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

Infectious complications of CD20 x CD3 bispecific antibody therapy in patients with B-cell lymphoma. (ASCO 2025) - "Patients were treated with mosunetuzumab (n = 12), glofitamab (n = 10), and epcoritamab (n = 5). Most common antimicrobial prophylaxes were acyclovir (100%), SMX/TMP (89%), and fluconazole (42%)... CD20xCD3 therapy was associated with high rates of severe or fatal infection in this single-institution real world study. Greater consideration to preemptive IVIG and antimicrobial prophylaxis may be warranted with such therapy, and further studies to characterize individual risk and optimal management strategies are needed."

Clinical • B Cell Lymphoma • Candidiasis • Diffuse Large B Cell Lymphoma • Dyslipidemia • Febrile Neutropenia • Follicular Lymphoma • Hematological Malignancies • Hypertension • Infectious Disease • Lymphoma • Mantle Cell Lymphoma • Marginal Zone Lymphoma • Metabolic Disorders • Non-Hodgkin’s Lymphoma • Oncology • CD20

Comparative effectiveness of CAR-T cell therapy and BiTE therapy in relapsed/refractory diffuse large B-cell lymphoma: A propensity score matching analysis using real-world data from the US collaborative network database. (ASCO 2025) - "The CAR-T cell therapy included axicabtagene, lisocabtagene, tisagenlecleucel) or BiTE therapy included Epcoritamab and Glofitamab. This study provides valuable real-world insights into the comparative effectiveness of CAR-T cell therapy and BiTE therapy for relapsed/refractory DLBCL. The results, derived from propensity score-matched cohorts, offer far-reaching help to guide the holistic management of this patient population."

CAR T-Cell Therapy • Clinical • HEOR • Real-world • Real-world evidence • B Cell Lymphoma • Diffuse Large B Cell Lymphoma • Fatigue • Hematological Disorders • Hematological Malignancies • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology

Comparative analysis of adverse event profiles for CAR-T cell therapies and bispecific antibodies in lymphoma. (ASCO 2025) - " A retrospective analysis was conducted using the FAERS database to assess AE reports associated with CAR-T therapies (Breyanzi, Kymriah, Yescarta, and Tecartus) and BsAbs (Epcoritamab, Glofitamab, Odronextamab, Mosunetuzumab, and Plamotamab). This analysis highlights key differences in the safety profiles of CAR-T and BsAb therapies for lymphoma. CAR-T therapies were associated with a higher incidence of neurological and psychiatric AEs, while BsAbs demonstrated a greater risk of infections. These findings may offer valuable guidance for clinicians in therapy selection and underscore the importance of vigilant monitoring, particularly for neurological toxicities in CAR-T treatments and infection-related risks with BsAbs."

Adverse events • CAR T-Cell Therapy • CNS Disorders • Hematological Malignancies • Infectious Disease • Lymphoma • Mental Retardation • Musculoskeletal Diseases • Oncology • Psychiatry

Meta-analysis of the cardiovascular adverse effects of bispecific antibodies in malignant hematology therapies. (ASCO 2025) - "The BsAbs in this analysis were blinatumomab, elranatamab, epcoritamab, glofitamab, mosunetuzumab, talquetamab, and teclistamab and only monotherapy regimens were included. As BsAbs have demonstrated promising efficacy and increased use in the treatment of R/R hematologic malignancies, a wide variety of cardiac toxicities have been observed in these patients and more data on these toxicities are documented. This meta-analysis has identified tachycardia, cardiac arrhythmias, and hypotension as the most significant cardiac adverse events in a pooled analysis of multiple BsAbs. Practicing oncologists, cardiologists, and pharmacists need not only to be aware of these potential toxicities, but also to establish strategies for cardiac monitoring, prevention and management in order to provide quality care to cancer patients."

Adverse events • Retrospective data • Acute Lymphocytic Leukemia • Atrial Fibrillation • B Cell Lymphoma • Cardiovascular • Congestive Heart Failure • Heart Failure • Hematological Malignancies • Hypertension • Hypotension • Leukemia • Lymphoma • Multiple Myeloma • Myocardial Infarction • 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 | "We present updated efficacy and safety of Glofit-GemOx vs rituximab (R)-GemOx in pts with R/R DLBCL after ≥1 LOT from the Phase 3 STARGLO trial (NCT04408638), including landmark analyses of pts in complete remission (CR)...After obinutuzumab pretreatment, glofitamab was given in Cycle (C) 1 as weekly step-up doses (2.5/10mg) then 30mg target dose every 21 days from C2 Day 1... With 2 yrs follow-up, Glofit-GemOx sustained a clinically meaningful benefit in OS and PFS vs R-GemOx in ASCT-ineligible pts with R/R DLBCL, with most (82%) pts in CR at EOT still in remission. The safety profile was consistent with known risks of each drug. The updated analyses support the long-lasting remissions and maintained OS benefit in pts with R/R DLBCL treated with fixed duration Glofit-GemOx."

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

Longitudinal assessment from liquid biopsy of mutations in CD20: A pilot study using a PETE enrichment strategy. (ASCO 2025) - P1/2 | "Here we present the results from a pilot study screening patients treated with Glofitamab (CD20xCD3) using a single gene Primer Extension Target Enrichment (PETE) strategy for MS4A1 (CD20 gene) in liquid biopsies... This work identifies known and novel mutations in CD20 in plasma samples as a potential contributing mechanism to relapsed or refractory cases of NHL. Although the prevalence appears to be low, this is consistent with previous reports and supports investigation of the clinical utility, including utility as a potential predictive biomarker, of sequencing this gene during treatment with CD20xCD3 BsTCE. Future and ongoing work will screen additional cohorts and therapy combinations."

Biopsy • Clinical • Liquid biopsy • B Cell Lymphoma • Hematological Malignancies • Large B Cell Lymphoma • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • CD20 • MS4A1

Characterization of mechanisms driving CD20 loss in patients with relapsed or refractory large B-cell lymphoma treated with glofitamab. (ASCO 2025) - P1/2 | " Pts with LBCL and ≥2 prior therapies received obinutuzumab pretreatment followed by fixed-duration Glofitamab at the approved dose in phase I/II trial NP30179 (NCT03075696) (Dickinson, et al. In pts with R/R LBCL treated with Glofitamab, loss of tumor antigen CD20 expression is one resistance mechanism to Glofitamab. Genetic alterations (fs, del or missense mutations) and transcriptional downregulation can contribute to loss of CD20 expression and they were both observed in pts treated with Glofitamab. Acknowledgments: The NCT03075696 study is sponsored by F. Hoffmann-La Roche Ltd."

Clinical • B Cell Lymphoma • Hematological Malignancies • Large B Cell Lymphoma • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • CD20 • MS4A1 • PAX5

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 | "GLORY is a window-style, glofitamab-based, response-adapted study with polatuzumab-rituximab-miniCHP (pola-R-miniCHP) backbone specifically designed for unfit and frail older adults with DLBCL who are being treated with curative intent. This is a single stage design, and the study will be considered positive if 23 of 42 patients achieve a CR at the end of therapy. Additionally, the coprimary endpoint of CR rate after 2 cycles of glofitamab+polatuzumab will be used to stop for futility."

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

CHEMO-FREE REGIMENS CONTAINING GLOFITAMAB ARE SIGNIFICANTLY BENEFICIAL FOR RELAPSED/REFRACTORY DIFFUSE LARGE B CELL LYMPHOMA PATIENTS WITH TP53 GENE MUTATIONS: REAL-WORLD DATA FROM MULTI-CENTERS IN CHINA (EHA 2025) - "Background: TP53 gene mutations are an independent risk factor for the overall survival of patients with diffuse large B cell lymphoma (DLBCL), even though they receive the R-CHOP or Pola-R-CHP regimen as the frontline chemotherapy...Based on the nature of R/R DLBCL, chemo-free regimens are as follows below, acalabrutinib (100 mg twice daily) or zanubrutinib (160 mg twice daily) and obutinib (150 mg once daily), sintilimab (200 mg per cycle); glofitamab combined with polatuzumab vedotin (1.8 mg/kg) or lenalidomide (20 mg/day, days 1-14)... The chemo-free regimens combined with glofitamab displayed high efficacy and good tolerability in R/R DLBCL patients with TP53 gene mutations."

Clinical • Real-world • Real-world evidence • B Cell Lymphoma • Diffuse Large B Cell Lymphoma • Hematological Malignancies • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • TP53

Pharmacological Insights on USFDA-Approved Novel Drug Therapies in the Year 2023. (PubMed, Curr Drug Discov Technol) - "The novel drug therapies approved by the USFDA hold significant potential to enhance the patient's care by providing advanced treatment modalities. This manuscript, reporting the comprehensive description of therapeutic aspects of the mentioned new drug therapies, underscores the commitment of the pharmaceutical sector to address the unmet medical needs and reshape the landscape of the healthcare service system by instilling optimism among patients and healthcare providers."

FDA event • Journal • Pediatrics • Rare Diseases

A Study Evaluating the Safety and Efficacy of Glofitamab + Gemcitabine + Oxaliplatin in U.S. Patients With Relapsed or Refractory Diffuse Large B-Cell Lymphoma (clinicaltrials.gov) - P1 | N=50 | Recruiting | Sponsor: Hoffmann-La Roche | Trial primary completion date: Mar 2028 ➔ Mar 2030

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

Testing the Anti-cancer Drug, Glofitamab, in Patients With Mantle Cell Lymphoma (A Type of Blood Cancer) Whose Disease Returned After CAR-T Cell Therapy (clinicaltrials.gov) - P2 | N=20 | Not yet recruiting | Sponsor: National Cancer Institute (NCI)

New P2 trial • Hematological Malignancies • Lymphoma • Mantle Cell Lymphoma • Oncology

Bispecific Antibody-Based Salvage Therapy Followed by CAR-T ± ASCT in R/R Aggressive B-Cell Lymphoma (clinicaltrials.gov) - P2 | N=25 | Recruiting | Sponsor: Institute of Hematology & Blood Diseases Hospital, China

New P2 trial • B Cell Lymphoma • Hematological Malignancies • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology

Glofitamab in Real Life (clinicaltrials.gov) - P=N/A | N=250 | Not yet recruiting | Sponsor: The Lymphoma Academic Research Organisation

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

GO43075: A Study to Evaluate the Safety and Efficacy of Glofitamab in Combination With Rituximab (R) Plus Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone (CHOP) in Circulating Tumor (ct)DNA High-Risk Patients With Untreated Diffuse Large B-Cell Lymphoma (clinicaltrials.gov) - P2 | N=46 | Active, not recruiting | Sponsor: Hoffmann-La Roche | Trial completion date: Jun 2025 ➔ Sep 2026 | Trial primary completion date: Jun 2025 ➔ Oct 2024

Circulating tumor DNA • Trial completion date • Trial primary completion date • B Cell Lymphoma • Diffuse Large B Cell Lymphoma • Follicular Lymphoma • Hematological Malignancies • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • BCL2 • BCL6 • CD20 • MYC

Invitation to Roche’s Virtual Hematology Investor Event (Roche Press Release) - "We are pleased to invite investors and analysts to participate in our virtual event on Monday, 23 June 2025, to highlight new results from Roche’s Hematology pipeline including Phase III (STARGLO) Columvi in R/R DLBCL 2-year data , first presented at the American Society of Clinical Oncology (ASCO) Annual Meeting from 30 May-3 June, 2025, Phase III (POLARGO) data for Polivy in R/R DLBCL selected for Plenary presentation at both the European Hematology Association (EHA) Congress from 12-15 June 2025 and the International Conference on Malignant Lymphoma (ICML) from 17-21 June 2025..."

P3 data • Diffuse Large B Cell Lymphoma

GLOFITAMAB PLUS GEMCITABINE AND OXALIPLATIN (GLOFIT-GEMOX) IN PATIENTS WITH RELAPSED/REFRACTORY (R/R) DIFFUSE LARGE B-CELL LYMPHOMA (DLBCL): 2-YEAR FOLLOW-UP OF STARGLO (EHA 2025) - P3 | "In the Phase III randomized STARGLO trial, Glofit-GemOx demonstrated overall survival (OS) and progression-free survival (PFS) benefit over rituximab (R)-GemOx in autologous stem cell transplant (ASCT)-ineligible R/R DLBCL (Abramson, JS et al...After obinutuzumab pretreatment, glofitamab was given in Cycle (C) 1 as weekly step-up doses (2.5/10 mg) then 30 mg target dose every 21 days from C2 Day 1... With 2 years of follow-up, Glofit-GemOx sustained a clinically meaningful benefit in OS and PFS vs R-GemOx in ASCT-ineligible patients with R/R DLBCL, with most (82%) patients in CR at EOT still in remission. The safety profile was consistent with known risks of each drug. The updated analyses demonstrate durable remissions and maintained OS benefit in patients with R/R DLBCL treated with fixed duration Glofit-GemOx."

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

New two-year follow-up of Roche’s Columvi extends overall survival in relapsed or refractory diffuse large B-cell lymphoma patients (GlobeNewswire) - P3 | N=270 | STARGLO (NCT04408638) | Sponsor: Hoffmann-La Roche | "Roche...announced today two-year follow-up data from the phase III STARGLO study. After a median follow-up of 24.7 months, data showed a 40% improvement in overall survival (OS) for patients treated with Columvi (glofitamab) in combination with gemcitabine and oxaliplatin (GemOx) and OS was not reached, compared to 13.5 months for MabThera/Rituxan (rituximab) plus GemOx (R-GemOx)....There was a 59% reduction in the risk of disease progression or death (hazard ratio = 0.41, 95% confidence interval: 0.29–0.58) and more than twice as many patients sustained a CR (58.5% vs. 25.3%). Among patients with a CR at the end of the treatment period, 89% were alive and 82% had maintained remission one year after treatment."

P3 data • Diffuse Large B Cell Lymphoma

Glory: Glofitamab in Relapsed or Refractory Diffuse Large B-cell Lymphoma After CD19 Chimeric Antigen Receptor T-cell Therapy (clinicaltrials.gov) - P2 | N=30 | Active, not recruiting | Sponsor: Samsung Medical Center | Not yet recruiting ➔ Active, not recruiting | Initiation date: Aug 2024 ➔ Nov 2024

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

Novel Humanized anti-CD20 CAR-T cells Demonstrate Robust Efficacy in B-cell Lymphoma in Preclinical Studies. (ASGCT 2025) - "The efficacy of anti-CD20 therapies like Glofitamab post-CAR-T failure is well-established; however, high costs and limited availability restrict access to these therapies in India... The novel h2CAR20-T cells exhibit robust efficacy, and safety in preclinical models. This indigenous CD20 CAR-T product holds promise for use in combinational CAR-T therapy for r/r B-NHL. Disease Focus of Abstract:Lymphoma"

CAR T-Cell Therapy • IO biomarker • Preclinical • B Cell Lymphoma • Hematological Malignancies • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • IL2 • TNFA

FDA ODAC Votes Against the Applicability of STARGLO Data for Glofitamab Plus Chemo for U.S. Patients With R/R DLBCL (OncLive) - "The FDA’s Oncologic Drugs Advisory Committee (ODAC) voted 8 to 1 against the applicability of the patient population and results from the phase 3 STARGLO trial...to the United States (U.S.) population of patients with relapsed/refractory diffuse large B-cell lymphoma (DLBCL)....During the meeting, the regulatory agency raised concerns regarding the enrollment of STARGLO, which the FDA said was a multiregional trial with a large Asian population and smaller US representation. Additionally, the FDA flagged inconsistent efficacy results in different regional subgroups."

ODAC • Diffuse Large B Cell Lymphoma

INITIAL RESULTS FROM LOTIS-7: A PHASE 1B STUDY OF LONCASTUXIMAB TESIRINE PLUS GLOFITAMAB IN PATIENTS WITH RELAPSED/REFRACTORY (R/R) DIFFUSE LARGE B-CELL LYMPHOMA (DLBCL) (EHA 2025) - P1 | "Lonca + Glofit in R/R B-NHL showed a manageable safety profile consistent with each drug and encouraging efficacy in heavily pretreated aggressive lymphoma pts. Lonca + Glofit induced T-cell margination, and sustained circulating CD4+ and CD8+ T-cell activation was noted. Results support that Lonca complements Glofit's mechanism and provides additive efficacy."

Clinical • IO biomarker • P1 data • B Cell Lymphoma • Cardiovascular • Diffuse Large B Cell Lymphoma • Hematological Disorders • Hematological Malignancies • High-grade B-cell lymphoma • Infectious Disease • Lymphoma • Marginal Zone Lymphoma • Neutropenia • Non-Hodgkin’s Lymphoma • Oncology • Pneumonia • Respiratory Diseases • Septic Shock • CD20 • CD4 • CD8 • IL6

Cost Effectiveness of Glofitamab for Relapsed or Refractory Diffuse Large B-Cell Lymphoma Patients in China (ISPOR 2025) - "OBJECTIVES: Glofitamab, a bispecific antibody targeting CD3 and CD20, combined with gemcitabine and oxaliplatin (Glofit-GemOx), has demonstrated efficacy in treating relapsed or refractory diffuse large B-cell lymphoma (DLBCL). The Glofit-GemOx regimen was not cost-effective compared to the RCHOP regimen for the treatment of relapsed or refractory DLBCL in China."

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

EFFICACY AND SAFETY OF GLOFITAMAB COMBINED WITH TISLELIZUMAB IN RELAPSED/REFRACTORY DIFFUSE LARGE B-CELL LYMPHOMA: A PILOT STUDY IN CHINA (EHA 2025) - P1 | "In the first cycle, patients received obinutuzumab (1000 mg) on day 1, followed by glofitamab on day 8 (2.5 mg) and day 15 (10 mg). In this study, the combination of glofitamab and tislelizumab showed a favorable safety profile and an encouraging clinical outcomes. We have registered a phase 2, single-arm, prospective study (ChiCTR2400091464) to further evaluate its efficacy and safety."

Clinical • B Cell Lymphoma • Diffuse Large B Cell Lymphoma • Hematological Disorders • Hematological Malignancies • Infectious Disease • Lymphoma • Non-Hodgkin’s Lymphoma • Novel Coronavirus Disease • Oncology • CD20 • PD-1

BISPECIFIC ANTIBODIES AS HOLDING OR BRIDGING THERAPY BEFORE CAR-T IN LARGE B-CELL LYMPHOMA (EHA 2025) - "Other holding therapies before bridging with glofitamab or epcoritamab included rituximab and polatuzumab vedotin or R-GemOx...Furthermore, 7 patients were treated in the ICU after CAR-T therapy and 8 patients received tocilizumab after CART therapy. With the limitations of a small sample size and short follow-up, our data suggest that bridging therapy with bABs before CAR-T therapy is safe and effective. More detailed data in a larger group of patients with sufficient follow-up time will be presented at the conference."

B Cell Lymphoma • Hematological Disorders • Hematological Malignancies • Infectious Disease • Large B Cell Lymphoma • Lymphoma • Neutropenia • Non-Hodgkin’s Lymphoma • Oncology • Septic Shock