CD19 inhibitors(B-lymphocyte antigen CD19 inhibitors), ADCC(Antibody-dependent cell-mediated cytotoxicity (ADCC) effects), Antibody-dependent cellular phagocytosis (ADCP) effects

Therapeutic Areas

NeoplasmsImmune System DiseasesHemic and Lymphatic Diseases+ [1]

Active Indication

Recurrent Follicular LymphomaRefractory Follicular LymphomaDiffuse Large B-Cell Lymphoma+ [26]

Inactive Indication

Mantle cell lymphoma refractoryNon-Hodgkin's lymphoma refractory

Originator Organization

Xencor, Inc.

Active Organization

Incyte Corp.Incyte Biosciences Distribution BV

MorphoSys AG

+ [7]

Inactive Organization

Xencor, Inc.

License Organization

Incyte Corp.Specialised Therapeutics Asia Pte Ltd.

Knight Therapeutics, Inc.

+ [6]

Drug Highest PhaseApproved

First Approval Date

United States (31 Jul 2020),

Diffuse large B-cell lymphoma refractory

RegulationBreakthrough Therapy (United States), Accelerated Approval (United States), Orphan Drug (United States), Orphan Drug (European Union), Priority Review (China), Conditional marketing approval (China), Orphan Drug (Japan), Orphan Drug (South Korea), Orphan Drug (Australia), Conditional marketing approval (European Union), Conditional marketing approval (United States), Fast Track (United States)

Structure/Sequence

Sequence Code 1697872

Source: *****

Sequence Code 12960725

Source: *****

Clinical Trials associated with Tafasitamab-Cxix

NCT07502872

/ Not yet recruitingPhase 2IIT

TPG: a Phase 2 Trial of Polatuzumab Vedotin, Glofitamab, and Tafasitamab as Chemotherapy-sparing First-line Therapy for Diffuse Large B-cell Lymphoma and High-grade B-cell Lymphoma

This is a single-center, phase 2, open-label clinical trial of a novel combination of polatuzumab vedotin, glofitamab, and tafasitamab (TPG) as first-line treatment of patients with diffuse large B cell lymphoma (DLBCL) or high-grade B cell lymphoma (HGBL).

Start Date01 May 2026

Sponsor / Collaborator

Brown University

[+3]

NCT07104565

/ RecruitingPhase 2

A Phase 2a, Open-Label, Multicenter Study of Tafasitamab in Adult Participants With Primary Autoimmune Blood Cell Disorders

This study will evaluate the safety and efficacy of tafasitamab in adult participants with primary autoimmune blood cell disorders.

Start Date29 Dec 2025

Sponsor / Collaborator

Incyte Corp.

NCT07225439

/ Not yet recruitingPhase 1IIT

Phase I Clinical Trial of Rituximab (Rtx) and Tafasitamab in Combination With Allogeneic NK Cells for Treatment of Relapsed/Refractory (r/r) B-cell Non-Hodgkin Lymphoma

This research study is for people who have relapsed or refractory B-cell non-Hodgkin's lymphoma (NHL) that has not responded to two or more lines of therapy. The purpose of this study is to identify the recommended dose of allogeneic NK cells in combination with IL-2, Tafasitamab and Rituximab for the treatment of relapsed or refractory B-cell non-Hodgkin's lymphoma.
NK cells are an investigational (experimental) treatment which means they are not approved by the Food and Drug Administration (FDA). NK cells are a type of lymphocyte that's part of the body's natural immune system, and they can kill cancer cells by creating pores in the cancer cell membranes and inducing apoptosis (programmed cell death).
Participants in this study will receive lymphodepleting chemotherapy, as well as Allogeneic NK cells, Tafasitamab and Interleukin-2 (IL-2) by an intravenous (IV) infusion. Participants are expected to complete one cycle, and they may be eligible to complete a second cycle of the same regiment if they have stable disease, partial or complete remission at the end of the first cycle. Participants will be in this study for about 12 months.

Start Date01 Dec 2025

Sponsor / Collaborator

The Case Comprehensive Cancer Center

[+1]

100 Clinical Results associated with Tafasitamab-Cxix

100 Translational Medicine associated with Tafasitamab-Cxix

100 Patents (Medical) associated with Tafasitamab-Cxix

129

Literatures (Medical) associated with Tafasitamab-Cxix

01 Mar 2026·International Journal of Clinical Oncology

PMDA regulatory update on approval and revision of the precautions for use of anticancer drugs in Japan; imlunestrant for breast cancer, tafasitamab for follicular lymphoma, atezolizumab for thymic carcinoma, retifanlimab for anal canal squamous cell carcinoma, and tagraxofusp for blastic plasmacytoid dendritic cell neoplasm

Author: Matsumura, Noriomi

01 Feb 2026·ANTI-CANCER DRUGS

Anti-CD19 antibody tafasitamab therapy for relapsed or refractory diffuse large B-cell lymphoma: a case series

Article

Author: Yi, Hongmei ; Zhao, Weili ; Zhang, Mengping ; Chen, Wenting ; Xing, Tingting ; Yan, Zixun ; Xu, Pengpeng ; Wang, Zhi ; Feng, Yuan ; You, Jianhua ; Tian, Dengmei

Tafasitamab, an anti-CD19 mAb, has demonstrated promising efficacy in relapsed or refractory diffuse large B-cell lymphoma (R/R DLBCL) in Western populations, but its use in Chinese patients has not been reported. This case series reports the use of tafasitamab in four Chinese patients with R/R DLBCL. Four patients with R/R DLBCL were treated at the Department of Hematology, Hainan Hospital of Ruijin Hospital, Shanghai Jiao Tong University School of Medicine. All patients had previously received rituximab with cyclophosphamide, doxorubicin, vincristine, and prednisone therapy. After treatment with tafasitamab and lenalidomide, two patients with primary refractory disease, one achieved a partial response and another had stable disease. One patient who relapsed after autologous stem-cell transplantation received tafasitamab plus lenalidomide and a Bruton tyrosine kinase (BTK) inhibitor and showed remarkable tumor reduction in all sites except for the lymph nodes in the left inguinal region. One patient who relapsed after second-line therapy achieved complete remission with tafasitamab monotherapy. Tafasitamab-based treatment was well-tolerated, with the most common adverse event being neutropenia. Our real-world experience first suggests that tafasitamab-based flexible treatment may be a potential treatment option for Chinese patients with R/R DLBCL, supporting the need for further investigation into its efficacy and safety in Chinese patients, with a particular focus on exploring directions such as combinations with BTK inhibitors.

27 Jan 2026·CLINICAL CHEMISTRY AND LABORATORY MEDICINE

Tafasitamab interference in immunofixation electrophoresis

Letter

Author: Fink, Susan L. ; Treger, Rebecca S.

Keywords: immunofixation; therapeutic monoclonal antibody; assay interference To the Editor, The development of therapeutic monoclonal antibodies has transformed treatment of malignancies and autoimmune diseases. However, the presence of therapeutic monoclonal antibodies in patient specimens can interfere with clinical laboratory tests, including serum protein electrophoresis (SPEP) and immunofixation, potentially leading to misinterpretation of results. We identified a small immunoglobulin G (IgG) kappa clonal band by immunofixation in a serum specimen from a patient who had no history of prior protein electrophoresis testing in our laboratory (Figure 1). Review of the electronic medical record revealed that this patient had a history of kappa monoclonal free light chain multiple myeloma diagnosed seven years prior, and achieved a stringent complete response with treatment including autologous stem cell transplantation and lenalidomide. Serum free light chain testing performed concurrently with immunofixation was consistent with the continued absence of a monoclonal kappa free light chain, with kappa free light chains measured at 0.005 g/L (0.5 mg/dL), lambda free light chains measured at 0.006 g/L (0.6 mg/dL), and a kappa/lambda free light chain ratio of 0.9. However, while receiving maintenance lenalidomide, the patient developed a second hematologic malignancy, characterized by flow cytometry as B lymphoblastic leukemia/lymphoma. At the time of specimen collection, the patient was undergoing treatment of this second malignancy with a regimen that included tafasitamab. Tafasitamab is a humanized IgG kappa therapeutic monoclonal antibody targeting CD19, which is present on the surface of surface of B lymphocytes. The patient had received multiple doses of tafasitamab prior to immunofixation, with the most recent administration being only 4 days prior to the specimen draw. Pharmacokinetic studies described the mean maximum concentration of tafasitamab at steady-state as 0.5 g/L (500 μg/mL) [1], consistent with the size of the observed band in the patient's specimen. Figure 1:The IgG kappa clonal band in the patient's serum comigrates with the IgG kappa therapeutic monoclonal antibody tafasitamab. Serum gel electrophoresis immunofixation for a normal control sample (left), the patient's sample (middle), and the patient's sample adjacent to 0.5 g/L tafasitamab (right). For each gel, serum electrophoresis (E) is shown along with immunofixation for IgG heavy chain (G), IgA heavy chain (A), IgM heavy chain (M), kappa light chain (κ), and lambda light chain (λ). The control sample was applied at a dilution of 1:6 for IgG and 1:3 for the other immunofixation lanes. The patient's samples were applied at a dilution of 1:3 for IgG and undiluted for the other immunofixation lanes. The tafasitamab was applied undiluted in both lanes. We therefore performed immunofixation of tafasitamab (MedChemExpress) diluted to 0.5 g/L and observed an IgG kappa band with identical electrophoretic migration to the band found in the patient's' specimen (Figure 1). This result strongly suggested that the clonal band in the patient's specimen represented interference from tafasitamab and not a new endogenous monoclonal component. Detection of therapeutic monoclonal antibodies such as tafasitamab can mimic monoclonal gammopathies, posing a diagnostic conundrum for clinicians and laboratory professionals. This highlights the importance of correlating laboratory findings with clinical history. Although tafasitamab is a therapy for B cell lymphoma and not multiple myeloma, for which immunofixation monitoring is indicated, patients treated for multiple myeloma with lenalidomide may be at an increased risk of subsequently developing a second hematologic malignancy, including B lineage disease [2], [3], [4]. Increased age is also a risk factor for lymphoma, and as these patients continue to be monitored for recurrence of myeloma by immunofixation, therapeutic monoclonal antibodies such as tafasitamab that are used for the treatment of lymphoma may become more common in tertiary centers that use such novel therapies. In addition to serum protein immunofixation, tafasitamab has also been described to interfere with flow cytometric assessment for residual disease, causing the potential to mimic the presence of residual lymphoma cells, leading to false conclusion of treatment failure [5]. As our case illustrates, obtaining a complete medication history is crucial to avoid misinterpretation and unnecessary additional workup of patients undergoing therapy with monoclonal antibodies. Fortunately, many therapeutic monoclonal antibodies do not achieve serum concentrations high enough to be detected by serum protein immunofixation, although the list of potentially detectable drugs is growing. Awareness of the possibility of this interference and the migration characteristics of therapeutic monoclonal antibodies can help to prevent misdiagnosis. Corresponding author: Susan L. Fink, Department of Laboratory Medicine and Pathology, University of Washington, 1959 NE Pacific St Box 357110, Seattle, WA, 98195, USA, E-mail: sfink@uw.edu Acknowledgments The authors wish to thank the University of Washington Clinical Immunology Laboratory staff, especially Maggie Mayes and Jeanne Kim, for running the immunofixations. Research ethics: Not applicable. Informed consent: Not applicable. Author contributions: All authors have accepted responsibility for the entire content of this manuscript and approved its submission. Use of Large Language Models, AI and Machine Learning Tools: Not applicable. Conflict of interest: The authors state no conflict of interest. Research funding: None declared. Data availability: Not applicable. References 1. Jurczak, W, Zinzani, PL, Gaidano, G, Goy, A, Provencio, M, Nagy, Z, et al.. Phase IIa study of the CD19 antibody MOR208 in patients with relapsed or refractory B-cell non-Hodgkin's lymphoma. Ann Oncol 2018;29:1266–72. https://doi-org.libproxy1.nus.edu.sg/10.1093/annonc/mdy056.Search in Google Scholar PubMed PubMed Central 2. Saleem, K, Franz, J, Klem, ML, Yabes, JG, Boyiadzis, M, Jones, JR, et al.. Second primary malignancies in patients with haematological cancers treated with lenalidomide: a systematic review and meta-analysis. Lancet Haematol 2022;9:e906–18. https://doi-org.libproxy1.nus.edu.sg/10.1016/s2352-3026-22-00289-7.Search in Google Scholar 3. Musto, P, Anderson, KC, Attal, M, Richardson, PG, Badros, A, Hou, J, et al.. Second primary malignancies in multiple myeloma: an overview and IMWG consensus. Ann Oncol 2017;28:228–45. https://doi-org.libproxy1.nus.edu.sg/10.1093/annonc/mdw606.Search in Google Scholar PubMed 4. Poh, C, Keegan, T, Rosenberg, AS. Second primary malignancies in multiple myeloma: a review. Blood Rev 2021;46:100757. https://doi-org.libproxy1.nus.edu.sg/10.1016/j.blre.2020.100757.Search in Google Scholar PubMed PubMed Central 5. Proost, L, Lambrecht, S, Hofmans, M, De Vriendt, C, Speeckaert, M, Bonroy, C, et al.. Flow cytometry interference in patients treated with tafasitamab: unraveling the diagnostic maze. Hemasphere 2024;8:e39. https://doi-org.libproxy1.nus.edu.sg/10.1002/hem3.39.Search in Google Scholar PubMed PubMed Central Received: 2025-08-06Accepted: 2025-09-07Published Online: 2025-09-15© 2025 the author(s), published by De Gruyter, Berlin/BostonThis work is licensed under the Creative Commons Attribution 4.0 International License.

200

News (Medical) associated with Tafasitamab-Cxix

23 Apr 2026

·www.globenewswire.com

InnoCare Releases 2026 Q1 Results: Strong Revenue Growth and Sustained Profitability

BEIJING, April 23, 2026 (GLOBE NEWSWIRE) -- InnoCare Pharma (HKEX: 09969; SSE: 688428) today announced its results and business highlights for the first quarter of 2026 as of 31 March 2026. Over the past decade, InnoCare has achieved remarkable results. 2026 marks the beginning of the Company’s next golden decade of development. Driven by its outstanding performance in 2025, the Company continued its rapid progress in the first quarter of 2026, increasing its investment in innovation, commercialization and globalization to achieve its 2.0 strategic goals. Commercialization & BD Drive Sustainable ProfitabilityInnoCare’s drug sales in the first quarter of 2026 increased by 44.5% year-on-year (YoY), reaching RMB 450.5 million, and total revenue grew by 38.7%YoY to reach RMB 528.6 million, primarily driven by commercial growth and incremental income generated from global business development (BD) initiatives. Orelabrutinib has grown rapidly since the inclusion of its new indication for first line chronic lymphocytic leukemia/small lymphocytic lymphoma (1L CLL/SLL) in the National Reimbursement Drug List (NRDL), while maintaining its exclusive indication advantage in marginal zone lymphoma (MZL). Meanwhile, the commercialization of tafasitamab and zurlectrectinib has brought new growth opportunities. Based on its first full year profitability in 2025, InnoCare remained profitable in the first quarter of 2026, with net profit increasing by 607.7% YoY to RMB 102.4 million. InnoCare’s Research and Development (R&D) Investment increased by 10.4% YoY to RMB 229.2 million in the first quarter of 2026, reflecting advancements of global registrational trials, as well as increased investment in new technology platforms such as ADCs and molecular glue. Cash and Related Accounts Balance1 stood at approximately RMB 7.9 billion as of 31 March 2026. This strong cash position provides InnoCare with the flexibility to expedite global clinical development of key assets and invest in new technology platforms. Dr. Jasmine Cui, the Co-founder, Chairwoman, and CEO of InnoCare, said, “Standing at the new starting point of the next decade of development, we maintained strong growth momentum in the first quarter of 2026, with enhanced market penetration, accelerated globalization, and breakthroughs across multiple pipelines, laying a solid foundation for high-quality development throughout the year of 2026. Upholding the core value of ‘Science driving innovation for the benefit of patients’, we will continue to uplift our innovation, commercialization and globalization, and accelerate clinical trials in China and globally, so as to benefit more patients worldwide.” Enhanced CommercializationIn the first quarter of 2026, all four approved indications of orelabrutinib were included in the updated NRDL. InnoCare achieved rapid growth in orelabrutinib following the inclusion of 1L CLL/SLL in the NRDL, while maintaining its exclusive indication advantage in MZL. Additionally, both tafasitamab and zurletrectinib have been approved for marketing in 2025 and have begun to contribute to sales. Tafasitamab became the first CD19 antibody approved for the treatment of relapsed or refractory diffuse large B-cell lymphoma (DLBCL) in China, while the next-generation TRK inhibitor, zurletrectinib, has been prescribed in hospitals across China. As a result, drug sales increased by 44.5%, reaching RMB 450.5 million in the first quarter of 2026. The Company’s commercial team has further strengthened its execution capabilities and focused on strategic priorities, laying a solid foundation for sustained revenue growth and long-term business success. Continued Breakthroughs Across Multiple PipelinesEffective 27 March 2026, the special "U" designation was officially removed from the Company's stock ticker in the STAR market, marking InnoCare’s entry into a phase of sustainable growth and development. Ten years of hard work have laid a solid foundation, and 2026 marks the beginning of a new decade for the Company. Building on its outstanding performance throughout 2025, the Company continued its high-quality and rapid development in the first quarter of 2026. The following are the main achievements during this period. The Phase III clinical trial of the novel BCL2 inhibitor mesutoclax (ICP-248) in combination with orelabrutinib as a first-line treatment for CLL/SLL has completed patient enrollment. This fixed-duration therapy is expected to achieve deeper remissions in treatment-naïve CLL/SLL patients, while avoiding resistance mutations and offering the hope for a clinical cure. As the first BCL2 inhibitor granted breakthrough therapy designation (BTD) in China, mesutoclax’s latest data will be presented at the 2026 American Society of Clinical Oncology (ASCO) annual meeting. The registrational trial in BTKi-treated mantle cell lymphoma (MCL) is progressing rapidly. In addition, global clinical trials of mesutoclax in acute myeloid leukemia (AML) and myelodysplastic syndromes (MDS) are advancing across China, U.S., and Australia. The New Drug Application (NDA) for orelabrutinib in primary immune thrombocytopenia (ITP) is expected to be submitted in the first half of 2026. The Phase III trial of orelabrutinib in systemic lupus erythematosus (SLE) has been initiated. Orelabrutinib’s two Phase III clinical trials for Primary Progressive Multiple Sclerosis (PPMS) and for Secondary Progressive Multiple Sclerosis (SPMS) are progressing.The first healthy volunteer has been dosed in the clinical trial of ICP-538, the first VAV1 degrader approved to enter clinical trials in China and the second globally. ICP-538 is a novel, potent, highly selective, orally administered molecular glue degrader targeting VAV1, a key protein downstream of T-cell and B-cell receptors. ICP-538 will be developed for the treatment of autoimmune diseases, such as inflammatory bowel disease (IBD), systemic lupus erythematosus (SLE), and multiple sclerosis (MS).The novel oral IL-17AA/AF inhibitor ICP-054 (ZB021) has received IND approval. ICP-054 is a novel, oral, highly potent and selective IL-17AA/AF inhibitor with significant therapeutic potential in autoimmune and inflammatory diseases. ICP-054 can effectively block the signal transduction pathways of IL-17AA homodimer and IL-17AF heterodimer, thereby inhibiting the release of pro-inflammatory cytokines and chemokines, exerting an anti-inflammatory effect. Simultaneously, it reduces excessive proliferation of keratinocytes and inflammatory cell infiltration, improving skin lesions and thus suppressing the occurrence of autoimmune and inflammatory diseases.The CD20xCD3 T-cell engager (TCE) ICP-B02 (PRO-203) has completed single ascending dose (SAD) trials of healthy volunteers for severe autoimmune diseases. Meanwhile, Prolium, InnoCare’s partner, expects to initiate a multinational Phase I/II trial in systemic sclerosis (SSc) in the second quarter of 2026, with additional studies in other severe B-cell-driven autoimmune diseases to start this year.The novel TYK2 inhibitor soficitinib (ICP-332) has completed patient enrollment in its Phase III clinical trial for moderate to severe atopic dermatitis (AD). The Phase II clinical study of soficitinib in patients with vitiligo has also completed patient enrollment. Data from the Phase II clinical trial of soficitinib in patients with moderate-to-severe AD was published in JAMA Dermatology. The journal concluded that soficitinib demonstrated a favorable safety profile and encouraging efficacy in patients with AD.The novel TYK2 inhibitor ICP-488 has completed patient enrollment in its Phase III clinical trial for psoriasis, potentially providing a new oral treatment option for patients with psoriasis.The next-generation TRK inhibitor zurletrectinib was granted priority review for the treatment of pediatric patients (ages 2–12) with solid tumors harboring NTRK fusions.The novel B7-H3 targeted ADC ICP-B794 showed promising preclinical data and was selected for presentation at the 2026 American Association for Cancer Research (AACR) annual meeting. The Phase I ascending dose trial is progressing. The IND application for the novel CDH17-targeted ADC ICP-B208 has been submitted which will be developed for the treatment of gastrointestinal cancers, including gastric, colorectal, pancreatic ductal adenocarcinoma, and cholangiocarcinoma. Preclinical studies show that ICP-B208 demonstrates potent anti-tumor activity even in CDH17-low tumors. Accelerating GlobalizationIn 2025, InnoCare accelerated its globalization strategy, focusing on unlocking the global value of its core pipelines, and completed two out-licensing transactions, further enhancing the Company's globalization efforts and financial performance, and marking a significant breakthrough in its global expansion. In 2026, InnoCare will continue to build long-term, win-win partnerships through business development, promote the Company's globalization process, and bring more benefits and growth opportunities to the Company and its partners, while benefiting patients worldwide. To know more about the detailed financial data of InnoCare 2026 Q1 results, please log in to https://www.innocarepharma.com/en/investor/home. To know more about the detailed financial data of InnoCare 2025 annual results, please log in to https://www.innocarepharma.com/en/news/activity/en020260325-InnoCare-2025-Annual-Results. Forward-looking StatementThis report contains the disclosure of some forward-looking statements. Except for statements of facts, all other statements can be regarded as forward-looking statements, that is, about our or our management's intentions, plans, beliefs, or expectations that will or may occur in the future. Such statements are assumptions and estimates made by our management based on its experience and knowledge of historical trends, current conditions, expected future development and other related factors. This forward-looking statement does not guarantee future performance, and actual results, development and business decisions may not match the expectations of the forward-looking statement. Our forward-looking statements are also subject to a large number of risks and uncertainties, which may affect our short-term and long-term performance. About InnoCare InnoCare (HKEX: 09969; SSE: 688428) is a commercial stage biopharmaceutical company committed to discovering, developing, and commercializing first-in-class and/or best-in-class drugs for the treatment of cancer and autoimmune diseases with unmet medical needs in China and worldwide. InnoCare has branches in Beijing, Nanjing, Shanghai, Guangzhou, Hong Kong, and United States. Contact MediaInvestor RelationsChunhua Lu 86-10-66609879chunhua.lu@innocarepharma.com86-10-66609999ir@innocarepharma.com 1 Include cash and bank balances, other current assets, financial assets among other non-current assets, and interest receivable

Phase 2Phase 1Phase 3Drug ApprovalBreakthrough Therapy

23 Apr 2026

·www.prnewswire.com

MINJUVI® (tafasitamab) for Relapsed or Refractory Follicular Lymphoma Approved in Australia

Minjuvi® (tafasitamab), in combination with rituximab and lenalidomide, is the first and only chemotherapy-free CD19 and CD20 dual-targeted immunotherapy combination regimen to be approved in Australia for adults with relapsed or refractory follicular lymphoma (R/R FL) (Grade 1-3a).1,2 Despite the availability of existing treatments, R/R FL remains incurable, is characterised by repeated relapses and typically has a poor prognosis.3 Follicular lymphoma is the second most common form of non-Hodgkin lymphoma, with 1,500 Australians newly diagnosed each year.4,5 SINGAPORE, April 23, 2026 /PRNewswire/ -- Independent biopharmaceutical company Specialised Therapeutics (ST) is pleased to announce that Minjuvi® (tafasitamab), in combination with rituximab and lenalidomide, has been registered by the Therapeutic Goods Administration (TGA) for the treatment of Australian adults with relapsed or refractory follicular lymphoma (R/R FL) (Grade 1-3a).1 The TGA registration establishes Minjuvi as the first and only chemotherapy-free CD19 and CD20 dual-targeted immunotherapy combination regimen to be approved in Australia for this group of patients.2 "While most patients with follicular lymphoma respond well to initial treatment and patients' prognosis has improved, around one in five will see their lymphoma return within two years, which is often linked to poorer long-term outcomes," said Professor Judith Trotman, Senior Staff Specialist and Lymphoma Group Lead in the Haematology Department at Concord Repatriation General Hospital in Sydney. "For these patients, current therapies do not always deliver durable responses, highlighting the urgent need for evidence-based options that can meaningfully extend and improve their lives." Follicular Lymphoma (FL) is the second most common form of non-Hodgkin Lymphoma (NHL), accounting for 20-30% of all NHL cases.4 An estimated 1,500 Australians are newly diagnosed with FL each year.5 "The TGA registration of Minjuvi marks an important new advance for patients with relapsed or refractory follicular lymphoma, bringing Australian clinical practice in line with accepted global standards of care," said Professor Trotman. The TGA registration of Minjuvi in combination with rituximab and lenalidomide in R/R FL was based on the results from the global Phase 3 inMIND clinical study. This trial evaluated the efficacy and safety of the regimen in 652 patients, including 548 participants with R/R FL. Notably, 54 Australians participated across 12 local trial sites across the country.6 In the clinical trial, patients receiving the Minjuvi combination regimen achieved a statistically significant and clinically meaningful improvement in median progression-free survival (PFS) of 22.4 months (compared to 13.9 months in patients receiving placebo added to lenalidomide and rituximab) — representing a 57% reduction in the risk of disease progression, relapse or death.6 Minjuvi was generally well-tolerated, with a manageable safety profile.6 The most common adverse reactions in the Phase 3 study (≥20%) in patients receiving Minjuvi, excluding laboratory abnormalities, were respiratory tract infections (including COVID-19 infection and pneumonia), diarrhoea, rash, fatigue, constipation, musculoskeletal pain and cough.6 In 2021, ST entered into an exclusive distribution agreement with Incyte (NASDAQ:INCY) to commercialise Minjuvi in Australia, New Zealand and Singapore. "Follicular lymphoma is an incurable blood cancer and treatment options after relapse remain limited, with each recurrence more challenging to find effective treatments," said Carlo Montagner, ST Chief Executive Officer. "We are extremely proud to bring the first and only chemotherapy-free treatment option to eligible Australians with relapsed or refractory follicular lymphoma, addressing a critical need for new therapies that may lower the risk of disease progression, relapse or death." "The Minjuvi approval represents the ninth time ST has successfully navigated the Project Orbis process since 2021," said Mr Montagner. "With TGA registration secured, we are committed to working with the Pharmaceutical Benefits Advisory Committee and Department of Health, Disability and Ageing to enable equitable access to Minjuvi for Australians with relapsed or refractory follicular lymphoma as soon as possible." For further details on Minjuvi, contact your healthcare professional and please refer to the approved Australian Consumer Medicine Information or Product Information available from the TGA website. PBS Information: Minjuvi is not listed on the Pharmaceutical Benefits Scheme (PBS). Important safety Information on Minjuvi 7 Minjuvi should be administered to patients with an active infection only if the infection is treated appropriately and well controlled. Patients with a history of recurring or chronic infections may be at increased risk of infection and should be monitored appropriately. Patients should be advised to contact their healthcare professionals if fever or other evidence of potential infection, such as chills, cough or pain on urination, develops. Treatment with Minjuvi in combination with lenalidomide and/or rituximab should not be initiated in female patients unless pregnancy has been excluded. In the inMIND study, the most common adverse reactions were infections (68%), including viral infections (41%) and bacterial infections (27%); neutropenia (57%), rash (36.4%), asthenia (34.9%), pyrexia (19%), thrombocytopenia (17%), anaemia (17%), infusion related reaction (15.9%), pruritus (15.6%), and headache (10.4%). The most common serious adverse reactions were infections (26%), including viral infections (13%) and bacterial infections (6%), febrile neutropenia (2.8%), and pyrexia (1.8%). Treatment with tafasitamab can cause serious or severe myelosuppression including neutropenia, thrombocytopenia, and anaemia. Complete blood counts should be monitored throughout treatment and prior to administration of each treatment cycle. Ends. About Minjuvi ® (tafasitamab) Minjuvi® (tafasitamab) is a humanised Fc-modified cytolytic CD19-targeting monoclonal antibody. Tafasitamab incorporates an XmAb® engineered Fc domain, which mediates B-cell lysis through apoptosis and immune effector mechanism including Antibody-Dependent Cell-Mediated Cytotoxicity (ADCC) and Antibody-Dependent Cellular Phagocytosis (ADCP). Incyte licenses exclusive worldwide rights to develop and commercialise tafasitamab from Xencor, Inc. In Australia, Minjuvi is also indicated in combination with lenalidomide followed by Minjuvi monotherapy for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) who are not eligible for autologous stem cell transplant (ASCT). Minjuvi is not indicated and is not recommended for the treatment of patients with relapsed or refractory marginal zone lymphoma outside of controlled clinical trials. ▼ This medicine is included in the TGA Black Triangle Scheme. Please report suspected adverse events to the TGA. In the U.S., Monjuvi® (tafasitamab-cxix) is approved by the U.S. FDA in combination with lenalidomide and rituximab for the treatment of adult patients with relapsed or refractory follicular lymphoma (FL). Monjuvi is not approved and is not recommended for the treatment of patients with relapsed or refractory marginal zone lymphoma outside of controlled clinical trials. Additionally, Monjuvi received accelerated approval in the United States in combination with lenalidomide for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) not otherwise specified, including DLBCL arising from low grade lymphoma, and who are not eligible for autologous stem cell transplant (ASCT). In Europe, Minjuvi (tafasitamab) received conditional Marketing Authorisation from the European Medicines Agency in combination with lenalidomide, followed by Minjuvi monotherapy, for the treatment of adult patients with relapsed or refractory DLBCL who are not eligible for ASCT. Additionally, Minjuvi is approved in combination with lenalidomide and rituximab for the treatment of adult patients with relapsed or refractory follicular lymphoma (FL) (Grade 1-3a) after at least one line of systemic therapy in Europe. In Japan, Minjuvi is approved in combination with rituximab and lenalidomide for adult patients with relapsed or refractory follicular lymphoma (2L+ FL). XmAb® is a registered trademark of Xencor, Inc. Monjuvi and Minjuvi are registered trademarks of Incyte. About the inMIND Study 6,7 A global, double-blind, randomised, placebo-controlled Phase 3 study, inMIND (NCT04680052) evaluated the efficacy and safety of tafasitamab in combination with rituximab and lenalidomide compared with placebo in combination with rituximab and lenalidomide in patients with relapsed or refractory follicular lymphoma (FL) Grade 1 to 3a or relapsed or refractory nodal, splenic or extranodal marginal zone lymphoma (MZL). The study enrolled a total of 654 adults (age ≥18 years). The primary endpoint of the study is progression-free survival (PFS) by investigator assessment in the FL population, and the key secondary endpoints are PFS in the overall population as well as positron emission tomography complete response (PET-CR) and overall survival (OS) in the FL population. The clinical trial met its primary endpoint, with the data demonstrating a statistically significant and clinically meaningful improvement in progression-free survival (PFS) in comparison to placebo added to lenalidomide and rituximab.6 Patients receiving Minjuvi in combination with rituximab and lenalidomide achieved a median PFS by investigator assessment of 22.4 months (95% CI, 19.2-not evaluable [NE]) compared to 13.9 months (95% CI, 11.5-16.4) in the control arm (hazard ratio [HR]: 0.43 [95% CI, 0.32-0.58]; P<0.0001).6 The PFS assessed by an Independent Review Committee (IRC) was consistent with investigator-based results.6 Median PFS by IRC was not reached (95% CI, 19.3-NE) in the Minjuvi group versus 16.0 months (95% CI, 13.9-21.1) in the placebo group (HR: 0.41 [95% CI, 0.29-0.56].6 Minjuvi was generally well-tolerated, with a manageable safety profile.6 Safety and tolerability were comparable with the addition of tafasitamab to lenalidomide in combination with rituximab.6 The most common adverse reactions in the Phase 3 study (≥20%) in patients receiving Minjuvi, excluding laboratory abnormalities, were respiratory tract infections (including COVID-19 infection and pneumonia), diarrhoea, rash, fatigue, constipation, musculoskeletal pain and cough.6 About Specialised Therapeutics Founded in 2007, Specialised Therapeutics is an independent specialty pharmaceutical company, providing novel therapies and technologies to patients in Australia, New Zealand and across Southeast Asia. Headquartered in Singapore, ST partners with global pharmaceutical, biotech and diagnostic companies to bring novel healthcare opportunities to patients who are impacted by a range of diseases. ST has built a strong track record of success, navigating complex regulatory, reimbursement and commercialisation environments in its diverse regions across multiple therapeutic areas. The ST mission is to provide specialty therapies where there is an unmet need to communities that would otherwise not have ready access to such therapies. The company's broad therapeutic portfolio currently includes novel agents in oncology, haematology, CNS, neurology, endocrinology, ophthalmology and supportive care, although it is not confined to these areas. Additional information can be found at . SOURCE Specialised Therapeutics 21% more press release views with Request a Demo

Clinical ResultImmunotherapyPhase 3Drug ApprovalCell Therapy

21 Apr 2026

·www.businesswire.com

Incyte Highlights New Phase 3 Tafasitamab Data at the 2026 American Society of Clinical Oncology (ASCO) Annual Meeting

WILMINGTON, Del.--(BUSINESS WIRE)--Incyte (Nasdaq:INCY) today announced that full results from the Phase 3 pivotal study evaluating tafasitamab (Monjuvi®/Minjuvi®) in first-line diffuse large b-cell lymphoma (DLBCL) will be featured as an oral presentation at the 2026 American Society of Clinical Oncology (ASCO) Annual Meeting, to be held May 29 – June 2, 2026, in Chicago. “The positive Phase 3 frontMIND results for tafasitamab in patients with newly diagnosed DLBCL highlight Incyte’s continued focus on advancing novel differentiated approaches ... ,” said Pablo J. Cagnoni, M.D., President and Head of R&D, Incyte. “The positive Phase 3 frontMIND results for tafasitamab in patients with newly diagnosed diffuse large B-cell lymphoma highlight Incyte’s continued focus on advancing novel differentiated approaches with the potential to meaningfully impact patients,” said Pablo J. Cagnoni, M.D., President and Global Head of Research and Development, Incyte. “We look forward to sharing the full data at ASCO, and to progressing our pipeline.” Presentation details: frontMIND: Phase 3 Study of tafasitamab (Tafa) Plus lenalidomide (Len) and R-CHOP for Patients (pts) with Newly Diagnosed Diffuse Large B-cell Lymphoma (DLBCL) (Abstract #7000. Session: Oral Abstract Session - Hematologic Malignancies—Lymphoma and Chronic Lymphocytic Leukemia. May 30, 4:00 – 7:00 p.m. ET (3:00 – 6:00 p.m. CDT)) More information regarding the 2026 ASCO Annual Meeting can be found at: https://www.asco.org/annual-meeting. About Tafasitamab (Monjuvi®/Minjuvi®) Tafasitamab (Monjuvi®/Minjuvi®) is a humanized Fc-modified cytolytic CD19-targeting monoclonal antibody. Tafasitamab incorporates an XmAb® engineered Fc domain, which mediates B-cell lysis through apoptosis and immune effector mechanism including Antibody-Dependent Cell-Mediated Cytotoxicity (ADCC) and Antibody-Dependent Cellular Phagocytosis (ADCP). Incyte licenses exclusive worldwide rights to develop and commercialize tafasitamab from Xencor, Inc. In the U.S., Monjuvi® (tafasitamab-cxix) is approved by the U.S. Food and Drug Administration in combination with lenalidomide and rituximab for the treatment of adult patients with relapsed or refractory follicular lymphoma (FL). Additionally, Monjuvi received accelerated approval in the United States in combination with lenalidomide for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) not otherwise specified, including DLBCL arising from low grade lymphoma, and who are not eligible for autologous stem cell transplant (ASCT). Monjuvi is not indicated and is not recommended for the treatment of patients with relapsed or refractory marginal zone lymphoma outside of controlled clinical trials. In Europe, Minjuvi® (tafasitamab) received conditional Marketing Authorization from the European Medicines Agency in combination with lenalidomide, followed by Minjuvi monotherapy, for the treatment of adult patients with relapsed or refractory DLBCL who are not eligible for ASCT. In addition, in December 2025, the EMA approved Minjuvi, in combination with lenalidomide and rituximab, for the treatment of adult patients with relapsed or refractory FL (Grade 1-3a) after at least one line of systemic therapy. In Japan, Minjuvi is approved in combination with rituximab and lenalidomide for adult patients with relapsed or refractory follicular lymphoma (2L+ FL). XmAb® is a registered trademark of Xencor, Inc. Monjuvi and Minjuvi are registered trademarks of Incyte. About Incyte® Incyte is redefining what’s possible in biopharmaceutical innovation. Through deep scientific expertise and a relentless focus on patients, we have built an established portfolio of first-in-class medicines and an extensive portfolio of next-generation medicines across our key franchises: Hematology, Oncology and Inflammation & Autoimmunity. To learn more, visit Incyte.com and Investor.Incyte.com. Follow us on social media: LinkedIn, X and Instagram. Incyte Forward-Looking Statements Except for the historical information set forth herein, the matters set forth in this press release, including statements regarding the presentation of data from Incyte’s clinical development pipeline, the potential and promise offered by tafasitamab, including its ability to provide a differentiated treatment option or meaningfully impact patients with newly diagnosed diffuse large B-cell lymphoma, among other conditions, and the overall strength of Incyte’s hematology and oncology portfolio contain predictions, estimates and other forward-looking statements. These forward-looking statements are based on Incyte’s current expectations and subject to risks and uncertainties that may cause actual results to differ materially, including risks and uncertainties regarding research and development of products and product candidates, the sufficiency of clinical trial data to meet applicable regulatory standards or warrant continued development, the ability to enroll sufficient numbers of subjects in clinical trials, determinations made by the FDA, EMA and other regulatory authorities and the timing thereof, the efficacy or safety of Incyte’s products, the acceptance of Incyte’s products in the marketplace, market competition, sales, marketing, manufacturing and distribution requirements, and other risks detailed from time to time in Incyte’s reports filed with the U.S. Securities and Exchange Commission, including its annual report on form 10-K for the year ended December 31, 2025. Incyte disclaims any intent or obligation to update these forward-looking statements.

100 Deals associated with Tafasitamab-Cxix

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KEGG	Wiki	ATC	Drug Bank
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R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Recurrent Follicular Lymphoma	United States	MorphoSys US, Inc.	18 Jun 2025
Refractory Follicular Lymphoma	United States	MorphoSys US, Inc.	18 Jun 2025
Diffuse Large B-Cell Lymphoma	Canada	Incyte Corp.	06 Dec 2021
Diffuse large B-cell lymphoma recurrent	Canada	Incyte Corp.	19 Aug 2021
Diffuse large B-cell lymphoma refractory	United States	MorphoSys US, Inc.	31 Jul 2020

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Follicular Lymphoma	Phase 3	United States	MorphoSys AG	30 Jan 2022
T-cell/histiocyte rich large B-cell lymphoma	Phase 3	United States	Incyte Corp.	11 May 2021
T-cell/histiocyte rich large B-cell lymphoma	Phase 3	Japan	Incyte Corp.	11 May 2021
T-cell/histiocyte rich large B-cell lymphoma	Phase 3	Argentina	Incyte Corp.	11 May 2021
T-cell/histiocyte rich large B-cell lymphoma	Phase 3	Australia	Incyte Corp.	11 May 2021
T-cell/histiocyte rich large B-cell lymphoma	Phase 3	Austria	Incyte Corp.	11 May 2021
T-cell/histiocyte rich large B-cell lymphoma	Phase 3	Canada	Incyte Corp.	11 May 2021
T-cell/histiocyte rich large B-cell lymphoma	Phase 3	Colombia	Incyte Corp.	11 May 2021
T-cell/histiocyte rich large B-cell lymphoma	Phase 3	Czechia	Incyte Corp.	11 May 2021
T-cell/histiocyte rich large B-cell lymphoma	Phase 3	France	Incyte Corp.	11 May 2021

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT04809467 (topMIND, CTgov)	Phase 1/2	Chronic Lymphocytic Leukemia \| Non-Hodgkin's lymphoma refractory	54	tafasitamab+parsaclisib (Cohort 1: R/R DLBCL)	akakxppelv = zbglbdcpmm yaarwkhvbp (vvnzedqqej, oymoczxrzs - slbkynepkd) View more	-	29 Jan 2026
				tafasitamab+parsaclisib (Cohort 2: R/R MCL)	akakxppelv = zsltsyagig yaarwkhvbp (vvnzedqqej, ltncuudncz - kvkihxfunq) View more
NCT05718869 (ASH2025)	Phase 2	Chronic Lymphocytic Leukemia \| Small Lymphocytic Lymphoma First line	22	TafasitamabZanubrutinib + TafasitamabZanubrutinib	juuwbfhvxe(ntkvwmkbpv) = hqbhcrpyvd calfasekmy (mgjeyjjszh ) View more	Positive	06 Dec 2025
NCT05351593 (ASH2025)	Phase 1/2	Recurrent Central Nervous System Lymphoma	9	Tafasitamab plus lenalidomide	ojjsecqtid(xnvxmgclbv) = febrile neutropenia associated with urinary tract infection fscnzlpzeq (fmiwxxvidr )	Positive	06 Dec 2025
NCT04978584 (Smart Stop, ASH2025)	Phase 2	Diffuse Large B-Cell Lymphoma First line	61	Lenalidomide+Tafasitamab+Rituximab+Acalabrutinib (2 cycles of CHOP)	ypixkitdwe(pbhrmtjhdc) = lyzfqbiloc uyckyxazed (ctniwiwuvt ) View more	Positive	06 Dec 2025
				Lenalidomide+Tafasitamab+Rituximab+Acalabrutinib (no cycles of CHOP)	ypixkitdwe(pbhrmtjhdc) = rpbiqrhvon uyckyxazed (ctniwiwuvt ) View more
NCT04680052 (inMIND, ASH2025)	Phase 3	Refractory Follicular Lymphoma Second line CD19+ \| CD20+	548	LenalidomideRituximabTafasitamab + LenalidomideRituximabTafasitamabe + LenalidomideRituximabTafasitamab	yaxtczxeru(ilzcjfymtn) = mnrjemjpzp zoogxgsaqn (wazrvqhbfu ) View more	Positive	06 Dec 2025
				LenalidomideRituximab + LenalidomideRituximabide + LenalidomideRituximab	yaxtczxeru(ilzcjfymtn) = kulwabfjsi zoogxgsaqn (wazrvqhbfu ) View more
NCT04680052 (inMIND, Pubmed \| Lancet)	Phase 3	Refractory Follicular Lymphoma Second line	548	Tafasitamab+lenalidomide+rituximab	qrrfkyyzlg(hncbyxtmmn) = cnwjlvrttl owhxoyflsi (clglqsmprq )	Positive	01 Dec 2025
				Placebo+lenalidomide+rituximab	qrrfkyyzlg(bmbmtocbrb) = vybkpbqoxa jcpwuobsjm (hifegwvmzv ) View more
L-MIND (ESMO2025)	Not Applicable	Diffuse Large B-Cell Lymphoma	236	Tafasitamab combined with lenalidomide	qzmoxwbwgk(rypkjroxpt) = fdrfcqihrk kkxsnmvmdv (uizmsdewep ) View more	Positive	17 Oct 2025
				Glofitamab	qzmoxwbwgk(rypkjroxpt) = citzlsztlg kkxsnmvmdv (uizmsdewep ) View more
NCT05222555 (MINDway, CTgov)	Phase 1/2	Diffuse large B-cell lymphoma recurrent	53	Lenalidomide+Tafasitamab (Tafasitamab Dose Level 1 + 25 mg Lenalidomide)	rezewazlou = tgjpjislkk cknxxhkgjs (mwjgzshyoc, vebjugvbzf - iojopypver) View more	-	28 Jul 2025
				Lenalidomide+Tafasitamab (Tafasitamab Dose Level 2 + 25 mg Lenalidomide)	rezewazlou = plonlkhkwb cknxxhkgjs (mwjgzshyoc, kwllsuelzy - unwuyrbnvx) View more
NCT02763319 (B-MIND, CTgov)	Phase 2/3	Refractory Diffuse Large B-Cell Lymphoma Activated B-Cell Type \| Diffuse large B-cell lymphoma recurrent	453	Tafasitamab+Bendamustine (Tafasitamab + Bendamustine)	dpjihayitv(hkfzpldvqk) = pvnndfbkoo exkzzfwppp (rntkgcesml, wlzqxmrcmo - vccwvpurgw) View more	-	17 Jul 2025
				Bendamustine+Rituximab (Rituximab + Bendamustine)	dpjihayitv(hkfzpldvqk) = omoiktbeor exkzzfwppp (rntkgcesml, exopkpdsfy - fcjbqbwxwb) View more
NCT04680052 (inMIND, FDA_CDER) Manual	Phase 3	Follicular Lymphoma	548	MONJUVI in Combination with Lenalidomide and Rituximab	bwplfymbnp(kisrjmkcxq) = iwtaaovkyr dtbwxitczq (njclmmncpa, 19.2 - NE) View more	Positive	18 Jun 2025
				Placebo in Combination with Lenalidomide and Rituximab	bwplfymbnp(kisrjmkcxq) = ywsjsenvcz dtbwxitczq (njclmmncpa, 11.5 - 16.4) View more

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