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Zynlonta

(Loncastuximab Tesirine)

Phase 3Antibody–drug conjugate

Akero Therapeutics

Loncastuximab tesirine is used to treat a type of blood cancer called diffuse large B-cell lymphoma in patients who have already tried other treatments.[1] Zynlonta is currently being investigated across 13 indications[3], with its most advanced program in Phase 3.[1]

Zynlonta is one of 164 small molecule programs targeting Follicular Lymphoma. It is currently in Phase 3.

13

Indications

25

Total Trials

16

Active Trials

163

Competitors

1

FDA Application

NDA/BLA/ANDA regulatory filings

Pipeline

Status by Indication[3][1]

Indication

Follicular LymphomaTerminated

Waldenstrom MacroglobulinemiaRecruiting

B-Cell Non-Hodgkins LymphomaUnknown

B-Cell NeoplasmUnknown

B-Cell Non Hodgkin LymphomaActive, not recruiting

Double-Expressor LymphomaRecruiting

Large B-Cell LymphomaRecruiting

Post-Transplant Lymphoproliferative DisorderNot yet recruiting

Relapsed or Refractory B-Cell MalignanciesRecruiting

Diffuse Large B-Cell LymphomaActive, not recruiting

Follicular LymphomaPhase 2

Terminated

Waldenstrom MacroglobulinemiaPhase 2

Recruiting

B-Cell Non-Hodgkins LymphomaPreclinical

Unknown

B-Cell NeoplasmPreclinical

Unknown

B-Cell Non Hodgkin LymphomaPhase 1

Active, not recruiting

Double-Expressor LymphomaPhase 2

Recruiting

Large B-Cell LymphomaPhase 2

Recruiting

Post-Transplant Lymphoproliferative DisorderPreclinical

Not yet recruiting

Relapsed or Refractory B-Cell MalignanciesPhase 2

Recruiting

Diffuse Large B-Cell LymphomaPhase 3

Active, not recruiting

Showing 10 of 13 indications

Competition

Competitive Landscape

401 competitors in Lymphoma

#DrugCompanyPhaseTrials

Zynlonta

Akero Therapeutics

Zofran

Norvir

Cabenuva

Emend

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

Kenalog

BBausch Health Americas, Inc.

Nuvigil

NNuvo Research GmbH

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

Q1 2027

Phase 2Recruiting

Recurrent Diffuse Large B-Cell Lymphoma

NCT05672251

Q2 2027

Phase 2Recruiting

Diffuse Large B-Cell Lymphoma

NCT06918912

Q3 2027

Phase 2Recruiting

Relapsed or Refractory B-Cell Malignancies

NCT05453396

Q4 2027

Phase 2Recruiting

Double-Expressor Lymphoma

NCT05600686

Clinical

Trials by Indication[1]

Diffuse Large B-Cell Lymphoma9 trials

Loncastixumab Tesirine (ADCT-402) Expanded Access Program (EAP) for Patients With Relapsed/Refractory Diffuse Large B-Cell Lymphoma

No longer available·AADC Therapeutics S.A.··NCT04705454

A Study of Loncastuximab Tesirine and Rituximab (Lonca-R) in Previously Untreated Unfit/Frail Participants With Diffuse Large B-cell Lymphoma (DLBCL)

Terminated·AADC Therapeutics S.A.·Phase 2·NCT05144009·41 enrolled

Study to Evaluate the Efficacy and Safety of Loncastuximab Tesirine in Patients With Relapsed or Refractory Diffuse Large B-Cell Lymphoma

Completed·AADC Therapeutics S.A.·Phase 2·NCT03589469·145 enrolled

Show 6 more trials

Study of Loncastuximab Tesirine in Patients With Relapsed/Refractory Diffuse Large B-Cell Lymphoma (DLBCL) or High-Grade B-Cell Lymphoma (HGBCL) Following CAR-T Therapy Failure

Recruiting·IIstituto Clinico Humanitas·Phase 2·NCT06918912·50 enrolled

Study to Evaluate Loncastuximab Tesirine With Rituximab Versus Immunochemotherapy in Participants With Relapsed or Refractory Diffuse Large B-Cell Lymphoma

Active, not recruiting·AADC Therapeutics S.A.·Phase 3·NCT04384484·440 enrolled

Trial of Loncastuximab Tesirine in High Risk Diffuse Large B-cell Lymphoma Post Transplant

Withdrawn·BBarbara Ann Karmanos Cancer Institute·Phase 2·NCT05222438

Loncastuximab Tesirine in Combination With Chemotherapy Prior to Stem Cell Transplant for the Treatment of Recurrent or Refractory Diffuse Large B-Cell Lymphoma

Withdrawn·FFred Hutchinson Cancer Center·Phase 1·NCT05228249

A Study to Evaluate the Tolerability, Safety, Pharmacokinetics, and Antitumor Activity of Loncastuximab Tesirine in Combination With Rituximab, Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone (R-CHOP) in Participants With Previously Untreated Diffuse Large B-cell Lymphoma (LOTIS-8)

Withdrawn·AADC Therapeutics S.A.·Phase 1·NCT04974996

A Phase 1b Open-Label Study to Evaluate the Pharmacokinetics and Safety of Loncastuximab Tesirine in Patients With Relapsed or Refractory Diffuse Large B-cell Lymphoma or High-grade B-cell Lymphoma With Hepatic Impairment (LOTIS-10)

Terminated·AADC Therapeutics S.A.·Phase 1·NCT05660395·5 enrolled

Lymphoma4 trials

A Global Study of Novel Agents in Paediatric and Adolescent Relapsed and Refractory B-cell Non-Hodgkin Lymphoma

Recruiting·UUniversity of Birmingham·Phase 2/3·NCT05991388·210 enrolled

Loncastuximab Tesirine and Rituximab as Bridging Therapy Before Standard-of-care CAR-T Therapy in Patients With Large B-cell Lymphoma (CORAL)

Recruiting·UUniversity of Utah·Phase 2·NCT06788964·29 enrolled

Epcoritamab in Combination With Loncastuximab Tesirine in Relapsed/Refractory Large B-cell Lymphoma

Recruiting·UUniversity of Miami·Phase 2·NCT06919939·26 enrolled

Show 1 more trial

Loncastuximab Tesirine and Venetoclax for Relapsed/ Refractory Non-Hodgkin Lymphoma

Active, not recruiting·PPaolo Caimi, MD·Phase 1·NCT05053659·23 enrolled

Follicular Lymphoma2 trials

Study to Evaluate the Efficacy and Safety of Loncastuximab Tesirine Versus Idelalisib in Participants With Relapsed or Refractory Follicular Lymphoma

Terminated·AADC Therapeutics S.A.·Phase 2·NCT04699461·6 enrolled

Loncastuximab Tesirine in Combination With Rituximab in Patients With Relapsed or Refractory Follicular Lymphoma

Recruiting·—·Phase 2·NCT04998669·100 enrolled

Relapsed or Refractory B-cell Malignancies1 trial

Loncastuximab Tesirine for the Treatment of Relapsed or Refractory B-Cell Malignancies

Recruiting·UUniversity of Washington·Phase 2·NCT05453396·40 enrolled

Mantle Cell Lymphoma1 trial

Safety and Efficacy Study of Loncastuximab Tesirine + Ibrutinib in Diffuse Large B-Cell or Mantle Cell Lymphoma

Terminated·AADC Therapeutics S.A.·Phase 1/2·NCT03684694·136 enrolled

8 more indications

Lymphoma, Non-Hodgkin1 trial

A Phase 1, First-in-Human Study of a Novel CD79bxCD20xCD3 Trispecific Antibody in B-Cell Non-Hodgkin Lymphoid Malignancies (NHLs)

Recruiting· Johnson & Johnson logo

Johnson & Johnson·Phase 1·NCT07308132·340 enrolled

Central Nervous System Lymphoma1 trial

A Phase 1 Study of Loncastuximab Tesirine and Rituximab Following Stereotactic Radiosurgery (SRS) in Patients With Primary and Secondary Central Nervous System Lymphomas

Recruiting·UUniversity of Utah·Phase 1·NCT06607549·12 enrolled

Post-Transplant Lymphoproliferative Disorder1 trial

A Phase 1/2 Study of Loncastuximab Tesirine and Rituximab as First-line Therapy in Patients With Post-transplant Lymphoproliferative Disorder (PLUTO)

Not yet recruiting·UUniversity of Utah·Preclinical·NCT07573436·23 enrolled

B-cell Non Hodgkin Lymphoma1 trial

A Phase 1b Open-Label Study to Evaluate the Safety and Anti-cancer Activity of Loncastuximab Tesirine in Combination With Other Anti-cancer Agents in Patients With Relapsed or Refractory B-cell Non-Hodgkin Lymphoma (LOTIS-7)

Active, not recruiting·AADC Therapeutics S.A.·Phase 1·NCT04970901·154 enrolled

Large B-cell Lymphoma1 trial

A Phase II Study of Loncastuximab Tesirine as Consolidation Strategy in Patients With LBCL in PR After CAR T-cell Therapy

Recruiting·MM.D. Anderson Cancer Center·Phase 2·NCT05464719·30 enrolled

Recurrent Diffuse Large B-Cell Lymphoma1 trial

A Phase 2 Study of Loncastuximab Tesirine Plus Mosunetuzumab in Patients With Relapsed/Refractory Diffuse Large B-cell Lymphoma

Recruiting·CCity of Hope Medical Center·Phase 2·NCT05672251·36 enrolled

Double-Expressor Lymphoma1 trial

A Phase 2 Study of Loncastuximab Tesirine and Rituximab (Lonca-R) Followed by DA-EPOCH-R in Previously Untreated High-Risk Diffuse Large B-Cell Lymphoma

Recruiting·JJoseph Tuscano·Phase 2·NCT05600686·24 enrolled

Unspecified1 trial

Loncastuximab Tesirine in WM

Recruiting·—·Phase 2·NCT05190705·36 enrolled

Regulatory

FDA Approval Timeline[4]

Apr 23, 2021

ZYNLONTA

BLA BLA761196

Sources

References

[1]
ClinicalTrials.gov — 25 trial records for Loncastuximab Tesirine. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — Loncastuximab Tesirine compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for Loncastuximab Tesirine. EMBL-EBI & Wellcome Sanger Institute.
[4]
OpenFDA — FDA approval records (BLA BLA761196). U.S. Food & Drug Administration.
[5]
SEC EDGAR — Akero Therapeutics company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Mechanism of Action: B-Lymphocyte Antigen CD19 Binding Agent[2]
Modality: Antibody–drug conjugate[2]
Highest Phase: Phase 3[1]
Company: Akero Therapeutics

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