Marginal Zone Lymphoma Drug Development Pipeline Analysis 2025

DelveInsight's comprehensive "Marginal Zone Lymphoma Pipeline Insight 2025" analysis delivers thorough insights about over 50 organizations and more than 50 investigational medications within the Marginal Zone Lymphoma development landscape. The report encompasses drug candidate profiles across both clinical and preclinical phases, offering therapeutic evaluations organized by product category, developmental phase, administration method, and molecular classification. Additionally, it spotlights dormant pipeline candidates in this therapeutic area.

Access DelveInsight's comprehensive Marginal Zone Lymphoma Pipeline Analysis to explore emerging therapies, key organizations, and future treatment landscapes @ Marginal Zone Lymphoma Pipeline Outlook

Major Highlights from the Marginal Zone Lymphoma Pipeline Analysis

As of December 05, 2025 - Shayna Sarosiek, MD launched a study being performed to examine the safety and effectiveness of pacritinib as a possible treatment for participants diagnosed with Waldenström macroglobulinemia (WM). The U.S. Food and Drug Administration (FDA) has not approved pacritinib for WM but it has been approved for Myelofibrosis. The research investigation procedures include screening for eligibility, in-clinic visits, questionnaires, blood tests, urine tests, Computerized Tomography (CT) scans, X-rays, echocardiograms (ECGs), bone marrow biopsies and aspirations.

As of December 04, 2025 - University of Utah performed a Phase II Investigation of Pirtobrutinib in Combination With Rituximab in Adults Diagnosed With Untreated Marginal Zone Lymphoma.

As of December 02, 2025 - Genmab disclosed a trial representing an open-label, multi-center safety and preliminary efficacy trial of epcoritamab (EPKINLY™) in Japanese participants diagnosed with relapsed, progressive or refractory B-cell lymphomas and Japanese participants diagnosed with B-cell lymphomas that have achieved partial response (PR) or complete response (CR) following prior standard of care (SOC). The trial consists of two parts: Part 1, dose escalation (phase 1), and Part 2, expansion (phase 2).

DelveInsight's Marginal Zone Lymphoma pipeline analysis reveals a dynamic field with over 50 active organizations advancing more than 50 investigational therapies for Marginal Zone Lymphoma management.

Premier Marginal Zone Lymphoma pharmaceutical organizations include Incyte Corporation, HUTCHMED, InnoCare Pharma, ENTEROME SA, Beijing Mabworks Biotech Co., Ltd., ADC Therapeutics, MEI Pharma, Inc., Genentech, Inc., Novartis, AstraZeneca, Kite Pharma, Roche, Oncternal Therapeutics, Inc., Celgene, IGM Biosciences, Inc., Loxo Oncology, Genmab, ArQule, Sound Biologics, Adicet Bio, Inc., Celldex Therapeutics, TG Therapeutics, Inc., VelosBio Inc., Newave Pharmaceutical Inc., Boryung Pharmaceutical Co., Ltd., Cellectar Biosciences, Inc., Bio-Path Holdings, Inc., Nurix Therapeutics, Inc., among others.

Notable Marginal Zone Lymphoma investigational agents include Pirtobrutinib, Obinutuzumab, Loncastuximab tesirine 150 µg/Kg, Copanlisib, Rituximab, Venetoclax, among others.

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Marginal Zone Lymphoma Disease Background

Marginal zone lymphoma (MZL) represents the second most common indolent non-Hodgkin's lymphoma (iNHL). There are three types of marginal zone lymphomas: the extranodal MZL (EMZL) of mucosa-associated lymphoid tissue (MALT or gastric GALT), the splenic MZL, and the nodal MZL. EMZL can originate at virtually any extranodal site and arises in organs that normally lack lymphoid tissue (e.g., stomach, intestine, thyroid, lung, and skin). The most frequently affected organ in EMZL is the stomach, and there is compelling evidence for a causal relationship between H. pylori and gastric EMZL. SMZL arises predominantly from the marginal zone memory B-cells located in the follicles of the spleen, splenic hilar lymph nodes, BM, and the peripheral blood.

Emerging Marginal Zone Lymphoma Drug Candidates

Tafasitamab: Incyte Corporation

Tafasitamab represents an investigational humanized Fc-engineered monoclonal antibody directed against CD19. In 2010, MorphoSys licensed exclusive worldwide rights to develop and commercialize tafasitamab from Xencor, Inc. Tafasitamab incorporates an XmAb® engineered Fc domain, which is designed to lead to a significant potentiation of antibody-dependent cell-mediated cytotoxicity (ADCC) and antibody-dependent cellular phagocytosis (ADCP), thus aiming to improve a key mechanism of tumor cell killing. The therapy is currently in Phase III stage of clinical trial evaluation to manage Marginal Zone Lymphoma.

Amdizalisib (HMPL-689): HUTCHMED

The investigational drug candidate amdizalisib represents a novel, selective small molecule inhibitor targeting the isoform phosphoinositide 3'-kinase delta (PI3Kδ), a key component in the B-cell receptor signaling pathway. We have designed amdizalisib with increased PI3Kδ isoform selectivity. Amdizalisib's pharmacokinetic properties have been found to be favorable with good oral absorption, moderate tissue distribution and low clearance in pre-clinical pharmacokinetic studies. Amdizalisib is being investigated in studies in the U.S., Europe, China and Australia in various subtypes of advanced relapsed or refractory non-Hodgkin's lymphoma, including follicular lymphoma and marginal zone lymphoma.

Orelabrutinib: InnoCare Pharma

Orelabrutinib represents a small molecule Bruton's tyrosine kinase inhibitor (BTKi) developed for managing cancer and in development for the potential treatment of autoimmune diseases. In the field of oncology, InnoCare received approval for orelabrutinib from the China National Medical Products Administration (NMPA) in two indications: managing patients diagnosed with relapsed/refractory chronic lymphocytic leukemia (R/R CLL)/small lymphocytic lymphoma (R/R SLL), and managing patients diagnosed with relapsed/refractory mantle cell lymphoma (R/R MCL). Currently, it is in Phase II stage of clinical trial evaluation to manage Marginal Zone Lymphoma (MZL).

EO2463: Enterome

EO2463 represents an innovative, off-the-shelf microbiome-peptide based cancer vaccine that combines four microbiome-peptides of B lymphocyte-specific lineage markers. EO2463 is designed to trigger the immune system into recognizing B cells as bacterial (i.e. non-self) and eliciting a targeted cell-killing response. The clinical rationale behind targeting these specific lineage cell markers is to induce the full depletion of malignant B lymphocytes that cause NHL.

The Marginal Zone Lymphoma Pipeline Analysis Delivers Insights into

The analysis provides comprehensive insights about organizations developing therapeutic interventions for Marginal Zone Lymphoma management with aggregate therapies developed by individual companies for this indication.

It evaluates various therapeutic candidates organized into early-stage, mid-stage, and late-stage development for Marginal Zone Lymphoma Treatment.

Marginal Zone Lymphoma pharmaceutical organizations are engaged in targeted therapeutic development with corresponding active and inactive (dormant or discontinued) programs.

Marginal Zone Lymphoma investigational drugs categorized by developmental phase, administration route, target receptor, monotherapy or combination approach, various mechanisms of action, and molecular classification.

Comprehensive analysis of partnerships (company-company collaborations and company-academic partnerships), licensing agreements, and financial arrangements for future progression of the Marginal Zone Lymphoma marketplace.

Access a comprehensive analysis of the latest innovations in the Marginal Zone Lymphoma pipeline through DelveInsight's expert-driven analysis! @ Marginal Zone Lymphoma Unmet Needs

Marginal Zone Lymphoma Pharmaceutical Organizations

Incyte Corporation, HUTCHMED, InnoCare Pharma, ENTEROME SA, Beijing Mabworks Biotech Co., Ltd., ADC Therapeutics, MEI Pharma, Inc., Genentech, Inc., Novartis, AstraZeneca, Kite Pharma, Roche, Oncternal Therapeutics, Inc., Celgene, IGM Biosciences, Inc., Loxo Oncology, Genmab, ArQule, Sound Biologics, Adicet Bio, Inc., Celldex Therapeutics, TG Therapeutics, Inc., VelosBio Inc., Newave Pharmaceutical Inc., Boryung Pharmaceutical Co., Ltd., Cellectar Biosciences, Inc., Bio-Path Holdings, Inc., Nurix Therapeutics, Inc., among others.

The Marginal Zone Lymphoma pipeline analysis delivers therapeutic evaluation of pipeline medications by Administration Route:

• Inhalation

• Inhalation/Intravenous/Oral

• Intranasal

• Intravenous

• Intravenous/Subcutaneous

• NA

• Oral

• Oral/intranasal/subcutaneous

• Parenteral

• Subcutaneous

Marginal Zone Lymphoma Products have been organized under various Molecular classifications including:

• Antibody

• Antisense oligonucleotides

• Immunotherapy

• Monoclonal antibody

• Peptides

• Protein

• Recombinant protein

• Small molecule

• Stem Cell

• Vaccine

Access DelveInsight's latest analysis to gain strategic insights into upcoming Marginal Zone Lymphoma Therapies and key drug developments @ Marginal Zone Lymphoma Market Drivers and Barriers, and Future Perspectives

Coverage of the Marginal Zone Lymphoma Pipeline Analysis

Coverage: Global

Marginal Zone Lymphoma Pharmaceutical Organizations: Incyte Corporation, HUTCHMED, InnoCare Pharma, ENTEROME SA, Beijing Mabworks Biotech Co., Ltd., ADC Therapeutics, MEI Pharma, Inc., Genentech, Inc., Novartis, AstraZeneca, Kite Pharma, Roche, Oncternal Therapeutics, Inc., Celgene, IGM Biosciences, Inc., Loxo Oncology, Genmab, ArQule, Sound Biologics, Adicet Bio, Inc., Celldex Therapeutics, TG Therapeutics, Inc., VelosBio Inc., Newave Pharmaceutical Inc., Boryung Pharmaceutical Co., Ltd., Cellectar Biosciences, Inc., Bio-Path Holdings, Inc., Nurix Therapeutics, Inc., among others.

Marginal Zone Lymphoma Therapeutic Candidates: Pirtobrutinib, Obinutuzumab, Loncastuximab tesirine 150 µg/Kg, Copanlisib, Rituximab, Venetoclax, among others.

Marginal Zone Lymphoma Therapeutic Evaluation by Product Category: Mono, Combination, Mono/Combination

Marginal Zone Lymphoma Therapeutic Evaluation by Clinical Phases: Discovery, Pre-clinical, Phase I, Phase II, Phase III

Find out in DelveInsight's exclusive pipeline analysis—access it now! @ Marginal Zone Lymphoma Emerging Drugs and Major Companies

Report Structure

1. Introduction

2. Executive Summary

3. Marginal Zone Lymphoma: Overview

4. Pipeline Therapeutics

5. Therapeutic Assessment

6. Marginal Zone Lymphoma – DelveInsight’s Analytical Perspective

7. Late Stage Products (Phase III)

8. Tafasitamab: Incyte Corporation

9. Drug profiles in the detailed report…..

10. Mid Stage Products (Phase II)

11. Orelabrutinib: InnoCare Pharma

12. Drug profiles in the detailed report…..

13. Early Stage Products (Phase I/II)

14. EO2463: Enterome

15. Drug profiles in the detailed report…..

16. Preclinical and Discovery Stage Products

17. Drug name: Company name

18. Drug profiles in the detailed report…..

19. Inactive Products

20. Marginal Zone Lymphoma Key Companies

21. Marginal Zone Lymphoma Key Products

22. Marginal Zone Lymphoma- Unmet Needs

23. Marginal Zone Lymphoma- Market Drivers and Barriers

24. Marginal Zone Lymphoma- Future Perspectives and Conclusion

25. Marginal Zone Lymphoma Analyst Views

26. Marginal Zone Lymphoma Key Companies

27. Appendix

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