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

Tocilizumab Dosing for Management of T Cell-Engaging Bispecific Antibody-Related CRS in Patients With R/R B-Cell NHL. (PubMed, Clin Pharmacol Ther) - "Using this model, which incorporates target binding and receptor occupancy, we propose a new tocilizumab dosing regimen that is based on quantitative clinical pharmacology, cytokine analyses, and clinical practice patterns in patients with relapsed/refractory B-cell non-Hodgkin's lymphoma (R/R B-NHL) treated with the anti-CD20 bsAb mosunetuzumab or glofitamab. This schedule (up to two 8 mg/kg intravenous tocilizumab doses per CRS event at least 8 hours apart and a maximum of three doses in 6 weeks) can be used to effectively manage acute CRS induced by anti-CD20 bsAb in patients with R/R B-NHL."

Journal • B Cell Non-Hodgkin Lymphoma • Hematological Malignancies • Immunology • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • Pediatrics • Systemic Inflammatory Response Syndrome • IL6R

A Multicenter, Single-Arm, Open-Label, Phase II Trial of Mosunetuzumab in Combination With Tislelizumab for r/r FL (clinicaltrials.gov) - P2 | N=22 | Not yet recruiting | Sponsor: Tianjin Medical University Cancer Institute and Hospital

New P2 trial • Follicular Lymphoma • Hematological Malignancies • Lymphoma • Oncology

TISAGENLECLEUCEL VERSUS MOSUNETUZUMAB IN RELAPSED/REFRACTORY FOLLICULAR LYMPHOMA: AN UPDATED MATCHING-ADJUSTED INDIRECT COMPARISON (MAIC) ANALYSIS AFTER 3-YEAR FOLLOW-UP DATA (EHA 2025) - P1/2, P2 | "Efficacy outcomes (per investigator assessment), i.e., PFS, OS, ORR, and complete response (CR) rate, and safety outcomes, i.e., cytokine release syndrome (CRS), tocilizumab and corticosteroid use for CRS management, and immune effector cell-associated neurotoxicity syndrome (ICANS) were compared between tisagenlecleucel and mosunetuzumab after adjustment of baseline characteristics. In this updated MAIC analysis using 3-year follow up data, tisagenlecleucel continued to demonstrate more favorable PFS, ORR, and CR than mosunetuzumab in patients with r/r FL after adjustment for baseline characteristics. Despite a numerical benefit in hazard of death for tisagenlecleucel, OS was not mature enough to demonstrate significance and a longer follow-up is needed. Safety comparison remained unchanged with the extended follow-up, showing comparable CRS and ICANS rates between the two treatments."

Follicular Lymphoma • Hematological Malignancies • Lymphoma • Oncology

T-Cell Redirecting Strategies in Large B-Cell Lymphoma and Follicular Lymphoma (ICML 2025) - "The randomized STARGLO trial compared the combination of glofitamab with gemcitabine and oxaliplatin (GemOx) versus rituximab-GemOx, meeting its primary endpoint of OS in favor of the experimental arm (HR 0.62 [95% CI 0.43–0.88])...Other treatment options to consider in this R/R patient population are tafasitamab/lenalidomide [107], loncastuximab tesirine [108] and rituximab-bendamustine-polatuzumab [109], amongst others...Three CAR-T constructs are available based on Phase 2, single-arm trials, namely ZUMA-5 (axi-cel), ELARA (tisa-cel), and TRANSCEND-FL (liso-cel)...Mosunetuzumab, epcoritamab and odronextamab received regulatory approval (U.S...She started treatment with a bispecific antibody, aiming to carry out her first imaging assessment after three cycles. Permission to Reproduce Material From Other Sources The author has nothing to report."

IO biomarker • B Cell Lymphoma • Diffuse Large B Cell Lymphoma • Follicular Lymphoma • Hematological Malignancies • High-grade B-cell lymphoma • Large B Cell Lymphoma • Lymphoma • Mediastinal B Cell Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • Primary Mediastinal Large B-Cell Lymphoma • T Cell Histiocyte Rich Large B Cell Lymphoma • T Cell Non-Hodgkin Lymphoma • CD19

Nodular Lymphocyte-Predominant Hodgkin Lymphoma: Update on Biology and Treatment (ICML 2025) - P2 | "A single-center analysis included 27 NLPB/HL patients treated with R-CHOP (rituximab, cyclophosphamide, doxorubicin, vincristine, prednisone) either alone or followed by consolidation RT...A different analysis investigated 20 patients who had treatment with BR (bendamustine, rituximab)...At 26 months, the 2-year PFS estimate among 28 patients with relapsed NLPB/HL treated with eight weekly doses of ofatumumab was 80%...Novel approaches that might play a role in the future treatment of NLPB/HL include chimeric antigen receptor T-cell therapy and bispecific antibodies. A study investigating the CD20xCD3 bispecific antibody mosunetuzumab in NLPB/HL (NCT05886036) is currently open for recruitment in North America [55]."

IO biomarker • B Cell Lymphoma • B Cell Non-Hodgkin Lymphoma • Classical Hodgkin Lymphoma • Diffuse Large B Cell Lymphoma • Hematological Malignancies • Hodgkin Lymphoma • Indolent Lymphoma • Large B Cell Lymphoma • Lymphoma • Nodular Lymphocyte Predominant Hodgkin Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • T Cell Histiocyte Rich Large B Cell Lymphoma • BCL6 • CARD11 • CD163 • CD4 • CD79A • CD8 • DUSP2 • IGH • IRF4 • JAK2 • JUNB • MME • NOTCH2 • PAX5 • PD-1 • PD-L1 • SOCS1 • STAT6 • TET2 • TNFRSF8

Cost effectiveness of mosunetuzumab and CAR-T cell therapy in relapsed/refractory follicular lymphoma. (PubMed, Leuk Lymphoma) - "T cell redirecting therapies, including mosunetuzumab (mosun), axicabtagene ciloleucel (axi-cel), and tisagenlecleucel (tisa-cel), are FDA-approved for relapsed refractory follicular lymphoma (FL) in the 3rd line and beyond. Our base case analysis over 10 years showed that mosun provided $67,654 more Net Monetary Benefit (NMB) per patient than axi-cel and $111,709 more than tisa-cel. These findings suggest mosun is cost-effective at a $150,000 willingness-to-pay per QALY."

HEOR • Journal • Follicular Lymphoma • Hematological Malignancies • Hodgkin Lymphoma • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology

Therapy Sequencing in Relapsed/Refractory MCL (ICML 2025) - P1, P1/2, P2, P3 | "Although a direct comparison between them has only been performed for ibrutinib and temsirolimus [23], covalent BTK inhibitor (cBTKi) single agent therapy has been consolidated as the standard of care after first-line CIT. Moreover, to address cBTKi failure, two anti-CD19 CAR-T cell therapy products, brexucabtagene autoleucel [20, 21] and lisocabtagene maraleucel [22], and the first noncovalent BTKi, pirtobrutinib [19], have recently been approved...Liso-cel only FDA approved; CIT, chemoimmunotherapy options include BR, R-BAC, R-CHOP, R-DHAP or R-DHAOx, R-GEMOx, paliative options (avoid bendamustine pre-CART apheresis); pirtobrutinib, available after cBTKi failure in second-line (EMA) but third-line (FDA); RM, rituximab maintenance...Orelabrutinib [18] is licensed only in China...Of note, both acalabrutinib and zanubrutinib induce lower rates of atrial fibrillation, hypertension, and bleeding compared to ibrutinib in randomized studies..."

IO biomarker • Chronic Lymphocytic Leukemia • Diffuse Large B Cell Lymphoma • Hematological Malignancies • Leukemia • Lymphoma • Mantle Cell Lymphoma • Oncology • PLCG2 • TP53

TISAGENLECLEUCEL VERSUS MOSUNETUZUMAB IN RELAPSED/REFRACTORY FOLLICULAR LYMPHOMA: A MATCHING-ADJUSTED INDIRECT COMPARISON USING 3-YEAR FOLLOW-UP DATA (ICML 2025) - P1/2, P2 | "Efficacy (PFS, OS, ORR, and complete response [CR] rate) and safety (cytokine release syndrome [CRS], tocilizumab and corticosteroid use, and immune effector cell-associated neurotoxicity syndrome [ICANS]) outcomes were compared. Updated MAIC analysis shows that tisagenlecleucel continues to demonstrate more favorable PFS, ORR, and CR than mosunetuzumab in patients with R/R FL. Despite a numerical benefit in hazard of death for tisagenlecleucel, OS was not mature enough to demonstrate significance, and a longer follow-up is needed. Safety outcomes remain similar with comparable CRS and ICANS rates."

Follicular Lymphoma • Hematological Malignancies • Lymphoma • Oncology

Follicular Lymphoma: Current Therapeutic Landscape and Future Prospects (ICML 2025) - P3 | "The ability of maintenance rituximab, obinutuzumab induction, or bendamustine-based induction to lower early progression rates without affecting OS or HT rate [10, 12, 18] suggests that not all POD24 cases are equal, with a subset remaining resistant to current treatments...Since 2021, three CAR-T constructs—axicabtagene-ciloleucel (axi-cel), tisagenlecleucel (tisa-cel), and lisocabtagene maraleucel (liso-cel)—and three CD3 × CD20 BsAbs—mosunetuzumab, epcoritamab, and odronextamab—have gained regulatory approval in Europe and/or US as options for third line and later...Loncastuximab tesirine (CD19-directed ADC) shows promising activity in 2L+ R/R FL (CR 67%, manageable toxicity in a small Phase 2 cohort) [40]. Adding tafasitamab, an anti-CD19 antibody, to R2 in R/R FL patients improved PFS by 57% in the inMIND trial after a median follow-up of 14 months [41]...However, the ROSEWOOD trial showed obinutuzumab-zanubrutinib was superior to Obinutuzumab alone..."

IO biomarker • B Cell Lymphoma • Follicular Lymphoma • Hematological Malignancies • Large B Cell Lymphoma • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • T Cell Non-Hodgkin Lymphoma • EZH2 • IGH

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

Lunsumio IV: Data from P3 CELESTIMO trial (NCT04712097) in combination with lenalidomide for 2L+ follicular lymphoma in H2 2025 (Roche) - Roche’s Virtual Hematology Investor Event

P3 data • Follicular Lymphoma • Hematological Malignancies • Oncology

Lunsumio SC: “Lunsumio SC + Len induction with Lunsumio SC maintenance led to high response rates and durable responses in 1l HTB FL patients”; Follicular lymphoma (Roche) - Roche’s Virtual Hematology Investor Event

P1/2 data • Follicular Lymphoma • Hematological Malignancies • Oncology

Lunsumio SC + Polivy: “Mosun-Pola demonstrates a 59% risk reduction for progression or death compared with R-GemOx”; Large B-cell lymphoma (Roche) - Roche’s Virtual Hematology Investor Event

P3 data • Diffuse Large B Cell Lymphoma • Hematological Malignancies • Oncology

Lunsumio SC: “Lunsumio SC monoTx promising in 1L high-tumor burden FL (ORR: 87.3%; CRR: 60.8%)”; Follicular lymphoma (Roche) - Roche’s Virtual Hematology Investor Event

P2 data • Follicular Lymphoma • Hematological Malignancies • Oncology

Marginal Zone Lymphoma: Treatment Update With a Focus on Systemic Approaches (ICML 2025) - P2, P3 | "Amongst 454 enrolled patients and with a median follow up time of over 7 years, the combination of rituximab plus chlorambucil had superior EFS (5-year EFS 68% vs. 50%) but no difference in overall survival which was excellent at 90% [17]. Other approaches added bendamustine to rituximab...Initial trials with the first-in-class covalent BTKi inhibitor, ibrutinib, were promising...The second generation covalent BTKi zanubrutinib and acalabrutinib have also been evaluated in RR MZL, with zanubrutinib receiving regulatory approval in the United States and the European Union...Unfortunately, the first-in-class PI3Kδ inhibitor, idelalisib, was associated with significant toxicities, including infection and immune-mediated complications...In MZL, there is a recent publication of parsaclisib with intriguing findings [29]...ZUMA-5 is a multicenter Phase 2 trial of axicabtegene ciloleucel (axi-cel) conducted in patients with both FL and MZL [30]...Several CD20xCD3 BsAbs,..."

IO biomarker • B Cell Lymphoma • Diffuse Large B Cell Lymphoma • Extranodal Marginal Zone Lymphoma • Follicular Lymphoma • Hairy Cell Leukemia • Hematological Malignancies • Hodgkin Lymphoma • Indolent Lymphoma • Leukemia • Lymphoma • Marginal Zone Lymphoma • Nodal Marginal Zone Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • Splenic Marginal Zone Lymphoma • CD5 • CRBN • MME • MYD88 • PIK3CD

MOSUNETUZUMAB PLUS POLATUZUMAB VEDOTIN IS SUPERIOR TO R-GemOx IN TRANSPLANT-INELIGIBLE PATIENTS WITH R/R LBCL: PRIMARY RESULTS OF THE PHASE III SUNMO TRIAL (ICML 2025) - P3 | "The primary analysis of the Phase III SUNMO study demonstrated that M-Pola, a novel bispecific-ADC combination therapy, met its primary endpoints with a statistically significant and clinically meaningful improvement in PFS and ORR compared with R-GemOx. Mosunetuzumab plus polatuzumab vedotin as a fixed-duration, outpatient, off-the shelf regimen with a differentiated safety profile is an effective and valuable option for pts with transplant-ineligible R/R LBCL."

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

NEW TRENDS IN LYMPHOMA TREATMENT IN WESTERN COUNTRIES (ICML 2025) - "Second-line CAR T-cells have shown a remarkable superiority when compared to autologous stem cell transplant (ASCT) in DLBCL patients failing frontline approach (not achieving a complete response or relapsing within one year since the end of induction), which concretizes in a median event-free survival gain of at least 8 months for both axicabtagene ciloleucel and lisocabtagene maraleucel...Longer follow-up is also available for glofitamab and epcoritamab in DLBCL: for both it can be demonstrated that a 55%–64% of patients are still in CR at 24 months, and that among patients who obtained a CR at the end or during treatment (depending on the agent used) the 2-year overall survival largely exceeds 70%. Mosunetuzumab in follicular lymphoma has yielded a progression-free survival rate of 38% at 4 years, with no significant differences observed between patients progressing within 24 months since frontline treatment (POD24) and non-POD24 ones. The TRIANGLE trial has shown..."

B Cell Lymphoma • Diffuse Large B Cell Lymphoma • Follicular Lymphoma • Hematological Malignancies • Indolent Lymphoma • Lymphoma • Mantle Cell Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • Peripheral T-cell Lymphoma • T Cell Non-Hodgkin Lymphoma • JAK1

ADVANCING NURSING KNOWLEDGE OF CD20-CD3 BISPECIFIC ANTIBODY TREATMENT FOR B-CELL NON-HODGKIN LYMPHOMA IN AUSTRALIA: A SCOPING REVIEW OF ADVERSE EVENTS TO INFORM PRACTICE (ICML 2025) - "Six BsAbs were identified: epcoritamab, glofitamab, imvotamab, mosunetuzumab, odronextamab and plamotamab...Supportive management, tocilizumab and corticosteroids were used for the treatment of CRS... BsAbs represent an effective treatment option in B-NHL with a unique side-effect profile. Some agents are now available through compassionate access programs in Australia and are increasingly encountered in routine practice around the world. This is the first published scoping review to synthesize evidence from clinical trials of BsAbs for nursing practice, informing nurses of the most common AEs and nursing led interventions for safe delivery and informed the development of an education package."

Adverse events • Review • B Cell Non-Hodgkin Lymphoma • Hematological Malignancies • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • CD20

FIXED-DURATION OUTPATIENT SUBCUTANEOUS MOSUNETUZUMAB + POLATUZUMAB VEDOTIN SHOWS ROBUST EFFICACY IN A PHASE II STUDY OF RELAPSED/REFRACTORY POST-BTKi MANTLE CELL LYMPHOMA (ICML 2025) - P1/2 | "Fixed-duration, outpatient M-Pola demonstrates robust efficacy and manageable safety in R/R MCL, including in high-risk subgroups and the post-CAR T-cell setting. M-Pola appears to be a suitable regimen for pts with R/R MCL in need of rapid disease control."

Clinical • P2 data • Hematological Malignancies • Lymphoma • Mantle Cell Lymphoma • Oncology • TP53

MOSUNETUZUMAB (MOSUN) PRODUCES DURABLE BENEFIT IN PATIENTS (PTS) WITH NEWLY DIAGNOSED FOLLICULAR LYMPHOMA (FL): EXTENDED FOLLOW UP OF THE MITHIC-FL1 TRIAL (ICML 2025) - "In pts with newly diagnosed high-burden FL, single-agent SC mosun showed high CR rates irrespective of clinical or cytogenetic risk factors, and most pts remain progression-free. Additional cytogenetic and molecular data will be presented."

Clinical • IO biomarker • B Cell Lymphoma • Diffuse Large B Cell Lymphoma • Follicular Lymphoma • Hematological Malignancies • Lymphoma • Oncology • BCL2 • BCL6 • CD20 • CREBBP • DNMT3A • EP300 • KMT2D • SOCS1 • TNFAIP3 • TNFRSF14

FIXED DURATION SUBCUTANEOUS MOSUNETUZUMAB IN PATIENTS WITH PREVIOUSLY UNTREATED HIGH-TUMOR BURDEN FOLLICULAR LYMPHOMA: INTERIM RESULTS FROM THE PHASE II MORNINGSUN STUDY (ICML 2025) - P2 | "Mosunetuzumab SC demonstrated promising efficacy in patients with previously untreated high-tumor burden FL. The manageable safety profile, including rate of CRS, supports the administration of fixed duration mosunetuzumab SC in an outpatient setting. Additional data, including cytokine profiling and T/B/NK dynamics, will be presented."

Clinical • P2 data • Follicular Lymphoma • Hematological Malignancies • Lymphoma • Oncology • CD20

MACHINE LEARNING BASED UNSUPERVISED MULTIMODAL ANALYSIS IDENTIFIES PATIENT SUBSETS ASSOCIATED WITH RESPONSE TO MOSUNETUZUMAB IN RELAPSED/REFRACTORY NHL (ICML 2025) - P1/2 | "Background: Mosunetuzumab (mosun) is a CD20xCD3 T-cell engaging bispecific antibody that has received accelerated approval for the treatment of relapsed/refractory (R/R) follicular lymphoma. We identified distinct, histology independent, NHL subpopulations with unique tumor and immune profiles that exemplify the heterogeneity of NHL. Combination strategies that target immune dependent and independent mechanisms (e.g., MYC) could further improve treatment outcomes. Studies evaluating the combination of mosun with chemotherapy, targeted therapy (e.g., polatuzumab vedotin) or immunomodulatory agents are ongoing."

Clinical • Machine learning • Follicular Lymphoma • Lymphoma • Non-Hodgkin’s Lymphoma • CD20 • CD4 • CD8 • IFNG • IL6 • PAX5 • SMARCA2

HIGH COMPLETE RESPONSE RATES AND DIFFERENTIAL TOXICITY OF MOSUNETUZUMAB AND LENALIDOMIDE IN PREVIOUSLY UNTREATED FOLLICULAR AND MARGINAL ZONE LYMPHOMA (ICML 2025) - P2 | "CRS occurred in 10 pts (21%, all G1); 2 pts (4%) received tocilizumab. First-line Mosun with response-adapted Len immune augmentation achieved high CR rates including MRD negativity. The NK cell activation and association with EOT CR suggests that Mosun may elicit broader anti-lymphoma immunity, which could be exploited for improved efficacy. The higher CRS rates observed in the 3 patients with SMZL may suggest the need for additional risk mitigation strategies."

Clinical • Follicular Lymphoma • Hematological Malignancies • Leukemia • Lymphoma • Marginal Zone Lymphoma • Oncology • Splenic Marginal Zone Lymphoma • CD4

FIXED-DURATION SUBCUTANEOUS MOSUNETUZUMAB IN PATIENTS WITH RELAPSED/REFRACTORY FOLLICULAR LYMPHOMA WITH HIGH-RISK FEATURES: PIVOTAL PHASE II STUDY UPDATE (ICML 2025) - P1/2 | "Fixed-duration Mosun SC achieved clinically relevant efficacy with durable remissions in pts with 3L+ R/R FL and high-risk features. Most infections were low grade; COVID-19 was the most common serious infection."

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

MOSUNETUZUMAB DEMONSTRATES DURABLE CLINICAL BENEFIT IN PATIENTS WITH COMPLETE RESPONSE AND HIGH-RISK RELAPSED/REFRACTORY FOLLICULAR LYMPHOMA (ICML 2025) - P1/2 | "After a median follow-up of > 4 years, durable benefit continues to be observed in pts with R/R FL who achieved CR with fixed-duration Mosun. Durable remissions and clinically meaningful outcomes were observed in pts with high-risk disease features, including POD24 or double refractory disease. Infections were manageable; the absence of late-onset events supports fixed-duration treatment."

Clinical • Follicular Lymphoma • Hematological Malignancies • Lymphoma • Oncology