TALVEY

(Talquetamab)

Phase 3Monoclonal antibody

Talquetamab is used to treat multiple myeloma, a type of blood cancer affecting plasma cells. It works by helping the immune system recognize and attack cancer cells.[1] TALVEY is currently being investigated across 5 indications[3], with its most advanced program in Phase 3.[1]

TALVEY is one of 74 small molecule programs targeting Toxicity. It is currently in Phase 3.

Indications

Total Trials

Active Trials

Competitors

FDA Application

NDA/BLA/ANDA regulatory filings

Pipeline

Status by Indication[3][1]

Indication

ToxicityActive, not recruiting

Multiple MyelomaRecruiting

Relapsed/refractory Multiple MyelomaActive, not recruiting

Hematological MalignanciesRecruiting

Cytokine Release SyndromeRecruiting

ToxicityPhase 2

Active, not recruiting

Multiple MyelomaPhase 3

Recruiting

Relapsed/refractory Multiple MyelomaPhase 1

Active, not recruiting

Hematological MalignanciesPhase 2

Recruiting

Cytokine Release SyndromePhase 2

Recruiting

Competition

Competitive Landscape

1135 competitors in Multiple Myeloma

#DrugCompanyPhaseTrials

TALVEY

Johnson & Johnson

Phase 3

26 2

Ninlaro

Takeda

Preclinical

18 3

Prolia

Amgen

Preclinical

5 4

Eliquis

Bristol-Myers Squibb

Preclinical

3 5

Epogen

Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

Preclinical

2 6

Adriamycin

GGynecologic Oncology Group

Preclinical

9 7

Nolvadex

AstraZeneca

Preclinical

1 8

Intron a

Systemic Therapy

1 10

Abecma

Bristol-Myers Squibb

Preclinical

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Q4 2026

Phase 1/2Active, not recruiting

Multiple Myeloma

NCT04586426

Q2 2027

Phase 1Active, not recruiting

Multiple Myeloma

NCT04108195

Phase 1Active, not recruiting

Multiple Myeloma

NCT05050097

Phase 1Active, not recruiting

Relapsed/refractory Multiple Myeloma

NCT05338775

Phase 2Recruiting

Multiple Myeloma

NCT06461988

Q3 2027

Phase 2Active, not recruiting

Multiple Myeloma

NCT06550895

Clinical

Trials by Indication[1]

Multiple Myeloma26 trials

Pre-Approval Access Program for Talquetamab in Relapsed or Refractory Multiple Myeloma

Approved for marketing· Johnson & Johnson logo

Johnson & Johnson··NCT05757973

Study for Frail Patients With Newly Diagnosed Multiple Myeloma Treated With Daratumumab With Teclistamab or Talquetamab.

Not yet recruiting·EEuropean Myeloma Network B.V.·Phase 2·NCT07107529·150 enrolled

Outpatient Administration of Teclistamab or Talquetamab for Multiple Myeloma

Recruiting·SSCRI Development Innovations, LLC·Phase 2·NCT05972135·100 enrolled

Show 23 more trials

Mezigdomide and Talquetamab in Relapsed and Refractory Multiple Myeloma

Not yet recruiting·MMassachusetts General Hospital·Phase 1·NCT07032714·25 enrolled

A Study of Comparing Talquetamab to Belantamab Mafodotin in Participants With Relapsed/Refractory Multiple Myeloma

Withdrawn· Johnson & Johnson logo

Johnson & Johnson·Phase 3·NCT05461209

Bispecific T-cell Redirectors as Part of First Line Treatment in Transplant Eligible Multiple Myeloma Patients

Recruiting·—·Phase 2·NCT06505369·50 enrolled

Subcutaneous Talquetamab in Elderly Patients With Multiple Myeloma in Early Relapse

Recruiting·LLarysa Sanchez·Phase 2·NCT06827860·23 enrolled

A Study of Talquetamab for People With Multiple Myeloma Who Have Received BCMA CAR T-Cell Therapy

Recruiting·MMemorial Sloan Kettering Cancer Center·Phase 2·NCT06066346·17 enrolled

Teclistamab-Daratumumab and Talquestamab-Daratumumab in Newly Diagnosed High-risk Multiple Myeloma

Active, not recruiting·PPETHEMA Foundation·Phase 2·NCT05849610·30 enrolled

The Norwegian Immunotherapy in Multiple Myeloma Study

Recruiting·SSt. Olavs Hospital··NCT06855121·400 enrolled

A Study of JNJ-64407564 in Japanese Participants With Relapsed or Refractory Multiple Myeloma

Completed· Johnson & Johnson logo

Johnson & Johnson·Phase 1·NCT04773522·15 enrolled

A Study of the Combination of Talquetamab and Teclistamab in Participants With Relapsed or Refractory Multiple Myeloma

Active, not recruiting· Johnson & Johnson logo

Johnson & Johnson·Phase 1/2·NCT04586426·228 enrolled

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

Recruiting·MMedical College of Wisconsin·Phase 1·NCT07093554·31 enrolled

Talquetamab in Combination With Iberdomide and Dexamethasone for Relapsed or Refractory Multiple Myeloma

Recruiting·—·Phase 1·NCT06348108·32 enrolled

External Beam Radiation Therapy in Combination With Talquetamab for the Treatment of Multiple Myeloma Patients With Extramedullary Disease

Recruiting·—·Phase 1/2·NCT06572605·20 enrolled

Pre-Approval Access Single Patient Request for Talquetamab in Relapsed or Refractory Multiple Myeloma

No longer available· Johnson & Johnson logo

Johnson & Johnson··NCT05503550

Minimal Residual Disease-based Strategy With T-Cell Redirector After Treatment With Daratumumab, Bortezomib, Lenalidomide, and Dexamethasone (D-VRd) in Newly Diagnosed Multiple Myeloma

Active, not recruiting·NNantes University Hospital·Phase 2·NCT06353022·103 enrolled

An Efficacy and Safety Study of bb2121 in Subjects With Relapsed and Refractory Multiple Myeloma and in Subjects With High-Risk Multiple Myeloma

Completed· Bristol-Myers Squibb logo

Bristol-Myers Squibb·Phase 2·NCT03601078·312 enrolled

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

Active, not recruiting· Johnson & Johnson logo

Johnson & Johnson·Phase 3·NCT05455320·864 enrolled

A Phase 2, Open-label, Randomized Study to Evaluate GPRC5D-related Oral Events

Recruiting· Johnson & Johnson logo

Johnson & Johnson·Phase 2·NCT06500884·210 enrolled

A Phase 1b Study of Subcutaneous Daratumumab Regimens in Combination With Bispecific T Cell Redirection Antibodies for the Treatment of Subjects With Multiple Myeloma

Active, not recruiting· Johnson & Johnson logo

Johnson & Johnson·Phase 1·NCT04108195·290 enrolled

A Phase 2, Open-label Study to Evaluate the Efficacy and Safety of Different Sequences of Ciltacabtagene Autoleucel (Cilta-cel), Talquetamab SC in Combination With Daratumumab SC (Tal-D) and Teclistamab SC in Combination With Daratumumab SC (Tec-D) Following Induction With Daratumumab, Bortezomib, Lenalidomide and Dexamethasone (DVRd) in Participants With Standard-risk Newly Diagnosed Multiple Myeloma

Active, not recruiting· Johnson & Johnson logo

Johnson & Johnson·Phase 2·NCT06577025·43 enrolled

An Open-Label, Non-Randomized, Phase II Study to Study the Efficacy of Talquetamab (JNJ-64407564) and Lenalidomide as Post Stem Cell Transplant Maintenance in Multiple Myeloma (OPTIMMAL)

Recruiting·SStanford University·Phase 2·NCT06461988·20 enrolled

A Phase 2, Open-Label, Multicenter Study of Ciltacabtagene Autoleucel and Talquetamab for the Treatment of Participants With High-Risk Multiple Myeloma

Active, not recruiting· Johnson & Johnson logo

Johnson & Johnson·Phase 2·NCT06550895·11 enrolled

A Phase 3 Randomized Study Comparing Teclistamab in Combination With Daratumumab SC and Lenalidomide (Tec-DR) and Talquetamab in Combination With Daratumumab SC and Lenalidomide (Tal-DR) Versus Daratumumab SC, Lenalidomide, and Dexamethasone (DRd) in Participants With Newly Diagnosed Multiple Myeloma Who Are Either Ineligible or Not Intended for Autologous Stem Cell Transplant as Initial Therapy

Recruiting· Johnson & Johnson logo

Johnson & Johnson·Phase 3·NCT05552222·1,590 enrolled

A Multi-arm Phase 1b Study of Talquetamab With Other Anticancer Therapies in Participants With Multiple Myeloma

Active, not recruiting· Johnson & Johnson logo

Johnson & Johnson·Phase 1·NCT05050097·166 enrolled

Hematological Malignancies2 trials

64407564MMY1001: A Phase 1/2, First-in-Human, Open-Label, Dose Escalation Study of Talquetamab, a Humanized GPRC5D x CD3 Bispecific Antibody, in Subjects With Relapsed or Refractory Multiple Myeloma

Active, not recruiting· Johnson & Johnson logo

Johnson & Johnson·Phase 1·NCT03399799·279 enrolled

A Phase 1/2, First-in-Human, Open-Label, Dose Escalation Study of Talquetamab, a Humanized GPRC5D x CD3 Bispecific Antibody, in Subjects With Relapsed or Refractory Multiple Myeloma

Recruiting· Johnson & Johnson logo

Johnson & Johnson·Phase 2·NCT04634552·510 enrolled

Newly Diagnosed1 trial

Engaging T-cells to Eliminate MRD in Newly Diagnosed Myeloma Optimizing Response With Talquetmab and Teclistamab (ROTATE)

Recruiting·NNoffar Bar·Phase 2·NCT06993675·50 enrolled

Daratumumab1 trial

Teclistamab in Combination With Daratumumab for High-Risk Smoldering Myeloma: A Clinical and Correlative Phase 2 Immuno-Oncology Study (the REVIVE Study)

Recruiting·—·Phase 2·NCT06100237·50 enrolled

Relapsed or Refractory1 trial

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

Recruiting· Johnson & Johnson logo

Johnson & Johnson·Phase 3·NCT06208150·795 enrolled

3 more indications

Cytokine Release Syndrome1 trial

Phase 2 Study of Cytokine Release Syndrome Prophylaxis With Infliximab for Teclistamab/Talquetamab Therapy in Patients With Relapsed/Refractory Myeloma

Recruiting·NNaresh Bumma·Phase 2·NCT07657312·35 enrolled

Relapsed/Refractory Multiple Myeloma1 trial

A Phase 1b Study of Bispecific T Cell Redirection Antibodies in Combination With Checkpoint Inhibition for the Treatment of Participants With Relapsed or Refractory Multiple Myeloma

Active, not recruiting· Johnson & Johnson logo

Johnson & Johnson·Phase 1·NCT05338775·74 enrolled

Unspecified1 trial

GMMG-HD10 / DSMM-XX / 64007957MMY2003, MajesTEC-5

Recruiting·UUniversity of Heidelberg Medical Center·Phase 2·NCT05695508·160 enrolled

Regulatory

FDA Approval Timeline[4]

Aug 9, 2023

TALVEY

BLA BLA761342

Sources

References

[1]
ClinicalTrials.gov — 34 trial records for Talquetamab. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — Talquetamab compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for Talquetamab. EMBL-EBI & Wellcome Sanger Institute.
[4]
OpenFDA — FDA approval records (BLA BLA761342). U.S. Food & Drug Administration.
[5]
SEC EDGAR — Johnson & Johnson company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Mechanism of Action: G-Protein Coupled Receptor Family C Group 5 Member D Binding Agent; T Cell Surface Glycoprotein CD3 Binding Agent[2]
Modality: Monoclonal antibody[2]
Highest Phase: Phase 3[1]
Company: Johnson & Johnson

TALVEY

Status by Indication[3][1]

Competitive Landscape

Expected Milestones

Q4 2026

Q2 2027

Q3 2027

Trials by Indication[1]

Multiple Myeloma26 trials

Hematological Malignancies2 trials

Newly Diagnosed1 trial

Daratumumab1 trial

Relapsed or Refractory1 trial

Cytokine Release Syndrome1 trial

Relapsed/Refractory Multiple Myeloma1 trial

Unspecified1 trial

FDA Approval Timeline[4]

References

Drug Info

Quick Facts

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