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    DRUG:

    Talvey (talquetamab-tgvs)

    i
    Other names: JNJ-64407564, JNJ 64407564, JNJ-7564 , JNJ64407564, JNJ7564, JNJ 7564
    Company:
    Genmab, J&J
    Drug class:
    CD3 agonist, GPRC5D inhibitor
    Related drugs:
    7d
    MonumenTAL-6: A Study Comparing Talquetamab Plus Pomalidomide, Talquetamab Plus Teclistamab, and Elotuzumab, Pomalidomide, and Dexamethasone or Pomalidomide, Bortezomib, and Dexamethasone in Participants With Relapsed or Refractory Myeloma Who Have Received an Anti-CD38 Antibody and Lenalidomide (clinicaltrials.gov)
    P3, N=795, Recruiting, Janssen Research & Development, LLC | Trial completion date: Mar 2028 --> Dec 2028
    Trial completion date
    |
    lenalidomide • bortezomib • pomalidomide • Empliciti (elotuzumab) • Talvey (talquetamab-tgvs) • Tecvayli (teclistamab-cqyv) • dexamethasone injection
    8d
    Dermatologic Adverse Events Associated with T-Cell Engager Therapy. (PubMed, Am J Clin Dermatol)
    T-cell engager therapies, including bispecific T-cell engagers and the immune-mobilizing monoclonal T-cell receptor against cancer tebentafusp, are an emerging class of anticancer immunotherapy, with rapid expansion of the class since initial approval of blinatumomab in 2014 and with distinct dermatologic adverse events increasingly recognized across agents. Tebentafusp and talquetamab demonstrate highest rates of notable dermatologic toxicity reflecting on-target off-tumor cutaneous effects...Across agents, most dermatologic adverse events can be managed with topical corticosteroids, emollients, antihistamines, or brief courses of systemic corticosteroids without requiring treatment discontinuation. Recognition of these agent-specific and mechanistically linked patterns is essential for dermatologists as T-cell engager therapies become increasingly integrated into oncology practice.
    Review • Journal • Adverse events • IO biomarker
    |
    CD20 (Membrane Spanning 4-Domains A1)
    |
    Blincyto (blinatumomab) • Kimmtrak (tebentafusp-tebn) • Talvey (talquetamab-tgvs)
    24d
    Talquetamab: Mechanism of Action, Clinical, and Translational Science. (PubMed, Clin Transl Sci)
    During talquetamab treatment, 35.8% (130/363) of participants developed anti-drug antibodies, including 18.2% (66/363) with neutralizing antibodies, across both recommended doses, and no clinically meaningful impact of immunogenicity on talquetamab pharmacokinetics, efficacy, or safety was observed. Talquetamab has received accelerated approval (US) and conditional marketing authorization (EU) with further ongoing investigation as monotherapy or in combination regimens across various MM treatment settings.
    Review • Journal
    |
    GPRC5D (G Protein-Coupled Receptor Class C Group 5 Member D)
    |
    Talvey (talquetamab-tgvs)
    1m
    GEM-TECTAL: Teclistamab-Daratumumab and Talquestamab-Daratumumab in Newly Diagnosed High-risk Multiple Myeloma (clinicaltrials.gov)
    P2, N=30, Active, not recruiting, PETHEMA Foundation | Trial primary completion date: Mar 2025 --> Mar 2026
    Trial primary completion date
    |
    lenalidomide • bortezomib • Darzalex (daratumumab) • Talvey (talquetamab-tgvs) • Tecvayli (teclistamab-cqyv)
    1m
    Talisman: A Study to Evaluate Preventive Treatments for GPRC5D-related Oral Events (clinicaltrials.gov)
    P2, N=210, Recruiting, Janssen Research & Development, LLC | Trial completion date: Apr 2029 --> May 2030 | Trial primary completion date: Apr 2026 --> May 2030
    Trial completion date • Trial primary completion date
    |
    ramantamig (JNJ-5322) • Talvey (talquetamab-tgvs)
    1m
    TALMMY1001-PT3: A Study of Talquetamab in Participants With Relapsed or Refractory Multiple Myeloma (clinicaltrials.gov)
    P2, N=510, Recruiting, Janssen Research & Development, LLC | Trial primary completion date: Mar 2026 --> Jun 2027
    Trial primary completion date • First-in-human
    |
    Actemra IV (tocilizumab) • Talvey (talquetamab-tgvs)
    1m
    MonumenTAL-2: A Study of Talquetamab With Other Anticancer Therapies in Participants With Multiple Myeloma (clinicaltrials.gov)
    P1, N=166, Active, not recruiting, Janssen Research & Development, LLC | Trial completion date: Apr 2027 --> Oct 2027
    Trial completion date
    |
    carfilzomib • pomalidomide • Darzalex Faspro (daratumumab and hyaluronidase-fihj) • Talvey (talquetamab-tgvs)
    1m
    MonumenTAL-6: A Study Comparing Talquetamab Plus Pomalidomide, Talquetamab Plus Teclistamab, and Elotuzumab, Pomalidomide, and Dexamethasone or Pomalidomide, Bortezomib, and Dexamethasone in Participants With Relapsed or Refractory Myeloma Who Have Received an Anti-CD38 Antibody and Lenalidomide (clinicaltrials.gov)
    P3, N=795, Recruiting, Janssen Research & Development, LLC | N=468 --> 795
    Enrollment change
    |
    lenalidomide • bortezomib • pomalidomide • Empliciti (elotuzumab) • Talvey (talquetamab-tgvs) • Tecvayli (teclistamab-cqyv) • dexamethasone injection
    2ms
    A Preliminary Case Study to Evaluate the Efficacy and Safety of Talquetamab in Patients with Refractory Generalized Myasthenia Gravis (ChiCTR2600121843)
    P=N/A, N=2, The First Affiliated Hospital of Chongqing Medical University; The First Affiliated Hospital of Chongqing Medical University
    New trial
    |
    Talvey (talquetamab-tgvs)
    2ms
    EMN37 fitfix: Study for Frail Patients With Newly Diagnosed Multiple Myeloma Treated With Daratumumab With Teclistamab or Talquetamab. (clinicaltrials.gov)
    P2, N=150, Recruiting, European Myeloma Network B.V. | Not yet recruiting --> Recruiting
    Enrollment open
    |
    Darzalex (daratumumab) • Talvey (talquetamab-tgvs) • Tecvayli (teclistamab-cqyv)
    2ms
    MonumenTAL-3: A Study Comparing Talquetamab in Combination With Daratumumab or in Combination With Daratumumab and Pomalidomide Versus Daratumumab in Combination With Pomalidomide and Dexamethasone in Participants With Multiple Myeloma That Returns After Treatment or is Resistant to Treatment (clinicaltrials.gov)
    P3, N=864, Active, not recruiting, Janssen Research & Development, LLC | Trial completion date: Jun 2029 --> May 2028 | Trial primary completion date: Feb 2026 --> Jul 2027
    Trial completion date • Trial primary completion date
    |
    pomalidomide • Darzalex Faspro (daratumumab and hyaluronidase-fihj) • Talvey (talquetamab-tgvs) • dexamethasone injection
    2ms
    MajesTEC-7: A Study of Teclistamab in Combination With Daratumumab and Lenalidomide (Tec-DR) and Talquetamab in Combination With Daratumumab and Lenalidomide (Tal-DR) in Participants With Newly Diagnosed Multiple Myeloma (clinicaltrials.gov)
    P3, N=1590, Recruiting, Janssen Research & Development, LLC | N=568 --> 1590
    Enrollment change
    |
    lenalidomide • Darzalex Faspro (daratumumab and hyaluronidase-fihj) • Talvey (talquetamab-tgvs) • Tecvayli (teclistamab-cqyv)