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

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

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

Real-world safety profile of T-cell engagers: evidence from multi-database analysis with CAR-T comparisons. (PubMed, Front Immunol) - "The TCE class showed profound drug-specific heterogeneity, including severe oral/nail toxicities with talquetamab (oral toxicity ROR = 6066.40) and extramedullary relapse/infiltration with blinatumomab. TCEs are characterized by rapid early CRS/TLS AEs, elevated infection reporting, and target-specific toxicities, while CAR-T exhibits stronger CRS/ICANS signals. These findings support early monitoring and molecule-specific, syndrome-based risk management, advancing precision pharmacovigilance for T-cell redirecting therapies."

Clinical • Journal • Real-world evidence • Infectious Disease • Oncology

IMMUNOTHERAPY UNDER THE MICROSCOPE: CARDIO-RENAL OUTCOMES OF CHIMERIC ANTIGEN RECEPTOR T-CELL THERAPY (CART) VS BISPECIFICS IN A REAL-WORLD PROPENSITY-MATCHED COHORT STUDY (ACC 2026) - "Background: No current large studies directly compare cardiac outcomes of bispecific antibodies (Teclistamab, Elranatamab, Talquetamab, Blinatumomab, Epcoritamab, Mosunetuzumab) and CAR T-cell therapies. CART therapy was associated with lower all-cause mortality and fewer cardiac and renal adverse events compared to bispecific antibodies, supporting its potential cardio-oncology safety advantage. Further prospective studies are warranted to validate these findings."

Bispecific • CAR T-Cell Therapy • Clinical • Real-world • Real-world evidence • Cardiovascular

Clinical predictors of cytokine release syndrome in non-single chain CD3 directed therapies among cancer patients (AACR 2026) - "20 patients were identified with median age of 67 years. 30% were male and 70% were female. 35% received tarlatamab, 30% got glofitamab, 10% got talquetamab and epcoritamab each, 1 patient got mosunetuzumab and linvoseltamab."

Clinical • Cytokine release syndrome • Oncology

Dermatologic adverse events with bispecific T-cell engager therapies (AAD 2026) - " Among solid-tumor-directed BiTEs, tebentafusp dAEs include early, diffuse exanthems with pruritus, xerosis, edema, and bullous changes in high-grade events (dAE 83-91%; pruritus 69%; grade ≥3 rash 16-21%); delayed depigmentation/vitiligo-like changes are also reported. Tarlatamab presents with low-grade morbilliform eruptions (rash 6%, grade ≥3 2%; pruritus 11%). Among BiTEs for hematologic malignancies, talquetamab results in a distinctive mucocutaneous dAE profile involving hand-foot syndrome, nail changes (56%) including onychomadesis and onychodystrophy, dysgeusia (72%), and xerostomia (36%); dAE-related discontinuation is <1%. Mosunetuzumab leads to rash in 34-39% (grade ≥3 4%) and injection-site reactions in 53%. With blinatumomab, infusion-type exanthems predominate (7-16%; ≥ grade 3 ~1%); medium-vessel vasculitis and peri/subungual pyogenic granulomas have also occurred. For elranatamab, injection-site reactions (37%) and secondary cutaneous malignancies..."

Adverse events • Bispecific • IO biomarker • Dental Disorders • Hematological Malignancies • Immunology • Pruritus • Skin Cancer • Solid Tumor • Vasculitis • Vitiligo • Xerostomia

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

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

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

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

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

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

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

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

T cell transcriptome is altered by Talquetamab in presence of GPRC5D on MM cells (AACR 2026) - "Our findings demonstrate that talquetamab upregulates the expression of interferon signaling genes in T cells even in the absence of GPRC5D and this response is enhanced when GPRC5D is present on MM cells. Moreover, talquetmab alters the activation profile across T cells subsets and both abundance and distribution of different T cells subpopulations is changed by GPRC5D status of the MM cells in coculture."

IO biomarker • Hematological Malignancies • Multiple Myeloma • Oncology • CD4 • CD69 • CD8 • GPRC5D • IFIT2 • IFNG • IL2RA • IRF1 • IRF4 • JUNB • PRDM1 • SOCS3 • STAT1 • STAT5 • TNFRSF4

IFm2022-01: Minimal Residual Disease-based Strategy With T-Cell Redirector After Treatment With Daratumumab, Bortezomib, Lenalidomide, and Dexamethasone (D-VRd) in Newly Diagnosed Multiple Myeloma (clinicaltrials.gov) - P2 | N=103 | Active, not recruiting | Sponsor: Nantes University Hospital | Recruiting ➔ Active, not recruiting | Trial primary completion date: Apr 2026 ➔ Apr 2028

Enrollment closed • Minimal residual disease • Trial primary completion date • Breast Cancer • Hematological Malignancies • Multiple Myeloma • Myelodysplastic Syndrome • Oncology

BLOOD-dose: A Platform Trial Evaluating Dose Optimization in Hematological Diseases. (clinicaltrials.gov) - P4 | N=400 | Not yet recruiting | Sponsor: Anne Louise Tølbøll Sørensen

New P4 trial • Hematological Disorders • Hematological Malignancies • Lymphoma • Lymphoplasmacytic Lymphoma • Multiple Myeloma • Non-Hodgkin’s Lymphoma • Oncology • Waldenstrom Macroglobulinemia

CARDIOVASCULAR SAFETY SIGNALS OF BISPECIFIC ANTIBODIES: INSIGHTS FROM FAERS DATABASE (ACC 2026) - " FAERS (2017-2023) was queried for blinatumomab, teclistamab, talquetamab, elranatamab, epcoritamab, and glofitamab. Bispecific antibodies exhibit distinct cardiovascular safety signals: elranatamab, epcoritamab, and glofitamab with heart failure; epcoritamab with atrial fibrillation and myocardial infarction; and teclistamab with tachycardia. These findings emphasize the need for cardiovascular monitoring during therapy, particularly in patients with pre-existing risk."

Bispecific • Clinical • Atrial Fibrillation • Cardiovascular • Congestive Heart Failure • Heart Failure • Hematological Malignancies • Myocardial Infarction

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

SAFE DELIVERY OF BISPECIFIC ANTIBODIES AT CHRISTIE PRIVATE CARE: SERVICE IMPLEMENTATION AND EARLY SAFETY OUTCOMES (EBMT 2026) - "The cohort included 12 patients with relapsed/refractory multiple myeloma treated with Teclistamab or Talquetamab, and 1 patient with relapsed Burkitt's lymphoma treated with Glofitamab. Bi-specific antibodies were delivered safely within The Christie Private Care using structured monitoring pathways and early-intervention protocols. CRS events were mild and manageable with standard therapies, including dexamethasone and tocilizumab where required.Recurrent Hospitalization rates were low, and overall treatment delivery remained feasible and well-tolerated. These findings support the safe provision of advanced immunotherapies in a private-care setting."

Bispecific • Clinical • Burkitt Lymphoma • Hematological Malignancies • Infectious Disease • Lymphoma • Multiple Myeloma • Septic Shock

Talquetamab induces deep responses in heavily pre-treated patients with systemic light-chain amyloidosis. (PubMed, Ann Hematol) - No abstract available

Journal • Amyloidosis • Hematological Malignancies

Dexamethasone Versus Tocilizumab for Management of Talquetamab-Induced Cytokine Release Syndrome in Patients With Relapsed/Refractory Multiple Myeloma: A Multicenter, Retrospective Study (HOPA 2026) - "Although more patients had recurrent CRS with dexamethasone than with tocilizumab, subsequent events were low grade and generally manageable with repeated dexamethasone doses. Dexamethasone could be an alternative treatment option to tocilizumab for low-grade talquetamab-induced CRS. Rodriguez-Otero P, Usmani S, Cohen AD, et al."

Cytokine release syndrome • Late-breaking abstract • Retrospective data • Hematological Malignancies • Inflammation • Multiple Myeloma

CMV Reactivation With Bispecific Antibodies in Multiple Myeloma (HOPA 2026) - " This multicenter, retrospective review included 555 patients who received teclistamab, elranatamab, or talquetamab...Age, the number of previous lines of therapy, previous BCMA-directed therapy, maximum-grade cytokine release syndrome, tocilizumab treatment, dexamethasone treatment, use of IVIG, and IgG levels at day 30 and day 90 were evaluated via logistic regression; none of the above factors predicted CMV reactivation. CMV reactivation occurred in almost 25% of patients who are CMV seropositive and receiving bispecific antibodies for RRMM, with 33% of those patients requiring CMV-directed therapy. This incidence reflects the need for additional guidance for risk stratification, monitoring, and prophylactic strategies in this high-risk patient population."

Late-breaking abstract • Cytomegalovirus Infection • Hematological Malignancies • Infectious Disease • Inflammation • Multiple Myeloma

Outcomes of Supportive Care Versus Pharmacologic Intervention for the Management of CRS in Relapsed or Refractory Multiple Myeloma Treated With BCMA- and GPRC5D-Directed Bispecifics (HOPA 2026) - " This retrospective study included 555 patients with relapsed or refractory multiple myeloma from 7 US academic centers that initiated elranatamab, teclistamab, or talquetamab by March 2025...Recurrent CRS in all groups was at the same or lower grade, except for 1 patient who received dexamethasone and tocilizumab and had grade 1 CRS with SUD 1 and grade 2 CRS with SUD 2. Supportive care alone demonstrated similar outcomes to pharmacologic intervention for low-grade CRS, particularly grade 1, which supports its role as a safe, effective initial management strategy that may limit the need for additional intervention."

Late-breaking abstract • Hematological Malignancies • Inflammation • Multiple Myeloma

MonumenTAL-1: Dose Escalation Study of Talquetamab in Participants With Relapsed or Refractory Multiple Myeloma (clinicaltrials.gov) - P1 | N=87 | Recruiting | Sponsor: Janssen Research & Development, LLC | Trial completion date: Oct 2020 ➔ Apr 2021

First-in-human • Trial completion date • Hematological Malignancies • Multiple Myeloma • Oncology