Rituxan Hycela (rituximab/hyaluronidase) / Biogen, Roche, Halozyme - LARVOL DELTA

Outcomes from the Multicenter ACCRU-LY-1804/CARiBOU (Cytarabine, Acalabrutinib and Rituximab integrated with Bortezomib-based Outpatient therapy) Trial in 1st line Mantle Cell Lymphoma (ASH 2025) - "VR-CAP (cycles 1, 3, and 5) employed bortezomib 1.3 mg/m² subcutaneously days1,8, and 15; rituximab 375 mg/m² day 1; cyclophosphamide 750 mg/m² day 1; doxorubicin 50 mg/m2 day1; and prednisone 100 mg PO days 1-5. CARiBOU is an efficient, highly effective outpatient regimen for 1st line MCL, employingintermediate dose cytarabine with continuous acalabrutinib. With supportive care and plateletmonitoring, this approach safely yielded high rates of CMR and uMRD6, supporting multitargetedinduction therapy for appropriate pts with untreated MCL."

Clinical • Atrial Fibrillation • CNS Disorders • Febrile Neutropenia • Hematological Malignancies • Lymphoma • Mantle Cell Lymphoma • Neutropenia • Thrombocytopenia • TP53

Initial treatment of chronic lymphocytic leukemia with low-dose high-frequency rituximab followed by addition of acalabrutinib (ASH 2025) - P2 | "Thirty-eight untreated CLL patients with progressive disease received 50 mg intravenous (IV) rituximab oncycle 1 day 1 (C1D1), followed by 50 mg of subcutaneous (SQ) rituximab 48h later (C1D3), and then 50 mgSQ rituximab twice weekly for 23 weeks. One week of low dose rituximab effectively reduced CLL tumor burden. Clearance of circulating CLL cellsstopped within 1h of initiation of first rituximab IV dose. This was not due to insufficient serum rituximab,low serum complement, or loss of CLL cell CD20."

Chronic Lymphocytic Leukemia • Hematological Malignancies • Leukemia • CD20 • MS4A1

Subcutaneous rituximab in the treatment of primary CNS lymphoma: a retrospective case series (SNO 2025) - "Subcutaneous rituximab appears well-tolerated and potentially more cost-effective in achieving durable complete responses. Larger studies are needed to confirm these results."

Retrospective data • B Cell Lymphoma • Brain Cancer • CNS Lymphoma • Diffuse Large B Cell Lymphoma • Hematological Malignancies • Lymphoma • Non-Hodgkin’s Lymphoma • Primary Central Nervous System Lymphoma • Solid Tumor

Subcutaneous rituximab in the treatment of primary CNS lymphoma: a retrospective case series (WFNOS 2025) - P=N/A, P2 | "Subcutaneous rituximab appears well-tolerated and potentially more cost-effective in achieving durable complete responses. Larger studies are needed to confirm these results."

Retrospective data • B Cell Lymphoma • Brain Cancer • CNS Lymphoma • Diffuse Large B Cell Lymphoma • Hematological Malignancies • Lymphoma • Non-Hodgkin’s Lymphoma • Primary Central Nervous System Lymphoma • Solid Tumor

A Phase 1 Study of Subcutaneous Rituximab Hyaluronidase Combined with Local Standard-of-Care Chemotherapy for the Treatment of Diffuse Large B-Cell Lymphoma in Uganda (ASH 2023) - "The first cohort (n=6) received IV rituximab, 375mg/m2 on day 1 of cycle 1 plus CHOP chemotherapy (IV cyclophosphamide 750 mg/m2, IV doxorubicin 50 mg/m2, IV vincristine 1·4 mg/m2 (maximum 2 mg/m2) on day 1, and oral prednisone 100 mg on days 1-5). As demonstrated in other parts of the world, sqR together with CHOP chemotherapy was safe, well-tolerated, and efficacious among Ugandan patients with DLBCL. The very high CR, PFS, and OS rates are nearly double that of historical controls at the UCI, and comparable to outcomes expected in resource-rich settings. Colleagues have previously demonstrated the safety and efficacy of an oral chemotherapy regimen for aggressive non-Hodgkin's lymphoma in East Africa (Mwanda et al."

P1 data • Anorexia • B Cell Lymphoma • Cardiovascular • Diffuse Large B Cell Lymphoma • Heart Failure • Hematological Malignancies • Human Immunodeficiency Virus • Infectious Disease • Lymphoma • Neutropenia • Non-Hodgkin’s Lymphoma • CD4

EPCORE FL-1: Phase 3 Trial of Subcutaneous Epcoritamab with Rituximab and Lenalidomide (R2) Vs R2 Alone in Patients with Relapsed or Refractory Follicular Lymphoma (ASH 2023) - P1/2, P3 | "Exploratory endpoints include assessments of pharmacodynamic and pharmacokinetic data. The study opened for enrollment in 2022 in North America, South America, Europe, Africa, Asia, and Australia."

Clinical • P3 data • Follicular Lymphoma • Hematological Malignancies • Indolent Lymphoma • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology

Adding Pirtobrutinib to the Usual Treatment for People With Newly Diagnosed Richter Transformation, The PIRAMID Trial (clinicaltrials.gov) - P3 | N=102 | Not yet recruiting | Sponsor: SWOG Cancer Research Network

New P3 trial • B Cell Lymphoma • Chronic Lymphocytic Leukemia • Diffuse Large B Cell Lymphoma • Hematological Malignancies • Leukemia • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • Richter's Syndrome • Small Lymphocytic Lymphoma

AVOIDED DRUG COST BY ENROLLING PATIENTS WITH HEMATOLOGICAL DISEASES IN CLINICAL TRIALS: A SINGLE CENTER EXPERIENCE (SIE 2025) - "Thanks to an academic clinical trial 13 patients with Acute Myeloid Leukemia received gemtuzumab ozogamicin, avoiding around € 270.000 of SOC therapy...This allowed us to avoid the costs of drugs such as polatuzumab vedotin (more than 70.000€ enrolling 2 patients), intravenous and subcutaneous rituximab, liposomal doxorubicin, bendamustine and lenalidomide. Our analysis demonstrates the significant economic benefit of enrolling patients with hematological diseases in clinical trials. Participation in clinical trials not only reduces the direct pharmaceutical load on the Hematology Department budget, but also allows securing grants, reimbursements, and payments, factors not assessed in this analysis."

Clinical • Drug cost • HEOR • Acute Myelogenous Leukemia • Hematological Malignancies • Leukemia • Lymphoma • Non-Hodgkin’s Lymphoma

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 | Trial completion date: Jun 2025 ➔ Apr 2027

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

Polatuzumab Vedotin With R-GDP in Relapsed/Refractory Diffuse Large B-cell Lymphoma (clinicaltrials.gov) - P2 | N=5 | Active, not recruiting | Sponsor: UNC Lineberger Comprehensive Cancer Center | Recruiting ➔ Active, not recruiting | N=44 ➔ 5 | Trial completion date: Aug 2028 ➔ Nov 2026 | Trial primary completion date: Aug 2028 ➔ Mar 2025

Enrollment change • 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

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) | Trial completion date: Dec 2027 ➔ Dec 2026 | Trial primary completion date: Dec 2027 ➔ Dec 2026

Trial completion date • Trial primary completion date • 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

A Study of Venetoclax and Rituximab/Hyaluronidase Human in Relapsed/Refractory CLL (clinicaltrials.gov) - P2 | N=25 | Active, not recruiting | Sponsor: Georgetown University | Trial primary completion date: Jun 2025 ➔ Oct 2025

Trial primary completion date • Chronic Lymphocytic Leukemia • Hematological Malignancies • Leukemia • Lymphoma • Oncology

Tafasitamab, Retifanlimab, and Rituximab in Combination With Standard Therapy for the Treatment of Diffuse Large B-cell Lymphoma (clinicaltrials.gov) - P1/2 | N=35 | Recruiting | Sponsor: University of Washington | Trial completion date: Jul 2026 ➔ Jul 2027 | Trial primary completion date: Jan 2026 ➔ Jan 2027

Trial completion date • Trial primary completion date • B Cell Lymphoma • Diffuse Large B Cell Lymphoma • Follicular Lymphoma • Hematological Malignancies • High-grade B-cell lymphoma • Indolent Lymphoma • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology

SUBCUTANEOUS ULTRA-LOW DOSE RITUXIMAB VERSUS INTRAVENOUS ULTRA-LOW DOSE RITUXIMAB IN PATIENTS WITH RHEUMATOID ARTHRITIS: A RANDOMISED CONTROLLED NON-INFERIORITY TRIAL (EULAR 2025) - "Although the formal primary endpoint will follow, these results show lower systemic RTX levels than expected based on the previously mentioned bioavailability. However, with a non-inferior difference in disease activity and comparable B-cell depletion, subcutaneous ultra-low dose RTX may be as effective clinically as IV ultra-low dose RTX, and could therefore be a feasible option for the treatment of rheumatoid arthritis."

Clinical • Head-to-Head • Hematological Malignancies • Immunology • Infectious Disease • Inflammatory Arthritis • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • Rheumatoid Arthritis • Rheumatology

The cost of convenience: Evaluating economic differences in SQ and IV biotherapeutic formulations. (ASCO 2025) - " SQ formulations of Rituximab (Rituxan Hycela), Trastuzumab (Herceptin Hylecta), and Daratumumab (Darzalex Faspro) became available in 2017, 2019 and 2020, respectively. While subcutaneous (SQ) formulations offer convenience and potential clinical and administrative benefits, they generally cost more than their IV counterparts. SQ Daratumumab was more readily adopted possibly due to fewer drug-related reactions, shorter administration duration, patient convenience, and lack of biosimilar options. Despite the higher costs, convenience and patient preference for SQ formulations may justify their use in certain clinical scenarios."

Oncology

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

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

Real-World Subcutaneous Monoclonal Antibody Use Trends for Oncology in the US (ISPOR 2025) - " We analyzed de-identified data from Trisus Medication Compare (The Craneware Group, Edinburgh, UK) between 1/1/2019-12/31/2023 to identify patient encounters containing a dispensation for subcutaneous formulations of hyaluronidase with rituximab, trastuzumab, daratumumab, and combination pertuzumab and trastuzumab...The most used product was daratumumab with hyaluronidase (82.7% of dispensations), which correlates with the high rate of multiple myeloma in the sample... From 2019-2022, national data show increased use of subcutaneous monoclonal antibodies for oncology, an advantageous alternative offering opportunities to enhance patient care and improve cost and resource efficiency."

Clinical • Real-world • Real-world evidence • Amyloidosis • B Cell Lymphoma • Breast Cancer • Chronic Lymphocytic Leukemia • Follicular Lymphoma • Hematological Malignancies • Large B Cell Lymphoma • Leukemia • Lymphoma • Multiple Myeloma • Non-Hodgkin’s Lymphoma • Oncology • Pediatrics • Solid Tumor

Intravenous low-dose anti-CD20 Rituximab infusion contrasted with subsequent subcutaneous Rituximab injection during CLL patient treatment (IMMUNOLOGY 2025) - "Our data suggest slow SQ mAb diffusion into circulation steadily binds to CLL cells, resulting in low serum levels and slow depletion of CLL cells, with increasing serum RTX levels as SQ doses accumulate. Surviving CLL cells were still sensitive to mAb cytotoxicity, suggesting that cytotoxic effector cells were "exhausted" by RTX therapy.Keywords: Animals Human; Cells B Cells; Molecules Antibodies Antigens/Peptides/Epitopes; Processes Phagocytosis"

Clinical • Chronic Lymphocytic Leukemia

Subcutaneous rituximab in indolent primary cutaneous B cell lymphoma: A case series of 5 patients with the evaluation of the medico economic impact. (PubMed, Therapie) - No abstract available

HEOR • Journal • B Cell Lymphoma • Follicle Center Lymphoma • Follicular Lymphoma • Hematological Malignancies • Lymphoma • Marginal Zone Lymphoma • Non-Hodgkin’s Lymphoma • Oncology

Acalabrutinib With Bendamustine / Rituximab Followed by Cytarabine / Rituximab for Untreated Mantle Cell Lymphoma (clinicaltrials.gov) - P2 | N=13 | Completed | Sponsor: Washington University School of Medicine | Active, not recruiting ➔ Completed

Trial completion • Hematological Malignancies • Lymphoma • Mantle Cell Lymphoma • Neutropenia • Oncology • CCND1

Rituximab and Hyaluronidase Human in Patients With Advanced Melanoma Undergoing Nivolumab and Ipilimumab Therapy (clinicaltrials.gov) - P2 | N=15 | Active, not recruiting | Sponsor: Emory University | Trial completion date: Sep 2024 ➔ Jun 2026

Checkpoint inhibition • Trial completion date • Cutaneous Melanoma • Melanoma • Oncology • Solid Tumor

Phase I Study of Subcutaneous Rituximab Hyaluronidase Combined With CHOP Chemotherapy for the Treatment of Diffuse Large B-Cell Lymphoma in Uganda. (PubMed, JCO Glob Oncol) - "As demonstrated in other parts of the world, sqR together with CHOP was safe, well-tolerated, and efficacious among Ugandan patients with DLBCL. The very high OS rates are nearly double those of historical controls and comparable with outcomes expected in resource-rich settings. This study demonstrated the feasibility, safety, and efficacy of sqR-CHOP, increased the research infrastructure in Uganda, and will improve care in other resource-limited settings."

Journal • P1 data • B Cell Lymphoma • Diffuse Large B Cell Lymphoma • Hematological Disorders • Hematological Malignancies • Lymphoma • Neutropenia • Non-Hodgkin’s Lymphoma • Oncology

MCL R2: R-CHOP + R-HAD Vs R-CHOP Followed by Maintenance Lenalidomide + Rituximab Vs Rituximab for Older Patients with MCL (clinicaltrials.gov) - P3 | N=623 | Completed | Sponsor: The Lymphoma Academic Research Organisation | Active, not recruiting ➔ Completed | Trial completion date: Aug 2025 ➔ Jan 2025

Trial completion • Trial completion date • Hematological Malignancies • Lymphoma • Mantle Cell Lymphoma • Oncology

Nivolumab in Combination With Chemo-Immunotherapy for the Treatment of Newly Diagnosed Primary Mediastinal B-Cell Lymphoma (clinicaltrials.gov) - P3 | N=244 | Recruiting | Sponsor: National Cancer Institute (NCI) | Trial primary completion date: Sep 2027 ➔ Dec 2027 | Trial completion date: Sep 2027 ➔ Dec 2027

Trial completion date • Trial primary completion date • 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