Lunsumio (mosunetuzumab-axgb) / Roche, Biogen - LARVOL DELTA

Mosunetuzumab Plus Polatuzumab Vedotin vs Rituximab, Gemcitabine and Oxaliplatin in Patients With Relapsed/Refractory Large B-Cell Lymphoma: Updated Efficacy and Safety From the Phase 3 SUNMO Study Including Second-Line vs Third-Line or Later Patient Subgroups (SOHO 2026) - P3 | "Mosun-Pola continues to show notable efficacy with manageable safety in patients with ASCT-ineligible R/R LBCL, particularly in the 2L setting. 2L: second-line; 3L+: third-line and beyond; ASCT: autologous stem cell transplantation; CI: confidence interval; CR: complete response; CRS: cytokine release syndrome; DOCR: duration of complete response; DoR: duration of response; HR: hazard ratio; ICANS: immune effector cell-associated neurotoxicity syndrome; IRC: Independent Review Committee; LBCL: large B-cell lymphoma; LOT: line of therapy; Mosun-Pola: mosunetuzumab plus polatuzumab vedotin; ORR: objective response rate; OS: overall survival; PFS: progression-free survival; R-GemOx: rituximab, gemcitabine, and oxaliplatin; R/R: relapsed/refractory. This study (NCT05171647) is sponsored by F Hoffmann-La Roche Ltd."

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

Establishing T Cell–Engaging Bispecific Antibody Therapy in Community Practice (SOHO 2026) - "Introduction: T cell–engaging bispecific antibodies (TCEs) are increasingly used for relapsed or refractory malignancies, but implementation outside academic centers remains challenging because of step-up dosing requirements, cytokine release syndrome (CRS), immune effector cell–associated neurotoxicity syndrome (ICANS), supportive care needs, infections, and the requirement for immediate access to tocilizumab...Therapies included tarlatamab (n = 13), talquetamab (n = 6), teclistamab (n = 2), glofitamab (n = 3), and mosunetuzumab (n = 1)... A structured multidisciplinary care model (navigator, coordinator, infusion nurse, pharmacist, advanced nurse practitioner, hospitalist) incorporating standardized protocols, caregiver engagement, and rapid physician access enables safe, effective delivery and broader adoption of TCEs in the community."

Bispecific • Oncology

Mosunetuzumab with Response-Driven Lenalidomide Augmentation As First-Line Therapy for Symptomatic Follicular or Marginal Zone Lymphoma: Interim Analysis of a Multi-Center Phase 2 Study (ASH 2024) - P2 | "However, for the primary hypothesis evaluation, we used CT-based criteria to test the superiority of the CR rate over the historical 53% CR rate reported (using CT criteria only) with bendamustine/rituximab chemotherapy in the RELEVANCE trial (Morschhauser et al., NEJM 2018)...One patient received tocilizumab...Selective immune augmentation using low-dose continuous Len was safe and may facilitate conversion to CR for slow early responders. Study enrollment continues and both safety and efficacy analyses with longer follow-up will be presented."

Clinical • IO biomarker • P2 data • Cardiovascular • Fatigue • Follicular Lymphoma • Hematological Disorders • Hematological Malignancies • Hypertension • Infectious Disease • Lymphoma • Marginal Zone Lymphoma • Neutropenia • Oncology • Pneumonia • Respiratory Diseases • CD8 • LAG3 • PD-1

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

Fixed Duration Mosunetuzumab Plus Polatuzumab Vedotin Has Promising Efficacy and a Manageable Safety Profile in Patients with BTKi Relapsed/Refractory Mantle Cell Lymphoma: Initial Results from a Phase Ib/II Study (ASH 2023) - P1/2 | "Outcomes for R/R MCL pts with PD after the BTKi ibrutinib are very poor, demonstrated by a median overall survival of 2.9 months (Martin et al... Eligible pts had histologically confirmed R/R MCL and had received ≥2 prior regimens (including an anti-CD20 agent, BTKi, and anthracycline- or bendamustine-based therapy)...Ten pts (50%) experienced CRS events; 9 pts experienced Gr 1 events, and 1 pt experienced a Gr 2 event, which was managed with tocilizumab and low-flow oxygen... Fixed-duration Mosun SC in combination with Pola IV induced high CR rates in pts with R/R MCL who had previously received BTKi therapy, including those in high-risk subgroups and those who had received prior CAR T-cell therapy. CRs were observed early and persisted during the follow up period. M-Pola had a manageable safety profile, and all CRS events were low grade."

Clinical • P1/2 data • Alzheimer's Disease • B Cell Non-Hodgkin Lymphoma • CNS Disorders • Fatigue • Hematological Malignancies • Infectious Disease • Lymphoma • Mantle Cell Lymphoma • Musculoskeletal Pain • Non-Hodgkin’s Lymphoma • Ocular Inflammation • Oncology • Ophthalmology • Pain • Pneumonia • Pulmonary Disease • Respiratory Diseases • Uveitis • CD79B • TP53

Improvements in health-related quality of life (HRQoL) in the SUNMO study: Subcutaneous (SC) mosunetuzumab plus polatuzumab vedotin (Mosun-Pola) vs rituximab, gemcitabine and oxaliplatin (R-GemOx) in patients with relapsed/refractory (R/R) large B-cell lymphoma (LBCL) after at least one prior therapy (ASH 2025) - P3 | "In SUNMO, Mosun-Pola provided benefits across multiple aspects of HRQoL compared withR-GemOx, particularly in maintaining/improving physical functioning, fatigue, lymphoma symptoms, andPN. Pts treated with Mosun-Pola achieved clinically meaningful improvements in PROs, with scoresexceeding the MCID in several domains and exhibiting a delay in deterioration of >1 year for physicalfunctioning, and >2 months for PN and lymphoma symptoms. Improved PROs with Mosun-Pola vs R-GemOx suggest benefits in HRQoL with chemotherapy-free bispecific antibody combinations."

Clinical • HEOR • B Cell Lymphoma • Gastroenterology • Gastrointestinal Disorder • Gynecologic Cancers • Hematological Malignancies • Large B Cell Lymphoma • Lymphoma • Non-Hodgkin’s Lymphoma • Peripheral Neuropathic Pain

Mosunetuzumab Plus Polatuzumab Vedotin (MPola) Is Superior to Rituximab Plus Gemcitabine and Oxaliplatin (R-GemOx) in Autologous Stem Cell Transplant (ASCT)-Ineligible Patients With Relapsed/Refractory (R/R) Large B-cell Lymphoma (LBCL): Primary Results of the Phase 3 SUNMO Trial (SOHO 2025) - P3 | "M-Pola met its primary endpoints with statistically significant and clinically meaningful improvements in PFS and ORR compared with R-GemOx in the primary analysis of the phase 3 SUNMO study. M-Pola as a fixed-duration, outpatient, off-the-shelf regimen with a differentiated safety profile is an effective option for patients with transplant-ineligible R/R LBCL. SUNMO (NCT05171647) is sponsored by F. Hoffmann-La Roche Ltd."

Clinical • P3 data • B Cell Lymphoma • Hematological Malignancies • Large B Cell Lymphoma • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • CD20 • CD79B

Comparative Efficacy and Safety of Approved Therapies in ≥3L Relapsed/Refractory Large B-Cell Lymphoma: A Bayesian Network Meta-Analysis (SOHO 2026) - "Background: Multiple novel agents are approved for ≥3L relapsed/refractory large B-cell lymphoma, including chimeric antigen receptor T-cell (CAR-T) products (axicabtagene ciloleucel [axi-cel], lisocabtagene maraleucel [liso-cel], tisagenlecleucel [tisacel]), bispecific antibodies (epcoritamab, glofitamab, mosunetuzumab), antibody-drug conjugates (polatuzumab vedotin + bendamustine, rituximab [pola-BR], loncastuximab tesirine), and others (tafasitamab + lenalidomide, selinexor). CAR-T therapies ranked highest for CR rate but with greater toxicity and selection bias. Among bispecific antibodies, epcoritamab ranked among the most favorable for combined efficacy and safety (SUCRA, 58.3% vs 56.1% for glofitamab and 47.8% for mosunetuzumab). Given the near-disconnected, star-topology network and predominantly single-arm data, results carry very low certainty per CINeMA and should be interpreted cautiously."

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

Safety and efficacy of mosunetuzumab, a bispecific antibody, in patients with relapsed or refractory follicular lymphoma: a single-arm, multicentre, phase 2 study. (PubMed, Lancet Oncol) - P1/2 | "Fixed-duration mosunetuzumab has a favourable safety profile and induces high rates of complete remissions, allowing potential administration as an outpatient regimen, in patients with relapsed or refractory follicular lymphoma and two or more previous therapies."

Journal • P2 data • Diabetes • Follicular Lymphoma • Hematological Disorders • Hematological Malignancies • Inflammation • Lymphoma • Neutropenia • Non-Hodgkin’s Lymphoma • Oncology • Renal Disease

MOSUNETUZUMAB PLUS POLATUZUMAB VEDOTIN VERSUS RITUXIMAB, GEMCITABINE AND OXALIPLATIN IN LARGE B-CELL LYMPHOMA: UPDATED EFFICACY AND SAFETY FROM THE PHASE 3 SUNMO STUDY INCLUDING IN PATIENT SUBGROUPS (EHA 2026) - P3 | "Reused with permission. This abstract was accepted and previously presented at the 2026 ASCO Annual Meeting."

Clinical • P3 data • B Cell Lymphoma • Hematological Malignancies • Large B Cell Lymphoma • Lymphoma

MULTIVARIABLE ANALYSES OF OVERALL SURVIVAL IN THE PHASE 3 SUNMO, STARGLO AND POLARGO TRIALS IN RELAPSED/REFRACTORY LARGE B-CELL LYMPHOMA (EHA 2026) - P1/2, P3 | "Methods A multivariable Cox regression model was used to estimate treatment effect while adjusting for potential confounding factors selected by a systematic process involving: 1) univariable analysis of prespecified baseline factors; 2) multicollinearity assessment of pairwise correlation among selected factors; 3) MVA of the experimental arm (SUNMO: Mosun-Pola [an investigational regimen]; STARGLO: glofitamab [Glofit]-GemOx; POLARGO: Pola-R-GemOx [an investigational regimen]) vs the control arm (R-GemOx) and selected non-collinear prognostic baseline factors from steps 1 and 2. This abstract was accepted and previously presented at the 2026 ASCO Annual Meeting. ASCT, autologous stem cell transplant; BMI, body-mass index; CI, confidence interval; COO, cell of origin; ECOG PS, Eastern Cooperative Oncology Group Performance Status; HR, hazard ratio; IHC, immunohistochemistry; IPI, International Prognostic Index; LDH, lactate dehydrogenase; Mosun-Pola,..."

Clinical • P3 data • B Cell Lymphoma • Hematological Malignancies • Large B Cell Lymphoma • Lymphoma

RESPONSE-ADAPTED TREATMENT WITH MOSUNETUZUMAB WITH OR WITHOUT OBINUTUZUMAB AND POLATUZUMAB VEDOTIN IN TREATMENT NAÏVE FOLLICULAR AND MARGINAL ZONE LYMPHOMA: INTERIM RESULTS AND PHASED-SEQ MRD ANALYSIS (EHA 2024) - P2 | "Fixed duration mosun monotherapy achieves a high CR rate in untreated pts with follicular and marginal zonelymphoma, with high rates of MRD negativity. Obinutuzumab and pola appeared to reverse early signs oftreatment failure in patients with an inadequate radiographic and MRD response to mosun monotherapy."

Follicular Lymphoma • Hematological Malignancies • Herpes Zoster • Infectious Disease • Lymphoma • Marginal Zone Lymphoma • Oncology • Pain • Respiratory Diseases • Varicella Zoster

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

SUNMO: A phase III trial evaluating the efficacy and safety of mosunetuzumab in combination with polatuzumab vedotin vs rituximab plus gemcitabine and oxaliplatin in patients with relapsed/refractory aggressive B-cell non-Hodgkin lymphoma. (ASCO 2023) - P3 | "Enrollment is ongoing, and an estimated 75 sites globally will enroll approximately 222 pts (M-Pola, 148 pts; R-GemOx, 74 pts). Clinical trial information: NCT05171647."

Clinical • Combination therapy • P3 data • Bone Marrow Transplantation • Diffuse Large B Cell Lymphoma • Follicular Lymphoma • Hematological Malignancies • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • Transplantation • CD20 • CD79B

Mosunetuzumab with response-driven lenalidomide augmentation achieves high response rates and immune reprogramming in untreated follicular and marginal zone lymphoma: A multicenter Phase 2 trial (ASH 2025) - "Two pts receivedtocilizumab and 2 received dexamethasone. Fixed-duration Mosun with response-adapted low-dose Len augmentation attained a highCR rate, including MRD negativity, sparing most patients the toxicities of Len. Low-dose Len induced CD8⁺T-cell effector reactivation but did not prevent progression in cases of occult LBCL transformation.Progression was not usually associated with CD20 antigen loss, suggesting immune evasion as analternative resistance mechanism."

Clinical • IO biomarker • P2 data • B Cell Lymphoma • CNS Disorders • Follicular Lymphoma • Hematological Disorders • Hematological Malignancies • Hepatology • Immunology • Infectious Disease • Large B Cell Lymphoma • Lymphoma • Marginal Zone Lymphoma • Neutropenia • Non-Hodgkin’s Lymphoma • Pneumonia • Respiratory Diseases • Splenic Marginal Zone Lymphoma • CCR7 • CD20 • CD8 • CTLA4 • GZMB • HAVCR2 • IFNG • IRF4 • KLRG1 • LAG3 • PD-1 • TCF7 • TNFRSF9

Mosunetuzumab in Combination with Lenalidomide Has a Manageable Safety Profile and Encouraging Activity in Patients with Relapsed/Refractory Follicular Lymphoma: Initial Results from a Phase Ib Study (ASH 2021) - P1 | "No pt required tocilizumab, ICU admission, high flow oxygen, or vasopressor support. M+Len appears to have an acceptable safety profile in pts with R/R FL who have received at least one prior line of therapy, with encouraging preliminary anti-lymphoma activity observed. These data support initiation of a randomized Phase III study of M+Len versus rituximab+Len. Updated safety, efficacy, and pharmacokinetic data will be presented at the meeting."

Clinical • Combination therapy • P1 data • Febrile Neutropenia • Follicular Lymphoma • Hematological Disorders • Hematological Malignancies • Immune Modulation • Inflammation • Lymphoma • Neutropenia • Oncology • Transplantation • CSF3

Mosunetuzumab plus polatuzumab vedotin in transplant-ineligible refractory/relapsed large B-cell lymphoma: primary results of the phase 3 SUNMO trial. (PubMed, J Clin Oncol) - P3 | "Mosun-Pola demonstrated superior efficacy verus R-GemOx, with significant improvements in both overall response rate and progression-free survival, and infrequent cytokine release syndrome events with a manageable safety profile.(Funded by F. Hoffmann-La Roche Ltd; ClinicalTrials.gov, NCT05171647)."

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

Mosunetuzumab with Lenalidomide Augmentation As First-Line Therapy for Follicular (FL) and Marginal Zone Lymphoma (MZL) (ASH 2022) - P2 | "Background: The current standard first-line systemic therapy for symptomatic/high-burden FL and MZL includes immunochemotherapy, most commonly rituximab with bendamustine. Correlative studies aim at determining predictive biomarkers of response to first-line mosunetuzumab therapy (± lenalidomide augmentation), which include immune signatures based on circulating T-cell and macrophage subsets and serum cytokines. The investigators will further analyze changes in the circulating tumor DNA (ctDNA) during first-line immunotherapy with mosunetuzumab in this setting."

Clinical • IO biomarker • Bone Marrow Transplantation • Hematological Malignancies • Immune Modulation • Inflammation • Lymphoma • Marginal Zone Lymphoma • Oncology • Transplantation

Mosunetuzumab Monotherapy Demonstrates Durable Efficacy with a Manageable Safety Profile in Patients with Relapsed/Refractory Follicular Lymphoma Who Received ≥2 Prior Therapies: Updated Results from a Pivotal Phase II Study (ASH 2022) - P1/2 | "The efficacy of Mosun was compared with that of pts' last prior therapy: most pts (63%) received chemoimmunotherapy as their last prior therapy, and the remainder received PI3K inhibitor-containing regimens (8%), anti-CD20 antibodies plus lenalidomide (2%), CAR-T therapy (2%), or other therapies. In this updated analysis, with a median follow-up of 27 months, durable responses continued to be observed with Mosun in pts with R/R FL. Compared with pts' last prior therapy, Mosun demonstrated higher ORR and CR rates, with longer DOR, DOCR, PFS and time to next therapy, although limitations should be noted for retrospective comparisons and the absence of standardized imaging assessment for the last prior therapy. The safety profile, characterized by a low rate of AEs leading to treatment discontinuation and predominantly low-grade CRS events, was consistent with previous reports and supports the administration of Mosun as an outpatient regimen."

Clinical • Monotherapy • P2 data • Follicular Lymphoma • Hematological Malignancies • Inflammation • Lymphoma • Oncology

SUNMO: PHASE III TRIAL OF MOSUNETUZUMAB PLUS POLATUZUMAB VEDOTIN VERSUS RITUXIMAB PLUS GEMCITABINE AND OXALIPLATIN IN RELAPSED/REFRACTORY AGGRESSIVE NON-HODGKIN LYMPHOMA (ICML 2023) - P3 | "Enrollment is ongoing, and an estimated 75 sites globally will enroll approximately 222 pts (M-Pola, 148 pts; R-GemOx, 74 pts). Encore Abstract—previously submitted to ASCO 2023"

P3 data • Diffuse Large B Cell Lymphoma • Follicular Lymphoma • Hematological Malignancies • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • CD20 • CD79B

Preliminary Findings of a Phase Ib/II Trial Indicate Manageable Safety and Promising Efficacy for Mosunetuzumab in Combination with Lenalidomide (M+Len) in Previously Untreated (1L) Follicular Lymphoma (FL) (ASH 2023) - P1/2 | "This fixed-duration, chemotherapy-free M+Len regimen offers a convenient means for outpatient SC administration, and has a manageable early safety profile with promising anti-lymphoma activity in pts with 1L FL requiring systemic therapy, based on the preliminary data. Advancing M+Len into the first-line setting offers potential benefits in chemotherapy-naïve pts. Safety, efficacy, biomarker, and pharmacokinetic data from the complete cohort (40 pts) will be presented."

Clinical • Combination therapy • IO biomarker • P1/2 data • Follicular Lymphoma • Hematological Disorders • Hematological Malignancies • Lymphoma • Neutropenia • Ocular Inflammation • Oncology • Ophthalmology • Uveitis • CD4 • CD69 • CD8

Roche’s Lunsumio-based regimen significantly improves progression-free survival in follicular lymphoma in phase III CELESTIMO study (Roche Press Release) - "Results demonstrated a statistically significant and clinically meaningful improvement in progression-free survival (PFS). Overall survival (OS) data were immature at the time of interim analysis. The safety profile of the Lunsumio and lenalidomide combination was consistent with the known profiles of the individual study medicines, with no new safety signals identified. Data from the study will be submitted to health authorities and presented at an upcoming medical meeting."

P3 data • Follicular Lymphoma

FIL_MOZART: Study With Mosunetuzumab and Zanubrutinib in R/R Follicular Lymphoma Patients (clinicaltrials.gov) - P2 | N=56 | Active, not recruiting | Sponsor: Fondazione Italiana Linfomi - ETS | Recruiting ➔ Active, not recruiting

Enrollment closed • Follicular Lymphoma • Hematological Malignancies • Lymphoma • Oncology

Mosunetuzumab Monotherapy Continues to Demonstrate Promising Efficacy and Durable Complete Responses in Elderly/Unfit Patients with Previously Untreated Diffuse Large B-Cell Lymphoma (ASH 2022) - P1/2 | "Background: Elderly/unfit patients (pts) with diffuse large B-cell lymphoma (DLBCL) who are unable to tolerate standard first-line (1L) chemoimmunotherapy (CIT) due to age or pre-existing comorbidities, often receive no treatment, reduced-dose R-CHOP, or therapies such as R-CVP or R-bendamustine...Pre-phase prednisone with or without vincristine was allowed... Mosun monotherapy continued to demonstrate promising efficacy with durable responses and a manageable safety profile. These data support a potential future role for Mosun in elderly/unfit pts with previously untreated DLBCL and may help to identify pts whose tumors respond to treatment with bispecific antibody monotherapy."

Clinical • IO biomarker • Monotherapy • Chronic Kidney Disease • Diffuse Large B Cell Lymphoma • Fatigue • Febrile Neutropenia • Hematological Disorders • Hematological Malignancies • Infectious Disease • Inflammation • Lymphoma • Neutropenia • Non-Hodgkin’s Lymphoma • Novel Coronavirus Disease • Oncology • Pneumonia • Renal Disease • Respiratory Diseases • Transplantation • CD8

Subcutaneous (SC) Mosunetuzumab (mosun) As First-Line Therapy for Patients (pts) with High Tumor-Burden Follicular Lymphoma (FL): First Results of a Multicenter Phase 2 Study (ASH 2023) - "Premedication consisted of dexamethasone, diphenhydramine, and acetaminophen before each mosun dose during C1 and on C2D1 if cytokine release syndrome (CRS) occurred in C1...Hospitalization and tocilizumab were only required in the two pts who experienced G2 CRS... SC mosun demonstrated a manageable safety profile and highly encouraging efficacy in pts with newly diagnosed high-burden FL, including those with higher-risk disease. Assessment of durability of responses will require additional follow-up. Enrollment continues and updated data will be presented."

Clinical • P2 data • Dermatology • Diffuse Large B Cell Lymphoma • Fatigue • Follicular Lymphoma • Hematological Disorders • Hematological Malignancies • Infectious Disease • Lymphoma • Neutropenia • Oncology • Pneumonia • Respiratory Diseases