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

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 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

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

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 for relapsed/refractory DLBCL: 3-year follow-up of STARGLO. (PubMed, Blood Adv) - P3 | "In the phase 3 STARGLO trial (NCT04408638), glofitamab plus gemcitabine-oxaliplatin (Glofit-GemOx) demonstrated superior overall survival (OS) vs rituximab (R)-GemOx, in patients with autologous stem cell transplant (ASCT)-ineligible relapsed/refractory (R/R) diffuse large B-cell lymphoma (DLBCL). With extended follow-up, fixed-duration Glofit-GemOx continues to demonstrate superior survival vs R-GemOx in ASCT-ineligible patients with R/R DLBCL, with favorable outcomes pronounced in the 2L setting, and consistent across subgroups including elderly and early relapsing patients. These data support Glofit-GemOx as an effective off-the-shelf treatment with curative potential in R/R DLBCL."

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

Risk factors for CRS and ICANS with Bispecific Antibodies for Aggressive Lymphomas. (PubMed, Blood Adv) - "CRS occurred in 31% (Grade 3+: 5%) and ICANS in 8% (Grade 3+: 2%) of patients, with no significant differences across glofitamab, mosunetuzumab, or epcoritamab. All patients with Grade 3+ CRS had very high serum C-Reactive Protein (sCRP, ≥15 mg/L) and elevated ferritin (>336 ng/mL) when available. These findings identify candidate laboratory thresholds and treatment related factors that warrant prospection validation for risk stratification and outpatient BsAb administration."

Journal • B Cell Lymphoma • Hematological Malignancies • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • CRP

Cd3-Engaging Bispecific Antibodies Convert Human Regulatory T Cells into Cytotoxic Effectors (IMS 2026) - P2 | "11 patients were treated with teclistamab plus daratumumab, lenalidomide, and dexamethasone (Tec-DRD, n = 11) in the ongoing MajesTEC-5 (HD10/DSMMXX) trial (NCT05695508); 6 patients recived standard-of-care DRD as controls (n=6)...Generalizability was tested in vitro using three BTCEs (teclistamab (BCMA×CD3), blinatumomab (CD19×CD3), glofitamab (CD20×CD3)) to redirect primary human Tregs towards BCMA+, CD19+, and CD20+ cell lines... Our findings uncover a novel mechanism where BTCEs actively convert suppressive Tregs into cytotoxic, pro-inflammatory effectors that contribute to antitumor activity. Multi-color flow cytometry validates these dynamics in patients, showing a shift toward activated, cytotoxic memory Tregs. We identified the BATF/JUNB axis and IMiD-mediated Helios destabilization as targetable regulators of this process, supporting rational combination regimens to enhance T-cell-redirecting immunotherapies."

Bispecific • IO biomarker • Hematological Malignancies • Multiple Myeloma • FOXP3 • GZMA • IKZF2 • IL2RA • JUNB • NKG7 • TBX21

Accessing BTK Inhibitors and Other Novel Therapies for Mantle Cell Lymphoma: Are We All Invited to the Party? (SOHO 2024) - "In the phase 3 RAY trial,2 ibrutinib led to better responses and significant improvements in progression-free survival (PFS) and tolerability versus temsirolimus in patients with R/R MCL...In the SHINE trial,3 the combination of ibrutinib with bendamustine and rituximab for 6 cycles, followed by rituximab maintenance and ibrutinib until progression, led to an unprecedented PFS of 80.6 months in patients not eligible for ASCT...Second-generation BTK inhibitors have also been approved for R/R MCL, including acalabrutinib and zanubrutinib with a more favorable safety profile. In first line therapy, the results of bendamustine, rituximab, and acalabrutinib are expected to be presented soon...Pirtobrutinib, a third-generation non-covalent BTK inhibitor has shown promising activity in MCL after exposure to covalent BTK inhibitors. Moreover, the BCL-2 inhibitors, venetoclax and sonrotoclax, have also shown activity in the post-BTK inhibitor scenario, and sonrotoclax is..."

Chronic Lymphocytic Leukemia • Hematological Malignancies • Lymphoma • Mantle Cell Lymphoma • Non-Hodgkin’s Lymphoma • Oncology

GOLDILOX: FIRST EXPERIENCE OF TWO DOSING STRATEGIES OF PIRTOBRUTINIB AND GLOFITAMAB FOR MANTLE CELL LYMPHOMA PREVIOUSLY TREATED WITH COVALENT BTK INHIBITORS (ICML 2025) - P2 | "Cohort 1 and 2 (C1, C2) consisted of a 7-day pre-phase of pirto 200 mg daily and obinutuzumab IV pre-treatment of 2g in 2–3 divided doses over 1 week IV (dGPT), followed by pirto and either standard 2.5 mg/10 mg/30 mg step-up glo (SSG) IV or 1.25 mg/5 mg/10 mg/30 mg weekly. 16 pts were enrolled across C1–3, with 13 evaluable for the primary endpoint. Median age was 74 (range 67–77) yrs; 19% had blastoid/pleomorphic morphology, 81% had int-high MIPI, 62.5% had 17p deletion. Median number of prior therapies was 3 (range 2–3), all with prior cBTKi, 38% prior ASCT and 31% prior CAR-T."

Hematological Malignancies • Leukemia • Lymphoma • Mantle Cell Lymphoma • Oncology

GASTROINTESTINAL AND HEPATOBILIARY TOXICITY OF BISPECIFIC T-CELL ENGAGING ANTIBODIES: A COMPARATIVE DISPROPORTIONALITY ANALYSIS OF THE FAERS DATABASE (UEGW 2026) - "Since 2022, the FDA has approved five agents across three target classes: teclistamab (BCMA); mosunetuzumab, glofitamab, and epcoritamab (CD20); and talquetamab (GPRC5D). Bispecific TCEs demonstrate distinct, target-specific GI and hepatobiliary safety profiles, with several high-magnitude and predominantly unlabeled signals. CD20-directed agents were enriched for hepatotoxicity and perforation-related events, while GPRC5D-targeting therapy showed a concentrated oral toxicity profile. These hypothesis-generating findings support targeted clinical vigilance and prospective studies to define absolute risks."

Bispecific • Gastrointestinal Disorder • Hematological Malignancies • Hepatology • Immunology • Liver Failure • Xerostomia • GPRC5D

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

Glofitamab in combination with immunochemotherapy in patients with relapsed/refractory B-cell non-Hodgkin lymphoma: Phase 1b dose-escalation study. (PubMed, Br J Haematol) - P1 | "Glofitamab was investigated with obinutuzumab/rituximab plus cyclophosphamide, doxorubicin, vincristine and prednisone (G/R-CHOP) in patients with relapsed/refractory B-cell non-Hodgkin lymphoma (B-NHL) who had ≥1 prior obinutuzumab/rituximab-containing therapy (NCT03467373). Median progression-free survival was not reached after 44.2 months follow-up. Glofitamab plus G/R-CHOP showed promising benefit in relapsed/refractory B-NHL, supporting future investigation of glofitamab (2.5/10/30 mg) with R-CHOP in untreated diffuse large B-cell lymphoma."

Journal • P1 data • B Cell Lymphoma • B Cell Non-Hodgkin Lymphoma • Diffuse Large B Cell Lymphoma • Fatigue • Follicular Lymphoma • Hematological Disorders • Hematological Malignancies • Infectious Disease • Lymphoma • Mantle Cell Lymphoma • Marginal Zone Lymphoma • Non-Hodgkin’s Lymphoma • Oncology

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 | Active, not recruiting ➔ Recruiting

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

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

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 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

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

FRONTLINE PHASE II RITUXIMAB-POLATUZUMAB-GLOFITMAB (R-POLA-GLO) TRIAL DEMONSTRATES A MANAGEABLE SAFETY PROFILE AND HIGH RESPONSE RATES IN ELDERLY AND MEDICAL UNFIT PATIENTS WITH AGGRESSIVE LYMPHOMA (EHA 2025) - "R-Pola-Glo combines the anti-CD20 antibody rituximab (R), the antibody-drug conjugate polatuzumab vedotin (anti-CD79B, Pola) and the bispecific antibody glofitamab (CD20×CD3, Glo)...Cycle 1 includes obinutuzumab, Pola, and Glo with step-up dosing (2.5 mg and 10 mg); cycles 2-6 include R, Pola, and Glo at the 30 mg target dose, followed by six cycles of Glo consolidation (30 mg)... R-Pola-Glo demonstrates high EOT CMR rates with manageable safety, warranting its further clinical investigation as a potential first-line treatment option for elderly/frail and medically unfit pts with aggressive lymphoma.* Equal contributions"

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

Early Experience With Glofitamab Plus Polatuzumab Vedotin as Bridging Therapy Prior to CD19-Directed CAR T-Cell Therapy in Relapsed/Refractory Large B-Cell Lymphoma (SOHO 2026) - "Cycle 1: obinutuzumab (1000 mg) or rituximab (375 mg/m2) day 1, Pola (1.8 mg/kg) day 2, Glofit (2.5 mg) day 8 and (10 mg) day 15 in a 21-day cycle...After fludarabine-cyclophosphamide, a single Tali-cel infusion of ≥5 × 106 cells/kg was given... Glofit-Pola BT in R/R LBCL achieved high responses and enabled 93% to proceed to CAR-T therapy. Responses were largely maintained post Tali-cel. BT: bridging therapy, CAR-T: chimeric antigen receptor T-cell therapy, CI: confidence interval, CR: complete response, CRS: cytokine release syndrome, Glofit-Pola: glofitamab and polatuzumab vedotin, ICANS: immune effector cell–associated neurotoxicity syndrome, ICU: intensive care unit, LDH: lactate dehydrogenase, ORR: objective response rate, OS: overall survival, PD: progressive disease, PFS: progression-free survival, R/R LBCL: relapsed/refractory large B-cell lymphoma, SD: stable disease, Tali-cel: talicabtagene autoleucel."

CAR T-Cell Therapy • B Cell Lymphoma • Hematological Malignancies • Large B Cell Lymphoma • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology

NCI-2023-03181: Glofitamab With Obinutuzumab, Venetoclax, and Lenalidomide for the Treatment of Patients With Newly Diagnosed High Risk Mantle Cell Lymphoma (clinicaltrials.gov) - P1/2 | N=50 | Suspended | Sponsor: City of Hope Medical Center | Recruiting ➔ Suspended

Trial suspension • Hematological Malignancies • Lymphoma • Mantle Cell Lymphoma • Oncology • CCND1 • CDKN2A • KMT2D • NOTCH2 • NSD2 • SOX11 • TP53

Glofitamab in Relapsed/Refractory Mantle Cell Lymphoma: Results From a Phase I/II Study. (PubMed, J Clin Oncol) - P1/2 | "Fixed-duration glofitamab induced high CR rates in heavily pretreated patients with R/R MCL; the safety profile was manageable with appropriate support."

Journal • P1/2 data • Hematological Malignancies • Infectious Disease • Lymphoma • Mantle Cell Lymphoma • Non-Hodgkin’s Lymphoma • Oncology

UPCC 48420: CAR-T Followed by Bispecific Antibodies (clinicaltrials.gov) - P2 | N=23 | Active, not recruiting | Sponsor: Abramson Cancer Center at Penn Medicine | Recruiting ➔ Active, not recruiting

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

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

GLOFITAMAB MONOTHERAPY INDUCES DURABLE COMPLETE REMISSIONS AND HAS A MANAGEABLE SAFETY PROFILE IN PATIENTS WITH RICHTER’S TRANSFORMATION (ICML 2023) - P1/2 | "Pts received obinutuzumab pretreatment (1000 or 2000mg) 7 days before the first glofitamab dose and intravenous glofitamab at a fixed dose (0.6, 16, or 25mg) or with step-up dosing (SUD) in Cycle 1 (target dose 16 or 30mg) every 3 weeks for up to 12 cycles. Fixed-duration glofitamab monotherapy induces durable complete remissions and has a manageable safety profile in pts with RT. Glofitamab represents a potential therapy for pts with RT who have a high unmet need. Longer-term follow-up data will be presented."

Clinical • Monotherapy • Diffuse Large B Cell Lymphoma • Non-Hodgkin’s Lymphoma • Richter's Syndrome