Truxima (rituximab-abbs) / Indukern, Teva, Mundipharma, Celltrion, Nippon Kayaku - LARVOL DELTA

Celltrion’s Rituxan biosimilar wins rare disease nod as Pfizer, Amgen land same-day OKs (Korea Biomedical Review) - "Celltrion just checked off a major box in its race to match Roche’s Rituxan (rituximab). On Wednesday U.S. time, the FDA approved Truxima for use in moderate to severe pemphigus vulgaris (PV), a rare autoimmune blistering disease, granting the Korean biosimilar maker its fifth adult indication for the CD20-targeting therapy....But Celltrion wasn’t the only winner. Pfizer and Amgen also scored approvals the same day for their Rituxan biosimilars, Ruxience and Riabni, respectively, in the PV indication."

FDA approval • Pemphigus Vulgaris

BEST-NMOSD: Rituximab Versus Ravulizumab, Inebilizumab, Satralizumab, and Eculizumab in NMOSD (clinicaltrials.gov) - P4 | N=160 | Not yet recruiting | Sponsor: Massachusetts General Hospital

New P4 trial • CNS Disorders • Neuromyelitis Optica Spectrum Disorder • Rare Diseases

Study for Patients With Hairy Cell Leukemia to Test the Targeted Agent Tovorafenib in Combination With Rituximab and Compare the Combination With Current Standard Treatment (clinicaltrials.gov) - P1/2 | N=78 | Not yet recruiting | Sponsor: National Cancer Institute (NCI) | Initiation date: Jun 2025 ➔ Sep 2025

Trial initiation date • Hairy Cell Leukemia • Hematological Malignancies • Leukemia • Oncology • BRAF

NCI-2017-01957: Testing the Addition of an Immunotherapy Agent, Atezolizumab, When Given With the Usual Chemo-Immunotherapy Drug Combination (Rituximab Plus Gemcitabine and Oxaliplatin) for Relapsed/Refractory (That Has Come Back or Not Responded to Treatment) Transformed Diffuse Large B-Cell Lymphoma (clinicaltrials.gov) - P1 | N=24 | Active, not recruiting | Sponsor: National Cancer Institute (NCI) | Trial completion date: Jun 2025 ➔ Jun 2026 | Trial primary completion date: Jun 2025 ➔ Jun 2026

Trial completion date • Trial primary completion date • B Cell Lymphoma • Chronic Lymphocytic Leukemia • Diffuse Large B Cell Lymphoma • Follicular Lymphoma • Hematological Malignancies • Indolent Lymphoma • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • Richter's Syndrome • CD4

Study of Palifermin (Kepivance) in Persons Undergoing Unrelated Donor Allogeneic Hematopoietic Cell Transplantation (clinicaltrials.gov) - P1/2 | N=34 | Completed | Sponsor: National Cancer Institute (NCI) | Active, not recruiting ➔ Completed | Trial completion date: Dec 2027 ➔ Mar 2025

Trial completion • Trial completion date • Acute Myelogenous Leukemia • Hematological Malignancies • Leukemia • Lymphoma • Multiple Myeloma • Myelodysplastic Syndrome • Non-Hodgkin’s Lymphoma • Oncology • Transplantation • ABL1 • ASXL1 • BCR • CD34 • FLT3 • HLA-B • HLA-C

Etoposide, Prednisone, Vincristine, Cyclophosphamide, and Doxorubicin (DA-EPOCH) With or Without Rituximab Plus Recombinant Erwinia Asparaginase (JZP458) for the Treatment of Newly Diagnosed Ph Negative B-Acute Lymphoblastic Leukemia or T Acute Lymphoblastic Leukemia (clinicaltrials.gov) - P2 | N=30 | Not yet recruiting | Sponsor: University of Washington | Initiation date: Jun 2025 ➔ Sep 2025

Trial initiation date • Acute Lymphocytic Leukemia • B Acute Lymphoblastic Leukemia • Hematological Malignancies • Leukemia • Lymphoma • Oncology • T Acute Lymphoblastic Leukemia

NCI-2015-00960: Ibrutinib, Rituximab, and Consolidation Chemotherapy in Treating Young Patients With Newly Diagnosed Mantle Cell Lymphoma (clinicaltrials.gov) - P2 | N=131 | Active, not recruiting | Sponsor: M.D. Anderson Cancer Center | Trial completion date: Jun 2025 ➔ Jun 2027 | Trial primary completion date: Jun 2025 ➔ Jun 2027

Trial completion date • Trial primary completion date • Hematological Malignancies • Lymphoma • Mantle Cell Lymphoma • Oncology • CD20 • MYC • TP53

Nivolumab in Combination With Chemo-Immunotherapy for the Treatment of Newly Diagnosed Primary Mediastinal B-Cell Lymphoma (clinicaltrials.gov) - P3 | N=244 | Active, not recruiting | Sponsor: National Cancer Institute (NCI) | Recruiting ➔ Active, not recruiting

Enrollment closed • B Cell Lymphoma • Hematological Malignancies • Large B Cell Lymphoma • Lymphoma • Mediastinal B Cell Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • Primary Mediastinal Large B-Cell Lymphoma

Real-world experience of effectiveness of non-medical switch from originator to biosimilar rituximab and between biosimilars in connective tissue diseases and vasculitis (EULAR 2025) - "Furthermore, between 2021-2023, patients on Truxima® were switched to Rixathon® and then reverted to Truxima® in 2024 due to contractual agreement...Kaplan-Meier analysis showed no difference in 5-year RTX retention survival between Group 1 and Group 2; HR 0.71 (95% CI 0.30-1.71), p=0.448, adjusted for disease duration, number of RTX cycles and oral prednisolone dose (Figure 1)... Our findings support the non-medical switch either from RTX-O to RTX-B or between biosimilars in CTD-VAS with no difference in clinical response and the depth of B-cell depletion before and after switch. 5-year rituximab retention rate was very good regardless of non-medical switch and appeared higher than in RA. Given its low cost and durability, future studies should assess the cost-effectiveness of first-line use of rituximab biosimilars in patients with CTD-VAS."

Clinical • Real-world • Real-world evidence • Infectious Disease • Inflammatory Arthritis • Myositis • Novel Coronavirus Disease • Pneumonia • Pulmonary Disease • Respiratory Diseases • Rheumatoid Arthritis • Rheumatology • Scleroderma • Septic Shock • Systemic Sclerosis • Vasculitis • CD20

RITUXERA: Tapering of Rituximab Based on Interval Prolongation Compared to Disease Activity-guided Dose Reduction in Patients With Rheumatoid Arthritis (clinicaltrials.gov) - P4 | N=134 | Recruiting | Sponsor: Universitaire Ziekenhuizen KU Leuven | Trial completion date: Dec 2026 ➔ Dec 2027 | Trial primary completion date: Dec 2026 ➔ Dec 2027

Trial completion date • Trial primary completion date • Immunology • Inflammatory Arthritis • Rheumatoid Arthritis • Rheumatology

Ibrutinib, Rituximab, Etoposide, Prednisone, Vincristine Sulfate, Cyclophosphamide, and Doxorubicin Hydrochloride in Treating Patients With HIV-Positive Stage II-IV Diffuse Large B-Cell Lymphomas (clinicaltrials.gov) - P1 | N=54 | Active, not recruiting | Sponsor: National Cancer Institute (NCI) | Recruiting ➔ Active, not recruiting

Enrollment closed • B Cell Lymphoma • Diffuse Large B Cell Lymphoma • Hematological Malignancies • Human Immunodeficiency Virus • Infectious Disease • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • CD20 • CD4

Window-2: Ibrutinib, Rituximab, Venetoclax, and Combination Chemotherapy in Treating Patients With Newly Diagnosed Mantle Cell Lymphoma (clinicaltrials.gov) - P2 | N=51 | Active, not recruiting | Sponsor: M.D. Anderson Cancer Center | Trial completion date: May 2025 ➔ Mar 2027 | Trial primary completion date: May 2025 ➔ Mar 2027

Trial completion date • Trial primary completion date • Hematological Malignancies • Lymphoma • Mantle Cell Lymphoma • Oncology • CD20 • NSD2 • TP53

REDUCE-PMR-1: Rituximab Effect on Decreasing glUcoCorticoid Exposition in PolyMyalgia Rheumatica Patients Recently Diagnosed (clinicaltrials.gov) - P3 | N=114 | Active, not recruiting | Sponsor: Sint Maartenskliniek | Recruiting ➔ Active, not recruiting | Trial completion date: Jan 2027 ➔ Apr 2026

Enrollment closed • Trial completion date • Giant Cell Arteritis • Immunology • Musculoskeletal Pain • Pain • Rheumatology

Direct Tumor Microinjection and FDG-PET in Testing Drug Sensitivity in Patients With Relapsed or Refractory Non-Hodgkin Lymphoma, Hodgkin Lymphoma, or Stage IV Breast Cancer (clinicaltrials.gov) - P1 | N=17 | Terminated | Sponsor: Mayo Clinic | N=39 ➔ 17 | Suspended ➔ Terminated; funding - sponsor filing Chapter 11 bankruptcy

Enrollment change • Trial termination • Breast Cancer • Cutaneous T-cell Lymphoma • Dermatology • Hematological Malignancies • Hodgkin Lymphoma • Lymphoma • Marginal Zone Lymphoma • Mycosis Fungoides • Nodal Marginal Zone Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • Solid Tumor • T Cell Non-Hodgkin Lymphoma

DS-1594b With or Without Azacitidine, Venetoclax, or Mini-HCVD for the Treatment of Relapsed or Refractory Acute Myeloid Leukemia or Acute Lymphoblastic Leukemia (clinicaltrials.gov) - P1/2 | N=17 | Terminated | Sponsor: M.D. Anderson Cancer Center | Completed ➔ Terminated; supporting/funding source decided to de-prioritize and stop development of DS-1594

Trial termination • Acute Lymphocytic Leukemia • Acute Myelogenous Leukemia • Chronic Myelomonocytic Leukemia • Hematological Malignancies • Leukemia • Myelodysplastic Syndrome • Oncology • T Acute Lymphoblastic Leukemia • FLT3 • NPM1

NCI-2018-01100: Venetoclax, Ponatinib, and Dexamethasone in Participants With Philadelphia Chromosome or BCR-ABL Positive Relapsed or Refractory Acute Lymphoblastic Leukemia or Chronic Myelogenous Leukemia (clinicaltrials.gov) - P1/2 | N=9 | Terminated | Sponsor: M.D. Anderson Cancer Center | Completed ➔ Terminated; The study was terminated early due to slow accrual and low level of interest both by the sponsor and by the department

Trial termination • Acute Lymphocytic Leukemia • Chronic Lymphocytic Leukemia • Chronic Myeloid Leukemia • Hematological Malignancies • Leukemia • Oncology • T Acute Lymphoblastic Leukemia • ABL1 • BCL2 • BCR

An Early Phase Study of Venetoclax, Lenalidomide, and Rituximab/Hyaluronidase in Slow-Growing Lymphomas That Have Come Back After Treatment or Have Not Responded to Treatment (clinicaltrials.gov) - P1 | N=4 | Active, not recruiting | Sponsor: Thomas Jefferson University | Recruiting ➔ Active, not recruiting | N=30 ➔ 4 | Trial completion date: Mar 2025 ➔ Jun 2025

Enrollment change • Enrollment closed • Trial completion date • B Cell Non-Hodgkin Lymphoma • Follicular Lymphoma • Hematological Malignancies • Indolent Lymphoma • Lymphoma • Marginal Zone Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • BCL2

Rituximab, Lenalidomide, Acalabrutinib, Tafasitamab Alone and With Combination Chemotherapy for the Treatment of Newly Diagnosed Non-germinal Center Diffuse Large B-Cell Lymphoma, Smart Stop Study (clinicaltrials.gov) - P2 | N=62 | Active, not recruiting | Sponsor: M.D. Anderson Cancer Center | Recruiting ➔ Active, not recruiting

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

Cost-Efficiency Modeling of Conversion to Biosimilar Rituximab-pvvr in Diffuse Large B-Cell Lymphoma in Medicare (ISPOR 2025) - "These savings represent 33% and 66% reductions in cost vs. originator-based treatment, respectively, and exceed savings from alternative biosimilars rituximab-abbs or -arrx. We found that R-CHOP with rituximab-pvvr can achieve substantial cost savings relative to originator-based treatment, allowing reinvestment to treat a substantial number of additional patients with DLBCL, or fund other costs of care in Medicare, on a budget-neutral basis."

Medicare • Reimbursement • US reimbursement • B Cell Lymphoma • Diffuse Large B Cell Lymphoma • Hematological Malignancies • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology

REDUCE-PMR-2: Rituximab Effect on Decreasing glUcoCorticoid Exposition in PolyMyalgia Rheumatica Patients Experiencing a PMR Relapse (clinicaltrials.gov) - P3 | N=174 | Recruiting | Sponsor: Sint Maartenskliniek | Trial completion date: Jan 2027 ➔ Jan 2028 | Trial primary completion date: Jan 2026 ➔ Jan 2027

Trial completion date • Trial primary completion date • Giant Cell Arteritis • Immunology • Musculoskeletal Pain • Pain • Rheumatology

Empirical Time-Series Analysis (1991–2023) of Immune Thrombocytopenia Medications in U.S. Medicaid Programs (ISPOR 2025) - "Comparative market-share analyses were conducted across therapeutic classes to identify key drivers of market changes, including policy shifts, competition, and new drug entries The utilization trends revealed Rituxan dominated until 2020, after biosimilars (Ruxience, Truxima) gained traction, with Ruxience leading. In the IVIG category, Gammagard consistently held the highest utilization, peaking in 2022, followed by Rhophylac and Privigen. Among TPO-RAs, Promacta surpassed Nplate in 2018, reflecting a shift in prescribing patterns. Pricing data highlighted Promacta as the most expensive TPO-RA, Panzyga led IVIG pricing by 2019... This analysis highlights evolving patterns in the utilization, reimbursement, and pricing of ITP therapies within Medicaid programs, shaped by factors like the introduction of biosimilars, competitive market dynamics, and clinical advancements. These findings provide valuable insights for healthcare policymakers, payers, and clinicians to..."

Medicaid • Reimbursement • US reimbursement • Hematological Disorders • Immune Thrombocytopenic Purpura • Thrombocytopenia • Thrombocytopenic Purpura

Study for Patients With Hairy Cell Leukemia to Test the Targeted Agent Tovorafenib in Combination With Rituximab and Compare the Combination With Current Standard Treatment (clinicaltrials.gov) - P1/2 | N=78 | Not yet recruiting | Sponsor: National Cancer Institute (NCI)

New P1/2 trial • Hairy Cell Leukemia • Hematological Malignancies • Leukemia • Oncology • BRAF

Mismatched Related Donor Versus Matched Unrelated Donor Stem Cell Transplantation for Children, Adolescents, and Young Adults With Acute Leukemia or Myelodysplastic Syndrome (clinicaltrials.gov) - P3 | N=435 | Active, not recruiting | Sponsor: Children's Oncology Group | Recruiting ➔ Active, not recruiting | Trial completion date: Dec 2027 ➔ Jun 2026 | Trial primary completion date: Dec 2027 ➔ Jun 2026

Enrollment closed • Trial completion date • Trial primary completion date • Acute Lymphocytic Leukemia • Acute Myelogenous Leukemia • Hematological Malignancies • Leukemia • Myelodysplastic Syndrome • Oncology • Transplantation • ABL1 • BCR • CEBPA • FLT3 • HLA-B • HLA-C • HLA-DQB1 • HLA-DRB1 • NPM1

Personalized NK Cell Therapy in CBT (clinicaltrials.gov) - P2 | N=100 | Recruiting | Sponsor: M.D. Anderson Cancer Center | Trial completion date: May 2025 ➔ May 2027 | Trial primary completion date: May 2025 ➔ May 2027

Trial completion date • Trial primary completion date • Acute Lymphocytic Leukemia • Acute Myelogenous Leukemia • B Acute Lymphoblastic Leukemia • B Cell Lymphoma • Chronic Lymphocytic Leukemia • Chronic Myeloid Leukemia • Chronic Myelomonocytic Leukemia • Hematological Malignancies • High-grade B-cell lymphoma • Hodgkin Lymphoma • Leukemia • Lymphoma • Multiple Myeloma • Myelodysplastic Syndrome • Myeloproliferative Neoplasm • Non-Hodgkin’s Lymphoma • Oncology • T Acute Lymphoblastic Leukemia • BCL2 • FLT3

NCI-2011-00344: Genetically Engineered Lymphocyte Therapy After Peripheral Blood Stem Cell Transplant in Treating Patients With High-Risk, Intermediate-Grade, B-cell Non-Hodgkin Lymphoma (clinicaltrials.gov) - P1/2 | N=8 | Active, not recruiting | Sponsor: City of Hope Medical Center | Trial completion date: Mar 2025 ➔ Feb 2026

Trial completion date • B Cell Lymphoma • B Cell Non-Hodgkin Lymphoma • Bone Marrow Transplantation • Follicular Lymphoma • Hematological Malignancies • Lymphoma • Mantle Cell Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • Transplantation