCAGN01876 in Combination With Immune Therapies in Subjects With Advanced or Metastatic Malignancies

Terminated·IIncyte Biosciences International Sàrl·Phase 1/2·NCT03277352·10 enrolled

Squamous Cell Carcinoma2 trials

Neoadjuvant Pembrolizumab + Epacadostat Prior to Curative Surgical Care for Squamous Cell Carcinoma of the Head and Neck

Withdrawn·UUniversity of Chicago·Phase 2·NCT03325465

Nivolumab Plus Epacadostat in Combination With Chemotherapy Versus the EXTREME Regimen in Squamous Cell Carcinoma of the Head and Neck (CheckMate 9NA/ECHO-310)

Withdrawn· Incyte logo

Incyte·Phase 3·NCT03342352

Melanoma1 trial

Epacadostat and Vaccine Therapy in Treating Patients With Stage III-IV Melanoma

Completed·FFred Hutchinson Cancer Center·Phase 2·NCT01961115·11 enrolled

Safety and Efficacy1 trial

Safety and Efficacy of CRS-207 With Epacadostat in Platinum Resistant Ovarian, Fallopian or Peritoneal Cancer

Terminated·AAduro Biotech, Inc.·Phase 1/2·NCT02575807·35 enrolled

Head and Neck Squamous Cell Carcinoma1 trial

Pembrolizumab Plus Epacadostat, Pembrolizumab Monotherapy, and the EXTREME Regimen in Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma (KEYNOTE-669/ECHO-304)

Completed· Incyte logo

Incyte·Phase 3·NCT03358472·89 enrolled

Small Cell Lung Cancer1 trial

ALCMI-005: Pembrolizumab and Epacadostat in Treating Patients With Extensive Stage Small Cell Lung Cancer

Withdrawn·—·Phase 2·NCT03402880

Gastric Cancer1 trial

Epacadostat and Pembrolizumab in Treating Patients With Metastatic or Unresectable Gastroesophageal Junction or Gastric Cancer

Completed·GGeorge Albert Fisher·Phase 2·NCT03196232·3 enrolled

Locally Advanced1 trial

A Study of Epacadostat, an IDO1 Inhibitor, in Combination With Pembrolizumab in Patients With Metastatic and/or Locally Advanced Sarcoma

Active, not recruiting·MMemorial Sloan Kettering Cancer Center·Phase 2·NCT03414229·30 enrolled

Esophageal Cancer1 trial

Epacadostat and Pembrolizumab Before Surgery in Treating Participants With Stage II-III Esophageal or Gastroesophageal Cancer

Withdrawn·—·Phase 2·NCT03592407

Patients With Advanced Solid Tumors1 trial

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

Completed· Incyte logo

Incyte·Phase 1·NCT03589651·83 enrolled

Nasopharyngeal Cancer1 trial

Durvalumab and Epacadostat for Treatment of Unresectable, Recurrent, or Metastatic Epstein-Barr Virus Positive Nasopharyngeal Cancer

Withdrawn·AAlain Algazi·Phase 2·NCT04231864

Lymphoma1 trial

UCDCC#271: Phase I/II Trial of Epacadostat, Intralesional SD101, Radiotherapy in Patients With Lymphoma

Completed·UUniversity of California, Davis·Phase 1/2·NCT03322384·20 enrolled

Endometrial Cancer1 trial

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

Advanced Malignancy1 trial

Epacadostat (INCB24360) in Combination With Sirolimus in Advanced Malignancy

Unknown status·CChao Huang·Phase 1·NCT03217669·15 enrolled

Metastatic Melanoma1 trial

A Phase 1/2 Randomized, Blinded, Placebo Controlled Study of Ipilimumab in Combination With Epacadostat or Placebo in Subjects With Unresectable or Metastatic Melanoma

Terminated· Incyte logo

Incyte·Phase 1/2·NCT01604889·136 enrolled

Chemotherapy1 trial

A Phase 2 Study of the IDO Inhibitor Epacadostat Versus Tamoxifen for Subjects With Biochemical-recurrent-only EOC, PPC or FTC Following Complete Remission With First-line Chemotherapy

Terminated· Incyte logo

Incyte·Phase 2·NCT01685255·83 enrolled

Patients With Locally Advanced Rectal Cancer1 trial

Epacadostat (INCB024360) Added to Preoperative Chemoradiation in Patients With Locally Advanced Rectal Cancer

Recruiting·WWashington University School of Medicine·Phase 1/2·NCT03516708·49 enrolled

Pancreas Cancer1 trial

Epacadostat, Pembrolizumab, and CRS-207, With or Without CY/GVAX Pancreas in Patients With Metastatic Pancreas Cancer

Completed·SSidney Kimmel Comprehensive Cancer Center at Johns Hopkins·Phase 2·NCT03006302·41 enrolled

Immunotherapy1 trial

Phase I/II Study of Immunotherapy Combination BN-Brachyury Vaccine, M7824, N-803 and Epacadostat (QuEST1)

Completed·NNational Cancer Institute (NCI)·Phase 1/2·NCT03493945·59 enrolled

Advanced or Metastatic Solid Tumors1 trial

A Study of Epacadostat in Combination With Pembrolizumab and Chemotherapy in Participants With Advanced or Metastatic Solid Tumors (ECHO-207/KEYNOTE-723)

Completed· Incyte logo

Incyte·Phase 1/2·NCT03085914·70 enrolled

Thymic Carcinoma1 trial

Pembrolizumab and Epacadostat in Patients With Thymic Carcinoma

Unknown status·GGeorgetown University·Phase 2·NCT02364076·45 enrolled

Advanced Cancers1 trial

A Study of the Safety, Tolerability, and Efficacy of Epacadostat Administered in Combination With Nivolumab in Select Advanced Cancers (ECHO-204)

Completed· Incyte logo

Incyte·Phase 1/2·NCT02327078·307 enrolled

Solid Tumor Malignancies1 trial

A Window of Opportunity Study to Investigate Mechanisms of Actions of Novel Therapeutic Agents in Patients With Resectable Solid Tumor Malignancies

Terminated·SSidney Kimmel Comprehensive Cancer Center at Johns Hopkins·Phase 1·NCT03471286·2 enrolled

Pancreatic Cancer1 trial

Epacadostat and Pembrolizumab in Treating Participants With Advanced Pancreatic Cancer

Withdrawn·MM.D. Anderson Cancer Center·Phase 2·NCT03432676

Glioma1 trial

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

Bladder Urothelial Cancer1 trial

Pembrolizumab-Epacadostat Combination to Treat Muscle-invasive Bladder UrotheLIAl canceR: PECULIAR Study

Withdrawn·FFondazione IRCCS Istituto Nazionale dei Tumori, Milano·Phase 2·NCT03832673

Sources

References

[1]
ClinicalTrials.gov — 50 trial records for Epacadostat. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — Epacadostat compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for Epacadostat. 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: Indoleamine 2,3-Dioxygenase Inhibitor[2]
Modality: Small molecule[2]
Highest Phase: Phase 3[1]
Company: Incyte

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