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

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) - No abstract available

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

Outcomes From the Phase 3 inMIND Study of Tafasitamab (Tafa) Plus Lenalidomide (Len) and Rituximab (R) for Patients With Relapsed/Refractory Follicular Lymphoma (R/R FL) (ICML 2025) - No abstract available

Clinical • P3 data • Follicular Lymphoma • Hematological Malignancies • Lymphoma • Oncology

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) - No abstract available

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

Ongoing Trial: A Phase I/II Study of Tafasitamab plus Lenalidomide in Patients with Relapsed Central Nervous System Lymphoma (ICML 2025) - No abstract available

Clinical • P1/2 data • CNS Lymphoma • Hematological Malignancies • Lymphoma • Oncology

PRO-MIND: Prospective Real-World Study of Tafasitamab Plus Lenalidomide in Relapsed or Refractory Diffuse Large B-cell Lymphoma in Italy – An Ongoing Trial (ICML 2025) - No abstract available

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

Matching-Adjusted Indirect Comparison of Epcoritamab With Rituximab + Lenalidomide vs Tafasitamab With Rituximab + Lenalidomide in Second-Line + Follicular Lymphoma (ICML 2025) - No abstract available

Clinical • Follicular Lymphoma • Hematological Malignancies • Lymphoma • Oncology

IELSG49: A Phase II trial of acalabrutinib in combination with tafasitamab in patients with previously treated marginal zone lymphomas (ICML 2025) - No abstract available

Clinical • Combination therapy • P2 data • Hematological Malignancies • Lymphoma • Marginal Zone Lymphoma • Oncology

Phase 1b/2 study of maplirpacept (PF-07901801), tafasitamab, and lenalidomide in transplant-ineligible relapsed/refractory diffuse large B cell lymphoma participants (ICML 2025) - No abstract available

P1/2 data • B Cell Lymphoma • Diffuse Large B Cell Lymphoma • Hematological Malignancies • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology

ARV-393, a PROTAC B-cell lymphoma 6 (BCL6) degrader, combined with biologics or small molecule inhibitors (SMIs) induces tumor regressions in diffuse large B-cell lymphoma (DLBCL) models (AACR 2025) - P1 | "For example, CREBBP/EP300 and BCL6 have opposing transcriptional activities and BCL6 degradation may prevent CD20 downregulation by restoring CREBBP/EP300 chromatin access, supporting combination with anti-CD20 biologics; cooperation of EZH2 with the BCL6 repressor complex supports combining with tazemetostat (taz). Thus, we assessed the activity of ARV-393 in combination with biologics or SMIs based on potential complementary mechanistic roles.ARV-393 was administered in combination with clinically relevant doses of the standard of care (SOC) biologics rituximab, tafasitamab (tafa) and polatuzumab to mice bearing SU-DHL-4 CDX, representing a high-grade B-cell lymphoma (HGBCL, with MYC, BCL2 and BCL6 rearrangements). ARV-393 was also combined with investigational SMIs of EZH2 (taz), BCL2 (venetoclax) and BTK (acalabrutinib), in HGBCL or aggressive CDX models SU-DHL-6 (EZH2mut), OCI-Ly1 (BCL2+) and activated B-cell (ABC)-like OCI-Ly10 (MYD88 mut),..."

B Cell Lymphoma • Diffuse Large B Cell Lymphoma • Hematological Malignancies • High-grade B-cell lymphoma • Lymphoma • Oncology • BCL2 • BCL6 • CREBBP • EP300 • MYC • MYD88

Initial 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). (ASCO 2025) - P2 | "Clinical Trial Registration Number: NCT05453500 The abstract will be released to the public on May 22, 2025 at 4:00 PM CDT"

Clinical • P2 data • Hematological Malignancies • Leukemia • Oncology

Incyte Reports 2025 First Quarter Financial Results and Provides Updates on Key Clinical Programs (Businesswire) - "The Phase 3 study evaluating tafasitamab as first-line treatment for 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 and enrolling patients. Initial proof of concept data for both studies are anticipated in the second half of 2025."

P1 data • P3 data • Diffuse Large B Cell Lymphoma • Solid Tumor

Cytokine-induced memory-like NK cells with tafasitamab show efficacy against B-cell acute lymphoblastic leukemia (AACR 2025) - "The combination of CIMLNK and TAFA exerts synergistic effects against B-ALL both in vitro and in vivo."

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

Study to Evaluate the Safety and Efficacy of Tafasitamab Plus Lenalidomide in Participants With Relapsed or Refractory Diffuse Large B-Cell Lymphoma (firmMIND) (clinicaltrials.gov) - P3 | N=82 | Active, not recruiting | Sponsor: Incyte Corporation | Recruiting ➔ Active, not recruiting | Trial completion date: Dec 2026 ➔ Apr 2027 | Trial primary completion date: Dec 2025 ➔ Apr 2026

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

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. (PubMed, J Med Econ) - "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). Across all sensitivity analyses, the inclusion of glofitamab had minimal PMPM budget impact, ranging from -$0.0256 to -$0.0108. 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."

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

Phase II MOR00208 in Combination With Lenalidomide for Patients With Relapsed or Refractory CLL, SLL or PLL or Older Patients With Untreated CLL, SLL or PLL (clinicaltrials.gov) - P2 | N=41 | Active, not recruiting | Sponsor: Ohio State University Comprehensive Cancer Center | Trial completion date: Dec 2024 ➔ Dec 2025

Trial completion date • Chronic Lymphocytic Leukemia • Hematological Malignancies • Leukemia • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • Prolymphocytic Leukemia • Richter's Syndrome • Small Lymphocytic Lymphoma • ZAP70

A PHASE I/II STUDY OF TAFASITAMAB FOR THE PREVENTION OF RELAPSE AFTER STEM CELL TRANSPLANTATION IN PEDIATRIC PATIENTS WITH ALL (EBMT 2025) - P1/2 | "The majority of patients had received prior immunotherapies, including blinatumomab (n=7), inotuzumab ozogamicin (n=3) and CAR-T cell therapies (n=5). Based on the available data, long-term outpatient use of tafasitamab at a dose of 12 mg/kg body weight appears to be safe and well tolerated in pediatric patients with ALL at highest risk of relapse. Whether treatment with tafasitamab reduces the risk of relapse as anticipated can only be assessed in the further course of the study. Clinical Trial Registry: Clinicaltrials.gov: NCT05366218"

Clinical • P1/2 data • Acute Lymphocytic Leukemia • Bone Marrow Transplantation • Hematological Malignancies • Infectious Disease • Leukemia • Oncology • Pediatrics • Transplantation

A PHASE I/II STUDY OF TAFASITAMAB FOR THE PREVENTION OF RELAPSE AFTER STEM CELL TRANSPLANTATION IN PEDIATRIC PATIENTS WITH ALL (EBMT 2025) - P1/2 | "The majority of patients had received prior immunotherapies, including blinatumomab (n=7), inotuzumab ozogamicin (n=3) and CAR-T cell therapies (n=5). Based on the available data, long-term outpatient use of tafasitamab at a dose of 12 mg/kg body weight appears to be safe and well tolerated in pediatric patients with ALL at highest risk of relapse. Whether treatment with tafasitamab reduces the risk of relapse as anticipated can only be assessed in the further course of the study. Clinical Trial Registry: Clinicaltrials.gov: NCT05366218"

Clinical • P1/2 data • Acute Lymphocytic Leukemia • Bone Marrow Transplantation • Hematological Malignancies • Infectious Disease • Leukemia • Oncology • Pediatrics • Transplantation

Synergistic activity of tafasitamab and metronomic chemotherapy on diffuse large B-cell lymphoma through inhibition of the AKT/mTOR signaling pathway. (PubMed, Sci Rep) - "Our study aims to enhance the direct, non-immune-mediated, activity of tafasitamab (TAFA) with the combination of metronomic chemotherapy (mCHEMO), including vinorelbine (mVNR) and etoposide (mETO), in preclinical models of diffuse large B-cell lymphoma (DLBCL). In vivo, the TAFA + mVNR combination was well tolerated, significantly reduced the volumes of subcutaneous DLBCL masses, and increased the overall survival of mice affected by systemic DLBCL. We report additional mechanisms to enhance the direct activity of TAFA with mCHEMO synergistically in DLBCL cells in vitro and in vivo, suggesting the use of this combination schedule into future clinical trials."

Journal • B Cell Lymphoma • Diffuse Large B Cell Lymphoma • Hematological Malignancies • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • ABCB1 • ABCG2 • MYC • RPS6 • TSC2

Synergistic activity of tafasitamab and metronomic chemotherapy on diffuse large B-cell lymphoma through inhibition of the AKT/mTOR signaling pathway (Nature) - "In all cell lines, the concomitant treatment with TAFA and mVNR or mETO showed a marked synergism, except for TAFA + mETO on SU-DHL10 cells. The TAFA + mCHEMO treatments promoted apoptosis, and the TAFA + mVNR combination significantly inhibited, already after 24 h, the phosphorylation of GSK3α/β, mTOR, p70S6K, RPS6, and TSC2 proteins in DLBCL cells. TAFA significantly increased the VNR and ETO intracellular concentrations in all DLBCL cells after 24 h, except for ETO levels in SU-DHL10...In vivo, the TAFA + mVNR combination was well tolerated, significantly reduced the volumes of subcutaneous DLBCL masses, and increased the overall survival of mice affected by systemic DLBCL."

Preclinical • Diffuse Large B Cell Lymphoma

Knight Therapeutics Reports Fourth Quarter and Year-End 2024 Results (GlobeNewswire) - "For the quarter ended December 31, 2024...Revenues from our key promoted products increased by $5,781 or 42% on a constant currency basis driven by the growth of Lenvima, Akynzeo, Trelstar and the launch of Minjuvi in Brazil...For the year ended December 31, 2024, the oncology/hematology portfolio increased by $26,211 or 23% of which $11,336 is due to the Hyperinflation Impact1. Excluding IAS 29, the oncology/hematology portfolio increased by $14,875 or 12%. Our key promoted brands grew by $23,831 or 49% on a constant currency2 basis driven by the growth of Lenvima, Akynzeo, Trelstar and the launch of Minjuvi in Brazil."

Commercial • Breast Cancer • Diffuse Large B Cell Lymphoma • Endocrine Cancer • Endometrial Cancer • Hepatocellular Cancer • Prostate Cancer • Renal Cell Carcinoma • Thyroid Gland Carcinoma • Urothelial Cancer • Uterine Cancer • Uterine Leiomyoma

Knight Therapeutics Announces Launch of Minjuvi (tafasitamab) in Mexico (GlobeNewswire) - "Knight Therapeutics Inc...announced today the launch of Minjuvi (tafasitamab) by its Mexican affiliate, Grupo Biotoscana de Especialidad S.A. de C.V....Minjuvi in combination with lenalidomide, followed by Minjuvi monotherapy, is indicated for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL), who are not eligible for autologous stem cell transplantation (ASCT)....The marketing authorization approval was based on the data from L-MIND trial..."

Launch non-US • Diffuse Large B Cell Lymphoma

Tafasitamab and Rituximab for Front-Line Treatment of Post-Transplant Lymphoproliferative Disorder (clinicaltrials.gov) - P2 | N=28 | Recruiting | Sponsor: Timothy Voorhees | Trial primary completion date: Dec 2024 ➔ Dec 2025

Trial primary completion date • Transplantation • CD19 • CD20 • CD4

Real-World Effectiveness of Chemoimmunotherapy and Novel Therapies for Patients With Relapsed/Refractory Aggressive Large B-Cell Lymphoma. (PubMed, Clin Lymphoma Myeloma Leuk) - "Patients with r/r LBCL have unfavorable outcomes and need more effective treatment alternatives."

Journal • Real-world evidence • B Cell Lymphoma • Hematological Malignancies • Large B Cell Lymphoma • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology

MINDway: Safety and Pharmacokinetics Study of a Modified Tafasitamab IV Dosing Regimen Combined With Lenalidomide in R-R DLBCL Patients (clinicaltrials.gov) - P1/2 | N=53 | Active, not recruiting | Sponsor: Incyte Corporation | Trial primary completion date: Nov 2024 ➔ Jul 2024

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

Tafasitamab in refractory diffuse large B-cell lymphoma with neurolymphomatosis. (PubMed, Ann Hematol) - "We report the case of an 88-year-old man with stage IVA DLBCL, who achieved the first complete response after six R-miniCHOP21 cycles. Treatment with tafasitamab and lenalidomide led to a complete morpho-metabolic remission and full neurological recovery, with minimal side effects. This case underscores for the very first time the efficacy and tolerability of this regimen in treating NL, highlighting its potential for frail patients unfit for more intensive therapies."

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