Monjuvi (tafasitamab-cxix) / Xencor, Incyte, InnoCare, Knight Therap, Specialised Therap - LARVOL DELTA

Knight Therapeutics Announces Regulatory Supplemental Submission of MINJUVI (tafasitamab) for Follicular Lymphoma in Brazil (GlobeNewswire) - "Knight Therapeutics...has submitted a supplemental application to ANVISA, the Brazilian health regulatory agency, seeking approval for an additional indication for MINJUVI (tafasitamab) in combination with rituximab and lenalidomide for the treatment of adult patients with previously treated follicular lymphoma (FL). The supplemental application for the additional indication was selected for review under Project Orbis....'We look forward to continuing to work towards regulatory submissions in additional countries in Latin America over the next months'....The submission is based on the results from the pivotal Phase 3 inMIND trial, a double-blind, placebo-controlled trial randomizing 548 patients with relapsed or refractory FL to receive tafasitamab or placebo with lenalidomide and rituximab."

Filing • Project Orbis • Follicular Lymphoma

Efficacy and Safety of Tafasitamab Combined with Lenalidomide in Patients with Diffuse Large B-Cell Lymphoma: A Matched-Adjusted Indirect Comparison Based on a Global Trial (ESMO 2025) - No abstract available

Clinical • B Cell Lymphoma • Diffuse Large B Cell Lymphoma • Hematological Malignancies • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology

Incyte...Provides Updates on Key Clinical Programs (Businesswire) - "The Phase 1 data in patients with myelofibrosis (MF) as monotherapy and in combination with ruxolitinib are anticipated in the second half of 2025...A Phase 1 study evaluating JAK2V617Fi in MPNs is ongoing. Initial proof of concept data are anticipated in the first half of 2026...Incyte plans to initiate Phase 3 studies for its potentially first-in-class CDK2 inhibitor (INCB123667), in ovarian cancer in 2025 and is also evaluating INCB123667 in combination with other treatments; The Phase 3 study evaluating tafasitamab as first-line treatment for diffuse large B-cell lymphoma (DLBCL) is ongoing. The Phase 3 data are anticipated in the second half of 2025; The Phase 1 studies evaluating KRASG12D and TGFßR2×PD-1 in solid tumors are ongoing. Initial proof of concept data for both studies are anticipated in the second half of 2025."

Clinical data • New P3 trial • Diffuse Large B Cell Lymphoma • Myelofibrosis • Myeloproliferative Neoplasm • Ovarian Cancer • Solid Tumor

CC-99282-NHL-001: A Safety and Preliminary Efficacy Study of CC-99282, Alone and in Combination With Anti-lymphoma Agents in Participants With Relapsed or Refractory Non-Hodgkin Lymphomas (R/R NHL) (clinicaltrials.gov) - P1/2 | N=438 | Active, not recruiting | Sponsor: Celgene | Recruiting ➔ Active, not recruiting | Trial completion date: Apr 2027 ➔ Feb 2028 | Trial primary completion date: Apr 2026 ➔ Apr 2027

Enrollment closed • Trial completion date • Trial primary completion date • Diffuse Large B Cell Lymphoma • Hematological Malignancies • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology

MONJUVI + Rituximab & Lenalidomide: The First and Only CD19- and CD20-targeted Immunotherapy Combination Approved for 2L+ Follicular Lymphoma Patients (SOHO 2025) - "This activity is sponsored by Incyte"

Clinical • Follicular Lymphoma • Hematological Malignancies • Lymphoma • Oncology

TAFASITAMAB PLUS LENALIDOMIDE AS SALVAGE THERAPY IN DIFFUSE LARGE B-CELL LYMPHOMA: REAL-WORLD EXPERIENCE FROM GELTAMO. (PubMed, Blood Adv) - "In summary, T/L is both well-tolerated and effective, irrespective of age or comorbidities. Our findings provide valuable insights into the real-world application of T/L and reinforce its role as a key treatment option for patients with R/R DLBCL."

Journal • Real-world evidence • B Cell Lymphoma • Diffuse Large B Cell Lymphoma • Hematological Malignancies • High-grade B-cell lymphoma • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology

HM2023-43:Ph 2 Trial of Tafasitamab With Lenalidomide+Rituximab in Treatment-naive FL and MZL (clinicaltrials.gov) - P2 | N=65 | Not yet recruiting | Sponsor: Masonic Cancer Center, University of Minnesota | Initiation date: Jul 2025 ➔ Oct 2025

Trial initiation date • Follicular Lymphoma • Hematological Malignancies • Lymphoma • Marginal Zone Lymphoma • Oncology

J-MIND: To Assess the Safety and Tolerability of Tafasitamab Alone or in Combination With Other Drugs in Japanese Participants With Non-Hodgkins Lymphoma (NHL) (clinicaltrials.gov) - P1/2 | N=72 | Active, not recruiting | Sponsor: Incyte Biosciences Japan GK | Recruiting ➔ Active, not recruiting | Trial completion date: Jul 2026 ➔ Dec 2026 | Trial primary completion date: May 2025 ➔ Dec 2026

Enrollment closed • Trial completion date • Trial primary completion date • B Cell Lymphoma • Diffuse Large B Cell Lymphoma • Hematological Malignancies • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology

Cytokine-induced memory-like NK cells combined with Tafasitamab demonstrate efficacy against B-cell acute lymphoblastic leukemia. (PubMed, Immunother Adv) - "In vivo, the combination of CIMLNK and TAFA led to a more pronounced survival benefit in leukemia-bearing mice. In summary, our findings suggest that this combination holds promise as a potential alternative treatment option for patients with relapsed refractory B-ALL."

Journal • Acute Lymphocytic Leukemia • Acute Myelogenous Leukemia • B Acute Lymphoblastic Leukemia • Hematological Malignancies • Leukemia • Oncology • IFNG • IL12A • IL15 • IL18

Follicular Lymphoma: Current Therapeutic Landscape and Future Prospects (ICML 2025) - P3 | "The ability of maintenance rituximab, obinutuzumab induction, or bendamustine-based induction to lower early progression rates without affecting OS or HT rate [10, 12, 18] suggests that not all POD24 cases are equal, with a subset remaining resistant to current treatments...Since 2021, three CAR-T constructs—axicabtagene-ciloleucel (axi-cel), tisagenlecleucel (tisa-cel), and lisocabtagene maraleucel (liso-cel)—and three CD3 × CD20 BsAbs—mosunetuzumab, epcoritamab, and odronextamab—have gained regulatory approval in Europe and/or US as options for third line and later...Loncastuximab tesirine (CD19-directed ADC) shows promising activity in 2L+ R/R FL (CR 67%, manageable toxicity in a small Phase 2 cohort) [40]. Adding tafasitamab, an anti-CD19 antibody, to R2 in R/R FL patients improved PFS by 57% in the inMIND trial after a median follow-up of 14 months [41]...However, the ROSEWOOD trial showed obinutuzumab-zanubrutinib was superior to Obinutuzumab alone..."

IO biomarker • B Cell Lymphoma • Follicular Lymphoma • Hematological Malignancies • Large B Cell Lymphoma • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • T Cell Non-Hodgkin Lymphoma • EZH2 • IGH

T-Cell Redirecting Strategies in Large B-Cell Lymphoma and Follicular Lymphoma (ICML 2025) - "The randomized STARGLO trial compared the combination of glofitamab with gemcitabine and oxaliplatin (GemOx) versus rituximab-GemOx, meeting its primary endpoint of OS in favor of the experimental arm (HR 0.62 [95% CI 0.43–0.88])...Other treatment options to consider in this R/R patient population are tafasitamab/lenalidomide [107], loncastuximab tesirine [108] and rituximab-bendamustine-polatuzumab [109], amongst others...Three CAR-T constructs are available based on Phase 2, single-arm trials, namely ZUMA-5 (axi-cel), ELARA (tisa-cel), and TRANSCEND-FL (liso-cel)...Mosunetuzumab, epcoritamab and odronextamab received regulatory approval (U.S...She started treatment with a bispecific antibody, aiming to carry out her first imaging assessment after three cycles. Permission to Reproduce Material From Other Sources The author has nothing to report."

IO biomarker • B Cell Lymphoma • Diffuse Large B Cell Lymphoma • Follicular Lymphoma • Hematological Malignancies • High-grade B-cell lymphoma • Large B Cell Lymphoma • Lymphoma • Mediastinal B Cell Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • Primary Mediastinal Large B-Cell Lymphoma • T Cell Histiocyte Rich Large B Cell Lymphoma • T Cell Non-Hodgkin Lymphoma • CD19

Bypassing the immunosuppressive effects of CA125/MUC16 via re-engineered rituximab (NAV-006) to improve its antitumor activity in vivo. (PubMed, Antib Ther) - "Additionally, CA125/MUC16 bound to newer antibody-based lymphoma treatment agents, including obinutuzumab and tafasitamab, suppressing their immune effector functions. Bispecific antibodies mosunetuzumab and glofitamab also exhibited reduced cytotoxicity in the presence of CA125/MUC16. These findings suggest that NAV-006 could improve therapeutic efficacy in B-cell lymphomas, particularly in patients with elevated CA125/MUC16 levels."

Journal • Preclinical • B Cell Lymphoma • Follicular Lymphoma • Hematological Malignancies • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • MUC16

Chemotherapy (DA-EPOCH+/-R) and Targeted Therapy (Tafasitamab) for the Treatment of Newly-Diagnosed Philadelphia Chromosome Negative B Acute Lymphoblastic Leukemia (clinicaltrials.gov) - P2 | N=30 | Recruiting | Sponsor: University of Washington | Trial completion date: Sep 2030 ➔ Mar 2031 | Trial primary completion date: Sep 2025 ➔ Mar 2026

Trial completion date • Trial primary completion date • Acute Lymphocytic Leukemia • B Acute Lymphoblastic Leukemia • Hematological Malignancies • Leukemia • Lymphoma • Oncology

Effects of Maplirpacept (PF-07901801),Tafasitamab, and Lenalidomide in People With Relapsed or Refractory Diffuse Large B-cell Lymphoma (clinicaltrials.gov) - P2 | N=6 | Terminated | Sponsor: Pfizer | Phase classification: P1/2 ➔ P2 | Active, not recruiting ➔ Terminated; The trial terminated due to the inability to recruit the planned number of subjects. The decision was not based on any safety and/or efficacy concerns

Phase classification • Trial termination • B Cell Lymphoma • Diffuse Large B Cell Lymphoma • Hematological Malignancies • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • Transplantation

TAFASITAMAB (TAFA) PLUS LENALIDOMIDE (LEN) AND RITUXIMAB (R) FOR PATIENTS WITH RELAPSED OR REFRACTORY FOLLICULAR LYMPHOMA (R/R FL): RESULTS FROM THE PHASE 3 INMIND STUDY (EHA 2025) - P3 | "Tafa added to len+R resulted in significant and clinically meaningful improvement in PFS, representing a 57% reduction in risk of progression, relapse, or death in pts with R/R FL; benefit was observed in all subgroups analysed. Although OS data are immature, a trend favouring tafa was observed. The safety profile was manageable and consistent with expected toxicities."

Clinical • P3 data • Diffuse Large B Cell Lymphoma • Follicular Lymphoma • Hematological Disorders • Hematological Malignancies • Lymphoma • Marginal Zone Lymphoma • Neutropenia • Oncology

Heavily Pretreated Refractory Diffuse Large B-Cell Lymphoma Successfully Treated with Epcoritamab: Case Report. (PubMed, Case Rep Oncol) - "He then received dose-adjusted etoposide, prednisone, vincristine, cyclophosphamide, and doxorubicin (DA-EPOCH) followed by high-dose methotrexate and initially responded but relapsed several months later. As the patient was not a candidate for transplant, subsequent treatment rounds included rituximab, gemcitabine, dexamethasone, and cisplatin (R-GDP) and CD19 CAR T-cell therapy; tafasitamab-cxix and lenalidomide; and polatuzumab vedotin plus bendamustine and rituximab (pola-BR)...Within approximately 1 month, he could resume treatment, achieving a Deauville score of 1 approximately 3 months after beginning epcoritamab, and continues follow-up nearly 2 years later. T-cell engager therapies, such as epcoritamab, can play a role in managing patients with refractory DLBCL, including those refractory to CAR T-cell therapy."

Journal • B Cell Lymphoma • Diffuse Large B Cell Lymphoma • Hematological Malignancies • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • Transplantation • BCL6 • CD20

POST HOC ANALYSIS OF OUTCOMES BY POD24 STATUS FROM THE inMIND STUDY OF TAFASITAMAB PLUS LENALIDOMIDE AND RITUXIMAB IN RELAPSED OR REFRACTORY FOLLICULAR LYMPHOMA (ICML 2025) - P3 | "POD24 is a known predictor of early mortality in FL. In inMIND, tafa+len+R reduced the risk of progression, relapse or death in patients with R/R FL regardless of POD24 status and the definition of POD24 used. Benefit of adding tafa was also observed regardless of POD12 status, and in other outcomes including PET-CR, ORR and TTNT."

Retrospective data • Follicular Lymphoma • Hematological Malignancies • Lymphoma • Oncology

VERLen: TAFASITAMAB, LENALINOMIDE, PLUS RITUXIMAB IN FRONTLINE DIFFUSE LARGE B-CELL LYMPHOMA PATIENTS OVER 80 Y/O OR OLDER, A LYSA PHASE 2 TRIAL (ICML 2025) - P2 | "VERLen (NCT04974216) was a multicenter phase II study that evaluated efficacy and safety of tafasitamab, lenalidomide and rituximab (TLR) in treatment naive DLBCL patients over 80y. Patients ≥ 80 y.o. with newly diagnosed DLBCL (WHO2017 classification, all subtypes, IPI or stage) and deemed able to receive R-miniCHOP regimen (according to investigator) were eligible... The VERLen study reached its endpoint and underlines the interest of theTLR combination in ≥ 80 y.o. patients with newly diagnosed DLBCL. As a chemo-free combination, TLR appears as an interesting alternative to chemotherapy, but toxicities do occur. Taken together, our results support further investigations of the TLR regimen and show that prospective trial in very elderly patients is feasible and needed to better design SOC."

Clinical • P2 data • B Cell Lymphoma • Diffuse Large B Cell Lymphoma • Hematological Malignancies • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • CD20

A Cost-Effectiveness Analysis of Diffuse Large B-Cell Lymphoma Treatment Pathways in the United States. (PubMed, MDM Policy Pract) - "Simulated patients received 2L axi-cel followed by 3L treatments, which were compared with treatment sequences of 2L intended autologous stem cell transplant (ASCT), polatuzumab vedotin with bendamustine and rituximab (Pola-BR), tafasitamab with lenalidomide (tafa-len), or rituximab with gemcitabine and oxaliplatin (R-GemOx), all of which were followed by 3L treatments (salvage chemotherapy, BsAbs, or axi-cel). In addition, axi-cel was compared directly with glofitamab and epcoritamab in 3L...The findings of the study suggest that although other treatments were cost-effective at lower thresholds, axi-cel is a cost-effective treatment option in 2L/3L settings in the United States. This study investigated whether axicabtagene ciloleucel (axi-cel) is cost-effective in second-line (2L) and third-line (3L) treatment sequences in the current relapsed or refractory (R/R) diffuse large B-cell lymphoma (DLBCL) treatment paradigm.Using a novel treatment sequencing model, axi-cel..."

HEOR • Journal • B Cell Lymphoma • Diffuse Large B Cell Lymphoma • Hematological Malignancies • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • Transplantation

TAFASITAMAB PLUS LENALIDOMIDE AND RITUXIMAB IN RELAPSED OR REFRACTORY FOLLICULAR LYMPHOMA: A POST HOC ANALYSIS OF OUTCOMES BY POD24 STATUS FROM THE INMIND STUDY (EHA 2025) - P3 | "In inMIND, tafa+len+R reduced the risk of progression, relapse, or death in patients with R/R FL regardless of POD24 status and the definition of POD24 used; benefit in PET-CR, ORR, and TTNT was also observed. As POD24 is a known predictor of early mortality in FL, tafa+len+R has the potential to improve outcomes in this high-risk population."

Retrospective data • Follicular Lymphoma • Hematological Malignancies • Lymphoma • Oncology

MATCHING-ADJUSTED INDIRECT COMPARISON OF EPCORITAMAB WITH RITUXIMAB + LENALIDOMIDE VS TAFASITAMAB WITH RITUXIMAB + LENALIDOMIDE IN SECOND-LINE+ FOLLICULAR LYMPHOMA (EHA 2025) - P1/2, P3 | "Findings from this MAIC highlight the potential of epcor + R2 to deliver improved ORR, CR, and PFS compared with tafasitamab + R2 in 2L+ FL."

Clinical • Follicular Lymphoma • Hematological Malignancies • Lymphoma • Oncology

CD19 EXPRESSION IS RETAINED IN PATIENTS WITH RELAPSED/REFRACTORY FOLLICULAR OR MARGINAL ZONE LYMPHOMA AFTER RECEIVING TAFASITAMAB, LENALIDOMIDE AND RITUXIMAB IN THE INMIND STUDY (EHA 2025) - P3 | "In these pts with R/R FL or MZL enrolled in inMIND, biopsy analyses and CD19 sequencing suggest that the CD19 antigen is preserved on tumor cells following tafa+L+R. Neither CD19 nor CD20 expression alone or in combination correlated with response to tafa+L+R."

Clinical • IO biomarker • B Cell Lymphoma • Diffuse Large B Cell Lymphoma • Follicular Lymphoma • Hematological Malignancies • Lymphoma • Marginal Zone Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • CD19

ONGOING TRIAL: A PHASE I/II STUDY OF TAFASITAMAB PLUS LENALIDOMIDE IN PATIENTS WITH RELAPSED CENTRAL NERVOUS SYSTEM LYMPHOMA (ICML 2025) - P1/2 | "Finally we noted that tafasitamab plus lenalidomide induces regressions of brain parenchymal lesions and functional improvement in consecutive CNSL patients with disease refractory to lenalidomide, pomalidomide and rituximab (British Journal of Haematology 2023 201(1):154–157). Patients with prior exposure to lenalidomide or pomalidomide or concomitant systemic lymphoma are allowed. Patients with HIV infection, CNS PTLD, and those who previously received a CD19-targeting CAR-T product are ineligible."

Clinical • IO biomarker • P1/2 data • CNS Lymphoma • Hematological Malignancies • Lymphoma • Oncology • Primary Central Nervous System Lymphoma • Secondary Central Nervous System Lymphoma • CD19 • IL10

MATCHING-ADJUSTED INDIRECT COMPARISON OF EPCORITAMAB WITH RITUXIMAB + LENALIDOMIDE VERSUS TAFASITAMAB WITH RITUXIMAB + LENALIDOMIDE IN SECOND-LINE + FOLLICULAR LYMPHOMA (ICML 2025) - P1/2 | "Findings from this MAIC highlight the potential of epcor+R2 to deliver improved ORR, CR, and PFS compared with tafa+R2 in 2L+ FL."

Clinical • Follicular Lymphoma • Hematological Malignancies • Lymphoma • Oncology

BRIDGING TO CAR-T CELL THERAPY IN LARGE B-CELL LYMPHOMA WITH EITHER CONVENTIONAL THERAPY OR THE CD3xCD20 BISPECIFIC ANTIBODY GLOFITAMAB (ICML 2025) - "NoGLO-treatment consisted of rituximab-based immunochemotherapy (12/23, 52%), tafasitamab-lenalidomide (6/23, 26%), high dose melphalan (3/23, 13%), or ibrutinib (2/23, 9%). Despite small sample size and limited follow-up, our data suggest glofitamab as an effective and safe bridging prior to CAR-T cell therapy, potentially superior to conventional approaches. Data on molecular immune effects will be presented at the conference."

CAR T-Cell Therapy • B Cell Lymphoma • Hematological Malignancies • Large B Cell Lymphoma • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology