Talvey (talquetamab-tgvs) / J&J, Genmab - LARVOL DELTA

Talquetamab plus daratumumab for the treatment of relapsed or refractory multiple myeloma in the TRIMM-2 study. (PubMed, Blood) - P1 | "Talquetamab plus daratumumab demonstrated promising efficacy outcomes in heavily pretreated patients, with a safety profile consistent with each agent as monotherapy. ClinicalTrials.gov ID: NCT04108195."

Journal • Dental Disorders • Hematological Malignancies • Infectious Disease • Inflammation • Mucositis • Multiple Myeloma • Oncology • Stomatitis

Phase 2 Study of Talquetamab + Teclistamab in Patients With Relapsed/Refractory Multiple Myeloma and Extramedullary Disease: RedirecTT-1 (EHA 2025) - P1/2 | "With 90 pts with confirmed EMD, the phase 2 cohort of RedirecTT-1 is the largest dedicated EMD study to date. Tal + Tec led to a high ORR and deep, durable responses; efficacy exceeded standard therapies, including BsAb monotherapies, and was comparable to CAR-T therapies in pts with RRMM with EMD. No new safety signals were identified, including no exacerbated Tal or Tec AEs."

Clinical • Late-breaking abstract • P2 data • Hematological Disorders • Hematological Malignancies • Infectious Disease • Multiple Myeloma • Neutropenia • Oncology • Plasmacytoma • Pneumonia • Respiratory Diseases • Septic Shock

Infections and parameters of humoral immunity with talquetamab in relapsed/refractory multiple myeloma in MonumenTAL-1. (PubMed, Blood Adv) - P1, P2 | "Few patients started IVIG following talquetamab (9.8% [QW], 6.9% [Q2W], and 5.9% [prior TCR]). Patients treated with talquetamab demonstrated relatively low rates of grade 3/4 infections and preservation of humoral immunity, distinguishing talquetamab as an important and potentially less immunosuppressive, novel treatment option for patients with RRMM."

Journal • Hematological Malignancies • Infectious Disease • Multiple Myeloma • Novel Coronavirus Disease • Oncology • Respiratory Diseases

Interim analysis of LimiTec, a prospective trial of limited-duration teclistamab for relapsed/refractory multiple myeloma (ASH 2025) - P2 | "10/43 (23%) had ≥1 prior BCMA-directed therapies (BCMA-DT) (4 bela-maf, 2cilta-cel, 6 ide-cel)...3/3 pts with PD who received talquetamab (Tal) as next therapyresponded (2 VGPR, 1 CR)... In this preliminary analysis, discontinuation of Tec after 6-9m yields outcomes comparableto historical expectations with continuous therapy with estimated median FFS of 73% at 12m post-discontinuation in a cohort with 23% prior BCMA-DT. Early instances of PD (<6m after Tecdiscontinuation) that were evaluable exhibited BCMA loss and were thus unlikely due to Tecdiscontinuation. Response to Tal immediately after failing Tec re-treatment and low sBCMA at PD furthersuggest resistance due to BCMA loss/mutation as an important mechanism of PD even months after Tecdiscontinuation."

Clinical • IO biomarker • Hematological Malignancies • Multiple Myeloma • SDC1

Phase 2 study of cevostamab consolidation following BCMA CAR T cell therapy: preliminary safety, efficacy, and correlative data from the "STEM" (Sequential T Cell-Engagement for Myeloma) trial (ASH 2025) - P2 | "Median number of prior lines was 4 (2-10), with 74% triple-class refractory, 11% prior BCMA therapy, and 11% prior talquetamab. Twenty-five (93%) received cilta-cel and 2 (7%) ide-cel... To date, cevostamab consolidation starting 10-12 weeks post-CAR T cell infusion at 3.6mgsingle step-up and 132mg q3wk target dose appears feasible and well-tolerated in heavily-pretreatedRRMM, with low rates of non-hematologic G3/4 TEAE's, including infections. Preliminary efficacy appearspromising, with over 90% showing sustained MRD-negative CR at 1 year. Analyses and follow-up areongoing."

CAR T-Cell Therapy • Clinical • IO biomarker • P2 data • Ataxia • Autoimmune Hepatitis • Cough • Gastroenterology • Gastrointestinal Disorder • Hepatology • Immunology • Infectious Disease • Movement Disorders • Multiple Myeloma • Musculoskeletal Pain • Neutropenia • Respiratory Diseases • Thrombocytopenia

Utility and sensitivity of wett-SA53 to measure dysgeusia associated with talquetamab, a GPRC5D×CD3 bispecific antibody, in Relapsed/Refractory multiple myeloma: Preliminary data from the talisman study (ASH 2025) - P2 | "Experimental prophylaxes include dexamethasone [Dex] mouthwash, oral pregabalin, orclonazepam orally dissolving tablets. In this randomized, phase 2 study utilizing the WETT SA-53 assessment tool for the first timein pts with MM, WETT scores appeared to be highly sensitive with the ability to objectively capture abroader spectrum of taste changes throughout Tal treatment compared with CTCAE grading. Preliminarydata showed the WETT scale was able to detect dysgeusia, and importantly, objective improvements indysgeusia by cycle 8. Results from this study will help characterize and guide management of dysgeusiaassociated with GPRC5D treatment and may establish the WETT assessment as an important objectivetool for cancer agents impacting taste."

IO biomarker • Dental Disorders • Hematological Malignancies • Mucositis • Multiple Myeloma • Stomatitis • Xerostomia

Efficacy and safety of talquetamab + teclistamab in patients with Relapsed/Refractory multiple myeloma and extramedullary disease: Updated Phase 2 results from the redirectt-1 study with extended follow-up (ASH 2025) - P1/2 | "With longer follow-up in pts with TCE RRMM with true EMD regardless of baseline tumorcharacteristics, Tal + Tec efficacy exceeded all approved therapies, including T-cell redirecting and cellulartherapies, noting limitations of cross-study comparisons. Lower total EMD tumor volume was associatedwith a higher ORR but low pt numbers in each group and lack of statistical testing limits robustinterpretation. The safety profile of Tal + Tec was generally consistent with each monotherapy; AEs werenot exacerbated with the combination."

Clinical • IO biomarker • P2 data • Hematological Disorders • Hematological Malignancies • Infectious Disease • Multiple Myeloma • Neutropenia • Plasmacytoma • Respiratory Diseases

Fixed-duration teclistamab and talquetamab for frail patients with newly diagnosed multiple myeloma: The EMN37 fitfix study (ASH 2025) - "The combination of daratumumab with bispecific antibodies may lead to deeper and moredurable responses that could enable a lenalidomide- and a dexamethasone-sparing regimen including atreatment-free interval (TFI) in the first-line therapy of frail NDMM patients...However, noformal comparison of efficacy or safety between Tec-Dara and Tal-Dara will be performed.To mitigate the risk of potential side effects, dose modifications and adequate supportive care areplanned, including prophylactic tocilizumab administration and prophylactic intravenousimmunoglobulin (IVIG) supplementation therapy.The study will be conducted in Italy (14 sites), the Netherlands (9), Spain (4), and Norway (2)...Theupdated status of the study will be presented at the meeting.The study is conducted by the European Myeloma Network (EMN), in collaboration with HOVON, NMSG,EMN Italy, and PETHEMA and in collaboration with and with the financial support of JanssenPharmaceutica NV, a member of the Johnson..."

Clinical • Hematological Malignancies • Multiple Myeloma

Safety and efficacy of talquetamab + teclistamab in patients with Relapsed/Refractory multiple myeloma from Phase 1b of redirectt-1: Results with an extended median follow-up of 3 years (ASH 2025) - P1/2 | "At an extended mFU of ~3 yrs, Tal + Tec continued to have a safety profile that was generallyconsistent with each monotherapy, with no exacerbation of AEs with the combination. The infectionprofile supported prophylaxis and vigilant monitoring and management. Tal + Tec led to a high ORR anddeep, durable responses in all pts, including at the RP2R and in pts with true EMD, contributing todurable PFS observed across all pts."

Clinical • P1 data • Candidiasis • Hematological Disorders • Hematological Malignancies • Infectious Disease • Multiple Myeloma • Neutropenia • Plasmacytoma • HEY1

Bridging Therapy Response and Pre-Lymphodepletion Plasma Cell Burden As Determinants of Ciltacabtagene Autoleucel Safety and Efficacy Outcomes in relapsed/refractory Multiple Myeloma (TCT-ASTCT-CIBMTR 2026) - "BT regimens were heterogeneous and associated with improved safety and efficacy after cilta-cel; higher responses were seen with talquetamab. BT response and <50% pre-LD PCB were associated with high treatment response and low CRS and neurotoxicity rates. These findings suggest BT management should be optimized beyond its traditional use as a temporizing measure."

Clinical • CNS Disorders • Hematological Malignancies • Movement Disorders • Multiple Myeloma • Parkinson's Disease

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

Clinical and Immunologic Correlates of out-of-Specification Ciltacabtagene Autoleucel In Multiple Myeloma: A University of Arizona Analysis (TCT-ASTCT-CIBMTR 2026) - "Despite reduced lymphocyte and T-cell reconstitution, OOS cilta-cel showed non-inferior PFS and comparable safety to IS products. OOS manufacturing was concentrated in heavily pretreated, talquetamab-exposed patients, suggesting prior T-cell exhaustion as a mechanistic driver. Low ALC and CD3 counts at leukapheresis were associated with OOS products, indicating impaired T-cell reserve and functional exhaustion."

Clinical • Hematological Disorders • Hematological Malignancies • Infectious Disease • Multiple Myeloma

Phase 2 Study of Cevostamab Consolidation Following BCMA CAR T Cell Therapy: Preliminary Safety and Efficacy Data from the "STEM" (Sequential T Cell-Engagement for Myeloma) Trial (IMS 2025) - P2 | "RRMM pts who received standard of care CAR T cells (ide-cel or cilta-cel), with stable disease or better, receive cevo starting 10-12 weeks (wks) post-CART at step-up dose of 3.6mg IV on Cycle 1 Day 1 (C1D1), followed by 132mg starting C1D8, then q3wks for total of 8 cycles...Median number of prior lines was 4 (2-10), with 74% triple-class refractory, 11% prior BCMA therapy, and 11% prior talquetamab... To date, cevostamab consolidation post-CAR T cell infusion appears feasible and well-tolerated in late-line RRMM, with low rates of non-hematologic G3/4 TEAEs, including infections. Preliminary efficacy appears promising, with over 90% showing sustained MRD-negative sCR at 1 year."

CAR T-Cell Therapy • Clinical • IO biomarker • Late-breaking abstract • P2 data • Ataxia • Autoimmune Hepatitis • Cough • Gastroenterology • Gastrointestinal Disorder • Hematological Malignancies • Hepatology • Immunology • Infectious Disease • Inflammation • Movement Disorders • Multiple Myeloma • Neutropenia • Respiratory Diseases • Thrombocytopenia

Safe and Effective Bridging to Ciltacabtagene Autoleucel Using Bispecific T-cell Engagers in relapsed/refractory Multiple Myeloma Among an Urban Underserved Population (TCT-ASTCT-CIBMTR 2026) - "Ciltacabtagene autoleucel (cilta-cel), a B-cell maturation antigen (BCMA)-directed CAR-T therapy, and bispecific T-cell engagers (BiTEs) such as talquetamab (GPRC5D-targeted) and teclistamab (BCMA-targeted) have demonstrated durable responses in heavily pretreated populations. Evaluate real-world safety and efficacy outcomes of this bridging strategy within an urban underserved population. Discuss the implications for access and equity in delivering advanced myeloma therapies in resource-limited settings."

Clinical • Hematological Disorders • Hematological Malignancies • Inflammation • Multiple Myeloma

Impact of Baseline and Dynamic IMWG Simplified Frailty Scores on Outcomes after CAR T-cell and Bispecific Antibody Therapy in Multiple Myeloma (TCT-ASTCT-CIBMTR 2026) - "We evaluated how baseline and dynamic frailty influence efficacy and toxicity among MM patients treated with CAR T- cell (ide-cel, cilta-cel) and bispecific antibody (teclistamab [tec], talquetamab [tal]) tx. Both fit and frail pts benefit from cellular therapies and are important therapeutic options for pts across all fitness categories. However, further work is required to understand impact on depth and durability of response. Ultra-frail pts durability of response and depth of response merits further investigation in a large cohort of MM pt."

CAR T-Cell Therapy • Geriatric Disorders • Hematological Malignancies • Multiple Myeloma

A Neurotoxicity Mimic: Progressive Multifocal Leukoencephalopathy Following BCMA-Directed CART and Bispecific Therapies (TCT-ASTCT-CIBMTR 2026) - "He received cilta-cel as 5th line therapy following bridging with talquetamab...He was treated with high-dose IVIG, mirtazapine, and pembrolizumab... These cases highlight a devastating complication of BCMA-directed therapy. Increasing use of BCMA- targeted platforms warrants collaboration to define incidence, risk factors, and develop strategies for prevention and treatment. Progressive multifocal leukoencephalopathy is rare, but catastrophic complication of BCMA-directed immune therapies."

CNS Disorders • Hematological Malignancies • Infectious Disease • Multiple Myeloma • Rare Diseases • CD4

Antibody-Drug Conjugates, T-Cell Engager Bispecific Antibodies and Chimeric Antigen Receptor T Cells for Multiple Myeloma: What's the Current Status? (PubMed, Target Oncol) - "This has resulted in European Medicines Agency and US Food and Drug Administration approval of agents targeting the B-cell maturation antigen: antibody-drug conjugate belantamab mafodotin (belantamab), bispecific T-cell engaging antibodies teclistamab, elranatamab and linvoseltamab, and chimeric antigen receptor T-cell products idecabtagene vicleucel (ide-cel) and ciltacabtagene autoleucel (cilta-cel). Talquetamab, a bispecific T-cell engaging antibody targeting G protein coupled receptor family C group 5 member D has also been approved by the European Medicines Agency and Food and Drug Administration. With increasing availability of these agents, knowledge on the efficacy and safety of these novel treatments will be essential for future multiple myeloma care. In this narrative review, we discuss the pivotal trials, current real-world evidence and recent insights in the mechanisms of resistance of antibody-drug conjugates, bispecific T-cell engaging antibodies and..."

Journal • Review • Hematological Malignancies • Multiple Myeloma • Oncology

Dual-antigen-targeting T-cell immunotherapies in MM: circumventing tumor heterogeneity and preventing antigen escape. (PubMed, Blood) - "Notably, the efficacy of the combination of teclistamab and talquetamab appears to have enhanced anti-MM activity, compared to the corresponding conventional BsAbs alone in similar patient populations. Furthermore, dual-antigen targeting with T-cell redirecting trispecific antibodies (e.g., ramantamig [BCMAxGPRC5D] and ISB2001 [BCMAxCD38]) has already demonstrated promising results in heavily pretreated MM with several studies ongoing in earlier stages of the disease. Studies with limited numbers of patients have demonstrated that CAR T-cell products with specificity for more than one antigen are also effective in advanced MM, but at this time none of the dual-targeting CAR T-cell products is clearly superior to targeting BCMA alone with ciltacabtagene autoleucel (cilta-cel). Dual-targeting should eventually be compared in large phase 3 trials with the classical approach of serial treatment with mono-targeting agents with target switch."

Heterogeneity • IO biomarker • Journal • Hematological Malignancies • Multiple Myeloma • Oncology

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

Dual Targeting of Extramedullary Myeloma with Talquetamab and Teclistamab. (PubMed, N Engl J Med) - P1/2 | "Most patients with drug-resistant, true extramedullary myeloma had a response with talquetamab plus teclistamab. The incidence of adverse events of grade 3 or above was high and was consistent with previous observations for each agent as monotherapy. (Funded by Johnson & Johnson; RedirecTT-1 ClinicalTrials.gov number, NCT04586426.)."

Journal • Gastrointestinal Disorder • Hematological Disorders • Hematological Malignancies • Infectious Disease • Inflammation • Multiple Myeloma • Oncology • Plasmacytoma • Xerostomia

Real-World Outcomes of Heavily Pretreated Relapsed Refractory Multiple Myeloma Patients Treated with Bispecific Antibodies (TCT-ASTCT-CIBMTR 2026) - "INTRODUCTION 4 Bispecific antibodies (BsAb): Teclistamab (Tec), Elranatamab (Elran), Talquetamab (Tal) & Linvoseltamab are approved for relapsed refractory multiple myeloma (RRMM) after ≥4 lines of therapy (LOT), with impressive overall response rates (ORR) and progression free survival (PFS). 3. To compare OS between early responders (those achieving partial response, VGPR, complete remission within ≤1 month of therapy initiation) and patients with stable or progressive disease at 2 month post bispecific antibody"

Clinical • Real-world • Real-world evidence • Hematological Malignancies • Multiple Myeloma

OPTec: Outpatient Administration of Teclistamab or Talquetamab for Multiple Myeloma (clinicaltrials.gov) - P2 | N=100 | Recruiting | Sponsor: SCRI Development Innovations, LLC | N=75 ➔ 100

Enrollment change • Hematological Malignancies • Multiple Myeloma • Neutropenia • Oncology • CD4

Clinical Outcomes of Subsequent Therapies in Patients with Relapsed/Refractory Multiple Myeloma Following Talquetamab Treatment: Analyses from the Phase 1/2 MonumenTAL-1 Study (ASH 2023) - P1, P2 | "In the QW and Q2W cohorts, respectively, 74.1% and 69.0% were triple-class refractory, 29.4% and 23.4% were penta-drug refractory, and 15.4% and 11.0% had prior belantamab mafodotin exposure. Pts from MonumenTAL-1 who discontinued tal were effectively treated with several classes of therapy. Subsequent treatment with T-cell redirection therapies appears feasible, with 25.0% of pts achieving a complete response or better with CAR-T therapy post tal. Further investigation in larger pt populations is warranted to better understand the sequencing of T-cell redirecting therapies after tal to optimize outcomes."

Clinical • Clinical data • P1/2 data • Hematological Malignancies • Infectious Disease • Multiple Myeloma • Oncology • Psychiatry

CREATT: Multi-center, Observational Study of Teclistamab or Talquetamab in The Treatment of Multiple Myeloma Patients in China (ChiCTR) - P4 | N=200 | Not yet recruiting | Sponsor: Peking Union Medical College Hospital, Chinese Academy of Medical Sciences; Peking Union Medical College Hospital, Chinese Academy of Medical Sciences

New P4 trial • Hematological Malignancies • Multiple Myeloma • Oncology

Optec/Optal: A Phase 2 Study to Evaluate Outpatient (OP) Step-Up Administration of Teclistamab (Tec) or Talquetamab (Tal) in Participants With Relapsed/Refractory Multiple Myeloma (RRMM) (SOHO 2025) - "In a separate MajesTEC-1 cohort, patients were administered prophylactic tocilizumab (prophyToci) and experienced less CRS (26%) with no negative impact on efficacy or infections. Administering prophyToci before SUD 1 of Tec reduced the risk of CRS and supports administration of Tec in the OP setting. The protocol was amended to add a Tal cohort. Enrollment is ongoing."

Clinical • P2 data • Hematological Malignancies • Multiple Myeloma • Oncology