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 6 indications[3], with its most advanced program in Phase 3.[1]

TALVEY is one of 112 small molecule programs targeting Multiple Myeloma. It is currently in Phase 3.

Indications

Total Trials

Active Trials

111

Competitors

FDA Application

NDA/BLA/ANDA regulatory filings

Pipeline

Status by Indication[3][1]

Indication

Multiple MyelomaWithdrawn

Relapse Multiple MyelomaNot yet recruiting

Multiple Myeloma (MM)Recruiting

Hematological MalignanciesRecruiting

Newly DiagnosedRecruiting

DaratumumabRecruiting

Multiple MyelomaPhase 3

Withdrawn

Relapse Multiple MyelomaPhase 1

Not yet recruiting

Multiple Myeloma (MM)Phase 3

Recruiting

Hematological MalignanciesPhase 2

Recruiting

Newly DiagnosedPhase 2

Recruiting

DaratumumabPhase 2

Recruiting

Competition

Competitive Landscape

258 competitors in Multiple Myeloma

#DrugCompanyPhaseTrials

Belamaf

GSK

Phase 3

39 2

Fludara

Sanofi

Phase 3

47 3

Sarclisa

AAzienda U.S.L. 1 di Massa e Carrara

Phase 3

42 4

Xpovio

KKaryopharm Therapeutics Inc

Phase 3

28 5

TALVEY

Johnson & Johnson

Phase 3

22 6

Vepesid

AAvyxa

Phase 3

17 7

Elranatamab

Pfizer

Phase 3

26 8

BLENREP

GGlaxo Dba Glaxosmithkline

Phase 3

11 9

Platinol

MMcNeil Consumer & Specialty Pharmaceuticals, a Division of McNeil-PPC, Inc.

Phase 3

9 10

Etentamig

AbbVie

Phase 3

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

Timeline

Expected Milestones

Q3 2027

Phase 2Active, not recruiting

Multiple Myeloma

NCT06550895

Q4 2027

Phase 2Recruiting

Multiple Myeloma

NCT06066346

Phase 2Recruiting

Multiple Myeloma

NCT05972135

Phase 1Active, not recruiting

Hematological Malignancies

NCT03399799

Phase 1Active, not recruiting

Multiple Myeloma

NCT04108195

Phase 1Active, not recruiting

Relapsed/refractory Multiple Myeloma

NCT05338775

Clinical

Trials by Indication[1]

Multiple Myeloma22 trials

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

Withdrawn· Johnson & Johnson logo

Johnson & Johnson·Phase 3·NCT05461209

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

Recruiting·—·Phase 1·NCT06348108·32 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

Show 19 more trials

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

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

Mezigdomide and Talquetamab in Relapsed and Refractory Multiple Myeloma

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

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

Outpatient Administration of Teclistamab or Talquetamab for Multiple Myeloma

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

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

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

Recruiting·—·Phase 2·NCT06505369·50 enrolled

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

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

64407564MMY3009: A Phase 3 Randomized Study Comparing Talquetamab in Combination With Pomalidomide (Tal-P), Talquetamab in Combination With Teclistamab (Tal-Tec), and Investigator's Choice of Either Elotuzumab, Pomalidomide, and Dexamethasone (EPd) or Pom

Active, not recruiting· Johnson & Johnson logo

Johnson & Johnson·Phase 3·NCT06208150·838 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 Talquetamab SC in Combination With Daratumumab SC and Pomalidomide (Tal-DP) or Talquetamab SC in Combination With Daratumumab SC (Tal-D) Versus Daratumumab SC, Pomalidomide and Dexamethasone (DPd), in Participants With Relapsed or Refractory Multiple Myeloma Who Have Received at Least 1 Prior Line of Therapy

Active, not recruiting· Johnson & Johnson logo

Johnson & Johnson·Phase 3·NCT05455320·864 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

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

Recruiting· Johnson & Johnson logo

Johnson & Johnson·Phase 2·NCT06500884·210 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

Multiple Myeloma (MM)3 trials

Bispecific Antibody Therapy vs Autologous Stem Cell Transplantation as Consolidation for Newly Diagnosed, Standard Risk Multiple Myeloma

Not yet recruiting·AAlliance for Clinical Trials in Oncology·Preclinical·NCT07887984·920 enrolled

Phase 3 Randomized Study of Teclistamab and Talquetamab (Tec-Tal) Versus Daratumumab and Lenalidomide (DR) in Minimal Residual Disease (MRD) Positive Patients With Newly Diagnosed Multiple Myeloma After Autologous Hematopoietic Stem Cell Transplantation (TiTan)

Not yet recruiting·PPolish Myeloma Consortium·Phase 3·NCT07740486·248 enrolled

iFIT (UK-MRA Myeloma XVIII): Immunotherapy Approaches Adapted for Fitness in Newly Diagnosed Transplant Ineligible Patients With Myeloma

Recruiting·UUniversity of Leeds·Phase 3·NCT07649525·1,226 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

Relapsed or Refractory Multiple Myeloma2 trials

64407564MMY4003: 64407564MMY4003 - Talquetamab NPP Global

Approved for marketing· Johnson & Johnson logo

Johnson & Johnson··NCT05757973

64407564MMY4002: PRE-APPROVAL ACCESS Single Patient Request (SPR) TREATMENT GUIDELINE for TALQUETAMAB for Treating Physician Use in Relapsed and Refractory Multiple Myeloma Concurrent With Relapsed and Refractory Light Chain (AL) Amyloidosis

No longer available· Johnson & Johnson logo

Johnson & Johnson··NCT05503550

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

8 more indications

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

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

Extramedullary Disease in Multiple Myeloma1 trial

A Phase 1b/2 Study of Talquetamab Plus Concomitant Priming Radiotherapy in Multiple Myeloma With Extramedullary Disease

Suspended·CCity of Hope Medical Center·Preclinical·NCT06572605·20 enrolled

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

Multiple Myeloma in Relapse1 trial

A Phase 2 Single-Arm Study of Subcutaneous Talquetamab in Elderly Patients With Multiple Myeloma in Early Relapse

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

Relapse Multiple Myeloma1 trial

TAlquetamab and BeLantamab Mafodotin in Relapsed/Refractory Multiple Myeloma (TaBleMM)

Not yet recruiting·MMontefiore Medical Center·Phase 1·NCT07720843·50 enrolled

Myeloma Multiple1 trial

The Norwegian Immunotherapy in Multiple Myeloma Study - A Population-based Longitudinal Observational Multicenter Study on Effectiveness and Complications of Immunotherapy in Multiple Myeloma in the Norwegian Myeloma Cohort

Recruiting·SSt. Olavs Hospital··NCT06855121·400 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 — 38 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

Q3 2027

Q4 2027

Trials by Indication[1]

Multiple Myeloma22 trials

Multiple Myeloma (MM)3 trials

Hematological Malignancies2 trials

Relapsed or Refractory Multiple Myeloma2 trials

Daratumumab1 trial

Newly Diagnosed1 trial

Relapsed/Refractory Multiple Myeloma1 trial

Extramedullary Disease in Multiple Myeloma1 trial

Cytokine Release Syndrome1 trial

Multiple Myeloma in Relapse1 trial

Relapse Multiple Myeloma1 trial

Myeloma Multiple1 trial

Unspecified1 trial

FDA Approval Timeline[4]

References

Drug Info

Quick Facts

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