Columvi (glofitamab-gxbm) / Roche, Biogen - LARVOL DELTA

Accelerating Oncology Drug Reimbursement in Canada: Impact of the CDA-AMC Time-Limited Recommendation and pCPA Temporary Access Process. (PubMed, Curr Oncol) - " Nine oncology NOC/c were granted during the selected period, of which three products, Columvi, Akeega, and Epkinly, received provincial listings, and the median time from regulatory approvals to provincial listings is 509 days (IQ range 306-544 days). No acceleration in each agency's review time was observed. Participation in the TLR-pTAP pathway can help mitigate concerns over uncertainties associated with novel therapies while providing timelier access for patients with life-threatening diseases."

Journal • Reimbursement • US reimbursement • Oncology

Insulin Therapy in Steroid-Induced Ketoacidosis (SIKA) with Normoglycemia (ENDO 2025) - "Acute physiological stress triggers a surge in counter-regulatory hormones, including epinephrine, cortisol, and growth hormone, which collectively promote lipolysis and ketogenesis. Corticosteroids, particularly dexamethasone, exacerbate this metabolic disruption by potentiating the lipolytic effects of growth hormone and upregulating key enzymes such as hormone-sensitive lipase (HSL) and adipose triglyceride lipase (ATGL). This steroid-driven augmentation of ketogenesis can lead to profound metabolic acidosis, even in the absence of marked hyperglycemia.Case Presentation: An 85-year-old female with non-Hodgkin's B-cell lymphoma developed immune effector cell-associated neurotoxicity syndrome (ICANS) following treatment with glofitamab... This case underscores the complex pathophysiology of SIKA and the potential for corticosteroids to precipitate ketoacidosis independent of severe hyperglycemia. By amplifying the lipolytic effects of growth hormone and upregulating..."

B Cell Lymphoma • Diabetes • Hematological Malignancies • Hypoglycemia • Lymphoma • Metabolic Disorders • Non-Hodgkin’s Lymphoma • Oncology

CSF1R-targeting T cell engaging bispecific antibodies for Acute Myeloid Leukemia treatment (ITOC 2025) - "Background The potential of T-cell engaging bispecific antibodies (TCEs) is illustrated by the success of targeting CD19 (Blinatumomab) and CD20 (Epcoritamab, Glofitamab, Mosuenetuzumab) in relapsed and refractory B-cell non-Hodgkin lymphoma. However, in AML, TCEs targeting CD33 (JNJ-67571244, AMG330) and CD123 (Vibecotamab) have shown low efficacy and high toxicity...Consistent with our single-cell RNA sequencing-based target analysis, the CSF1R-TCE exhibited a superior safety profile than the CD33-TCE while maintaining anti-tumor activity. CSF1R-targeting TCEs may represent a novel immunotherapeutic approach for AML with high translative potential."

Acute Myelogenous Leukemia • B Cell Non-Hodgkin Lymphoma • Hematological Malignancies • Leukemia • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • CD123 • CD33 • CD34 • CSF1R • IL3RA

Distinct mechanisms of CD28 and 4-1BB costimulation in glofitamab combination therapies for relapsed/refractory non-Hodgkin lymphoma (R/R NHL) (AACR 2025) - P1, P1/2 | "While both costimulators are designed to enhance the anti-tumor effects of T-cell engagers, we present, for the first time, key differences in the mechanisms and response profiles of CD28 and 4-1BB costimulation in these combinations. Exploratory biomarker analyses included 28 indolent and aggressive NHL patients treated with RO7443904 (CD19-CD28) and 99 with englumafusp alfa (CD19-4-1BBL) on Cycle 2 (C2) Day 8, after completion of glofitamab step-up dosing, followed by administration on the same day as glofitamab from C3 onwards (Q3W) for a fixed duration of 12 cycles. Our findings reveal distinct mechanisms of CD28 and 4-1BB costimulation with glofitamab, which may explain their different response dynamics. Specifically, 4-1BB promotes a sustained and prolonged immune response, while CD28 triggers rapid T-cell activation and proliferation. Moreover, 4-1BB appears to bypass macrophage suppression, and benefits from cDC-mediated antigen presentation and CD8..."

Combination therapy • IO biomarker • Hematological Malignancies • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • B2M • CD28 • CD4 • CD8 • CREBBP • PD-1 • TP53

EVOLVE205, a dual (2:1) CD20 targeted CD3 trispecific T cell engager with CD2 costimulation for the treatment of B cell malignancies and B cell autoimmune disorders (AACR 2025) - "T cell engager (TCE) CD3-bispecifics have improved the treatment of patients with B cell lymphomas leading to recent approvals of the CD20-targeted CD3 bispecifics including Glofitamab, Mosunetuzumab, and Epcoritamab for patients with relapsed, refractory diseases...Importantly, in a B-cell depleted PBMC-HT tumor co-culture assay, the tumor-killing potency of EVOLVE205 was improved by up to 70-fold compared to Glofitamab, and by over 1,000-fold compared to anti-CD20 mAbs such as Rituximab...It also demonstrates significant in vivo efficacy and a favorable developability profile. Our data indicated that EVOLVE205 with integrated CD2 co-stimulation offers greater efficacy and safety advantages compared to clinically available CD20-targeted TCE therapies and anti-CD20 mAbs for the treatment of B cell lymphomas and for B cell-mediated autoimmune diseases."

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

Columvi + Polivy: Regulatory submission in Japan for previously treated LBCL in 2028 and beyond (Chugai) - Q1 FY2025 Results

Japan filing • Diffuse Large B Cell Lymphoma • Hematological Malignancies • Oncology

Columvi: Regulatory submissions in US/EU for r/r MCL in 2027 (Roche) - Q1 2025 Results: Regulatory approval in China in combination with chemotherapy for 2L DLBCL in 2025

China approval • EMA filing • FDA filing • Diffuse Large B Cell Lymphoma • Hematological Malignancies • Mantle Cell Lymphoma • Oncology

Characterization of mechanisms driving CD20 loss in patients with relapsed or refractory large B-cell lymphoma treated with glofitamab. (ASCO 2025) - "The abstract will be released to the public on May 22, 2025 at 5:00 PM EDT"

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

Optimizing frontline therapy for diffuse large B cell lymphoma (DLBCL) in older adults: A glofitamab-based, response-adapted, window-style study (GLORY). (ASCO 2025) - P2 | "Clinical Trial Registration Number: NCT06765317 The abstract will be released to the public on May 22, 2025 at 5:00 PM EDT"

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

Glofitamab plus gemcitabine and oxaliplatin (Glofit-GemOx) in patients (pts) with relapsed/refractory (R/R) diffuse large B-cell lymphoma (DLBCL): 2-year (yr) follow-up of STARGLO. (ASCO 2025) - P3 | "Clinical Trial Registration Number: NCT04408638 The abstract will be released to the public on May 22, 2025 at 5:00 PM EDT"

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

Columvi + Polivy: Regulatory submissions in US/EU for 1L DLBCL in combination with R-CHP in 2027 (Roche) - Q1 2025 Results

EMA filing • FDA filing • Diffuse Large B Cell Lymphoma • Hematological Malignancies • Oncology

Real World Experience of Glofitamab and Epcoritamab: A Retrospective U.K. Multicentre Analysis (BSH 2025) - No abstract available

Real-world • Real-world evidence • Retrospective data • Chronic Lymphocytic Leukemia • Hematological Malignancies • Lymphoma • Oncology

Glofitamab Plus Ibrutinib With Obinutuzumab for the Treatment of Patients With Mantle Cell Lymphoma (clinicaltrials.gov) - P1/2 | N=27 | Not yet recruiting | Sponsor: OHSU Knight Cancer Institute | Trial completion date: May 2029 ➔ Nov 2029 | Trial primary completion date: May 2027 ➔ Nov 2027

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

Columvi: The First FDA-Approved Fixed-Duration Bispecific Antibody for 3L+ Diffuse Large B-Cell Lymphoma (ONS 2025) - "Sponsored by Genentech. Review the current management of 3L+ DLBCL Discuss the study design and efficacy data for COLUMVI Explore the safety profile of COLUMVI Understand how to administer COLUMVI"

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

Successful treatment of primary refractory DLBCL/HGBL - MYC/BCL2 transformed from FL using glofitamab: a case report. (PubMed, Front Immunol) - "Conventional R-CHOP-like chemoimmunotherapy regimens have demonstrated limited efficacy in DLBCL/HGBL-MYC/BCL2, and the clinical outcome remains poor, with a median overall survival of less than 2 years, and even shorter in cases transformed from indolent lymphoma. The patient achieved partial response following treatment with the CD20×CD3 bispecific antibody glofitamab and maintained long-term remission. Although only one successful case is presented, glofitamab could be considered as salvage therapy for transformed relapsed/refractory DLBCL/HGBL-MYC/BCL2."

Journal • 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 • BCL2 • CD20 • MYC

European Commission approves Roche’s Columvi as the first bispecific antibody for diffuse large B-cell lymphoma after initial therapy (GlobeNewswire) - "Roche...announced today that the European Commission has approved Columvi (glofitamab) in combination with gemcitabine and oxaliplatin (GemOx) for the treatment of adult patients with relapsed or refractory (R/R) diffuse large B-cell lymphoma (DLBCL) not otherwise specified who are ineligible for autologous stem cell transplant (ASCT). With this approval, this Columvi combination is the first bispecific antibody regimen available for people with DLBCL in Europe whose cancer has returned or for those who did not respond to initial treatment....Approval is based on results from the pivotal phase III STARGLO study..."

EMA approval • Diffuse Large B Cell Lymphoma

Glofitamab With Obinutuzumab Pre-treatment for the Treatment of Central Nervous System Lymphoma (clinicaltrials.gov) - P1 | N=20 | Not yet recruiting | Sponsor: City of Hope Medical Center

New P1 trial • CNS Lymphoma • Hematological Malignancies • Lymphoma • Neutropenia • Non-Hodgkin’s Lymphoma • Oncology • Primary Central Nervous System Lymphoma • Secondary Central Nervous System Lymphoma

“Submission of the updated 2-year follow-up report from study NP30179 listed as a Specific Obligation in the Annex II of the Product Information. The Annex II and the RMP version 4.0 are updated accordingly. Consequently, the MAH proposes a switch from conditional marketing authorization to full marketing authorization.” (European Medicines Agency) - Pharmacovigilance Risk Assessment Committee (PRAC) Minutes of meeting on 10 – 13 Feb 2025

PRAC • Hematological Malignancies • Non-Hodgkin’s Lymphoma • Oncology

Glofitamab results in cost savings versus epcoritamab in relapsed/refractory diffuse large B-cell lymphoma: a total cost of care analysis‡. (PubMed, Leuk Lymphoma) - P1/2 | "While adverse event ($364) and treatment administration ($8,398) costs were higher for glofitamab versus epcoritamab, these were offset by consistently lower glofitamab treatment costs across all time horizons. Glofitamab showed per-patient TCC savings versus epcoritamab at every cumulative cycle and across all time horizons investigated, offering greater budget predictability and cost savings at the healthcare system and population levels."

HEOR • Journal • B Cell Lymphoma • Diffuse Large B Cell Lymphoma • Hematological Malignancies • 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

PHARMACEUTICAL BENEFITS ADVISORY COMMITTEE (PBAC) MEETING AGENDA July 2025 PBAC MEETING: Columvi for DLBCL (Pharmaceutical Benefits Scheme (PBS)) - "To request a Section 100 (Efficient Funding of Chemotherapy Program) Authority Required (Telephone/Online) listing for the treatment of patients with RR DLBCL"

Reimbursement • Diffuse Large B Cell Lymphoma • Hematological Malignancies • Oncology

SKYGLO: An Open-Label Study Comparing Glofitamab and Polatuzumab Vedotin + Rituximab, Cyclophosphamide, Doxorubicin, and Prednisone Versus Pola-R-CHP in Previously Untreated Patients With Large B-Cell Lymphoma (clinicaltrials.gov) - P3 | N=1130 | Recruiting | Sponsor: Hoffmann-La Roche | Trial completion date: Feb 2029 ➔ Dec 2030 | Trial primary completion date: Jun 2026 ➔ Dec 2027

Trial completion date • Trial primary completion date • B Cell Lymphoma • Hematological Malignancies • Large B Cell Lymphoma • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • CD20

Feasibility Trial of Glofitamab in a Response Adapted Approach Incorporating Interim FDG PET and ctDNA to Optimize Primary Therapy of DLBCL (GRAIL) (clinicaltrials.gov) - P2 | N=40 | Recruiting | Sponsor: University Health Network, Toronto | Not yet recruiting ➔ Recruiting

Enrollment open • B Cell Lymphoma • Diffuse Large B Cell Lymphoma • Hematological Malignancies • Indolent Lymphoma • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • BCL2 • BCL6

GLOFITAMAB COMBINED WITH SALVAGE THERAPY FOR RELAPSED OR REFRACTORY DIFFUSE LARGE B-CELL LYMPHOMA: INSIGHTS FROM A REAL-WORLD PROSPECTIVE OBSERVATIONAL STUDY IN CHINESE PATIENTS (EBMT 2025) - P | " Adult patients (≥18 years) with R/R DLBCL were treated with glofitamab in combination with salvage therapies, including lenalidomide, BTKi, polatuzumab vedotin, venetoclax, GemOx and the EPOCH regimen . Patients received obinutuzumab 1000 mg on Cycle 1 Day 1 as a pre-treatment, followed by step-up dosing of glofitamab on Cycle 1 Day 8 (2.5 mg), Cycle 1 Day 15 (10 mg), and 30 mg starting Cycle 2... Preliminary results from this prospective study demonstrate that the combination of glofitamab and salvage therapy offers promising efficacy and manageable safety for heavily pre-treated patients with high-risk prognostic factors in a real-world setting. Further follow-up data and exploratory analyses will be presented to assess the long-term outcomes and potential expanded applications of glofitamab. Clinical Trial Registry: NCT06497452"

Clinical • IO biomarker • Observational data • Real-world • Real-world evidence • B Cell Lymphoma • Burkitt Lymphoma • Diffuse Large B Cell Lymphoma • Hematological Disorders • Hematological Malignancies • High-grade B-cell lymphoma • Indolent Lymphoma • Lymphoma • Neutropenia • Non-Hodgkin’s Lymphoma • Oncology • BCL2 • CD20 • CD4 • CD8 • MYC

Glofitamab in refractory or relapsed diffuse large B cell lymphoma after failing CAR-T cell therapy: a phase 2 LYSA study. (PubMed, Nat Cancer) - P2 | "A total of 46 participants received at least one glofitamab infusion following obinutuzumab (anti-CD20 monoclonal antibody) pretreatment. Despite the shortened setup dosing, no excess cytokine release syndrome or neurotoxicity events were observed (grade ≥ 3, 0% for both). In conclusion, glofitamab improved OS in participants with R/R DLBCL after CAR-T cell therapy, with a favorable safety profile."

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