Tecvayli (teclistamab-cqyv)
/ Genmab, J&J
- LARVOL DELTA
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December 09, 2025
Teclistamab plus Daratumumab in Relapsed or Refractory Multiple Myeloma.
(PubMed, N Engl J Med)
- P3 | "In patients with multiple myeloma who had received one to three previous lines of therapy, those in the teclistamab-daratumumab group had significantly longer progression-free survival than those in the DPd or DVd group. (Funded by Johnson & Johnson; ClinicalTrials.gov number, NCT05083169.)."
Journal • Hematological Malignancies • Multiple Myeloma • Oncology
June 26, 2026
Teclistamab-based induction treatment in transplant-eligible, newly diagnosed multiple myeloma: a phase 2 trial.
(PubMed, Nat Med)
- P2 | "In this prespecified pooled analysis of three cohorts, 49 patients received teclistamab/daratumumab/lenalidomide (Tec-DR; arms A and A1) or Tec-DR with bortezomib (Tec-DVR; arm B). Data support the feasibility of Tec-D(V)R induction in transplant-eligible NDMM, with a consistent safety profile compared with individual regimen components and notable early MRD negativity rates. ClinicalTrials.gov identifier: NCT05695508 ."
Journal • P2 data • Hematological Disorders • Hematological Malignancies • Infectious Disease • Inflammation • Leukopenia • Multiple Myeloma • Neutropenia • Novel Coronavirus Disease • Oncology • Pneumonia • Respiratory Diseases • Transplantation
August 23, 2026
MRD-Guided Frontline T-Cell Redirection Therapy for Newly Diagnosed High-Risk Multiple Myeloma Using Teclistamab-Daratumumab Intensification and Talquetamab-Daratumumab Early Rescue Intervention
(IMS 2026)
- P2 | "To evaluate the safety and preliminary efficacy of teclistamab-daratumumab (Tec-D) intensification following daratumumab-bortezomib-lenalidomide-dexamethasone (D-VRd) induction in ND-HRMM...CRS occurred in 7 patients (25%), all grade 1; only one required tocilizumab... Early MRD-guided incorporation of Tec-D intensification induced deep responses and high MRD-CR in ND-HRMM, supporting the evaluation of a full-immune based bispecific antibody-based, transplant-free approach in difficult to treat high-risk disease."
Late-breaking abstract • Hematological Malignancies • Infectious Disease • Multiple Myeloma • Pneumonia • Respiratory Diseases
August 23, 2026
Projecting Functional Cure in Patients (Pts) With Relapsed/Refractory Multiple Myeloma (RRMM) in the MajesTEC-3 Study of Teclistamab-Daratumumab (Tec-Dara) Using a Mixture Cure Model
(IMS 2026)
- P3 | "Introduction: In the phase 3 MajesTEC-3 study (NCT05083169) , Tec-Dara significantly improved progression-free survival (PFS; HR 0.17; 95% CI 0.12–0.23) and overall survival (OS; HR 0.46; 95% CI 0.32–0.65) vs Dara plus dexamethasone with pomalidomide or bortezomib (DPd/DVd) in pts with RRMM and 1–3 prior lines of therapy ( median follow-up 34.5 mo) . Best fit models estimated >85% cure fractions for OS and PFS in Tec-Dara pts in MajesTEC-3. While functional cure does not imply biological/clinical cure, the analysis suggests that a substantial fraction of Tec-Dara-treated pts will experience a mortality risk and projected life expectancy similar to the general population. MajesTEC-3 is ongoing, and if continued follow-up confirms the model-based predictions, Tec-Dara may help redefine survival expectations in RRMM"
Clinical • Hematological Malignancies • Multiple Myeloma
August 23, 2026
Overall Survival, Progression and Non-Relapse Mortality With Teclistamab Plus Daratumumab (Tec-Dara) vs Dara-Based Triplets in Relapsed/Refractory Multiple Myeloma (RRMM): MajesTEC-3 Post Hoc Analysis
(IMS 2026)
- "Introduction: Tec-Dara showed significant survival benefits vs Dara + dexamethasone + pomalidomide/bortezomib (DPd/DVd) in MajesTEC-3 in early-line RRMM, a setting in which disease progression is the leading cause of death... Patients (pts) had 1–3 prior lines of therapy (LOT), including a proteasome inhibitor and lenalidomide (len; len-refractory if 1 prior LOT) with progression on/after last LOT... Tec-Dara significantly improved OS over DPd/DVd in pts with RRMM and 1–3 prior LOT. This analysis demonstrates that the observed OS benefit is driven by a profound reduction in disease progression, the leading cause of mortality in RRMM. Despite early curve crossing, Tec-Dara did not increase NRM."
Clinical • Retrospective data • Hematological Malignancies • Multiple Myeloma
August 23, 2026
Phase 2 Study of Talquetamab (Tal), Daratumumab (D), and Lenalidomide (R) as Induction Therapy in Patients (Pts) With Transplant Eligible Newly Diagnosed Multiple Myeloma (TE-NDMM): MajesTEC-5
(IMS 2026)
- " Eligible pts aged 18–70 years with TE-NDMM received Tal-DR induction therapy: Tal 0.8 mg/kg SC Q4W, preceded by 3 step-up doses in cycle (C)1; D 1800 mg SC QW in C1–2 and Q2W in C3–6; oral R 25 mg in C2–6; and dexamethasone 20 mg in C1–2 only. Tal-DR induction demonstrated promising early efficacy results in TE-NDMM, with rapid, deep responses and high MRD-negative rates. The gr 3-4 infection rate was lower than previously reported for the teclistamab induction therapy arms of this study, and no new safety signals emerged. This suggests pts at high risk for infection may benefit from targeting non-BCMA myeloma antigens."
Clinical • P2 data • Ataxia • Atopic Dermatitis • Hematological Disorders • Hematological Malignancies • Immunology • Infectious Disease • Mood Disorders • Movement Disorders • Multiple Myeloma • Neutropenia • Otorhinolaryngology • Transplantation • Vertigo • CD34
August 23, 2026
Teclistamab Plus Talquetamab Consolidation in Newly Diagnosed Myeloma Patients With Positive Measurable Residual Disease After DVRD Induction : Interim Analysis of the Phase 2 Study IFM 2022-01
(IMS 2026)
- P2 | "IFM 2022-01 is a phase 2 trial evaluating tec plus tal or tec plus lenalidomide consolidation in TE-NDMM patients according to measurable residual disease (MRD) after Daratumumab Bortezomib Lenalidomide Dexamethasone (D-VRd) induction. The combination of tec+tal resulted in early and high undetectable MRD rates in NDMM patients with detectable MRD after D-VRD induction. These preliminary data showed no new safety signal was observed with tec+tal used in frontline."
Clinical • P2 data • Residual disease • Hematological Malignancies • Infectious Disease • Multiple Myeloma
May 28, 2026
Safety of Concurrent Systemic Therapy and Palliative Radiation in Multiple Myeloma
(ASTRO 2026)
- "For neutropenia, 11/12 had RT to active marrow (10 axial); agents included targeted [daratumumab (8% of drug exposures), lenalidomide (8%), bortezomib (9%), pomalidomide (10%), carfilzomib (7%)], cytotoxic chemotherapy (68%) and teclistimab (33%). Among this cohort, CCRT toxicities caused no unintended treatment breaks. Grade 3 SAEs were mainly hematologic. Given frequent need for palliative RT in MM, these data suggest it is reasonable to consider CCRT with close hematologic monitoring."
Clinical • Hematological Malignancies • Multiple Myeloma • Oncology
November 04, 2025
A phase 2 Study of teclistamab in combination with daratumumab in elderly patients with newly diagnosed multiple myeloma: The IFM2021-01 teclille trial, cohort a
(ASH 2025)
- P2 | "The IFM2021-01 trial is a phase 2study evaluating the doublets teclistamab-daratumumab (Cohort A) and teclistamab-lenalidomide(Cohort B) in frontline transplant-ineligible patients...Daratumumab SC (1800 mg) was given weekly in Cycles 1–2, every 2 weeks inCycles 3–6, and every 4 weeks thereafter...Conclusions. IFM2021-01 Cohort A demonstrates that an "all-antibody–based" doublet regimen ofteclistamab and daratumumab is highly effective and well-tolerated in elderly patients with NDMM, withdeep responses, high MRD negativity, and a favorable safety profile."
Clinical • Combination therapy • P2 data • Hematological Disorders • Hematological Malignancies • Infectious Disease • Multiple Myeloma • Neutropenia
September 25, 2026
Teclistamab in relapsed, multi-refractory acquired hemophilia A after failure of anti-CD19 CAR-T cell therapy.
(PubMed, J Thromb Haemost)
- "Prompt and durable remission was observed that lasted for more than one year post treatment. This is the first case of refractory AHA successfully treated with teclistamab, providing a proof-of-concept of plasma cell-directed bispecific antibodies, supporting its further evaluation."
Journal • Hematological Disorders • Hemophilia • Hemophilia A • Rare Diseases
September 25, 2026
Teclistamab for the treatment of autoantibody-mediated coagulation disorders.
(PubMed, J Thromb Haemost)
- "Teclistamab treatment was associated with complete remissions in patients with autoantibody-mediated coagulation disorders. These observations warrant further evaluation of teclistamab in selected patients."
Journal • Cardiovascular • Complement-mediated Rare Disorders • Gastroenterology • Gastrointestinal Disorder • Genetic Disorders • Hematological Disorders • Hemophilia • Immunology • Inflammation • Inflammatory Arthritis
November 26, 2025
Phase 3 randomized study of teclistamab plus daratumumab versus investigator's choice of daratumumab and dexamethasone with either pomalidomide or Bortezomib (DPd/DVd) in patients (Pts) with relapsed refractory multiple myeloma (RRMM): Results of majestec-3
(ASH 2025)
- P3 | " Eligible pts had 1-3 prior LOTs including a PI and lenalidomide (Len; pts with 1 prior LOT must have been Len-refractory) with progressive disease (PD) on or after the last LOT. We demonstrate the clinically remarkable and statistically significant PFS and OS benefits of Tec-Dara vs SoC triplets in RRMM, with 83.4% of Tec-Dara pts alive and progression-free at 3 yrs. Infections with Tec-Dara were well managed with established protocols. This highly effective, off-theshelf, immunotherapy combination represents a new SoC for RRMM as early as first relapse."
Clinical • IO biomarker • Late-breaking abstract • P3 data • Hematological Malignancies • Infectious Disease • Multiple Myeloma • Plasmacytoma
September 08, 2026
BCMAxCD3 bispecific antibody therapy with teclistamab induces B- and plasma cell depletion and clinical efficacy in treatment of refractory systemic sclerosis - a case series
(ACR Convergence 2026)
- No abstract available
Bispecific • Clinical • Immunology • Scleroderma • Systemic Sclerosis
September 08, 2026
Plasma Cell-Targeted Therapy with Teclistamab in Treatment-Refractory Autoimmune Diseases
(ACR Convergence 2026)
- No abstract available
Immunology
September 08, 2026
Teclistamab-Induced Immune-Related Adverse Events in Autoimmune Diseases: Gastrointestinal Symptoms and Psoriasis
(ACR Convergence 2026)
- No abstract available
Adverse events • Dermatology • Gastrointestinal Disorder • Immunology • Psoriasis
September 11, 2026
Matching-Adjusted Indirect Comparisons (MAICs) of Anitocabtagene Autoleucel (Anito-Cel) Versus Teclistamab and Talquetamab for the Treatment of 4L+ Relapsed And/or Refractory Multiple Myeloma (RRMM)
(IMS 2026)
- "Anito -cel showed superior response, and a differentiated safety profile versus TEC and TAL, highlighted by lower odds of any-grade ICANS versus TAL, and high-grade infections/NRM across all comparators, supporting a clinically meaningful benefit–risk advantage compared to BCMA and GPRC5D targeting BsAbs in 4L+ RRMM."
Hematological Malignancies • Infectious Disease • Multiple Myeloma
September 11, 2026
Patient-Reported Outcomes (PROs) of Teclistamab-Based Treatment (Tx) in Relapsed/Refractory Multiple Myeloma (RRMM) After 1-3 Lines of Therapy (LOT)
(IMS 2026)
- P3 | "Introduction: Significant PFS and OS benefits were seen with teclistamab + daratumumab (Tec-Dara) in MajesTEC-3 (NCT05083169) and Tec monotherapy in MajesTEC-9 (NCT05572515) vs controls ( Dara + dexamethasone [dex] + pomalidomide/bortezomib [DPd/DVd] in MajesTEC-3; pomalidomide + bortezomib + dex or carfilzomib + dex [PVd/Kd] in MajesTEC-9) in patients (pts) with RRMM and 1-3 prior LOT. Tec-Dara and Tec improved HRQoL and significantly prolonged time to symptom worsening vs controls. Building on transformative PFS, OS, and safety data, PROs support pt-relevant benefits, complementing improved pt experience with monthly dosing and steroid-sparing regimens. Findings reinforce Tec-based tx as SoC in 2L+ RRMM across practice settings."
Clinical • Patient reported outcomes • Hematological Malignancies • Infectious Disease • Multiple Myeloma
September 11, 2026
ALTITUDE - ALTernating Induction Therapies to Achieve Undetectable Disease Endpoints: Ph 1/2 Dara-RVd/Teclistamab-RVd in Transplant Eligible Standard-Risk Newly Diagnosed Multiple Myeloma
(IMS 2026)
- "Use of prophylactic tocilizumab (toci) was permitted. Ph 1 run-in of ALTITUDE demonstrates tolerability with no additional safety DLTs with the incorporation of Tec-RVd to frontline therapy. Following Ph 1, Ph 2 launched on March 25, 2026, with an additional 7 patients enrolled to date. Updated results to be presented at meeting."
Febrile Neutropenia • Hematological Malignancies • Infectious Disease • Multiple Myeloma • Neutropenia • Thrombocytopenia • Transplantation • CD34
September 11, 2026
POLB 001, an Oral p38 MAPK Inhibitor for the Prevention of Cytokine Release Syndrome
(IMS 2026)
- "POLB 001 reduced key CRS-associated cytokines and clinical CRS scores in humanised mouse models without impairing BsAb anti-tumour efficacy in in vitro models and had no meaningful impact on T cell phenotype. A Phase I/II trial of POLB 001 in teclistamab-treated patients with multiple myeloma is now commencing."
Cytokine release syndrome • First-in-human • IO biomarker • Hematological Malignancies • Inflammation • Multiple Myeloma • CCL3 • CCR7 • CXCL8 • GZMB • IFNG • IL10 • IL2 • IL2RA • IL4 • IL6 • POLG2
September 11, 2026
Recurrent Anterior Uveitis Associated with Teclistamab in Relapsed/Refractory Multiple Myeloma
(IMS 2026)
- " The patient had previously received multiple treatment lines, including VTd, lenalidomide-dexamethasone, daratumumab-based therapy, and KPd, which was discontinued after ocular thrombotic complications... We describe a rare case of recurrent anterior uveitis temporally associated with teclistamab exposure in RRMM. The recurrence after rechallenge and exclusion of infectious or viral etiologies support a possible immune-mediated mechanism. This report highlights the importance of multidisciplinary management and close ophthalmologic monitoring in patients receiving BCMA-directed bispecific antibodies."
Glaucoma • Hematological Disorders • Hematological Malignancies • Infectious Disease • Inflammation • Multiple Myeloma • Ocular Inflammation • Ophthalmology • Retinal Disorders • Retinal Vein Occlusion • Uveitis
September 11, 2026
Treatment of Waldenstrom Macroglobulinemia Associated with AL Amyloidosis with Teclistamab
(IMS 2026)
- " We report a 50-year-old female patient with WM who developed progressive IgM‑λ–associated systemic AL amyloidosis (cardiac involvement) after zanubrutinib and bendamustine‑rituximab treatment...The treatment was manageable with grade 2 cytokine release syndrome (CRS) resolved by tocilizumab. To our knowledge, this is the first report demonstrating that teclistamab can induce rapid, deep, and durable hematologic and organ responses in a patient with WM‑associated AL amyloidosis. BCMA‑targeted therapy represents a novel and effective strategy for this high‑risk population, supporting further clinical development."
IO biomarker • Amyloidosis • B Cell Lymphoma • Hematological Disorders • Hematological Malignancies • Indolent Lymphoma • Lymphoma • Lymphoplasmacytic Lymphoma • Otorhinolaryngology • Waldenstrom Macroglobulinemia
September 11, 2026
Teclistamab Plus Daratumumab (Tec-Dara) Versus Real-World Physician'S Choice of Therapy for Relapsed/Refractory Multiple Myeloma: Comparative Effectiveness Based on an Indirect Treatment Comparison
(IMS 2026)
- P3 | "Introduction: Tec-Dara significantly improved progression-free (PFS) and overall survival (OS) vs standard-of-care (SoC; Dara + dexamethasone + pomalidomide or bortezomib [DPd/DVd]) in patients (pts) with relapsed/refractory multiple myeloma (RRMM) and 1-3 prior lines of therapy (LOTs), in the phase 3 MajesTEC-3 study (NCT05083169)...An external cohort was created from the US Flatiron Health database, including pts who met key MajesTEC-3 criteria such as 1-3 prior LOTs, including a PI and lenalidomide (pts with 1 prior LOT were lenalidomide refractory), no prior BCMA-exposure or anti-CD38 mAb refractoriness (N=4224 observations from 2959 pts [Jan-2016 – Oct-2025])... Using IPTW-adjusted indirect comparisons in a large US RW cohort, Tec-Dara outperformed rwPC across a broad range of regimens in real-world practice, with significant improvements in PFS, OS and TTNT. These findings extend MajesTEC-3 results beyond the trial setting and support Tec-Dara as a robust,..."
Clinical • HEOR • Real-world • Real-world evidence • Hematological Malignancies • Multiple Myeloma
September 11, 2026
Teclistamab for Relapsed/Refractory Multiple Myeloma in Latin America: A Real-World Analysis from the GELAMM Registry
(IMS 2026)
- "Among pts developing CRS, 38.0% received tocilizumab alone and 21.0% dexamethasone alone. This GELAMM Registry analysis represents one of the largest RW Latin American experiences with TEC reported to date. TEC demonstrated substantial clinical activity, deep responses, and encouraging survival outcomes despite a high proportion of heavily pretreated and penta-drug refractory pts. The safety profile was manageable and consistent with the known toxicity spectrum of BCMA-directed bispecific antibodies, supporting the integration of TEC into routine clinical practice across Latin America."
Clinical • Real-world • Real-world evidence • Hematological Malignancies • Infectious Disease • Multiple Myeloma
September 11, 2026
Teclistamab as a Novel "Neuro-Rescue" Strategy for Refractory Neuropathy in POEMS Syndrome with Sustained Hematologic Response
(IMS 2026)
- " This is a retrospective case report of a patient with POEMS syndrome whose neurological symptoms showed inadequate improvement after induction therapy with the DRd (daratumumab, lenalidomide, dexamethasone) regimen, followed by sequential treatment with Teclistamab. This case demonstrates that switching to Teclistamab effectively reversed the “neurologic improvement plateau” in a POEMS syndrome patient with sustained hematologic remission on DRd therapy, serving as a successful “neuro-rescue” strategy. It highlights the potential of T-cell redirecting therapy to address the critical unmet need of hematologic-neurologic dissociation. The favorable initial safety and “off-the-shelf” availability support its further investigation in this setting."
Bone Marrow Transplantation • CNS Disorders • Rare Diseases
September 11, 2026
TARGET-LATAM Targeted Bispecific Antibodies Against BCMA and GPRC5D in Relapsed/Refractory Multiple Myeloma a Real-World Comparative Analysis from the GELAMM Group
(IMS 2026)
- "In this Latin American cohort of heavily pretreated RRMM patients, anti-BCMA (teclistamab/elranatamab) and anti-GPRC5D (talquetamab) bispecific antibodies demonstrated comparable efficacy in PFS and OS after propensity score matching. However, anti-BCMA therapy was associated with significantly higher rates of any-grade infectious toxicity (p < 0.001) and hypogammaglobulinemia < 400 mg/dL (p = 0.013), underscoring the importance of close infectious-disease monitoring and immunoglobulin replacement strategies in this population."
Bispecific • Clinical • Real-world • Real-world evidence • Hematological Malignancies • Infectious Disease • Multiple Myeloma
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