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

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

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 (ICML 2025) - P3 | "In the Phase 3 STARGLO trial, Glofit-GemOx demonstrated overall survival (OS) and progression-free survival (PFS) benefits over rituximab (R)-GemOx in autologous stem cell transplant (ASCT)-ineligible R/R DLBCL (Abramson 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 yrs of follow-up, Glofit-GemOx sustained a clinically meaningful benefit in OS and PFS versus 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 demonstrate durable 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 • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • CD20

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) (ICML 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 • Diffuse Large B Cell Lymphoma • Hematological Malignancies • High-grade B-cell lymphoma • Lymphoma • Marginal Zone Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • CD20 • CD4 • CD8 • IL6

Efficacy and Safety of Glofitamab Plus Polatuzumab Vedotin in Relapsed/Refractory Large B-Cell Lymphoma Including High-Grade B-Cell Lymphoma: Results From a Phase Ib/II Trial. (PubMed, J Clin Oncol) - P1/2 | "Glofit-Pola demonstrated high efficacy and durable responses, with manageable safety, in heavily pretreated patients with R/R LBCL, including patients with HGBCL and previous CAR T-cell therapy failure."

Journal • P1/2 data • B Cell Lymphoma • Hematological Malignancies • High-grade B-cell lymphoma • Large B Cell Lymphoma • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology

Mosunetuzumab (Mosun) or glofitamab (Glofit) in combination with golcadomide (Golca) demonstrates a manageable safety profile and encouraging efficacy in patients with relapsed or refractory (R/R) B-cell non-Hodgkin lymphoma (B-NHL) (ASH 2025) - P1 | "In Arm 2, ptsreceived intravenous obinutuzumab pretreatment on C1D1 and Glofit on C1D8 (2.5mg), D15 (10mg),then D1 of subsequent cycles (30mg); oral Golca was given daily from C2 or C3 onwards (D1–10; 21-daycycles) in dose escalation (0.2 or 0.4mg). Early data suggest Mosun/Glofit+Golca is an active regimen with a manageable safetyprofile consistent with the risks of individual agents. No new safety signals were observed; CRS eventswere low grade. Neutropenia was the most common overlapping toxicity and was manageable withprophylactic and therapeutic G-CSF."

Clinical • Combination therapy • B Cell Lymphoma • B Cell Non-Hodgkin Lymphoma • CNS Disorders • Cognitive Disorders • Developmental Disorders • Diffuse Large B Cell Lymphoma • Febrile Neutropenia • Follicular Lymphoma • Hematological Disorders • Hematological Malignancies • Herpes Zoster • Infectious Disease • Large B Cell Lymphoma • Lymphoma • Neutropenia • Non-Hodgkin’s Lymphoma • Thrombocytopenia • Varicella Zoster • CRBN • IKZF1

iMATRIX GLO: A Study to Evaluate Glofitamab Monotherapy and Glofitamab + Chemoimmunotherapy in Pediatric and Young Adult Participants With Relapsed/Refractory Mature B-Cell Non-Hodgkin Lymphoma (clinicaltrials.gov) - P1/2 | N=65 | Recruiting | Sponsor: Hoffmann-La Roche | Trial completion date: Sep 2029 ➔ Nov 2032 | Trial primary completion date: May 2029 ➔ Nov 2029

Monotherapy • Trial completion date • Trial primary completion date • B Cell Non-Hodgkin Lymphoma • Hematological Malignancies • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • Pediatrics • CD20 • CD4

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) (SOHO 2025) - P1 | "Lonca-Glofit in R/R B-NHL showed a manageable/consistent safety profile and encouraging efficacy in heavily pretreated aggressive lymphoma patients. Results suggest Lonca complements Glofit's mechanism and provides additive efficacy. Funding: ADC Therapeutics SA and Sobi; medical writing: Citrus Health Group."

Clinical • P1 data • B Cell Lymphoma • Diffuse Large B Cell Lymphoma • Hematological Malignancies • High-grade B-cell lymphoma • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • CD20 • CD4 • CD8 • IL6

CCTG LY18-A: Phase I Master Protocol of Novel Combination Therapy for Patients With Relapsed or Refractory Aggressive B-Cell Lymphoma (clinicaltrials.gov) - P1 | N=18 | Recruiting | Sponsor: Canadian Cancer Trials Group | Trial completion date: Jul 2026 ➔ Dec 2026 | Trial primary completion date: Dec 2025 ➔ Dec 2026

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

Glofitamab as a salvage therapy postallogenic hematopoietic stem cell transplant in relapsed-refractory Burkitt lymphoma. (PubMed, Leuk Lymphoma) - No abstract available

Journal • Bone Marrow Transplantation • Burkitt Lymphoma • Hematological Malignancies • Lymphoma • Oncology • Transplantation

Sustained clinical benefit of glofitamab plus gemcitabine and oxaliplatin (GemOx) versus rituximab plus GemOx (R-GemOx) in patients with relapsed/refractory (R/R) diffuse large B-cell lymphoma (DLBCL): 3-year follow-up of STARGLO (ASH 2025) - P3 | "We report updated efficacy and safety of Glofit-GemOxversus R-GemOx, with 3 years of follow-up, in patients with R/R DLBCL after ≥1 prior line of therapy (LOT)from the global Phase III STARGLO trial (NCT04408638).MethodsPatients were randomized 2:1 to either Glofit-GemOx (8 cycles plus 4 cycles glofitamab monotherapy) orR-GemOx (8 cycles) and stratified by number of prior LOT (1 vs ≥2) and refractoriness to last therapy.Following obinutuzumab pretreatment, glofitamab was given in Cycle 1 as weekly step-up doses(2.5/10mg), then 30mg target dose every 21 days from Cycle 2 Day 1. The safety profile remained consistent with the known risks of each study drug and wasmanageable. This updated analysis demonstrates the sustained remission and continued survivaladvantages that fixed-duration Glofit-GemOx offers for patients with R/R DLBCL."

Clinical • B Cell Lymphoma • Diffuse Large B Cell Lymphoma • Hematological Malignancies • Infectious Disease • Inflammation • Lymphoma • Non-Hodgkin’s Lymphoma • Novel Coronavirus Disease

Glofitamab and obinutuzumab (GLOBIN) as first-line therapy for patients with high-tumor burden follicular lymphoma: First results of a multicenter phase II trial (ASH 2025) - P2 | "G3 CRS (fever, hypoxia) developed in apt with lung involvement by lymphoma and resolved rapidly (<24 hours) after administration ofdexamethasone and tocilizumab. Glofit and obin has a manageable safety profile and is associated with high CMR rates among pts withpreviously untreated, high-tumor burden FL. Pre-treatment with 4 doses of obin appears to reduce therisk of CRS with no cases of G2 and 1 case of G3 CRS observed among 35 patients. These results supportfurther exploration of glofit in FL."

Clinical • P2 data • Cough • Dermatology • Follicular Lymphoma • Hematological Malignancies • Infectious Disease • Lymphoma • Marginal Zone Lymphoma • Musculoskeletal Pain • Neutropenia • Oncology • Pruritus • Respiratory Diseases

GLO-PACT: Glofitamab as a Bridge to and/or Consolidation Post Autologous Stem Cell Transplant in Patients With Relapsed B Cell Lymphomas (clinicaltrials.gov) - P2 | N=40 | Not yet recruiting | Sponsor: American University of Beirut Medical Center

New P2 trial • B Cell Lymphoma • Diffuse Large B Cell Lymphoma • Hematological Malignancies • Lymphoma • Neutropenia • Non-Hodgkin’s Lymphoma • Oncology • Transplantation • CD4

Sequential Bispecific Antibodies and CAR-T Use Is a Safe and Effective Strategy in Relapsed Refractory Hematologic Malignancies (TCT-ASTCT-CIBMTR 2026) - "BsAb was initiated for disease stabilization (60%) or progressive disease (PD) (40%) using talquetamab (20%), mosunetuzumab (20%), blinatumomab (30%), and glofitamab (30%) over a median of 58 days...CAR-T included axicabtagene ciloleucel (40%), brexucabtagene autoleucel (40%), and ciltacabtagene autoleucel (20%)...Compare CRS and ICANS rates between bispecific antibodies and CAR-T in the same patients. Contrast the toxicity profile of the sequential approach with that reported in pivotal CAR-T trials."

Acute Lymphocytic Leukemia • B Cell Non-Hodgkin Lymphoma • Cerebral Hemorrhage • CNS Disorders • Hematological Malignancies • Infectious Disease • Leukemia • Lymphoma • Multiple Myeloma • Non-Hodgkin’s Lymphoma • Oncology

GLOFITAMAB MONOTHERAPY IN PATIENTS WITH HEAVILY PRETREATED RELAPSED OR REFRACTORY MANTLE CELL LYMPHOMA: UPDATED ANALYSIS FROM A PHASE I/II STUDY (EHA 2024) - P1/2, P3 | " Eligible patients with R/R MCL received obinutuzumab pretreatment ( Gpt; 1000mg or 2000mg ) 7 days before their first glofitamab dose. Fixed-duration glofitamab continues to demonstrate compelling response rates that are maintained beyond EOT, with long-term durability observed in heavily pretreated patients with R/R MCL, including those with priorBTKi therapy. The safety profile was manageable and CRS was predominantly low grade. Glofitamab is a promising new therapy for patients with heavily pretreated R/R MCL, and glofitamab monotherapy ( 2000mg Gpt ) is currently under investigation in the Phase III GLOBRYTE study ( NCT06084936 ) ."

Clinical • Monotherapy • P1/2 data • Diffuse Large B Cell Lymphoma • Hematological Malignancies • Infectious Disease • Lymphoma • Mantle Cell Lymphoma • Novel Coronavirus Disease • Oncology • Septic Shock • BTK • CD20

Phase II frontline chemolight R-pola-glo trial induces high and durable response rates in elderly and medically unfit/frail patients with aggressive B-cell lymphoma (ASH 2025) - "For this reason, we developed R‑Pola‑Glo, comprising the CD20 antibodyrituximab (R), the antibody‑drug conjugate polatuzumab vedotin (anti‑CD79B; Pola), and the bispecificantibody glofitamab (CD20×CD3; Glo)...Cycle 1 included obinutuzumab, Pola, and step‑up Glo (2.5/10 mg); cycles 2‑6 combined R, Pola,and Glo at 30 mg; cycles 7‑12 consisted of Glo consolidation (30 mg)...Exploratory subgroup analysis suggested that R‑Pola‑Glo efficacy was consistent across allsGA risk groups and mitigated the adverse prognostic impact of classical IPI factors, including LDH.ConclusionsR-Pola-Glo achieved high and durable CMR rates with an expected and manageable safety profile,translating into favorable 1-year survival rates in elderly/frail and medically unfit patients with aggressiveB-cell lymphoma. Compared with other regimens for this population, R‑Pola‑Glo demonstrated higherresponse rates and improved survival outcomes at 1 year, strongly supporting its further..."

Clinical • P2 data • B Cell Lymphoma • Diffuse Large B Cell Lymphoma • Geriatric Disorders • Hematological Malignancies • Infectious Disease • Lymphoma • Non-Hodgkin’s Lymphoma • Respiratory Syncytial Virus Infections • CD79B

Glofitamab plus gemcitabine and oxaliplatin (GemOx) versus rituximab-GemOx for relapsed or refractory diffuse large B-cell lymphoma (STARGLO): a global phase 3, randomised, open-label trial. (PubMed, Lancet) - P3 | "Glofit-GemOx had a significant overall survival benefit compared with R-GemOx, supporting its use in transplant-ineligible patients with relapsed or refractory diffuse large B-cell lymphoma after one or more previous lines of therapy."

Clinical • Journal • P3 data • B Cell Non-Hodgkin Lymphoma • Diffuse Large B Cell Lymphoma • Hematological Malignancies • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • Transplantation

Fixed-Duration Glofitamab Monotherapy Continues to Demonstrate Durable Responses in Patients with Relapsed or Refractory Large B-Cell Lymphoma: 3-Year Follow-up from a Pivotal Phase II Study (ASH 2024) - P1/2 | "Methods : Patients with LBCL and ≥2 prior therapies received obinutuzumab pretreatment (1000mg) on Day (D)1 of Cycle (C)1. Evidence of B cell and immunoglobulin recovery after EOT was observed in patients in remission. These data support the potential for long-lasting remissions and a beneficial effect on immune system recovery in patients with R/R LBCL treated with fixed-duration glofitamab."

Clinical • Monotherapy • P2 data • B Cell Lymphoma • B Cell Non-Hodgkin Lymphoma • Hematological Disorders • Hematological Malignancies • Infectious Disease • Large B Cell Lymphoma • Lymphoma • Neutropenia • Non-Hodgkin’s Lymphoma • Oncology • Pancreatic Adenocarcinoma • Pancreatic Cancer

Englumafusp Alfa (CD19-4-1BBL) Combined with Glofitamab Is Safe and Efficacious in Patients with r/r B-NHL: Extended Follow up Analysis of the Dose-Escalation Part of Phase 1 Trial BP41072 (ASH 2024) - P1/2 | "Methods Pts with r/r B-NHL after at least one prior treatment, ECOG 0-1, received glofitamab step up dosing (2.5/10/30mg) after a single obinutuzumab dose (1000mg). Conclusions The off-the shelf glofitamab plus englumafusp alfa combination administered as a fixed duration treatment demonstrates a favorable activity in different r/r NHL subpopulations. A Phase 2 expansion study is currently underway."

Clinical • P1 data • Anemia • Diffuse Large B Cell Lymphoma • Hematological Disorders • Hematological Malignancies • Indolent Lymphoma • Infectious Disease • Lymphoma • Marginal Zone Lymphoma • Neutropenia • Non-Hodgkin’s Lymphoma • Oncology • Pneumonia • Respiratory Diseases

Glofitamab Plus Ibrutinib With Obinutuzumab for the Treatment of Patients With Mantle Cell Lymphoma, IGNITE MCL Trial (clinicaltrials.gov) - P1/2 | N=27 | Recruiting | Sponsor: OHSU Knight Cancer Institute | Not yet recruiting ➔ Recruiting

Enrollment open • Hematological Malignancies • Lymphoma • Mantle Cell Lymphoma • Oncology • CCND1 • CD20 • CD4 • CD5 • CDKN2A • KMT2D • NOTCH2 • NSD2 • PAX5 • SOX11 • TP53

Outpatient Administration of Bispecific Therapies in a Community Oncology Setting (TCT-ASTCT-CIBMTR 2026) - "Most adverse events are managed at home with oral dexamethasone and Tylenol, with IV dexamethasone or tocilizumab availability at the clinic. Findings & Interpretation Between March 2023 and July 2025, the TCT clinic treated 61 patients with outpatient BiTEs including Teclistamab, Talquetamab, Epcoritamab, Mosunetuzumab, Glofitamab, and Tarlatamab...Discussion & Implications This model demonstrates that outpatient BiTE therapy is feasible and safe in a community setting. With structured protocols, nursing support, and caregiver engagement, complex therapies can be delivered outside the hospital, expanding access and reinforcing the vital role of oncology nurses in advanced outpatient care."

Clinical • CNS Disorders • Endocrine Disorders • Hematological Malignancies • Metabolic Disorders • Solid Tumor

Glofitamab monotherapy retreatment in patients with heavily pre-treated relapsed or refractory (R/R) non-Hodgkin lymphoma (NHL): Results from a phase I/II study. (ASCO 2024) - P1/2 | "Initial treatment included obinutuzumab pre-treatment (Gpt) 7 days before the first glofitamab dose, then glofitamab intravenously at either a fixed dose of 0.015–25mg (14- or 21-day cycles) or step-up dosing (2.5mg, then 10mg in Cycle [C] 1, followed by a target dose of 16 or 30mg [C2 onward, 21- day cycles]) for up to 12 cycles. Glofitamab monotherapy retreatment was efficacious in heavily pre-treated pts with R/R NHL who responded to initial glofitamab treatment before subsequent progression. The safety profile was consistent with that of initial treatment."

Clinical • Monotherapy • P1/2 data • Diffuse Large B Cell Lymphoma • Follicular Lymphoma • Hematological Malignancies • Lymphoma • Mantle Cell Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • CD20

A prospective, multicenter, single-arm clinical study to evaluate the efficacy and safety of glofitamab in combination with gemcitabine, dexamethasone, and cisplatin (Glofit-GDP) as salvage therapy for patients with relapsed/refractory diffuse large B-cell lymphoma (ChiCTR) - P=N/A | N=43 | Not yet recruiting | Sponsor: The First Affiliated Hospital, College of Medicine, Zhejiang University; The First Affiliated Hospital, College of Medicine, Zhejiang University

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

Glofitamab Plus Polatuzumab Vedotin Continues to Demonstrate Frequent and Durable Responses and Has a Manageable Safety Profile in Patients with ≥2L Relapsed/Refractory DLBCL, Including HGBCL, and in Patients with Prior CAR T-Cell Therapy: Updated Results from a Phase Ib/II Study (ASH 2023) - P1/2 | " Patients received obinutuzumab 1000mg on Cycle (C) 1 Day (D) 1 to mitigate the risk of severe cytokine release syndrome (CRS). Glofit+Pola demonstrated high response rates and durable responses in heavily pre-treated patients, the majority of whom were refractory to their last prior therapy, across all histologies, including in patients with HGBCL and those with prior CAR T-cell therapy. The safety profile was manageable and consistent with the individual drugs. The rates of CRS events and AEs potentially consistent with ICANS were low."

CAR T-Cell Therapy • Clinical • P1/2 data • B Cell Lymphoma • Diffuse Large B Cell Lymphoma • Follicular Lymphoma • Hematological Disorders • Hematological Malignancies • High-grade B-cell lymphoma • Infectious Disease • Large B Cell Lymphoma • Lymphoma • Neutropenia • Non-Hodgkin’s Lymphoma • Oncology • Primary Mediastinal Large B-Cell Lymphoma • CD79B

Glofitamab for Relapsed or Refractory Diffuse Large B-Cell Lymphoma. (PubMed, N Engl J Med) - P1/2 | "Glofitamab therapy was effective for DLBCL. More than half the patients had an adverse event of grade 3 or 4. (Funded by F. Hoffmann-La Roche; ClinicalTrials.gov number, NCT03075696.)."

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

GLOFITAMAB+R-CHOP IN PATIENTS WITH PREVIOUSLY UNTREATED LARGE B-CELL LYMPHOMA DEFINED AS HIGH RISK BY CIRCULATING TUMOR DNA (ctDNA) DYNAMICS: PRIMARY RESULTS (ICML 2025) - P2 | "Dynamic on-treatment risk assessment using ctDNA offers the potential to identify high-risk pts with LBCL. 1L Glofit+R-CHOP induced high response rates with a manageable safety profile at EOT in pts with high-risk (by ctDNA) LBCL."

Circulating tumor DNA • Clinical • B Cell Lymphoma • Hematological Malignancies • Large B Cell Lymphoma • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology