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Last update 23 Jan 2025

Loncastuximab tesirine

Last update 23 Jan 2025

Overview

R&D Status

Clinical Result

Translational Medicine

Overview

Basic Info

Drug Type

Antibody drug conjugate (ADC)

Synonyms

Anti-CD19-PBD-conjugate-ADC, Immunoglobulin g1-kappa, anti-(homo sapiens b-lymphocyte antigen cd-19)chimeric monoclonal antibody conjugated to an average of two molecules of tesirine.gamma.1 heavy chain (1-449) (mus musculus vh (ighv1-69*02 (86%) (ighd)-ighj4*01)) (8.8.13) (1-120) -, Lonca

+ [12]

Target

CD19

Mechanism

CD19 inhibitors(B-lymphocyte antigen CD19 inhibitors)

Therapeutic Areas

NeoplasmsImmune System DiseasesHemic and Lymphatic Diseases+ [3]

Active Indication

Diffuse large B-cell lymphoma recurrentDiffuse large B-cell lymphoma refractoryDiffuse Large B-Cell Lymphoma+ [13]

Inactive Indication

Burkitt LymphomaMantle-Cell LymphomaMediastinal large B-cell lymphoma+ [4]

Originator Organization

ADC Therapeutics SA

Active Organization

ADC Therapeutics SA

Swedish Orphan Biovitrum AB

Mitsubishi Tanabe Pharma Corp.

+ [1]

Inactive Organization

BSP Pharmaceuticals SpA

Drug Highest PhaseApproved

First Approval Date

US (23 Apr 2021),

Diffuse Large B-Cell LymphomaHigh grade B-cell lymphoma

RegulationConditional marketing approval (CN), Accelerated assessment (US), Orphan Drug (EU), Priority Review (CN), Accelerated Approval (US)

Structure/Sequence

Molecular FormulaC42H65N5O17

InChIKeyNPTPHNNPPOZTSM-GSSDHLSPSA-N

CAS Registry-

View All Structures (2)

Boost your research with our ADC technology data.

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Sequence Code 315596552L

Source: *****

Sequence Code 315596551H

Source: *****

Clinical Trials associated with Loncastuximab tesirine

NCT06607549

/ Not yet recruitingPhase 1IIT

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

The purpose of this clinical trial is to learn if drugs loncastuximab tesirine and rituximab (lonca-R) after stereotactic radiosurgery are safe and effective for treatment of central nervous system lymphomas.

Start Date01 Jan 2025

Sponsor / Collaborator

University of Utah

[+1]

NCT05991388

/ RecruitingPhase 2/3IIT

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

The Glo-BNHL trial is trying to find better medicines for children and young people with B-cell non-Hodgkin Lymphoma (B-NHL) that does not go away (refractory B-NHL) or does but comes back again (relapsed B-NHL). B-NHL is a type of cancer that develops inside or outside of lymph nodes (glands) and organs such as the liver or spleen. Examples of B-NHL are Burkitt Lymphoma and Diffuse Large B Cell Lymphoma, which may be other names used to describe this type of cancer. It is very difficult to cure relapsed or refractory B-NHL. The medicines used now are very powerful with many side effects and only cure around 30 in every 100 children treated. It is very important that investigators quickly find better medicines for these children and young people.
The Glo-BNHL trial will include three groups of children and young people, each given a new medicine (either alone or with chemotherapy). The investigators are looking to make sure the new medicines are safe and that they work to treat the cancer. If the medicine in one group does not work for a child in the trial, then they may be able to join a different group to have another new medicine.
Experts from around the world will carefully pick the medicines most likely to be helpful to be part of the trial. If one of the new medicines seems not to be working as well as hoped then the investigators will take it out of the trial as soon as possible. This will let other new medicines be added to the trial and tested. If a medicine does seem to be working well, then it will continue in the trial to make sure it really is the most useful medicine available.
Children from around the world will be invited to take part in the trial. The investigators will then check on them for at least two years after they finish the trial treatment to look for possible side effects of the new medicine.

Start Date02 May 2024

Sponsor / Collaborator

University of Birmingham

[+3]

NCT05672251

/ RecruitingPhase 2IIT

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

This phase II trial studies the safety and how well of loncastuximab tesirine when given together with mosunetuzumab works in treating patients with diffuse large B-cell lymphoma that has come back (relapsed) or does not respond to treatment (refractory). Loncastuximab tesirine is a monoclonal antibody, loncastuximab, linked to a toxic agent called tesirine. Loncastuximab attaches to anti-CD19 cancer cells in a targeted way and delivers tesirine to kill them. Mosunetuzumab is a monoclonal antibody that may interfere with the ability of cancer cells to grow and spread. Giving loncastuximab tesirine with mosunetuzumab may help treat patients with relapsed or refractory diffuse large B-cell lymphoma.

Start Date02 Jan 2024

Sponsor / Collaborator

City of Hope National Medical Center

[+1]

100 Clinical Results associated with Loncastuximab tesirine

100 Translational Medicine associated with Loncastuximab tesirine

100 Patents (Medical) associated with Loncastuximab tesirine

Literatures (Medical) associated with Loncastuximab tesirine

16 Jan 2025·Blood

How I treat older patients with relapsed/refractory diffuse large B-cell lymphoma

Review

Author: Wallace, Danielle S. ; Casulo, Carla ; Loh, Kah Poh

AbstractDiffuse large B-cell lymphoma (DLBCL) is an aggressive, yet curable, malignancy, but older patients are at higher risk of relapsed disease because they may not be eligible for full-intensity frontline chemoimmunotherapy or have comorbidities that limit standard treatments. Recent years have brought more treatment options than ever for this patient population, but it remains challenging to determine which can be safely and effectively offered to older patients. Formal determinations of fitness including geriatric assessments remain critical, but there is less guidance on how to best use this tool in the relapsed setting. Chimeric antigen receptor T-cell therapy is accessible to older patients, provided they can be supported through the intensive road to this treatment. If relapse occurs despite this or alternative therapies are preferred, many novel therapeutic options and combinations exist with some potential modifications for older adults, such as bispecific antibodies, tafasitamab and lenalidomide, polatuzumab-containing regimens, or loncastuximab tesirine. This article provides a summary of our approach to the management of this diverse population of older patients with relapsed or refractory DLBCL.

01 Jan 2025·The Lancet Haematology

Loncastuximab tesirine with rituximab in patients with relapsed or refractory follicular lymphoma: a single-centre, single-arm, phase 2 trial

Article

Author: Kuker, Russ A ; Rosenblatt, Joseph D ; Pongas, Georgios ; Stanchina, Michele D ; Lessen, David S ; Schatz, Jonathan H ; Spiegel, Jay Y ; Lekakis, Lazaros J ; Reis, Isildinha M ; Trabolsi, Asaad ; Alencar, Alvaro J ; Beitinjaneh, Amer ; Moskowitz, Craig H ; Alderuccio, Juan Pablo ; Lossos, Izidore S ; Sandoval-Sus, Jose

BACKGROUNDPreliminary data suggest promising activity of loncastuximab tesirine in follicular lymphoma, and synergistic activity between rituximab-induced cytotoxicity and loncastuximab tesirine. In this study, we evaluated loncastuximab tesirine combined with rituximab for second-line and later treatment of follicular lymphoma.METHODSWe did a single-arm, investigator-initiated, phase 2 trial at Sylvester Comprehensive Cancer Center in Miami, FL, USA. We recruited patients aged 18 years or older with histologically confirmed relapsed or refractory follicular lymphoma (grade 1-3A) treated with one or more lines of therapy and presenting with progression or relapse of disease within 24 months (POD24) after the first line of treatment, one or more Groupe d'Etude des Lymphomes Folliculaires (GELF) criteria, or second relapse, and with an Eastern Cooperative Oncology Group performance status of 0-2. Intravenous loncastuximab tesirine was administered on day 1 of a 21-day cycle, at 0·15 mg/kg for two cycles, then 0·075 mg/kg thereafter. Intravenous rituximab was administered on day 1 of cycle 1, at 375 mg/m² for four once-weekly doses, followed by one dose every 8 weeks on cycles 5, 6, and 7. At week 21, patients with a complete response discontinued loncastuximab tesirine and received two more doses of rituximab once every 8 weeks. Patients with a partial response at week 21 continued both agents for 18 more weeks. The primary endpoint was complete response rate at week 12 assessed by the Lugano 2014 classification in patients who had received at least three doses of loncastuximab tesirine. The safety analysis included all patients who received one or more doses of loncastuximab tesirine. The trial is registered with ClinicalTrials.gov, NCT04998669, and is ongoing (open to recruitment); the data cutoff for this analysis was Sept 13, 2024.FINDINGSBetween Jan 28, 2022, and June 3, 2024, we enrolled 39 patients (median age 68 years [IQR 58-77]; 21 [54%] male patients and 18 [46%] female patients). All patients presented with one or more GELF criteria (n=36 [92%]) or POD24 after the first line of treatment (n=20 [51%]) at baseline. As of Sept 13, 2024, the median follow-up was 18·2 months (95% CI 12·0-19·3). Week 12 complete response rate was 67% (n=26 of 39). The most common grade 3 or worse treatment-emergent adverse events (TEAEs) were lymphopenia (eight [21%] of 39 patients) and neutropenia (five [13%] patients; one of whom had a serious grade 3 TEAE of febrile neutropenia that was considered to be related to study treatment). Generalised and peripheral oedema was predominantly grade 1-2 and all cases of oedema were treatable with diuretics. Serious TEAEs that were considered to be related to study drugs occurred in four (10%) of 39 patients. No fatal TEAEs occurred.INTERPRETATIONLoncastuximab tesirine with rituximab showed clinically meaningful activity in relapsed or refractory follicular lymphoma, and had a manageable safety profile.FUNDINGADC Therapeutics and Sylvester Comprehensive Cancer Center.

01 Jan 2025·Bioorganic & Medicinal Chemistry Letters

Synthesis of novel pyrrolobenzodiazepine (PBD) C1-substituted monomers and dimers with DNA-binding activity and cytotoxicity

Article

Author: Rahman, Khondaker Miraz ; Thurston, David E ; Hasan, Md Mahbub ; Jackson, Paul J M ; Veillard, Nicolas ; Procopiou, George ; Andriollo, Paolo

The pyrrolobenzodiazepines (PBDs) represent a major class of sequence-selective DNA-alkylating molecules, one example of which, in its dimeric DNA-cross-linking form, is employed as the payload in the anticancer Antibody Drug Conjugate (ADC) loncastuximab tesirine-lpyl. To date, PBD analogues have been produced with substituents at every position of the tricyclic skeleton except the C1-position. We report here the first synthesis of a C1-subsitituted PBD monomer and dimer, both of which possess DNA-binding activity and cytotoxicity in a cancer cell line.

145

News (Medical) associated with Loncastuximab tesirine

30 Dec 2024

·www.prnewswire.com

ADC Therapeutics Announces Completion of Enrollment of Phase 3 Confirmatory Clinical Trial of ZYNLONTA® in Combination with Rituximab in 2L+ Diffuse Large B-Cell Lymphoma

LAUSANNE, Switzerland, Dec. 30, 2024 /PRNewswire/ -- ADC Therapeutics SA (NYSE: ADCT), a commercial-stage global leader and pioneer in the field of antibody drug conjugates (ADCs), today announced the completion of enrollment in LOTIS-5, the Phase 3 confirmatory trial evaluating ZYNLONTA® (loncastuximab tesirine-lpyl) in combination with rituximab (Lonca-R) in patients with relapsed or refractory diffuse large B-cell lymphoma (r/r DLBCL). ZYNLONTA previously received accelerated approval for the treatment of r/r DLBCL after two or more lines of systemic therapy from the FDA in 2021. "This milestone for LOTIS-5 brings us a step closer to providing a potential combination treatment in the 2L+ DLBCL setting that we believe will offer competitive efficacy with favorable safety and a convenient dosing schedule, well-suited for use in patients across care settings," said Mohamed Zaki, MD, PhD, Chief Medical Officer of ADC Therapeutics. "We anticipate sharing topline results of the primary endpoint analysis by the end of 2025 once the pre-specified number of events is reached and potentially submitting our supplemental BLA to the U.S. Food and Drug Administration (FDA) in the first quarter of 2026." The randomized, open‐label, two‐part, two‐arm, multicenter study is designed to confirm accelerated approval and may support potential label expansion into 2L+ in combination with rituximab. Twenty patients were enrolled in part 1 of a non-randomized safety run‐in. As previously reported, the results showed an overall response rate (ORR) by central review of 80% (16/20) with a complete response (CR) rate of 50% (10/20) and no new safety signals. In part 2, patients with 2L+ DLBCL are randomized 1:1 to receive fixed-dose ZYNLONTA with rituximab or rituximab‐gemcitabine‐oxaliplatin (R‐GemOx). The primary endpoint of LOTIS-5 is progression-free survival with secondary endpoints of overall survival, ORR, CR rate and duration of response as well as frequency and severity of adverse events. Topline results of the primary endpoint analysis are anticipated by the end of 2025 once the required number of pre-specified events is reached followed by regulatory submission to the FDA in Q1 2026 and potential approval in late 2026. For more information about LOTIS-5, please visit (identifier NCT04384484). About ZYNLONTA® (loncastuximab tesirine-lpyl) ZYNLONTA® is a CD19-directed antibody drug conjugate (ADC). Once bound to a CD19-expressing cell, ZYNLONTA is internalized by the cell, where enzymes release a pyrrolobenzodiazepine (PBD) payload. The potent payload binds to DNA minor groove with little distortion, remaining less visible to DNA repair mechanisms. This ultimately results in cell cycle arrest and tumor cell death. The U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) have approved ZYNLONTA (loncastuximab tesirine-lpyl) for the treatment of adult patients with relapsed or refractory (r/r) large B-cell lymphoma after two or more lines of systemic therapy, including diffuse large B-cell lymphoma (DLBCL) not otherwise specified (NOS), DLBCL arising from low-grade lymphoma and also high-grade B-cell lymphoma. The trial included a broad spectrum of heavily pre-treated patients (median three prior lines of therapy) with difficult-to-treat disease, including patients who did not respond to first-line therapy, patients refractory to all prior lines of therapy, patients with double/triple hit genetics and patients who had stem cell transplant and CAR-T therapy prior to their treatment with ZYNLONTA. This indication is approved by the FDA under accelerated approval and in the European Union under conditional approval based on overall response rate and continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial. Please see full prescribing information including important safety information about ZYNLONTA at . ZYNLONTA is also being evaluated as a therapeutic option in combination studies in other B-cell malignancies and earlier lines of therapy. About ADC Therapeutics ADC Therapeutics (NYSE: ADCT) is a commercial-stage global leader and pioneer in the field of antibody drug conjugates (ADCs). The Company is advancing its proprietary ADC technology to transform the treatment paradigm for patients with hematologic malignancies and solid tumors. ADC Therapeutics' CD19-directed ADC ZYNLONTA (loncastuximab tesirine-lpyl) received accelerated approval by the FDA and conditional approval from the European Commission for the treatment of relapsed or refractory diffuse large B-cell lymphoma after two or more lines of systemic therapy. ZYNLONTA is also in development in combination with other agents and in earlier lines of therapy. In addition to ZYNLONTA, ADC Therapeutics has multiple ADCs in ongoing clinical and preclinical development. ADC Therapeutics is based in Lausanne (Biopôle), Switzerland, and has operations in London and New Jersey. For more information, please visit the Company website at adctherapeutics.com and follow us on LinkedIn. . ZYNLONTA® is a registered trademark of ADC Therapeutics SA. Forward-Looking Statements This press release contains forward-looking statements within the meaning of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. In some cases you can identify forward-looking statements by terminology such as "may", "will", "should", "would", "expect", "intend", "plan", "anticipate", "believe", "estimate", "predict", "potential", "seem", "seek", "future", "continue", or "appear" or the negative of these terms or similar expressions, although not all forward-looking statements contain these identifying words. Forward-looking statements are subject to certain risks and uncertainties that can cause actual results to differ materially from those described. Factors that may cause such differences include, but are not limited to: the timing of the achievement of the number of pre-specified events for LOTIS-5 and disclosure of full data read-out, the results of the LOTIS-5 study, the timing for regulatory submission of the supplemental BLA for ZYNLONTA, the timing and FDA approval of the same, future market acceptance and revenue for ZYNLONTA; the expected cash runway into mid-2026 the Company's ability to grow ZYNLONTA® revenue in the United States; the ability of our partners to commercialize ZYNLONTA® in foreign markets, the timing and amount of future revenue and payments to us from such partnerships and their ability to obtain regulatory approval for ZYNLONTA® in foreign jurisdictions; the timing and results of the Company's or its partners' research and development projects or clinical trials including LOTIS 5 and 7 and ADCT 602 as well as early research in certain solid tumors with different targets, linkers and payloads; the timing and results of investigator-initiated trials including those studying FL and MZL and the potential regulatory and/or compendia strategy and the future opportunity; the timing and outcome of regulatory submissions for the Company's products or product candidates; actions by the FDA or foreign regulatory authorities; projected revenue and expenses; the Company's indebtedness, including Healthcare Royalty Management and Blue Owl and Oaktree facilities, and the restrictions imposed on the Company's activities by such indebtedness, the ability to comply with the terms of the various agreements and repay such indebtedness and the significant cash required to service such indebtedness; and the Company's ability to obtain financial and other resources for its research, development, clinical, and commercial activities. Additional information concerning these and other factors that may cause actual results to differ materially from those anticipated in the forward-looking statements is contained in the "Risk Factors" section of the Company's Annual Report on Form 10-K and in the Company's other periodic and current reports and filings with the U.S. Securities and Exchange Commission. These statements involve known and unknown risks, uncertainties and other factors that may cause actual results, performance, achievements or prospects to be materially different from any future results, performance, achievements or prospects expressed in or implied by such forward-looking statements. The Company cautions investors not to place undue reliance on the forward-looking statements contained in this document. CONTACTS: Investors Marcy Graham ADC Therapeutics [email protected] +1 650-667-6450 Media Nicole Riley ADC Therapeutics [email protected] +1 862-926-9040 SOURCE ADC Therapeutics SA WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Phase 3ADCAccelerated ApprovalDrug ApprovalImmunotherapy

12 Dec 2024

·endpts.com

Elevation to pay up to $368M in ADC deal; Bavarian Nordic closes San Diego site

Plus, news about Essential Pharma, ADC Therapeutics, Caliway Biopharmaceuticals, AnaptysBio, Andera Partners and NewAmsterdam Pharma: Elevation’s ADC deal: The biotech will pay up to $368 million in upfront payments and biobucks to Lonza’s Synaffix, which will get access to its clinical-stage ADC platform and other technologies. — Kyle LaHucik Bavarian Nordic closes San Diego site: The Danish drugmaker is closing a site in California and laying off 48 employees, according to a WARN notice . The site came from Bavarian’s acquisition of part of Emergent BioSolutions last year. The company will “continue to have a significant footprint in the US,” a spokesperson told Endpoints News . — Kyle LaHucik Essential Pharma’s €900M recapitalization and €300 million financing: The financing will allow Essential to “build on its diversified portfolio and late-stage pipeline across established and rare disease medicines,” according to the company. AlpInvest, a subsidiary of Carlyle Global Investment Solutions, is leading the recapitalization, while Sixth Street is providing the financing facility. — Katherine Lewin ADC Therapeutics’ early-stage data for Zynlonta-Columvi combo: In 18 patients with diffuse large B cell lymphoma, the best overall response rate was 94%, and the complete response rate was 72%. Of the 13 patients who achieved a complete response, 12 remain in complete response as of the cutoff of Nov. 20. The company reported low-grade cases of CRS and ICANS, but no high-grade cases, and 24% of patients experienced grade 3 or 4 neutropenia. — Lei Lei Wu Caliway’s lipolysis injectable to enter Phase 3 in 2025: In a Phase 2b study , Caliway’s drug met all the primary and secondary endpoints, with 76.7% of patients achieving at least a 1-grade improvement on the Abdominal Fat Rating Scale at 12 weeks. The most common side effect was injection site reactions. — Katherine Lewin AnaptysBio’s drug fails in atopic dermatitis: The San Diego biotech said ANB032 failed the primary and secondary endpoints in a Phase 2b study. The Sanofi-backed biotech is now ending development of the BTLA agonist. The stock $ANAB closed 32% lower on Wednesday. — Kyle LaHucik Andera Partners sells 40% stake: The European investment firm, which has a life sciences unit, sold a 40% minority equity interest to global asset manager New York Life Investments. Andera’s biotech portfolio includes Inventiva and Nouscom. — Kyle LaHucik NewAmsterdam upsized its offering. It raised $416.5 million, up from the $300 million it initially planned to bring in. — Jaimy Lee

Clinical ResultPhase 2AcquisitionPhase 3

11 Dec 2024

·pipelinereview.com

ADC Therapeutics Announces Positive Initial Data from LOTIS-7 Clinical Trial Evaluating ZYNLONTA® in Combination with Bispecific Antibody in Patients with Relapsed/Refractory Diffuse Large B-cell Lymphoma

ZYNLONTA in combination with glofitamab demonstrated clinically meaningful benefit with 94% best ORR and 72% CR rate Safety data show no dose-limiting toxicities (DLTs), no high-grade cytokine release syndrome (CRS) or high-grade immune effector cell-associated neurotoxicity syndrome (ICANS) across all patients Company to host conference call today at 8:30 a.m. EST LAUSANNE, Switzerland I December 11, 2024 I ADC Therapeutics SA (NYSE: ADCT ), a commercial-stage global leader and pioneer in the field of antibody drug conjugates (ADCs), today announced positive initial data from the LOTIS-7 Phase 1b open-label clinical trial evaluating the safety and efficacy of ZYNLONTA ® in combination with the bispecific antibody glofitamab (COLUMVI ™ ) in patients with relapsed or refractory diffuse large B-cell lymphoma (r/r DLBCL). “We are excited by the strong initial results observed with ZYNLONTA plus glofitamab in second line plus patients with relapsed or refractory DLBCL,” said Mohamed Zaki, MD, PhD, Chief Medical Officer of ADC Therapeutics. “We believe these data support our hypothesis that combining these two potent, approved, single-agent-drugs with complementary mechanisms of action will yield additive or synergistic efficacy, and a manageable safety profile given no overlapping non-hematologic toxicities, enabling administration across care settings. We are encouraged by the initial promising safety and efficacy data at both doses tested in the expansion arm.” Initial Clinical Data from Phase 1b LOTIS-7 Trial LOTIS-7 is an ongoing Phase 1b global multicenter, multi-arm study in patients with relapsed or refractory (r/r) B-cell non-Hodgkin lymphoma (B-NHL) including Part 1 (dose escalation) and Part 2 (dose expansion). As of the November 20, 2024 cutoff date, a total of 29 B-NHL patients from Part 1 and Part 2 across all dose levels were treated and evaluated for safety. An initial efficacy analysis was conducted on all 18 evaluable 2L+ DLBCL patients who received dose levels of 120 µg/kg (n=9) or 150 µg/kg (n=9) of ZYNLONTA plus the bispecific antibody glofitamab: Encouraging efficacy data was observed across patients with different numbers of lines and types of prior treatments and across different histologies. Initial safety data on all 29 patients suggest that ZYNLONTA plus glofitamab is generally well tolerated with no DLTs across all dose levels: “These compelling initial results support the potential of ZYNLONTA plus the bispecific glofitamab to be a best-in-class combination in a highly competitive market,” said Ameet Mallik, Chief Executive Officer of ADC Therapeutics. “We look forward to completing enrollment of dose expansion in the first half of 2025 and plan to engage with regulatory authorities on the path forward as data including additional patients with longer follow-up become available.” Conference Call Information To access the conference call, please register here . The participant toll-free dial-in number is 1-800-836-8184 for North America and Canada. It is recommended that you join 10 minutes before the event, though you may pre-register at any time. A live webcast of the call will be available under “Events and Presentations” in the Investors section of the ADC Therapeutics website at ir.adctherapeutics.com . The archived webcast will be available for 30 days following the call. About LOTIS-7 LOTIS-7 is a Phase 1b global multicenter, multi-arm study in patients with relapsed or refractory B-cell non-Hodgkin lymphoma (B-NHL) including Part 1 (dose escalation) and Part 2 (dose expansion). The three dosing arms include ZYNLONTA plus polatuzumab vedotin, ZYNLONTA plus glofitamab, and ZYNLONTA plus mosunetuzumab T-cell-engaging bispecific monoclonal antibodies (BsAbs). Enrollment in LOTIS-7 includes Part 1 of the study with a 3+3 dose escalation in 3L/3L+ heavily pre-treated patients with ZYNLONTA doses starting at 90 µg/kg and then proceeding to 120 µg/kg and 150 µg/kg. Part 2 includes dose expansion in 2L/2L+ large B-cell lymphoma in the ZYNLONTA plus glofitamab arm at dose levels determined from Part 1 (120 µg/kg and 150 µg/kg of ZYNLONTA plus the approved dosing of glofitamab). Primary endpoints of the study include safety and tolerability. Secondary efficacy endpoints include ORR, DOR, CRR, PFS, RFS, and OS as well as pharmacokinetics and immunogenicity. For more information about the LOTIS-7 trial, visit clinicaltrials.gov (NCT04970901). About ADC Therapeutics ADC Therapeutics (NYSE: ADCT ) is a commercial-stage global leader and pioneer in the field of antibody drug conjugates (ADCs). The Company is advancing its proprietary ADC technology to transform the treatment paradigm for patients with hematologic malignancies and solid tumors. ADC Therapeutics’ CD19-directed ADC ZYNLONTA (loncastuximab tesirine-lpyl) received accelerated approval by the FDA and conditional approval from the European Commission for the treatment of relapsed or refractory diffuse large B-cell lymphoma after two or more lines of systemic therapy. ZYNLONTA is also in development in combination with other agents and in earlier lines of therapy. In addition to ZYNLONTA, ADC Therapeutics has multiple ADCs in ongoing clinical and preclinical development. ADC Therapeutics is based in Lausanne (Biopôle), Switzerland, and has operations in London and New Jersey. For more information, please visit https://adctherapeutics.com/ and follow the Company on LinkedIn . ZYNLONTA ® is a registered trademark of ADC Therapeutics SA. SOURCE: ADC Therapeutics

ADCClinical ResultPhase 1Drug ApprovalAccelerated Approval

100 Deals associated with Loncastuximab tesirine

External Link

KEGG	Wiki	ATC	Drug Bank
D11338	Loncastuximab tesirine	L01XC	DB16222

R&D Status

Approved

10 top approved records.

to view more data

Indication	Country/Location	Organization	Date
Diffuse large B-cell lymphoma recurrent	NO	Swedish Orphan Biovitrum AB	20 Dec 2022
Diffuse large B-cell lymphoma recurrent	LI	Swedish Orphan Biovitrum AB	20 Dec 2022
Diffuse large B-cell lymphoma recurrent	IS	Swedish Orphan Biovitrum AB	20 Dec 2022
Diffuse large B-cell lymphoma recurrent	EU	Swedish Orphan Biovitrum AB	20 Dec 2022
Diffuse large B-cell lymphoma refractory	EU	Swedish Orphan Biovitrum AB	20 Dec 2022
Diffuse large B-cell lymphoma refractory	IS	Swedish Orphan Biovitrum AB	20 Dec 2022
Diffuse large B-cell lymphoma refractory	NO	Swedish Orphan Biovitrum AB	20 Dec 2022
Diffuse large B-cell lymphoma refractory	LI	Swedish Orphan Biovitrum AB	20 Dec 2022
Diffuse Large B-Cell Lymphoma	US	ADC Therapeutics SA	23 Apr 2021
High grade B-cell lymphoma	US	ADC Therapeutics SA	23 Apr 2021

Developing

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Large B-cell lymphoma	NDA/BLA	CN	ADC Therapeutics SA	08 Jun 2023
Large B-cell lymphoma	NDA/BLA	CN	Overland PharmaceuticalsStartup	08 Jun 2023
Diffuse large B-cell lymphoma refractory	Phase 3	CA	ADC Therapeutics SA	16 Sep 2020
Diffuse large B-cell lymphoma refractory	Phase 3	CH	ADC Therapeutics SA	16 Sep 2020
Diffuse large B-cell lymphoma refractory	Phase 3	PL	ADC Therapeutics SA	16 Sep 2020
Diffuse large B-cell lymphoma refractory	Phase 3	AR	ADC Therapeutics SA	16 Sep 2020
Diffuse large B-cell lymphoma refractory	Phase 3	BR	ADC Therapeutics SA	16 Sep 2020
Diffuse large B-cell lymphoma refractory	Phase 3	BE	ADC Therapeutics SA	16 Sep 2020
Diffuse large B-cell lymphoma refractory	Phase 3	US	ADC Therapeutics SA	16 Sep 2020
Diffuse large B-cell lymphoma refractory	Phase 3	IT	ADC Therapeutics SA	16 Sep 2020

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT04970901 (LOTIS-7, PipelineReview) Manual	Phase 1	Diffuse Large B-Cell Lymphoma Second line \| Third line	29	ZYNLONTA + glofitamab (2L+ DLBCL)	(qtxfssdslm) = thkpvbbpna duhakonvrh (fjfqtbrkbr ) View more	Positive	11 Dec 2024
				ZYNLONTA (3L+ DLBCL)	(qtxfssdslm) = jaywxngaiw duhakonvrh (fjfqtbrkbr ) View more
NCT05190705 (ASH2024) Manual	Phase 2	Waldenstrom Macroglobulinemia	7	Loncastuximab Tesirine	(gutuvbupwn) = srcestsojc pkuyocijzy (tjbhxpojoi ) View more	Positive	09 Dec 2024
ASH2024 Manual	Phase 1	Non-Hodgkin Lymphoma	13	Loncastuximab tesirine + Venetoclax	(pglwwevqsw) = zxifrefjue ugjmhpsdrm (gtisdjpszd ) View more	Positive	09 Dec 2024
NCT05296070 (ASH2024) Manual	Phase 2	Marginal zone lymphoma recurrent \| Refractory Marginal Zone Lymphoma	22	Loncastuximab Tesirine 0.15mg/kgLoncastuximab Tesirine 0.15mg/kg	(huzxtuctbi) = hlrjluzgga hunnseizqr (bfinfyvmqi ) View more	Positive	08 Dec 2024
NCT04998669 (ASH2024) Manual	Phase 2	Follicular Lymphoma	39	Loncastuximab Tesirine + Rituximab	(hcliiudwun) = efqzvcirkv ytmtgothir (kamucivvyd ) View more	Positive	07 Dec 2024
				Loncastuximab Tesirine + Rituximab (Patients with POD24)	(hcliiudwun) = cykogrjfrh ytmtgothir (kamucivvyd ) View more
SOHO2024	Not Applicable	Diffuse large B-cell lymphoma recurrent	-	Loncastuximab Tesirine	(dwwqtmzsek) = ujpyzduksk etsetxxkbh (plhhitsrtf ) View more	-	04 Sep 2024
				Chimeric Antigen Receptor T-cell Therapy	(dwwqtmzsek) = vejymanezz etsetxxkbh (plhhitsrtf ) View more
NCT05296070 (Biospace) Manual	Phase 2	Refractory Marginal Zone Lymphoma	50	Zynlonta	(usljxqfvzx) = nxczzbemlv lghiimlnmu (pzykgdntzo )	Positive	07 May 2024
NCT03589469 (LOTIS-2, Pubmed) Manual	Phase 2	Diffuse large B-cell lymphoma refractory \| Diffuse large B-cell lymphoma recurrent CD19	145	Loncastuximab tesirine	(iplyecpjws) = huztphokav zsrtguhsbl (zlktgcwtao, 50.0 - 81.0) View more	Positive	01 Apr 2024
NCT03684694 (LOTIS 3, CTgov)	Phase 1/2	Mantle-Cell Lymphoma \| Diffuse Large B-Cell Lymphoma	136	Ibrutinib+Loncastuximab Tesirine (Phase 1: 60 µg/kg Loncastuximab Tesirine and Ibrutinib)	csvuiodwzj(lznpppkjrn) = zbhvafqskb tjhpgkvclp (brjwiqyhvq, tinjqyhbzz - dfozttemnj) View more	-	06 Feb 2024
				Ibrutinib+Loncastuximab Tesirine (Phase 1: 75 µg/kg Loncastuximab Tesirine and Ibrutinib)	csvuiodwzj(lznpppkjrn) = moguiowaaj tjhpgkvclp (brjwiqyhvq, pinhuzhoah - bzncqexcfx) View more
Tandem Meetings ASTCT and CIBMTR2024 Manual	Not Applicable	Diffuse Large B-Cell Lymphoma Third line	81	Loncastuximab Tesirine	(bxdexvaqxb) = sizcumyetw gzgzawdwpw (klainoowlt ) View more	Positive	01 Feb 2024
				Loncastuximab Tesirine	(bxdexvaqxb) = zizndmvfgm gzgzawdwpw (klainoowlt ) View more

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