CD3 stimulants(T cell surface glycoprotein CD3 stimulants), GPRC5D inhibitors(G-protein coupled receptor family C group 5member D inhibitors), ADCC(Antibody-dependent cell-mediated cytotoxicity (ADCC) effects)

Therapeutic Areas

NeoplasmsImmune System DiseasesHemic and Lymphatic Diseases+ [1]

Active Indication

Refractory Multiple MyelomaRelapse multiple myelomaMultiple Myeloma+ [4]

Inactive Indication-

Originator Organization

Janssen Pharmaceuticals, Inc.

Active Organization

Janssen Research & Development LLC

Johnson & Johnson (China) Investment Ltd.Janssen-Cilag International NV

+ [8]

Inactive Organization-

License Organization-

Drug Highest PhaseApproved

First Approval Date

United States (09 Aug 2023),

Multiple Myeloma

RegulationBreakthrough Therapy (United States), Accelerated Approval (United States), Orphan Drug (United States), Orphan Drug (European Union), Breakthrough Therapy (China), Orphan Drug (Japan), Orphan Drug (South Korea), Conditional marketing approval (European Union), Conditional marketing approval (China), Priority Review (China), PRIME (European Union)

Structure/Sequence

Sequence Code 10086313H

Source: *****

Sequence Code 10086327L

Source: *****

Sequence Code 453116282H

Source: *****

Sequence Code 525754800L

Source: *****

Clinical Trials associated with Talquetamab

NCT07029776

/ Not yet recruitingPhase 2IIT

A Phase 2 Study Exploring the Use of Bispecific Antibodies to Improve Progression Free Survival in Patients With High-Risk Newly Diagnosed Multiple Myeloma (MMulti-Immune HR)

The purpose of this research is to learn whether using teclistamab and talquetamab at different time points will improve survival in participants with high-risk Multiple Myeloma (MM).
The treatment on this study will consist of Induction chemotherapy and stem cell collection, Immunotherapy 1 chemotherapy and Immunotherapy 2 chemotherapy. For participants whose testing show they are Minimal Residual Disease (MRD) positive (still have myeloma cells present in the bone marrow testing), a Melphalan-based stem cell transplant will be performed. For participants whose testing show they are MRD negative, the stem cell transplant will not be performed. All participants will go on to receive Immunotherapy 3 chemotherapy, Immunotherapy 4 chemotherapy, and Maintenance therapy.

Start Date01 Apr 2026

Sponsor / Collaborator

The University of Arkansas

[+1]

NCT07032714

/ Not yet recruitingPhase 1IIT

MAGENTA: Phase I Study of Mezigdomide and Talquetamab in Relapsed and Refractory Multiple Myeloma

This is a phase 1 study to find the recommended dose and schedule of mezigdomide and talquetamab in relapsed and refractory multiple myeloma (RRMM), and to test the effects of the drugs on cancer. Cohort A will receive talquetamab + dexamethasone, then mezigdomide + talquetamab,+ dexamethasone. After Cohort A, Cohort B will evaluate mezigdomide + dexamethasone followed by step-up dosing of talquetamab (mezigdomide + talquetamab,+ dexamethasone).

Start Date16 Dec 2025

Sponsor / Collaborator

The Massachusetts General Hospital

[+2]

NCT07093554

/ Not yet recruitingPhase 1IIT

Cilta-Talq Fusion Study: A Phase 1b Study of Talquetamab Bridging Therapy Followed by Ciltacabtagene Autoleucel in Patients With Relapsed/Refractory Multiple Myeloma

This is a single-arm, open-label, phase 1b study evaluating the safety and feasibility of using talquetamab as bridging therapy prior to cilta-cel in patients with relapsed and refractory multiple myeloma (RRMM).

Start Date01 Dec 2025

Sponsor / Collaborator

Medical College of Wisconsin

100 Clinical Results associated with Talquetamab

100 Translational Medicine associated with Talquetamab

100 Patents (Medical) associated with Talquetamab

100

Literatures (Medical) associated with Talquetamab

23 Oct 2025·BLOOD

Sequential targeting in multiple myeloma: talquetamab, a GPRC5D bispecific antibody, as a bridge to BCMA CAR-T therapy

Article

Author: Dima, Danai ; Hansen, Doris ; Raza, Shahzad ; Jensen, Alexandria ; Freeman, Ciara ; Bhutani, Manisha ; Pan, Darren ; Merz, Maximilian ; Alsina, Melissa ; Parrondo, Ricardo ; Fandrei, David ; Hosoya, Hitomi ; Grajales-Cruz, Ariel ; Vazquez Martinez, Mariola ; Sidana, Surbhi ; Kumar, Anupama ; Costa, Luciano J. ; Anderson Jr, Larry D. ; Pasvolsky, Oren ; Cowan, Andrew ; Mikkilineni, Lekha ; Castaneda Puglianini, Omar ; Akhtar, Othman S. ; Costello, Patrick ; Friend, Reed ; Ferreri, Christopher ; Lin, Yi ; Rees, Matthew ; Afrough, Aimaz ; Nadeem, Omar ; Chhabra, Saurabh ; Patel, Krina ; Dhakal, Binod ; Reshef, Ran ; Banerjee, Rahul ; Gaballa, Mahmoud ; Davis, James A. ; Richard, Shambavi ; Wagner, Charlotte ; Midha, Shonali ; Gagelmann, Nico ; Kapoor, Prashant ; Sborov, Douglas

Abstract:

Ciltacabtagene autoleucel (cilta-cel) and idecabtagene vicleucel (ide-cel), 2 B-cell maturation antigen (BCMA)–directed chimeric antigen receptor T-cell (CAR-T) therapies, have transformed outcomes for relapsed/refractory multiple myeloma; however, the 6 to 8 weeks manufacturing time risks disease progression or death in up to 10% of patients. Talquetamab, a G-protein–coupled receptor, family C, group 5, member D (GPRC5D)–targeting bispecific antibody, represents a promising option. We performed a multi-institutional retrospective analysis across 20 centers (18 United States, 2 Germany) evaluating talquetamab as a bridging therapy prior to cilta-cel or ide-cel. Among 134 patients receiving talquetamab, 119 proceeded to CAR-T (n = 98 cilta-cel, n = 21 ide-cel). Reasons for not proceeding (n = 15) included progression (n = 7), manufacturing failure (n = 6), or patient decision (n = 2). Median age was 65 years and had median 5 prior lines of therapy. Notably, 85% would not have met CARTITUDE-1/KarMMa eligibility criteria. Talquetamab was administered for a median 23 days. Toxicity was manageable: no grade ≥3 cytokine release syndrome (CRS), 2% grade 3 immune effector cell–associated neurotoxicity syndrome (ICANS) and grade 1 to 2 talquetamab unique toxicities (70% oral, 38% skin, and 17% nail; 60% resolved). Talquetamab achieved 71% response rate. After CAR-T, 88% responded (54% complete response), with low-grade toxicities (2 grade ≥3 CRS, 1 grade 3 ICANS, and 5% grade ≥3 infections). Two cases of facial palsy and 1 acute myeloid leukemia occurred. Talquetamab correlated with sustained soluble BCMA decline and peak CAR-T expansion around day 14. Talquetamab bridging appears safe, enabling the majority of difficult-to-treat patients to successfully proceed to BCMA CAR-T therapy.

15 Oct 2025·CANCER

Correction to “Understanding quality of life under talquetamab: Learning to measure what matters”

14 Oct 2025·Blood Advances

Tocilizumab prophylaxis for patients with multiple myeloma treated with bispecific antibodies

Article

Author: Kazandjian, Dickran ; Landgren, Ola ; Diamond, Benjamin ; Kowalski, Andrew ; Coffey, David ; Pandey, Abhishek ; Lykon, Jill ; Maura, Francesco ; Kaddoura, Marcella ; Hoffman, James

Abstract:

Bispecific antibodies for treatment for multiple myeloma are highly effective but commonly cause cytokine release syndrome (CRS) and immune effector cell–associated neurotoxicity syndrome (ICANS). Emerging data indicate that prophylactic tocilizumab may reduce CRS, without impacting efficacy. We administered a single dose of tocilizumab before the first dose of bispecific antibodies to 119 patients to determine the impact on CRS in a real-world setting including B-cell maturation antigen × CD3– and G-protein–coupled receptor class C group 5 member D × CD3–targeted antibodies. The best overall response rate was 65.7% (binomial 95% confidence interval [CI], 55.8-74.7). We observed a low overall rate of CRS (10.1%; 95% CI, 5.3-17). For teclistamab, elranatamab, linvoseltamab, and talquetamab individually, the CRS rate was 8.9%, 12.5%, 0%, and 13%, respectively. The overall rate of ICANS (5.9%; 95% CI, 2.4-11.7) was low but similar to rates without prophylactic tocilizumab. CRS was limited to grade 1 for 10 of 12 events. There were no grade 3 CRS events, and no additional doses of tocilizumab or corticosteroids were given for CRS. Our real-world evidence results suggest that tocilizumab may be effective as a preventive, rather than reactive, measure to prevent CRS without compromising efficacy.

129

News (Medical) associated with Talquetamab

24 Nov 2025

·firstwordpharma.com

ASH25: 83.4% of MM patients taking J&J's Tecvayli doublet alive after 3 years

Johnson & Johnson on Monday shared detailed survival data from a Phase III study evaluating a combination of its anti-BCMA bispecific Tecvayli (teclistamab-cqyv) plus Darzalex Faspro (daratumumab/hyaluronidase-fihj) in patients with relapsed/refractory multiple myeloma (MM) who had received one to three prior lines of treatment. Yusri Elsayed, J&J's global therapeutic area head for oncology, had said the duo was "poised to be a new standard of care option" when top-line results from the 587-patient MajesTEC-3 trial were shared last month (see – ViewPoints: J&J continues to raise its own bar in MM).Physicians also see Tecvayli as the preferred bispecific for MM. The results of a recent FirstWord poll showed that it was the top choice for 47% of US haematologists and oncologists, ranking it above other bispecifics including Talvey (talquetamab), Elrexfio (elranatamab) and Lynozyfic (linvoseltamab). For more on which treatments doctors are picking for their MM patients, see Physician Views In-Depth: US oncologists heavily favour Tecvayli among MM bispecifics.'Clinically remarkable'The pharma had reported in October that the Tecvayli-Darzalex Faspro combo helped patients with MM live significantly longer without their disease worsening than those on two standard-of-care comparators — investigator's choice of either Darzalex Faspro plus pomalidomide and dexamethasone, or Darzalex Faspro plus bortezomib and dexamethasone (DPd/DVd).Now, J&J has pulled back the curtain on the study's survival specifics in a late-breaking abstract posted ahead of the American Society of Hematology (ASH) meeting (see – Spotlight On: Late-breakers to watch at ASH 2025).The drugmaker revealed that its Tecvayli-Darzalex Faspro combo achieved a 36-month progression-free survival (PFS) rate of 83.4%, versus 29.7% for the DPd/DVd comparator arm. While the standard-of-care group saw a median PFS of 18.1 months, that milestone was not reached after a median follow-up of 34.5 months for those taking the experimental regimen. Overall survival "significantly favoured" the doublet, with a hazard ratio of 0.46 and 45 patient deaths, compared to 96 deaths the standard-of-care arm. More than 90% of patients taking Tecvayli-plus-Darzalex Faspro who were alive after 6 months remained alive at the 30-month mark, and close to half remained on treatment as of the data cut-off. J&J's duo also bested DPd/DVd on several key secondary measures, including complete response rate (81.8% versus 32.1%), overall response rate (89% vs 75.3%) and MRD-negativity rate (58.4% vs 17.1%), all of which were statistically significant results. The rate of treatment-emergent adverse events (TEAEs) was comparable between the two study arms. Serious TEAEs occurred in 70.7% of those taking Tecvayli-Darzalex Faspro with a discontinuation rate of 4.6%, versus 62.4% and 5.5%, respectively, for the comparator group. Grade 1 and 2 cytokine release syndrome (CRS) was reported in 44.2% and 15.9% of doublet recipients, respectively; the rate of immune effector cell-associated neurotoxicity syndrome (ICANS) was 1.1%.The abstract authors described the findings as "clinically remarkable," adding that the off-the-shelf immunotherapy combination could represent a new standard-of-care for relapsed/remitting MM as early as first relapse.

Clinical ResultPhase 3ASHImmunotherapy

21 Nov 2025

·www.prnewswire.com

Hackensack Meridian John Theurer Cancer Center Unveils Research at the 67th American Society of Hematology Annual Meeting

Advances span leukemia, lymphoma, myeloma, myeloproliferative neoplasms, sickle cell disease, and AI-enabled diagnostics HACKENSACK, N.J., Nov. 21, 2025 /PRNewswire/ -- Investigators from Hackensack Meridian John Theurer Cancer Center (JTCC)—a leading research partner of the NCI-designated Lombardi Comprehensive Cancer Center at Georgetown University, and number one Cancer Center in New Jersey—will present 65 studies at the 67th American Society of Hematology (ASH) Annual Meeting, taking place December 6–9, 2025, in Orlando. This represents one of JTCC's largest and most diverse scientific contributions to ASH to date, highlighting innovations in cell therapy, targeted agents, AI-driven diagnostics, stem cell transplantation, and real-world evidence across virtually every hematologic disease area. "John Theurer Cancer Center continues to help shape the future of blood cancer care," said André Goy, MD, chair, physician-in-chief and vice president of oncology at Hackensack Meridian Health. "Our teams are redefining transplantation, advancing CAR-T science, and co-leading trials testing next-generation targeted therapies and immunotherapies. The depth and breadth of our ASH presentations underscore our mission: to bring transformational science rapidly to the clinic for patients with blood cancers and other serious blood disorders." Highlights of JTCC Research to be presented at ASH 2025 can be found here. Leukemia High event-free (EFS) and overall survival (OS) after non-total body irradiation (TBI) conditioning and allogeneic hematopoietic cell transplantation (HCT) in next-generation-sequencing minimal residual disease (NGS-MRD) negative B-acute lymphoblastic leukemia (B-ALL): Results from the EndRAD trial (PTCTC ONC1701) (ABSTRACT 25-12959) A phase 2 dose confirmation trial of oral ASTX030, a combination of oral azacitidine with cedazuridine among patients with myelodysplastic syndromes, chronic myelomonocytic leukemia, and acute myeloid leukemia (ABSTRACT 25-7509) Ziftomenib in combination with venetoclax and azacitidine in relapsed/refractory NPM1-m or KMT2A-r acute myeloid leukemia: Updated phase 1a/b safety and clinical activity results from KOMET-007 (ABSTRACT 25-3910) MRD-guided therapy of sonrotoclax (BGB-11417) + obinutuzumab (O) in patients with treatment-naive CLL: Initial results from an ongoing phase 1/1b study, BGB-11417-101 (ABSTRACT 25-7489) Real world outcomes of bispecific T-cell engagers in plasma cell leukemia (ABSTRACT 25-4651) Etoposide can be safely removed from induction chemotherapy without impacting survival for pediatric acute myeloid leukemia – a report from the Children's oncology group study AAML1831 (ABSTRACT 25-12270) Updated response and safety analyses from a Phase 1 study of ivosidenib combined with intensive chemotherapy in patients with newly diagnosed (ND) Acute Myeloid Leukemia with isocitrate dehydrogenase (IDH)1 mutation (ABSTRACT 25-421) AI-derived prediction of response and relapse to venetoclax plus hypomethylating agent based therapy in Acute Myeloid Leukemia (ABSTRACT 25-14588) TSC-101 eliminates recipient hematopoietic cells and demonstrates potential for improved relapse-free survival in patients with AML, ALL, or MDS undergoing allogeneic HCT: Updated results from the Phase 1 (ALLOHA) trial (ABSTRACT 25-12098) Trials in progress: Design of a registrational Phase 2 trial (ALLOHA) using an external control arm for TSC-101 for prevention of relapse post allogeneic HCT in patients with ALL, AML, or MDS (ABSTRACT 25-13827) Developing artificial intelligence-based transcriptomic signature for selecting patients with HOXA-MEIS1 pathway abnormalities for the treatment with menin inhibitors (ABSTRACT 25-4126) Evaluation of ventoclax initiation prophylaxis and monitoring outcomes at each dose level and time point in patients with chronic lymphocytic leukemia: A real-world experience (ABSTRACT 25-2129) Developing transcriptomic signature for IDH1 and IDH2 acute leukemia and the demonstration of high prevalence of these signatures in mutation-negative leukemia (ABSTRACT 25-4127) Impact of DUSP22 and TP63 rearrangements in patients with ALK-negative ALCL treated with frontline BV-CH(E)P (ABSTRACT 25-1798) Harnessing repressive LEF1/ β-catenin complexes to overcome drug resistance in chronic lymphocytic leukemia (ABSTRACT 25-14485) Reducing Acute Myeloid Leukemia resistance to CAR T cell therapy by epigenetic activation of the tumor inflammasome-pyroptosis signaling (ABSTRACT 25-13458) Lymphoma Epcoritamab + R-mini-CHOP results in 2-year remissions and high MRD negativity rates in elderly patients with newly diagnosed DLBCL: Results from the EPCORE NHL-2 trial (ABSTRACT 25-3828) Epcoritamab with rituximab + lenalidomide (R2) and epcoritamab maintenance deliver deep and durable remissions in previously untreated (1L) follicular lymphoma (FL): 3-year outcomes from epcore NHL-2 arms 6 and 7 (ABSTRACT 25-2787) Liquid-biopsy mutation landscape and its concordance with skin biopsies in cutaneous T-cell lymphoma (ABSTRACT 25-2858) ZUMA-25 preliminary analysis: A Phase 2 study of brexucabtagene autoleucel (brexu-cel) in patients (Pts) with relapsed/refractory (R/R) Burkitt lymphoma (BL), substudy C (ABSTRACT 25-2841) Final results of a phase 1 trial with soquelitinib (SQL), a selective interleukin-2-inducible T cell kinase (ITK) inhibitor for treatment of relapsed/refractory (R/R) T cell lymphomas (TCL) (ABSTRACT 25-2574) Acalabrutinib plus venetoclax and rituximab in patients with treatment-naive (TN) mantle cell lymphoma (MCL): Results from the Phase 2 TrAVeRse study (ABSTRACT 25-7289) Two-year update of ZUMA-2 Cohort 3: Brexucabtagene autoleucel (Brexu-cel) in patients (pts) with relapsed/refractory mantle cell lymphoma (R/R MCL) who had not received prior Bruton tyrosine kinase inhibitor (BTKi) therapy (ABSTRACT 25-2240) Phase 2 bellwave-003 cohort f: Updated clinical outcomes of nemtabrutinib in participants with relapsed or refractory marginal zone lymphoma (ABSTRACT 25-2322) A real-world analysis of safety and outcomes with first line nivolumab in combination with doxorubicin, vinblastine, and dacarbazine (NAVD) in patients with classic Hodgkin lymphoma (cHL) – a multicenter cohort study (ABSTRACT 25-2368) Safety and efficacy of brexucabtagene autoleucel in elderly patients with relapsed or refractory Mantle Cell Lymphoma: A retrospective, multicenter, international study (ABSTRACT 25-2034) Developing artificial intelligence-based transcriptomic signature for the diagnosis of dark zone lymphoma in patients without MYC gene rearrangement (ABSTRACT 25-7855) A multicenter real-world analysis of combined chemotherapy followed by consolidative radiation versus chemotherapy alone in the management of early-stage Hodgkin lymphoma – the HODGKIN25 study (ABSTRACT 25-1471) Nivolumab with doxorubicin, vinblastine, and dacarbazine (NAVD) in older adults with classic Hodgkin lymphoma: Do S1826 results hold up in the real world? (ABSTRACT 25-7840) First-line salvage therapies in relapsed/refractory large B-cell lymphoma after second- or third-line CD19-directed CAR T-cell therapy (ABSTRACT 25-3402) Multicenter, randomized Phase II study of epcoritamab for patients with large B-cell lymphomas achieving a partial response after CD19-directed CAR T-cell therapy: Trial in progress (ABSTRACT 25-15528) Zanubrutinib + obinutuzumab + sonrotoclax in patients with treatment-naive chronic lymphocytic leukemia/small lymphocytic lymphoma (TN CLL/SLL): Initial results from an ongoing phase 1/1b study, BGB-11417-101 (ABSTRACT 25-4113) Sustained remissions beyond 4 years with epcoritamab monotherapy: Long term follow-up results from the pivotal EPCORE NHL-1 trial in patients with relapsed or refractory large B-cell lymphoma (ABSTRACT 25-7543) Multiple Myeloma Real-world outcomes with elranatamab in multiple myeloma: A multi-center analysis from the United States multiple myeloma immunotherapy consortium (ABSTRACT 25-2557) Phase 1 study of ktx-1001, a first-in-class oral MMSET/NSD2 inhibitor, demonstrates clinical activity in relapsed/refractory multiple myeloma (ABSTRACT 25-2077) Phase 2 registrational study of anitocabtagene autoleucel for the treatment of patients with relapsed and/or refractory multiple myeloma: Updated results from iMMagine--1 (ABSTRACT 25-4541) Alterations in the gut microbiome and the association of butyrate producers with progression-free survival in multiple myeloma patients undergoing autologous stem cell transplantation (ABSTRACT 25-14794) Talquetamab outcomes in relapsed/refractory myeloma with extramedullary and paraskeletal soft tissue plasmacytomas (ABSTRACT 25-7804) Safety and efficacy of talquetamab in patients with relapsed and refractory multiple myeloma (RRMM) with and without renal impairment (ABSTRACT 25-7724) Enhancing the safety of ciltacabtagene autoleucel in relapsed multiple myeloma (MM): Identification of potentially modifiable risk-factors associated with delayed neurotoxicity and non-relapse mortality (ABSTRACT 25-2357) An open-label, multi-center Phase 2 study to assess the safety and efficacy of burixafor (GPC-100) and propranolol with G-CSF for the mobilization of hematopoietic progenitor cells in patients with multiple myeloma (ABSTRACT 25-14982) Prospective real-world evaluation of SKY92 for risk stratification in multiple myeloma: Comparison with updated ims/IMWG criteria in the prommis study (ABSTRACT 25-8818) Pomalidomide salvage in T-cell engager monotherapy failures: Real-world experience with talquetamab or elranatamab with pomalidomide combinations in heavily pretreated multiple myeloma (ABSTRACT 25-10539) Prolonged elranatamab treatment interruption in patients with relapsed or refractory multiple myeloma (RRMM) is feasible: A retrospective analysis from MagnetisMM-3 (ABSTRACT 25-8338) Talquetamab, a GPRC5D×CD3 bispecific antibody, in combination with pomalidomide in patients with Relapsed/Refractory multiple myeloma: Updated safety and efficacy results from the Phase 1b monumental-2 study (ABSTRACT 25-11949) Prospective study of fluoroquinolone resistance colonization in patients undergoing autologous hematopoietic stem cell transplantation in the treatment of multiple myeloma (ABSTRACT 25-13625) Identifying high-risk profiles and adverse prognoses in relapsed/refractory multiple myeloma treated with bispecific antibodies: A real-world analysis of 943 treatment initiations (ABSTRACT 25-8860) Intratumoral cellular immunotherapy with autologous hyperactivated M1 SIRP α -low macrophages in non-Hodgkin lymphoma: Clinical results from a first-in-human Phase 1 study (ABSTRACT 25-8309) Real-world disease burden and treatment patterns among triple-class–exposed patients with relapsed/refractory multiple myeloma and extramedullary disease in the US: A retrospective analysis using Flatiron Health electronic medical records (ABSTRACT 25-9053) Shared immune features correspond to high-risk multiple myeloma across multiple human subtypes and murine models (ABSTRACT 25-13910) Real-world efficacy and safety of teclistamab in relapsed or refractory multiple myeloma: Results from 87 patients treated by the polish myeloma group (ABSTRACT 25-11305) Myeloproliferative Neoplasms Preliminary data from the Phase I/II study of nuvisertib, an oral investigational selective PIM1 inhibitor, in combination with momelotinib showed clinical responses in patients with relapsed/refractory myelofibrosis (ABSTRACT 25-3882) Safety and efficacy results from A phase 1b study of R289, a dual irak 1/4 inhibitor, in patients with Relapsed/Refractory (R/R) lower risk myelodysplastic syndrome (LR-MDS) (ABSTRACT 25-13480) Nuvisertib, an oral investigational selective PIM1 kinase inhibitor, showed clinical responses strongly correlating with cytokine modulation in patients with relapsed/refractory myelofibrosis in the ongoing global phase I/II study (ABSTRACT 25-2614) Bone marrow microenvironment overlap between vexas and myelodysplastic syndrome demonstrated by targeted transcriptomic and artificial intelligence (ABSTRACT 25-7376) Noncancerous Blood Disorders Reduced intensity haploidentical bone marrow transplantation in children with severe sickle cell disease (SCD): BMT CTN 1507 (ABSTRACT 25-11982) End-of-study results from the ICON3 pines trial, a phase 3, randomized trial of eltrombopag vs. standard first-line treatment for newly diagnosed immune thrombocytopenia in children (ABSTRACT 25-4324) The real-world safety and efficacy of BCMA-directed chimeric antigen receptor T-cell therapy in systemic AL amyloidosis (ABSTRACT 25-2732) Robust HbF induction and improvement of anemia and hemolysis with base editing in sickle cell disease: Safety and efficacy findings from the ongoing BEACON study (ABSTRACT 25-2531) Children and adolescents with sickle cell disease demonstrate improved health-related quality of life and low decisional regret after hematopoietic cell transplantation: A sickle cell transplant advocacy and research alliance (STAR) study (ABSTRACT 25-12128) Increased age-adjusted mortality rates from hemophagocytic lymphohistiocytosis (HLH), 2010-2023 (ABSTRACT 25-7365) Rapid decrease in age-adjusted mortality rates associated with ITP following eltrombopag and romiplostim approvals, but not in TMA following eculizumab approval, 1999-2023 (ABSTRACT 25-9103) Technology B- and T-cell clonality using peripheral blood cell-free RNA (cfRNA) in liquid biopsy (ABSTRACT 25-7865) Not so exclusive: Co-mutations in JAK2, MPL and CALR define distinct hematologic and clonal signatures (ABSTRACT 25-10661) Temporal control of CAR expression enables thymic generation of autoreactive T cells targeting tumor-associated antigens (ABSTRACT 25-8390) About Hackensack Meridian John Theurer Cancer Center Hackensack Meridian John Theurer Cancer Center at Hackensack University Medical Center is recognized as New Jersey's #1 cancer center in New Jersey by U.S. News & World Report. They are also the largest and most comprehensive center dedicated to diagnosis, treatment, management, research, screening, and preventive care as well as survivorship of patients with all types of cancers. The 16 specialized divisions covering the complete spectrum of cancer care have developed a close-knit team of medical, research, nursing, and support staff with specialized expertise that translates into more advanced, focused care for all patients. Each year, more people in the New Jersey/New York metropolitan area turn to John Theurer Cancer Center for cancer care than to any other facility in New Jersey. John Theurer Cancer Center is part of the NCI-designated Lombardi Comprehensive Cancer Center at Georgetown University. Housed within a 781-bed not-for-profit teaching, tertiary care, and research hospital, John Theurer Cancer Center provides state-of-the-art technological advances, compassionate care, research innovations, medical expertise, and a full range of aftercare services that distinguish John Theurer Cancer Center from other facilities. The center expanded to Jersey Shore University Medical Center, serving patients in southern New Jersey and parts of Pennsylvania. Toms River Regional Cancer Center and Saint Joseph's Health are affiliated with the cancer center. For additional information, please visit . SOURCE Hackensack Meridian John Theurer Cancer Center 21% more press release views with Request a Demo

Clinical ResultPhase 2Phase 1ImmunotherapyASH

20 Nov 2025

·pmlive.com

J&J receives positive NICE recommendation for multiple myeloma treatment

Johnson & Johnson (J&J) has received a positive recommendation from the UK’s National Institute for Health and Care Excellence (NICE) for TALVEY (talquetamab), for use within the NHS in England and Wales as a treatment option for relapsed and refractory multiple myeloma (RRMM). Multiple myeloma is an incurable blood cancer affecting plasma cells in the bone marrow. When these cells become malignant, they proliferate rapidly and replace healthy cells, forming tumours. Approximately 6,200 new cases are diagnosed in the UK each year, and an estimated 33,000 people are currently living with the disease. Symptoms may include bone pain, recurrent infections, fatigue, peripheral neuropathy, hypercalcaemia and renal impairment. There remains a significant unmet need, particularly for patients who are heavily pre-treated, as the risk of relapse increases with each successive line of therapy. TALVEY is a bispecific antibody designed to bind to both myeloma cells and T cells. By redirecting T cells to the myeloma cells, the therapy activates an immune response that results in targeted tumour cell death. Under the final draft guidance, TALVEY may now be offered as a monotherapy for adults with RRMM following three or more lines of prior treatment, including an immunomodulatory drug, a proteasome inhibitor and an anti-CD38 antibody, where the disease has progressed on the most recent therapy. NICE’s recommendation is supported by data from the single-arm, open-label phase 1/2 MonumenTAL-1 study, which met both primary and secondary endpoints, demonstrating clinically meaningful responses across overall response rate, progression-free survival and overall survival. “Given the relapsing and remitting nature of multiple myeloma, patients can face a challenging care journey,” said Amanda Cunnington, UK Senior Director of Patient Access, Johnson & Johnson Innovative Medicine. “People with myeloma need access to as many treatments as possible at every stage of their disease, and this is especially important at the later stages when options are more limited. “ Targeted medicines have the potential to help us get in front of cancer by delivering improved outcomes for patients versus standard of care therapies, and we look forward to today’s decision translating into uptake throughout England and Wales.”

Clinical ResultImmunotherapy

100 Deals associated with Talquetamab

R&D Status

Approved

10 top approved records.

to view more data

Indication	Country/Location	Organization	Date
Refractory Multiple Myeloma	Japan	Janssen Pharmaceutical KK	24 Jun 2025
Relapse multiple myeloma	Japan	Janssen Pharmaceutical KK	24 Jun 2025
Multiple Myeloma	United States	Janssen Biotech, Inc.	09 Aug 2023

Developing

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Residual Neoplasm	Phase 2	United States	Johnson & Johnson	21 Aug 2025
Peripheral Stem Cell Transplantation	Phase 2	United States	Janssen Scientific Affairs LLC	05 Jun 2025
Smoldering Multiple Myeloma	Phase 2	United States	Janssen Scientific Affairs LLC	04 Dec 2023
Hematologic Neoplasms	Phase 1	United States	Janssen Research & Development LLC	16 Dec 2017
Hematologic Neoplasms	Phase 1	Belgium	Janssen Research & Development LLC	16 Dec 2017
Hematologic Neoplasms	Phase 1	Netherlands	Janssen Research & Development LLC	16 Dec 2017
Hematologic Neoplasms	Phase 1	Spain	Janssen Research & Development LLC	16 Dec 2017

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


ASH2025	Not Applicable	Relapse multiple myeloma	87	Talquetamab	qynukpbbev(uldcwhdxcb) = qofuuszeuj hwfxltmqxa (gafhlugkkg ) View more	Positive	06 Dec 2025
NCT04586426 (RedirecTT-1, ASH2025)	Phase 2	Relapse multiple myeloma \| Extramedullary Plasmacytoma	90	Talquetamab + Teclistamab	lvwiwcrhhb(kezpbxelfo) = dbafujeean omvzvrvszm (cfaejovmez, 43.0 - 85.4) View more	Positive	06 Dec 2025
NCT06500884 (TALISMAN, ASH2025)	Phase 2	Relapse multiple myeloma	17	Talquetamab + Dexamethasone[Dex] mouthwash	noxwfpcbxl(cnzpohbpyb) = other oral AEs included xerostomia (2/5 pts, all grade 1) and oral mucositis (1/5 pts, grade 1) tbmbvgylqa (fmzthccrop ) View more	Positive	06 Dec 2025
ASH2025	Not Applicable	Multiple Myeloma	417	Talquetamab (patients with renal impairment (RI))	lvysbrzaeg(xmilnwzpvu) = fryjxbgiit rknrooyiat (hkfsdqbwox ) View more	Positive	06 Dec 2025
ASH2025	Not Applicable	Multiple Myeloma	417	Talquetamab (without renal impairment (RI))	lvysbrzaeg(xmilnwzpvu) = lhichrrtka rknrooyiat (hkfsdqbwox ) View more	Positive	06 Dec 2025
ASH2025	Not Applicable	Relapse multiple myeloma	25	Talquetamab	knliljadjc(prcaxmbfjg) = wachsgbpok umhpszsaul (chdxdldgdn ) View more	Positive	06 Dec 2025
ASH2025	Not Applicable	Relapse multiple myeloma	25	Talquetamab	knliljadjc(prcaxmbfjg) = wlplfxbkxt umhpszsaul (chdxdldgdn ) View more	Positive	06 Dec 2025
ASH2025	Not Applicable	Relapse multiple myeloma	484	Talquetamab	nlwoyhnssa(okyteuqgyt) = bkqxjfiork kmirnavvnh (raouvarutw ) View more	Positive	06 Dec 2025
ASH2025	Not Applicable	-	463	Talquetamab (pts with extramedullary disease)	ctyvlxjagw(xtzvarlqmw) = mxubjelopf yurjdugzxw (vlkefkddku ) View more	Negative	06 Dec 2025
ASH2025	Not Applicable	-	463	Talquetamab (pts with paraskeletal disease)	ctyvlxjagw(xtzvarlqmw) = zcfsnhslfr yurjdugzxw (vlkefkddku ) View more	Negative	06 Dec 2025
ASH2025	Not Applicable	Multiple Myeloma \| B-Cell Lymphoma	199	T-cell engaging bispecific antibodies (Severe Neutropenia)	clhterrkmx(zokwcoqqiz) = qlcgmvbfiq tcsrlqgtsi (cdulakplkf ) View more	Positive	06 Dec 2025
ASH2025	Not Applicable	Multiple Myeloma	509	Teclistamab	mcikrmbwpv(qpaxxvftfa) = opkjybhkjf zlicczfbhm (bycqvbpyrv ) View more	Positive	06 Dec 2025
ASH2025	Not Applicable	Multiple Myeloma	509	Talquetamab	mcikrmbwpv(qpaxxvftfa) = tuitsburbw zlicczfbhm (bycqvbpyrv ) View more	Positive	06 Dec 2025
ASH2025	Not Applicable	Relapse multiple myeloma	77	BsAbs	xmgrdnnqtl(pvkjhagxrz) = debjdmwnro fowbjrkmcc (fidmuklnwf ) View more	Positive	06 Dec 2025

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