Drugs / Loncastuximab Tesirine
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Loncastuximab Tesirine

Other / unclassified targets CD19 via depletion

Developed for
diffuse large B-cell lymphoma · follicular lymphoma · mantle cell lymphoma · high grade B-cell lymphoma · large B-cell lymphoma · primary mediastinal large B-cell lymphoma · B-cell non-Hodgkin lymphoma · Burkitt lymphoma
+11 more · high grade B-cell lymphoma with MYC and/ or BCL2 and/or BCL6 rearrangement · marginal zone lymphoma · Waldenstrom macroglobulinemia · acute lymphoblastic leukemia · B-cell chronic lymphocytic leukemia · central nervous system non-hodgkin lymphoma · chronic lymphocytic leukemia/small lymphocytic lymphoma · non-Hodgkin lymphoma · post-transplant lymphoproliferative disease · relapsed/refractory diffuse large B-cell lymphoma · Richter transformation
Investigated by
ADC Therapeutics S.A. · University of Utah · National Cancer Institute (NCI) · University of Miami · ADC Therapeutics · AbbVie
+20 more · Barbara Ann Karmanos Cancer Institute · Cancer Research UK · City of Hope Medical Center · Fight Kids Cancer · Fondazione Italiana Linfomi - ETS · Fred Hutchinson Cancer Center · Genmab · Istituto Clinico Humanitas · Juan P. Alderuccio, MD · M.D. Anderson Cancer Center · Medical College of Wisconsin · Paolo Caimi, MD · Regeneron Pharmaceuticals · Shayna Sarosiek, MD · Sobi, Inc. · University of Alabama at Birmingham · University of Birmingham · University of California, Davis · University of Münster · University of Washington

Regulatory milestones approvals, filings & regulatory actions · 3 recorded

MilestoneJurisdictionBrandIndicationDateSentence it was read from
Filed diffuse large B-cell lymphoma 2 milestones
Filed China (NMPA) ZYNLONTA diffuse large B-cell lymphoma 2023-07-24

“China National Medical Products Administration (NMPA) has accepted the Biologics License Application (BLA) for ZYNLONTA” adctherapeutics.com ↗

Filed EU (EMA) ZYNLONTA diffuse large B-cell lymphoma —

“The medicine has orphan drug designation in the EU and is under regulatory review with a decision anticipated in the first quarter of 2023.” sobi.com ↗

“In the EU, loncastuximab tesirine has orphan drug designation for the treatment of DLBCL and is under regulatory review since October 2021.” sobi.com ↗

Approved Indication not stated 1 milestone
Approved · conditional EU (EMA) Zynlonta — 2022-12-20 europa.eu ↗

Trials 32

PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 111 trials
Phase 1 NCT06607549 Mar 2025 → Nov 2029 expected central nervous system non-hodgkin lymphoma University of Utah Recruiting No outcome recorded
Phase 1 NCT05971251 Dec 2023 → Dec 2026 expected chronic lymphocytic leukemia/small lymphocytic lymphoma University of Alabama at Birmingham Active not recruiting No outcome recorded
Phase 1 NCT05660395 Jul 2023 → Jun 2026 high grade B-cell lymphoma ADC Therapeutics S.A. Terminated No outcome recorded
Phase 1 NCT05228249 Apr 2023 → Oct 2025 high grade B-cell lymphoma with MYC and/ or BCL2 and/or BCL6 rearrangement, primary mediastinal large B-cell lymphoma Fred Hutchinson Cancer Center Withdrawn No outcome recorded Stop: Enrollment
Phase 1 NCT05270057 Jan 2023 → May 2025 overdue Burkitt lymphoma Medical College of Wisconsin Active not recruiting No outcome recorded
Phase 1 NCT05053659 Jun 2022 → Nov 2026 expected non-Hodgkin lymphoma Paolo Caimi, MD Active not recruiting No outcome recorded
Phase 1 NCT04970901 Jun 2022 → Mar 2027 expected B-cell non-Hodgkin lymphoma ADC Therapeutics S.A. Active not recruiting No outcome recorded
Phase 1 NCT04974996 Feb 2022 → Mar 2024 diffuse large B-cell lymphoma ADC Therapeutics S.A. Withdrawn No outcome recorded
Phase 1 NCT03685344 Feb 2019 → Oct 2020 diffuse large B-cell lymphoma, follicular lymphoma, mantle cell lymphoma ADC Therapeutics S.A. Terminated No outcome recorded
Phase 1 NCT02669264 Mar 2016 → Jul 2018 acute lymphoblastic leukemia ADC Therapeutics S.A. Terminated No outcome recorded Stop: Enrollment
Phase 1/22 trials
Phase 1/2 NCT07573436 Nov 2026 → Jun 2030 expected post-transplant lymphoproliferative disease University of Utah Not yet recruiting No outcome recorded
Phase 1/2 NCT03684694 Dec 2018 → Nov 2022 diffuse large B-cell lymphoma, mantle cell lymphoma ADC Therapeutics S.A. Terminated No outcome recorded
Phase 216 trials · 1 met primary
Phase 2 NCT06919939 Jan 2026 → Jan 2031 expected diffuse large B-cell lymphoma, large B-cell lymphoma University of Miami Recruiting No outcome recorded
Phase 2 NCT07197307 Oct 2025 → Jan 2030 expected high grade B-cell lymphoma University of Münster Not yet recruiting No outcome recorded
Phase 2 NCT06788964 Aug 2025 → Mar 2027 expected large B-cell lymphoma University of Utah Recruiting No outcome recorded
Phase 2 NCT05672251 Jan 2024 → Aug 2029 expected Richter transformation, high grade B-cell lymphoma, primary mediastinal large B-cell lymphoma City of Hope Medical Center Recruiting No outcome recorded
Phase 2 NCT05453396 Aug 2023 → May 2026 diffuse large B-cell lymphoma, follicular lymphoma, mantle cell lymphoma University of Washington Terminated No outcome recorded Stop: Enrollment
Phase 2 NCT06918912 Jun 2023 → Mar 2025 overdue high grade B-cell lymphoma Istituto Clinico Humanitas Recruiting No outcome recorded
Phase 2 NCT05600686 May 2023 → Oct 2026 expected diffuse large B-cell lymphoma, high grade B-cell lymphoma with MYC and/ or BCL2 and/or BCL6 rearrangement University of California, Davis Active not recruiting No outcome recorded
Phase 2 NCT05464719 Sep 2022 → Jan 2030 expected large B-cell lymphoma M.D. Anderson Cancer Center Recruiting No outcome recorded
Phase 2 NCT05144009 Jun 2022 → Jan 2024 diffuse large B-cell lymphoma ADC Therapeutics S.A. Terminated No outcome recorded
Phase 2 NCT05296070 Jun 2022 → Jun 2028 expected marginal zone lymphoma University of Miami Recruiting No outcome recorded
Phase 2/31 trial
Phase 2/3 NCT05991388 May 2024 → May 2031 expected B-cell non-Hodgkin lymphoma University of Birmingham Recruiting No outcome recorded
Phase 31 trial
Phase 3 NCT04384484 Sep 2020 → Mar 2026 overdue diffuse large B-cell lymphoma ADC Therapeutics S.A. Active not recruiting No outcome recorded
Phase not stated1 trial
— NCT04705454 — relapsed/refractory diffuse large B-cell lymphoma ADC Therapeutics S.A. No longer available No outcome recorded
Comparator or background therapy1 trial
Phase 1 NCT07308132 Background Jan 2026 → Aug 2028 expected non-Hodgkin lymphoma Janssen Research & Development, LLC Recruiting No outcome recorded

News releases announcing trial results or a regulatory action · 33

DateIssuerRelease
2026-06-03 ADC Therapeutics S.A. Results ADC Therapeutics Announces Results From LOTIS-5 Phase 3 Confirmatory Clinical Trial of ZYNLONTA® in Combination with Rituximab in Relapsed or Refractory Diffuse Large B-Cell Lymphoma adctherapeutics.com ↗
ZYNLONTA plus rituximab achieved statistical significance on the trial's primary endpoint of progression-free survival (PFS) and demonstrated no detrimental effect on the key secondary efficacy endpoint of overall survival (OS).
2026-01-29 Tanabe Pharma Corporation Results MT-2111 (loncastuximab tesirine-lpyl) Achieved Primary Endpoint in Phase 2 part of Japanese Phase 1/2 study for Relapsed or Refractory Diffuse Large B-cell Lymphoma tanabe-pharma.com ↗
MT-2111 (loncastuximab tesirine-lpyl) Achieved Primary Endpoint in Phase 2 part of Japanese Phase 1/2 study for Relapsed or Refractory Diffuse Large B-cell Lymphoma
2025-05-14 ADC Therapeutics S.A. Results ADC Therapeutics Announces Presentation of LOTIS-7 Clinical Trial Data at the European Hematology Association 2025 Congress (EHA2025) and the 18th International Conference on Malignant Lymphoma (ICML) adctherapeutics.com ↗
ZYNLONTA ® plus glofitamab (COLUMVI ® ) demonstrated ORR of 95.5% and CR of 90.9%, among 22 evaluable patients with relapsed/refractory DLBCL
2024-12-09 ADC Therapeutics S.A. Results ADC Therapeutics Announces The Lancet Haematology Publication of Data from Investigator-Initiated Trial Evaluating ZYNLONTA® in Combination with Rituximab to Treat Relapsed/Refractory Follicular Lymphoma adctherapeutics.com ↗
Combination in r/r follicular lymphoma shows best ORR of 97% and CR rate of 77% with 12-month PFS of 95%
2024-05-06 ADC Therapeutics S.A. Results ADC Therapeutics Reports First Quarter 2024 Financial Results and Provides Business Updates adctherapeutics.com ↗
Initial MZL IIT Phase 2 data from 15 patients showed 13 patients with CR and 1 patient with PR; encouraging data compared to current treatments in area with high unmet medical need
2024-05-06 ADC Therapeutics S.A. Results ADC Therapeutics Announces Initial Data from Investigator-Initiated Phase 2 Clinical Trial of ZYNLONTA® in Patients with Relapsed/Refractory Marginal Zone Lymphoma adctherapeutics.com ↗
Of these 15 patients evaluated, 13 achieved a complete response (CR) and one patient achieved a partial response (PR).
2024-04-04 ADC Therapeutics S.A. Results ADC Therapeutics Announces Updates on LOTIS-7 Clinical Trial Evaluating ZYNLONTA® in Combination with Glofitamab or Mosunetuzumab in Patients with Relapsed/Refractory B-cell Non-Hodgkin Lymphoma adctherapeutics.com ↗
Additionally, after the first investigator assessment, evidence of anti-tumor activity was observed among the majority of patients, with mixed histologies including diffuse large B-cell lymphoma (DLBCL), follicular lymphoma (FL) and marginal zone lymphoma (MZL).
2024-01-04 ADC Therapeutics S.A. Results ADC Therapeutics Provides Business Updates adctherapeutics.com ↗
We are also encouraged to see positive initial signals in the LOTIS-7 trial of ZYNLONTA in combination with bispecifics as well as early signs of antitumor activity in the Phase 1b trial of ADCT-601.
2023-12-12 ADC Therapeutics S.A. Results ADC Therapeutics Announces Initial Results from Investigator-Initiated Phase 2 Clinical Trial Evaluating ZYNLONTA® in Combination with Rituximab in Patients with Relapsed/Refractory Follicular Lymphoma (FL) adctherapeutics.com ↗
2023-11-02 ADC Therapeutics S.A. Results ADC Therapeutics Announces Abstracts Accepted for Presentation at the 65th ASH Annual Meeting adctherapeutics.com ↗
The combination was well tolerated with a 95% overall response rate at week 12 and at week 21, an 86% metabolic complete response rate.
2023-08-30 ADC Therapeutics S.A. Results ADC Therapeutics Announces Updates on ZYNLONTA® LOTIS Clinical Trial Programs at the Eleventh Annual Meeting of the Society of Hematologic Oncology (SOHO 2023) adctherapeutics.com ↗
2023-07-24 ADC Therapeutics S.A. Regulatory Overland ADCT BioPharma Announces NMPA Accepts Biologics License Application and Grants Priority Review for ZYNLONTA® for Treatment of Relapsed or Refractory Diffuse Large B-cell Lymphoma adctherapeutics.com ↗
The BLA has been granted priority review by the NMPA.

All press releases naming this drug 54 releases

DateIssuerRelease

Evidence & citations 11 cited values

Every value below carries the sentence it was read from. 36 sources stand behind the page.

FieldValueCited text
Known as Loncastuximab Tesirine “Loncastuximab tesirine, an anti-CD19 antibody-drug conjugate, in relapsed/refractory B-cell acute lymphoblastic leukemia.” PMID 32012214 ↗ Feb 2020
31

NCT06788964 ↗

NCT06918912 ↗

NCT05453396 ↗

NCT04384484 ↗

NCT06919939 ↗

NCT04699461 ↗

NCT05672251 ↗

NCT07308132 ↗

NCT05222438 ↗

NCT05464719 ↗

Show 21 more sources

Known as ADCT-402 “Based on published results we considered the expected 12-month PFS with available treatments to be \<20%; we hypothesized that, in this setting of patients, a consolidation...” NCT05249959 ↗
2

“The purpose of this phase 1 study is to evaluate the safety and anti-tumor activity of Loncastuximab Tesirine (ADCT-402) and Durvalumab in participants with Advanced Diffuse...” NCT03685344 ↗

NCT02669017 ↗

Known as ADCT-402 TESIRINE ChEMBL registry synonym — accepted as the source's own label CHEMBL4297778 ↗
Known as Lonca “Loncastuximab tesirine (loncastuximab tesirine-lpyl [Lonca]), an anti-CD19 antibody conjugated to a potent pyrrolobenzodiazepine dimer, demonstrated single-agent antitumor...” PMID 37646659 ↗ Apr 2024
Known as Loncastuximab tesirina ChEMBL registry synonym — accepted as the source's own label CHEMBL4297778 ↗
Known as loncastuximab tesirine-lpyl “Loncastuximab tesirine (loncastuximab tesirine-lpyl [Lonca]), an anti-CD19 antibody conjugated to a potent pyrrolobenzodiazepine dimer, demonstrated single-agent antitumor...” PMID 37646659 ↗ Apr 2024
Known as Zynlonta ChEMBL registry synonym — accepted as the source's own label CHEMBL4297778 ↗
Action Deplete “Loncastuximab tesirine has been designed to target and kill CD19-expressing malignant B-cells.” NCT03589469 ↗
Modality Other / unclassified “Loncastuximab tesirine is an antibody drug conjugate (ADC) composed of a humanized antibody directed against human cluster of differentiation 19 (CD19)” NCT03589469 ↗
Route Intravenous “intravenous infusion” NCT02669017 ↗
Target CD19 “comprising a CD19-targeting antibody and pyrrolobenzodiazepine dimers.” PMID 31685491 ↗ Nov 2019