Ontak

(denileukin diftitox)

Phase 3Biologic

Denileukin diftitox is used to treat a type of blood cancer called cutaneous T-cell lymphoma, where cancer cells affect the skin. It works by targeting and destroying these cancer cells.[1] Ontak is currently being investigated across 18 indications[3], with its most advanced program in Phase 3.[1]

Ontak is one of 439 biologic programs targeting T-cell acute lymphoblastic leukemia. It is currently in Phase 3.

Indications

Total Trials

Active Trials

438

Competitors

Pipeline

Status by Indication[3][1]

Indication

T-Cell Acute Lymphoblastic LeukemiaActive, not recruiting

Unspecified Peripheral T-Cell LymphomaActive, not recruiting

T-Cell Non-Hodgkin LymphomaActive, not recruiting

LymphomaActive, not recruiting

Cutaneous T-Cell LymphomaUnknown

Cutaneous MelanomaActive, not recruiting

LeukemiaActive, not recruiting

Metastatic MelanomaActive, not recruiting

Childhood LeukemiaUnknown

Fallopian Tube CancerActive, not recruiting

T-Cell Acute Lymphoblastic LeukemiaPhase 2

Active, not recruiting

Unspecified Peripheral T-Cell LymphomaPhase 3

Active, not recruiting

T-Cell Non-Hodgkin LymphomaPreclinical

Active, not recruiting

LymphomaPhase 3

Active, not recruiting

Cutaneous T-Cell LymphomaPreclinical

Unknown

Cutaneous MelanomaPhase 1

Active, not recruiting

LeukemiaPhase 2

Active, not recruiting

Metastatic MelanomaPhase 2

Active, not recruiting

Childhood LeukemiaPreclinical

Unknown

Fallopian Tube CancerPhase 1

Active, not recruiting

Showing 10 of 18 indications

Competition

Competitive Landscape

1774 competitors in Lymphoma

#DrugCompanyPhaseTrials

Ontak

Eisai

Phase 3

7 2

Blenoxane

SSequus Pharmaceuticals

Preclinical

25 3

Velban

EEastern Cooperative Oncology Group

Preclinical

15 4

Zofran

Novartis

Preclinical

2 5

Tafasitamab

Incyte

Preclinical

7 6

Emend

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

Preclinical

1 7

Kenalog

BBausch Health Americas, Inc.

Preclinical

1 8

PEG-Intron

Merck & Co.

Preclinical

1 9

Decadron

QQuince Therapeutics S.p.A.

Preclinical

—10

Solu-Medrol

MMassachusetts Eye and Ear Infirmary

Preclinical

—

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

Clinical

Trials by Indication[1]

Lymphoma7 trials

Denileukin Diftitox in Treating Patients With Relapsed or Refractory Non-Hodgkin's Lymphoma

Completed·JJonsson Comprehensive Cancer Center·Phase 2·NCT00138164·50 enrolled

Dexamethasone Followed by Denileukin Diftitox in Treating Patients With Persistent or Recurrent T-Cell Lymphoma

Completed·LLigand Pharmaceuticals·Phase 2·NCT00006345

Denileukin Diftitox in Treating Patients With Non-Hodgkin's Lymphoma

Completed·EEastern Cooperative Oncology Group·Phase 2·NCT00003615·77 enrolled

Show 4 more trials

Denileukin Diftitox in Treating Patients With Non-Hodgkin's Lymphoma

Unknown status·PPharmatech Oncology·Phase 2·NCT00026429

E7777 for the Treatment of Patients With Peripheral T-Cell Lymphoma

Completed· Eisai logo

Eisai·Phase 1·NCT01401530·13 enrolled

Rituximab and Denileukin Diftitox in Treating Patients With Previously Untreated Stage III or Stage IV Follicular B-Cell Non-Hodgkin's Lymphoma

Completed·AAlliance for Clinical Trials in Oncology·Phase 2·NCT00460109·24 enrolled

A Study of ONTAK and CHOP in Newly Diagnosed, Peripheral T-Cell Lymphoma

Completed· Eisai logo

Eisai·Phase 2·NCT00211185·49 enrolled

Melanoma2 trials

Therapeutic Autologous Lymphocytes, Aldesleukin, and Denileukin Diftitox in Treating Patients With Stage III-IV Melanoma

Terminated·FFred Hutchinson Cancer Center·Phase 1/2·NCT00945269·3 enrolled

Study of Denileukin Diftitox in Participants With Stage IIIC and Stage IV Melanoma

Completed· Eisai logo

Eisai·Phase 2·NCT01127451·75 enrolled

Metastatic Melanoma2 trials

Phase II Trial of Ontak With Metastatic Melanoma

Completed·—·Phase 2·NCT00299689·69 enrolled

Denileukin Diftitox in Treating Patients With Metastatic Melanoma or Metastatic Kidney Cancer

Completed·NNational Cancer Institute (NCI)·Phase 2·NCT00082914

Leukemia2 trials

Phase II Study of the Efficacy and Toxicity of Ontak(Registered Trademark) (Denileukin Diftitox) in the Therapy of Adult T-Cell Leukemia

Terminated·NNational Cancer Institute (NCI)·Phase 2·NCT00117845·17 enrolled

Haploidentical Natural Killer Cells to Treat Refractory or Relapsed Acute Myelogenous Leukemia (AML)

Terminated·MMasonic Cancer Center, University of Minnesota·Phase 2·NCT01106950·15 enrolled

Renal Cancer1 trial

Pilot Study of Denileukin Diftitox Plus High-Dose IL-2 for Patients With Metastatic Renal Cancer

Completed·NNorthwestern University·Phase 1·NCT00278369·20 enrolled

10 more indications

Non-Small Cell Lung Cancer1 trial

Cyclophosphamide or Denileukin Diftitox Followed By Expanding a Patient's Own T Cells in the Laboratory in Treating Patients With HER-2/Neu Overexpressing Metastatic Breast Cancer, Ovarian Cancer, or Non-Small Cell Lung Cancer Previously Treated With HER-2/Neu Vaccine

Completed·UUniversity of Washington·Phase 1·NCT00228358·8 enrolled

Acute Graft Versus Host Disease1 trial

Treatment for Acute Graft-Versus-Host Disease (BMT CTN 0302)

Completed·NNational Heart, Lung, and Blood Institute (NHLBI)·Phase 2·NCT00224874·180 enrolled

Metastatic Cancer1 trial

Denileukin Diftitox Followed by Vaccine Therapy in Treating Patients With Metastatic Cancer

Completed·HH. Kim Lyerly·Phase 1·NCT00128622·24 enrolled

Relapse1 trial

Denileukine Diftitox for Relapsed ALCL

Withdrawn·—·Phase 2·NCT00801918

Transplantation1 trial

Dose Escalation Trial of Denileukin Diftitox (Ontak) Post Autologous Transplantation

Terminated·BBarbara Ann Karmanos Cancer Institute·Phase 1·NCT01251952·2 enrolled

Treatment1 trial

Access Program With Denileukin Diftitox for the Treatment of Patients Currently Receiving Treatment With Commercially Available (Ontak)

No longer available· Eisai logo

Eisai··NCT01432483

Chronic Lymphocytic Leukemia1 trial

Denileukin Diftitox in Treating Patients With Fludarabine-Refractory B-Cell Chronic Lymphocytic Leukemia

Completed·WWake Forest University Health Sciences·Phase 2·NCT00082940

T-cell non-Hodgkin lymphoma1 trial

Combination Chemotherapy and Denileukin Diftitox in Treating Patients With Newly Diagnosed T-Cell Non-Hodgkin Lymphoma

Withdrawn·UUniversity of Miami·N/A·NCT00513188

Fallopian Tube Cancer1 trial

Denileukin Diftitox Used in Treating Patients With Advanced Refractory Ovarian Cancer, Primary Peritoneal Carcinoma, or Epithelial Fallopian Tube Cancer

Completed·UUniversity of Washington·Phase 1·NCT00357448·11 enrolled

Induction Therapy1 trial

Treatment of PTCL With Aggressive Induction Therapy Followed by Autologous SCT Using Denileukin Diftitox (Ontak)

Terminated·UUniversity of California, San Francisco·Phase 2·NCT00632827·21 enrolled

Sources

References

[1]
ClinicalTrials.gov — 24 trial records for denileukin diftitox. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — denileukin diftitox compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for denileukin diftitox. EMBL-EBI & Wellcome Sanger Institute.
[4]
SEC EDGAR — Eisai company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Mechanism of Action: Interleukin-2 Receptor Binding Agent; Elongation Factor 2 Inhibitor[2]
Modality: Biologic[2]
Highest Phase: Phase 3[1]
Company: Eisai

Ontak

Status by Indication[3][1]

Competitive Landscape

Trials by Indication[1]

Lymphoma7 trials

Melanoma2 trials

Metastatic Melanoma2 trials

Leukemia2 trials

Renal Cancer1 trial

Non-Small Cell Lung Cancer1 trial

Acute Graft Versus Host Disease1 trial

Metastatic Cancer1 trial

Relapse1 trial

Transplantation1 trial

Treatment1 trial

Chronic Lymphocytic Leukemia1 trial

T-cell non-Hodgkin lymphoma1 trial

Fallopian Tube Cancer1 trial

Induction Therapy1 trial

References

Drug Info

Quick Facts

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