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

Diffuse large B-cell lymphoma recurrentDiffuse large B-cell lymphoma refractoryDiffuse Large B-Cell Lymphoma+ [22]

Inactive Indication

Mantle cell lymphoma refractory

Originator Organization

Xencor, Inc.

Active Organization

Incyte Corp.

MorphoSys AGIncyte Biosciences Distribution BV

+ [5]

Inactive Organization

Xencor, Inc.

License Organization

Incyte Corp.Specialised Therapeutics Asia Pte Ltd.

Knight Therapeutics, Inc.

+ [5]

Drug Highest PhaseApproved

First Approval Date

United States (31 Jul 2020),

Diffuse Large B-Cell Lymphoma

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

Structure/Sequence

Sequence Code 1697872

Source: *****

Sequence Code 12960725

Source: *****

Clinical Trials associated with Tafasitamab-Cxix

NCT06792825

/ Not yet recruitingPhase 2IIT

HM2023-43: A Phase 2 Trial of Tafasitamab in Combination With Lenalidomide+Rituximab in Treatment-naive Follicular Lymphoma and Marginal Zone Lymphoma

The study follows a Simon's two-stage phase II trial design to evaluate the safety and efficacy of tafasitamab added to rituximab and lenalidomide for two treatment-naïve, parallel, independent cohorts: follicular lymphoma (FL) and marginal zone lymphoma (MZ). Each cohort, FL and MZ, will be evaluated separately. This study is presented to the patient and consent is signed prior to the initiation of treatment for their primary malignancy.

Start Date01 Jul 2025

Sponsor / Collaborator

University of Minnesota Masonic Cancer Center

[+1]

NCT06760156

/ RecruitingPhase 2IIT

Phase 2 Study of Tafasitamab and Lenalidomide as First Salvage Therapy for Residual Large B Cell Lymphoma After Axicabtagene Ciloleucel

The purpose of the study is to evaluate the safety and efficacy of tafasitamab and lenalidomide in participants with Large B Cell Lymphoma (LBCL) after axicabtagene ciloleucel (axi-cel) treatment. Participants will be asked to spend about 12 months in this study.

Start Date19 Mar 2025

Sponsor / Collaborator

H. Lee Moffitt Cancer Center & Research Institute, Inc.

[+1]

NCT05583071

/ RecruitingPhase 2IIT

Pilot-trial of Methotrexate, Tafasitamab (Minjuvi®), Lenalidomide (Revlimid®) and Rituximab in Patients Ineligible for HCT-ASCT With Primary Central Nervous System Lymphoma (PCNSL)

Pilot-trial of Methotrexate, Tafasitamab (Minjuvi®), Lenalidomide (Revlimid®) and Rituximab in patients ineligible for HCT-ASCT with Primary Central Nervous System Lymphoma (PCNSL)

Start Date23 Aug 2024

Sponsor / Collaborator

Universities of Cologne

[+1]

100 Clinical Results associated with Tafasitamab-Cxix

100 Translational Medicine associated with Tafasitamab-Cxix

100 Patents (Medical) associated with Tafasitamab-Cxix

111

Literatures (Medical) associated with Tafasitamab-Cxix

31 Dec 2025·JOURNAL OF MEDICAL ECONOMICS

Budget impact of introducing glofitamab for treatment of relapsed or refractory diffuse large B-cell lymphoma after two or more lines of systemic therapy in the United States

Article

Author: Li, Jia ; Mahmoudjafari, Zahra ; Masaquel, Anthony ; Parisé, Hélène ; Bercaw, Eric ; Bognar, Katalin ; Wang, Si-Tien

BACKGROUND:

Glofitamab is a T-cell engaging bispecific monoclonal antibody that was granted accelerated approval from the United States Food and Drug Administration for adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL), not otherwise specified or large B-cell lymphoma arising from follicular lymphoma, after ≥2 lines of systemic therapy (3L+).

METHODS:

A budget impact model was developed for a hypothetical blended commercial/Medicare health plan with 1,000,000 members. Comparators were axicabtagene ciloleucel (Axi-cel), lisocabtagene maraleucel (Liso-cel), tisagenlecleucel (Tisa-cel), loncastuximab tesirine, polatuzumab vedotin + bendamustine + rituximab, rituximab + gemcitabine + oxaliplatin, tafasitamab + lenalidomide, and epcoritamab (Epcor). Total costs included those for drugs, wastage, administration, grade ≥3 adverse reactions, and all-grade cytokine release syndrome) and routine care. Market shares were based on internal projections and expert opinions. Total and per-member per-month (PMPM) net budget impacts over 3 years were calculated.

RESULTS:

Approximately nine patients were projected to be eligible for 3L + DLBCL treatment in a health plan of 1,000,000 members. The introduction of glofitamab as a treatment option resulted in estimated total and PMPM cost savings of $728,697 and -$0.0202, respectively, over 3 years. Costs were reduced across all cost categories but particularly in drug costs. Among the newer therapies, total 3-year cost per treated patient was lowest for glofitamab: $226,658 versus Tisa-cel = $564,113; Axi-cel = $540,002; Liso-cel = $516,272; and Epcor = $335,293. Across all sensitivity analyses, the inclusion of glofitamab had minimal PMPM budget impact, ranging from -$0.0256 to -$0.0108.

CONCLUSIONS:

With the lowest 3-year total cost per treated patient among the newer therapies, glofitamab being an available option in the 3L + DLBCL market is estimated to save a hypothetical 1,000,000-member health plan $728,697 in cumulative total costs and $0.0202 in PMPM costs over 3 years.

01 Jun 2025·Clinical Lymphoma Myeloma & Leukemia

SOHO State of the Art Updates and Next Questions | Diffuse Large B-Cell Lymphoma in Older Adults: A Comprehensive Review

Review

Author: Iyengar, Varun ; Hamlin, Paul ; Torka, Pallawi

Older adults (OA) with DLBCL are a heterogenous population with suboptimal outcomes. In this review, we identify and address the unique challenges encountered in the care of OA with DLBCL. We elaborate on the role and limitations of current geriatric assessment (GA) tools and ways to incorporate fitness in therapeutic decision making. We suggest best practices to implement GA in routine practice and clinical trials. The most widely used tool is simplified GA (sGA) which categorizes patients into fit, unfit and frail groups. Patients who are fit benefit from full dose/curative approach, whereas consideration should be made to reduce the intensity of chemotherapy for unfit patients. Frail patients with DLBCL are a major unmet need without any satisfactory treatment options. Ongoing investigations combining novel therapies into chemotherapy-free regimens are underway with promising early results. In the relapsed/refractory (R/R) setting, anti-CD19 CAR-T cell therapy (CART) is now the standard of care for primary refractory disease or relapse within 12 months of completing therapy. Autologous stem cell transplant is still a consideration for fit OA with relapse >12 months after completing therapy. The recent approval of bispecific antibodies is a welcome advance that will greatly benefit OA not eligible for CART. Other regimens available for patients ineligible for CART or for those who experience progression post-CART include polatuzumab-rituximab±bendamustine, tafasitamab-lenalidomide, loncastuximab or chemotherapy-based approaches such as rituximab-gemcitabine-oxaliplatin. We discuss the changing paradigm in R/R DLBCL and spotlight emerging data from recent congresses that can improve outcomes in this vulnerable population.

01 Apr 2025·Clinical Lymphoma Myeloma & Leukemia

Real-World Effectiveness of Chemoimmunotherapy and Novel Therapies for Patients With Relapsed/Refractory Aggressive Large B-Cell Lymphoma

Article

Author: Huynh, Lynn ; Stanchina, Michele ; Haddadi, Sara ; Duh, Mei Sheng ; Kalsekar, Anupama ; Gao, Chi ; Wang, Yucai ; Lin, Ruitao ; Maurer, Matthew J ; Jun, Monika ; Larson, Melissa A ; Andersen, Clark R ; Kamalakar, Rajesh ; Ayers, Amy ; Flowers, Christopher R ; Nastoupil, Loretta J ; Cerhan, James R ; Martin, Peter ; Habermann, Thomas M ; Cohen, Jonathon B ; Wang, Tongsheng ; Chihara, Dai ; Casulo, Carla ; Koff, Jean L ; Kahl, Brad S ; Ramasubramanian, Ramya ; Lossos, Izidore S ; Link, Brian K ; Mutebi, Alex ; Wang, Anthony ; Ayyappan, Sabarish ; Li, Ziyi

INTRODUCTION:

Clinical trials provide meaningful data regarding the safety and efficacy of novel therapies but there is often a lag between the time of new drug approval and information on posttreatment clinical outcomes in real-world practice. This study evaluated clinical outcomes in a large real-world population of patients with relapsed and/or refractory large B-cell lymphoma (r/r LBCL) treated with chemoimmunotherapy or novel therapies in second or later lines of therapy (2L+).

MATERIALS AND METHODS:

Data from the Lymphoma Epidemiology of Outcomes (LEO) Consortium of Real-World Evidence (CReWE) cohort (1/1/2015-2/15/2023) were analyzed. Patients' demographic and clinical characteristics were described and response rates, duration of response, progression-free survival, and overall survival were evaluated. Multivariable Cox proportional hazards regression models were used to assess associations between patient clinical characteristics and outcomes.

RESULTS:

The 2L+ cohort included patients treated with chemoimmunotherapy (N = 593), lenalidomide-based therapy (n = 60), polatuzumab vedotin-based therapy (N = 116), tafasitamab-based therapy (N = 55), and loncastuximab tesirine (N = 42). Most patients who received prior chimeric antigen receptor T-cell therapy (CAR-T) were refractory to the treatment. Across all patients, overall response rates were <50%, with one-quarter achieving complete response and median duration of response and overall survival were short (<6 and <10 months, respectively) among patients treated with chemoimmunotherapy or novel therapies. The prognosis was worse for patients who had previously received CAR-T. Primary refractory status, high-risk disease, and failing 3 or more lines of therapy were significantly associated with worse outcomes.

CONCLUSION:

Patients with r/r LBCL have unfavorable outcomes and need more effective treatment alternatives.

174

News (Medical) associated with Tafasitamab-Cxix

30 May 2025

·www.globenewswire.com

Adaptive Biotechnologies Highlights New Data at 2025 ASCO Annual Meeting and EHA 2025 Congress Demonstrating How clonoSEQ® MRD Assessment is Optimizing Patient Care and Drug Development in Lymphoid Cancers

30 scientific abstracts will be presented using clonoSEQ for MRD assessment across multiple types of blood cancersSEATTLE, May 30, 2025 (GLOBE NEWSWIRE) -- Adaptive Biotechnologies Corporation (Nasdaq: ADPT), a commercial stage biotechnology company that aims to translate the genetics of the adaptive immune system into clinical products to diagnose and treat disease, today announced that its next-generation sequencing (NGS)-based clonoSEQ® test for measurable residual disease (MRD) assessment will be included in 30 presentations, including a total of 14 oral presentations, across the American Society of Clinical Oncology (ASCO) Annual Meeting taking place May 30-June 3 in Chicago and the European Hematology Association (EHA) Congress taking place June 12-15 in Milan. These presentations include notable new data supporting the clinical actionability of clonoSEQ in both multiple myeloma (MM) and chronic lymphocytic leukemia (CLL). "The breadth of new MRD evidence being shared across various blood cancer types at ASCO and EHA this year highlights the transformative impact MRD is having on clinical care and drug development," said Susan Bobulsky, Chief Commercial Officer, MRD, Adaptive Biotechnologies. "These data presentations are a testament to the central role that clonoSEQ MRD testing now plays in clinical management and drug development across lymphoid cancers, particularly when combined with several clonoSEQ data presentations in diffuse large B-cell lymphoma (DLBCL) anticipated at the 18th International Conference on Malignant Lymphoma (iCML) on June 17-21, 2025 in Lugano, Switzerland." Selected presentations include: Data advancing the clinical actionability of clonoSEQ MRD testing Results from MIDAS, a phase 3 randomized study of 718 transplant-eligible, newly diagnosed multiple myeloma (NDMM) patients, demonstrate the use of MRD status to guide therapy post-induction. (ASCO Abstract 7500, June 3, 9:45-9:57 a.m. CDT, S100bc, McCormick Place Convention Center)Interim data from ADVANCE, a phase 2 randomized study of 306 transplant-eligible patients with NDMM shows the impact of MRD-guided assessments post-induction (ASCO Abstract 7503, June 3, 10:21-10:33 a.m. CDT, S100bc, McCormick Place Convention Center)Interim results from VENETOSTOP, a phase 2 study of 66 CLL patients, report the use of MRD status to shorten duration of venetoclax-based therapy. (EHA Abstract PS1568, June 14, 6:30 p.m. CEST, Poster Hall, Milano Convention Centre) Studies utilizing clonoSEQ MRD assessment as a critical indicator of quadruplet regimen efficacy in multiple myeloma Results from the phase 3 IsKia study of 151 transplant-eligible NDMM patients demonstrates increased rates of sustained MRD negativity at 10-6 with isatuximab plus carfilzomib, lenalidomide, and dexamethasone. (ASCO Abstract 7502, June 3, 10:09-10:21 a.m. CDT, S100bc, McCormick Place Convention Center) Follow-up data from PERSEUS, a phase 3 trial of 709 transplant-eligible patients with NDMM reports the impact of sustained MRD negativity status on progression free survival (PFS) with subcutaneous daratumumab plus bortezomib, lenalidomide and dexamethasone (D-VRd) induction and DR maintenance. (ASCO Abstract 7501, June 3, 9:57-10:09 a.m. CDT, S100bc, McCormick Place Convention Center) Results from DREAMM-8, a Phase 3 study in 302 patients with relapsed or refractory multiple myeloma, found superior PFS and higher MRD negativity rates in patients treated with belantamab mafodotin plus pomalidomide and dexamethasone (BPd) as compared to standard-of-care pomalidomide, bortezomib, and dexamethasone (PVd). (ASCO Abstract 7515, June 2, 9:00-9:06 a.m. CDT E450b, McCormick Place Convention Center) Data to be presented at ASCO: Presentation Type and NumberTitlePresentation TimingB-Cell Acute Lymphoblastic LeukemiaPoster Presentation6540Initial results from a phase II study of dose-adjusted etoposide, prednisone, vincristine, cyclophosphamide, and doxorubicin (DA-EPOCH) ± rituximab (R) + tafasitamab (tafa) for adults with newly-diagnosed (ND) Philadelphia chromosome negative (Ph-) B lymphoblastic leukemia (B-ALL)Sunday, June 19 a.m.-12 p.m. CDTPoster Presentation6543Brexucabtagene autoleucel (Brexu-cel) as consolidation treatment in adults with B-cell acute lymphoblastic leukemiaSunday, June 19 a.m.-12 p.m. CDTMultiple MyelomaOral Presentation7500*MRD-driven strategy following IsaKRD induction in transplant-eligible NDMM: Primary endpoints of the phase 3 MIDAS trialTuesday, June 39:45-9:57 a.m. CDTOral Presentation7501Subcutaneous daratumumab (Dara) + bortezomib/lenalidomide/dexamethasone (VRd) with Dara + lenalidomide (DR) maintenance in transplant-eligible (TE) patients with newly diagnosed multiple myeloma (NDMM): Analysis of sustained minimal residual disease negativity in the phase 3 PERSEUS trialTuesday, June 39:57-10:09 a.m. CDTOral Presentation7502Sustained MRD negativity in patients with newly diagnosed multiple myeloma treated with carfilzomib-lenalidomide-dexamethasone with or without isatuximab (phase III IsKia trial)Tuesday, June 310:09-10:21 a.m. CDTOral Presentation7503*Randomized, multi-center study of carfilzomib, lenalidomide, and dexamethasone (KRd) with or without daratumumab (D) in patients with newly diagnosed multiple myeloma (NDMM): The ADVANCE clinical trialTuesday, June 310:21-10:33 a.m. CDTOral Presentation7507*Long-term (≥5 year) remission and survival after treatment with ciltacabtagene autoleucel (cilta-cel) in CARTITUDE-1 patients (pts) with relapsed/refractory multiple myeloma (RRMM)Tuesday, June 311:57 a.m.-12:09 p.m. CDTOral Presentation7515Minimal residual disease (MRD) negativity (neg) in patients (pts) with relapsed or refractory multiple myeloma (RRMM) treated with belantamab mafodotin plus pomalidomide and dexamethasone (BPd) vs pomalidomide, bortezomib, and dexamethasone (PVd): Analysis from the DREAMM-8 trialMonday, June 29-9:06 a.m. CDTOral Presentation7516Daratumumab plus bortezomib, lenalidomide, and dexamethasone (DVRd) in patients with newly diagnosed multiple myeloma (NDMM): Subgroup analysis of transplant-ineligible (TIE) patients in the phase 3 CEPHEUS studyMonday, June 29:06-9:12 a.m. CDTASCO Oral Presentation7517*Isatuximab, bortezomib, lenalidomide, and dexamethasone (Isa-VRd) in newly diagnosed multiple myeloma (NDMM): Outcomes in patients with 1q21+ status in the phase 3 IMROZ studyMonday, June 29:12-9:18 a.m. CDTPoster Presentation7529Daratumumab + bortezomib, lenalidomide, and dexamethasone (DVRd) vs VRd in transplant-ineligible (TIE)/transplant-deferred (TD) newly diagnosed multiple myeloma (NDMM): Phase 3 CEPHEUS trial cytogenetic subgroup analysisSunday, June 19 a.m.-12 p.m. CDTPoster Presentation7535Carfilzomib, lenalidomide, and dexamethasone (KRd) as maintenance therapy after autologous stem-cell transplantation (ASCT) in patients with newly diagnosed multiple myeloma (NDMM)Sunday, June 19 a.m.-12 p.m. CDTASCO Poster Presentation7551*Positron emission tomography with computed tomography (PET/CT) and minimal residual disease (MRD) for efficacy assessment in transplant-ineligible newly diagnosed myeloma (Ti NDMM) patients (pts): IMROZ analysisSunday, June 19 a.m.-12 p.m. CDT Data to be presented at EHA: Presentation Type and NumberTitlePresentation TimingB-Cell Acute Lymphoblastic LeukemiaOral PresentationS112Safety and efficacy of single-agent subcutaneous blinatumomab in adults with relapsed/refractory (R/R) b-cell acute lymphoblastic leukemia (B-ALL): results from a phase 1/2 dose expansion studySunday, June 1511:30-11:45 a.m. CESTOral PresentationS117Safety and efficacy of AZD0486 in adolescent and adult patients with relapsed or refractory b-cell acute lymphoblastic leukemia: early results from the phase 1/2 SYRUS studyFriday, June 135:30-5:45 p.m. CESTPoster PresentationPF372Donor-derived, allogeneic CD19/CD22-CAR T cells with myeloablative graft-engineered Allo-HCT for high-risk B-ALLFriday, June 136:30 p.m. CESTChronic Lymphocytic LeukemiaPoster PresentationPF575Preliminary results of the ongoing multicenter, phase 2 study of retreatment with venetoclax plus obinutuzumab (ReVenG) in patients with recurrent chronic lymphocytic leukemia (CLL)Friday, June 136:30 p.m. CESTPoster PresentationPS1568Using minimal residual disease status to guide venetoclax treatment duration in patients with chronic lymphocytic leukemia: interim results from the phase II VENETOSTOP studySaturday, June 146:30 p.m. CESTFollicular LymphomaPoster PresentationPF881Epcoritamab monotherapy demonstrates deep and durable responses at 3-year follow-up in patients with relapsed/refractory follicular lymphomaFriday, June 136:30 p.m. CESTPoster PresentationPS21504-year update of phase 2 ELARA trial: clinical outcomes of tisagenlecleucel in patients (pts) with high-risk relapsed/refractory follicular lymphoma (R/R FL)Saturday, June 146:30 p.m. CESTMantle Cell Lymphoma Poster PresentationPF882Minimal residual disease with bendamustine-rituximab with or without acalabrutinib in patients with previously untreated mantle cell lymphoma: results from the phase 3 ECHO trialFriday, June 136:30 p.m. CESTMultiple MyelomaOral PresentationS201Phase 2 registrational study of anitocabtagene autoleucel for relapsed and/or refractory multiple myeloma (RRMM): updated results from IMMAGINE-1Saturday, June 145:15-5:30 p.m. CESTOral PresentationS205*Minimal residual disease-driven strategy following isatuximab-carfilzomib-lenalidomide-dexamethasone induction in transplant-eligible newly diagnosed multiple myeloma: Primary endpoints of the phase 3 MIDAS trialSunday, June 1511:00-11:15 a.m. CESTOral Presentation S207*A randomized, multi-center study of carfilzomib, lenalidomide and dexamethasone (KRd) with or without daratumumab (D) for the treatment of patients with newly diagnosed multiple myeloma (NDMM): The ADVANCE clinical trialSunday, June 1511:30-11:45 a.m. CESTOral PresentationS208*Analysis of sustained MRD negativity in patients with newly diagnosed multiple myeloma treated with carfilzomib-lenalidomide-dexamethasone with or without isatuximab (phase III IsKia trial)Sunday, June 1511:45 a.m.-12 p.m. CESTPoster PresentationPF727Isa-vrd improves outcomes in high-risk (HR) newly diagnosed transplant-ineligible multiple myeloma (NDMM TI) using the IMS/IMWG consensus HR definition: results from the BENEFIT phase 3 trial (IFM 2020-05)Friday, June 136:30 p.m. CESTPoster Presentation PF729*Isatuximab, bortezomib, lenalidomide, and dexamethasone (Isa-VRd) in newly diagnosed multiple myeloma (NDMM): outcomes in patients with 1q21+ status in the phase 3 IMROZ studyFriday, June 136:30 p.m. CESTPoster PresentationPF750Isatuximab, bortezomib, lenalidomide, dexamethasone (Isa-VRd) in patients with transplant-ineligible (TI) newly diagnosed myeloma (NDMM) and plasmacytomas: IMROZ subgroup analysisFriday, June 136:30 p.m. CESTPoster PresentationPF754Interim analysis of MRD-guided maintenance therapy with belantamab mafodotin and lenalidomide after Auto-HCT in newly diagnosed multiple myelomaFriday, June 136:30 p.m. CESTPoster Presentation PS1722*Positron emission tomography with computed tomography and minimal residual disease for efficacy assessment in transplant-ineligible newly diagnosed myeloma patients: IMROZ analysisSaturday, June 146:30 p.m. CEST *Indicates data to be presented at both ASCO and EHA. About clonoSEQ clonoSEQ® is the first and only FDA-cleared in vitro diagnostic (IVD) test for detecting and tracking minimal (or measurable) residual disease (MRD) in patients with multiple myeloma (MM) or B-cell acute lymphoblastic leukemia (B-ALL) using bone marrow, and in patients with chronic lymphocytic leukemia (CLL) using blood or bone marrow. clonoSEQ is also available in diffuse large B-cell lymphoma (DLBCL), mantle cell lymphoma (MCL) and other lymphoid cancers and specimen types as a CLIA-validated laboratory developed test (LDT). clonoSEQ is covered by Medicare for MM, CLL, ALL, DLBCL and MCL. clonoSEQ identifies and quantifies DNA sequences in malignant cells—detecting one cancer cell in one million healthy cells—to help clinicians and researchers assess and monitor MRD with precision over time. It delivers standardized, sensitive results that inform treatment decisions, predict outcomes, and detect relapses earlier. clonoSEQ is CE-marked under the EU In Vitro Diagnostic Regulation (IVDR). For intended use details in the EU, see the instructions for use, available on request. To review the FDA-cleared uses of clonoSEQ, visit clonoSEQ.com/technical-summary. About Adaptive Biotechnologies Adaptive Biotechnologies ("we" or "our") is a commercial-stage biotechnology company focused on harnessing the inherent biology of the adaptive immune system to transform the diagnosis and treatment of disease. We believe the adaptive immune system is nature's most finely tuned diagnostic and therapeutic for most diseases, but the inability to decode it has prevented the medical community from fully leveraging its capabilities. Our proprietary immune medicine platform reveals and translates the massive genetics of the adaptive immune system with scale, precision and speed. We apply our platform to partner with biopharmaceutical companies, inform drug development, and develop clinical diagnostics across our two business areas: Minimal Residual Disease (MRD) and Immune Medicine. Our commercial products and clinical pipeline enable the diagnosis, monitoring, and treatment of diseases such as cancer, autoimmune disorders, and infectious diseases. Our goal is to develop and commercialize immune-driven clinical products tailored to each individual patient. Forward Looking Statements This press release contains forward-looking statements that are based on management's beliefs and assumptions and on information currently available to management. All statements contained in this release other than statements of historical fact are forward-looking statements, including statements regarding our ability to develop, commercialize and achieve market acceptance of our current and planned products and services, our research and development efforts, and other matters regarding our business strategies, use of capital, results of operations and financial position, and plans and objectives for future operations. In some cases, you can identify forward-looking statements by the words "may," "will," "could," "would," "should," "expect," "intend," "plan," "anticipate," "believe," "estimate," "predict," "project," "potential," "continue," "ongoing" or the negative of these terms or other comparable terminology, although not all forward-looking statements contain these words. These statements involve risks, uncertainties and other factors that may cause actual results, levels of activity, performance or achievements to be materially different from the information expressed or implied by these forward-looking statements. These risks, uncertainties and other factors are described under "Risk Factors," "Management's Discussion and Analysis of Financial Condition and Results of Operations" and elsewhere in the documents we file with the Securities and Exchange Commission from time to time. We caution you that forward-looking statements are based on a combination of facts and factors currently known by us and our projections regarding the future, about which we cannot be certain. As a result, the forward-looking statements may not prove to be accurate. The forward-looking statements in this press release represent our views as of the date hereof. We undertake no obligation to update any forward-looking statements for any reason, except as required by law. ADAPTIVE INVESTORS Karina Calzadilla, Vice President, Investor Relations and FP&A 201-396-1687 investors@adaptivebiotech.com ADAPTIVE MEDIAErica Jones, Associate Corporate Communications Director206-279-2423media@adaptivebiotech.com

Phase 2Phase 3Clinical ResultASCO

21 May 2025

·www.businesswire.com

InnoCare Announces the Approval of Minjuvi ® (Tafasitamab) in Combination with Lenalidomide for the treatment of Adult Patients with Relapsed or Refractory Diffuse Large B-Cell Lymphoma in China

BEIJING--(BUSINESS WIRE)--InnoCare Pharma (HKEX: 09969; SSE: 688428), a leading biopharmaceutical company focusing on the treatment of cancer and autoimmune diseases, announced today that the China National Medical Products Administration (NMPA) has granted approval for Minjuvi® (tafasitamab), a humanized Fc-modified cytolytic CD19 targeting monoclonal antibody, 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). This is the first CD19 antibody approved for the treatment of relapsed or refractory DLBCL in China. Minjuvi® (tafasitamab) is the first CD19 antibody approved for the treatment of relapsed or refractory DLBCL in China. “The data from the Chinese clinical study of Minjuvi - similar to the data from the global L-MIND study – reaffirms the significant clinical benefits for DLBCL patients treated with the Minjuvi combination, particularly the notably prolonged duration of response (DOR),” said Professor Jie Jin from the First Affiliated Hospital, Zhejiang University School of Medicine. “The approval of Minjuvi is a crucial milestone for eligible patients with DLBCL in China, and we hope this innovative therapy will benefit patients.” “The durable responses and consistent safety profile observed in both the Chinese and global studies are encouraging and support the Minjuvi regimen as an effective option for patients with DLBCL,” said Professor Weili Zhao from Shanghai Ruijin Hospital. “We are pleased that the first prescription of the Minjuvi regimen was filled in China at Ruijin Hainan Hospital for an eligible DLBCL patient under the early access program in Bo’ao. Looking ahead, we hope that more eligible patients with DLBCL will benefit from this novel therapy.” Dr. Jasmine Cui, Co-founder, Chairwoman and CEO of InnoCare, said, “Today's approval marks another important milestone for InnoCare as we will celebrate our 10th anniversary this year. I would like to extend my sincere gratitude to all the physicians, patients, partners and employees who have contributed to this achievement. DLBCL is the most common form of non-Hodgkin lymphoma globally, and there are significant unmet needs among patients with DLBCL in China. We believe the Minjuvi regimen will provide a novel therapeutic option to patients with DLBCL in China.” Tafasitamab, a humanized Fc-modified cytolytic CD19-targeting immunotherapy, in combination with lenalidomide, has already been approved for the treatment of eligible DLBCL patients in the region of Hong Kong, Macau and Taiwan. Furthermore, under the early access program in the Bo’ao Lecheng International Medical Tourism Pilot Zone and the Guangdong-Hong Kong-Macao Greater Bay Area, prescriptions of tafasitamab in combination with lenalidomide have been issued at Ruijin Hainan Hospital and Guangdong Clifford Hospital for eligible DLBCL patients. Tafasitamab is approved under accelerated approval by the U.S. Food and Drug Administration (FDA), and conditionally approved by the European Medicines Agency (EMA), in combination with lenalidomide for the treatment of relapsed or refractory DLBCL adult patients who are not eligible for ASCT. DLBCL is the most common type of non-Hodgkin lymphoma (NHL), and its incidence accounts for 31% to 34% of NHL globally. In China, DLBCL accounts for 45.8% of all NHL cases1. About Tafasitamab Tafasitamab is a humanized Fc-modified cytolytic CD19 targeting monoclonal antibody. Tafasitamab incorporates an 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). MorphoSys and Incyte entered into: (a) in January 2020, a collaboration and licensing agreement to develop and commercialize tafasitamab globally; and (b) in February 2024, an agreement whereby Incyte obtained exclusive rights to develop and commercialize tafasitamab globally. In August 2021, Incyte entered into a collaboration and license agreement with InnoCare for the development and exclusive commercialization of tafasitamab in hematology and oncology in Greater China. In the United States, Monjuvi® (tafasitamab-cxix) received accelerated approval by the U.S. Food and Drug Administration in combination with lenalidomide for the treatment of adult patients with relapsed or refractory 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 Authorization from the European Medicines Agency 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). Monjuvi, Minjuvi, the Minjuvi and Monjuvi logos and the “triangle” design are registered trademarks of Incyte. 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. InnoCare Forward-looking Statements This 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. 1 Hematology Branch of Chinese Medical Association

ImmunotherapyDrug ApprovalLicense out/inAccelerated ApprovalCell Therapy

16 May 2025

·www.biospace.com

Incyte’s PD-1 Blocker Wins First-Line Anal Cancer Approval

iStock, Bo Shen The FDA also approved the use of Zynyz as a monotherapy for patients with squamous cell carcinoma of the anal canal who are intolerant to platinum chemotherapy or whose disease has progressed. Incyte on Thursday successfully expanded the label of its cancer therapy Zynyz, opening up its use as a first-line therapy for patients with squamous cell carcinoma of the anal canal. Zynyz, first approved in 2023 for metastatic, recurrent or locally advanced Merkel cell carcinoma, is an intravenous PD-1 inhibitor that forms a substantial part of Incyte’s cancer portfolio. In an April 29 note to investors, in reaction to the company’s Q1 results, analysts at Truist noted that Zynyz—alongside the lymphoma drug Monjuvi—will help account for the company’s 2025 oncology sales forecast of $415 million to $455 million. Thursday’s approval covers the use of Zynyz in combination with carboplatin and paclitaxel as a frontline treatment option for patients with inoperable locally recurrent or metastatic squamous cell carcinoma of the anal canal (SCAC). The FDA also signed off on Zynyz as a monotherapy for patients whose disease has progressed or who are otherwise intolerant to platinum-based chemotherapy. The expansion snatched victory from the jaws of defeat, as the FDA rejected Zynyz in SCAC in 2021. In a note Friday morning, Leerink Partners wrote that “Zynyz + chemo demonstrated a clear benefit over 1L standard of care carboplatin–paclitaxel...likely helping to dispel former FDA concerns on the efficacy profile.” The approval is a “pivotal moment” for the SCAC space, CEO Hervé Hoppenot said, “bringing effective combination and monotherapy treatment options.” Zynyz is the first PD-1 blocker in the U.S. to be approved for the indication, according to Hoppenot. Backing Zynyz’s approval are data from the Phase III POD1UM-303 trial. Incyte presented results from this study at the September 2024 European Society of Medical Oncology (ESMO) meeting, touting a 37% reduction in the risk of disease progression or death in patients treated with Zynyz plus a platinum-based chemotherapy regimen versus chemotherapy alone. Incyte at the time called this effect “clinically meaningful.” The ESMO readout also demonstrated improvements in overall survival and overall response rates in patients treated with the Zynyz combo. Incyte is also seeking approval for Zynyz in SCAC in the European Union and Japan. Zynyz’s label expansion comes weeks after Incyte announced Q1 earnings that William Blair labeled “solid” in an April 29 note. The company made $1.053 billion in the quarter, a 20% year-on-year increase and a comfortable beat over the $990 million consensus expectation. Jakafi, a kinase inhibitor, remained Incyte’s strongest asset. The drug brought in $709 million in Q1, which surpassed the $643 analyst estimate. With this strong start to the year, the company raised its full-year guidance for the drug from $2.95 billion to $3 billion. Incyte’s heavy reliance on Jakafi, however, is double-edged, according to William Blair. “While we believe that Jakafi remains the best-in-class therapy in some approved indications, there is emerging competition and potential for a novel therapy to take market share,” the analysts wrote. Competition and impending loss of exclusivity—key patents are expected to expire in late 2028—are “ongoing concerns,” as per William Blair.

Drug ApprovalPhase 3Clinical ResultASCOAccelerated Approval

100 Deals associated with Tafasitamab-Cxix

External Link

KEGG	Wiki	ATC	Drug Bank
-	-	L01XC	DB15044

R&D Status

Approved

10 top approved records.

to view more data

Indication	Country/Location	Organization	Date
Diffuse large B-cell lymphoma recurrent	Canada	Incyte Corp.	19 Aug 2021
Diffuse large B-cell lymphoma refractory	Canada	Incyte Corp.	19 Aug 2021
Diffuse Large B-Cell Lymphoma	United States	MorphoSys AG	31 Jul 2020

Developing

10 top R&D records.

to view more data

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

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT05788289 (CTgov)	Phase 2	Mantle cell lymphoma refractory	4	Lenalidomide+Tafasitamab	zlxsksiaao = glykfhxtrj cprlriogqv (emnrprlsdd, ucfzudtnth - rolfchpatk) View more	-	20 Apr 2025
NCT04680052 (inMIND, ASH2024) Manual	Phase 3	Follicular Lymphoma	548	Tafasitamab + Lenalidomide + Rituximab	opqnrccvlm(bmhifhtbtd) = ufnwkmytvq tgmrxxlaep (veoqqnmpwi ) View more	Positive	10 Dec 2024
				Placebo + Lenalidomide + Rituximab	opqnrccvlm(bmhifhtbtd) = bjgzjcfaai tgmrxxlaep (veoqqnmpwi ) View more
ASH2024	Not Applicable	Diffuse large B-cell lymphoma recurrent	-	Tafasitamab + Lenalidomide	cxhcvyvhkn(vigpweqbzj) = twoqytqgmu bsslmyzixu (uqbivxfrmp, 1 - 3+)	-	08 Dec 2024
				Tafasitamab (Real-World Setting)	cxhcvyvhkn(vigpweqbzj) = isalsgnjsp bsslmyzixu (uqbivxfrmp, 1 - 3+)
NCT04134936 (FIRST-MIND, CTgov)	Phase 1	Diffuse Large B-Cell Lymphoma	66	Tafasitamab (Arm A)	akjirwuwfa = lqwuwwxsqn uppwuerjeo (kxvjdztznu, qvjcrvbfoh - rulgjngmzu) View more	-	16 Oct 2024
				lenalidomide+Tafasitamab (Arm B)	akjirwuwfa = ejmzhdaaez uppwuerjeo (kxvjdztznu, utdklnayjj - buvjwftfie) View more
SOHO2024	Not Applicable	Diffuse large B-cell lymphoma recurrent	-	Tafasitamab (Primary Refractory DLBCL)	edefntlkam(wrbaywruvc) = atslllrgrh avjifrfbvr (jkycfalkyx, 47.8 - 75.6)	-	04 Sep 2024
				Tafasitamab (Nonprimary Refractory DLBCL)	edefntlkam(wrbaywruvc) = zffcyxrzue avjifrfbvr (jkycfalkyx, 65.6 - 80.6)
NCT05552937 (ICP-CL-00901, EHA2024) Manual	Phase 2	Diffuse Large B-Cell Lymphoma	52	Tafasitamab cLenalidomide Lenalidomide	expbmpnswb(whisgjjyrs) = muuayzliic katwzvwtyw (btshvihpui, 52.9 - 79.7) View more	Positive	14 May 2024
NCT05429268 (firmMIND, EHA2024)	Phase 2	Diffuse Large B-Cell Lymphoma CD19+	6	Tafasitamab	mlsbyjsodf(zitudipova) = bqawdxjqqu jquvmrzdch (pixeubzgtq )	Positive	14 May 2024
				Placebo	mlsbyjsodf(zitudipova) = irlbnetlhg jquvmrzdch (pixeubzgtq )
NCT02399085 (L-MIND, EHA2024)	Phase 2	Diffuse Large B-Cell Lymphoma	-	Tafasitamab-lenalidomide (T/L)	ejhqhhkucx(trlhlvpkgs) = sbkiitkdsn bfisbegihd (zjvefpyzuj ) View more	Positive	14 May 2024
L-MIND trial (EHA2024)	Phase 2	Diffuse Large B-Cell Lymphoma CD19	181	Tafasitamab + Lenalidomide	wlknjuoayj(zucfmuhwul) = yoqffeqoul alboxfjnrt (entajdvphm, 13 - 24) View more	Positive	14 May 2024
EarlyMIND (EHA2024)	Not Applicable	Large B-cell lymphoma	214	Tafasitamab and lenalidomide combination therapy (TL)	widpcjjafy(hmwrztswma) = najeuzovht wygzjwugms (ttixpiigya, 39.4 - 54.2) View more	Positive	14 May 2024
				Tafasitamab-Lenalidomide (Cohort A)	widpcjjafy(hmwrztswma) = yjocphedsu wygzjwugms (ttixpiigya, 40.6 - 60.4) View more

Translational Medicine

Boost your research with our translational medicine data.

view full example data

Deal

Boost your decision using our deal data.

view full example data

Core Patent

Boost your research with our Core Patent data.

view full example data

Clinical Trial

Identify the latest clinical trials across global registries.

view full example data

Approval

Accelerate your research with the latest regulatory approval information.

view full example data

Biosimilar

Competitive landscape of biosimilars in different countries/locations. Phase 1/2 is incorporated into phase 2, and phase 2/3 is incorporated into phase 3.

view full example data

Regulation

Understand key drug designations in just a few clicks with Synapse.

view full example data

AI Agents Built for Biopharma Breakthroughs

Accelerate discovery. Empower decisions. Transform outcomes.

Get started for free today!

Accelerate Strategic R&D decision making with Synapse, PatSnap’s AI-powered Connected Innovation Intelligence Platform Built for Life Sciences Professionals.

Start your data trial now!

Synapse data is also accessible to external entities via APIs or data packages. Empower better decisions with the latest in pharmaceutical intelligence.

Bio

Bio Sequences Search & Analysis

Chemical

Chemical Structures Search & Analysis