Talquetamab

Generic Name: Talquetamab

Brand Names: Talvey

Drug Type: Biotech

Chemical Formula: -

CAS Number: 2226212-40-2

Unique Ingredient Identifier: 4W3KFI3TN3

Background: Talquetamab is a IgG4-PAA bispecific G protein-coupled receptor class C group 5 member D (GPRC5D)-directed CD3 T-cell engager. It consists of two arms - anti-GPRC5D and anti-CD3 arms - linked by two interchain disulfide bonds, each arm comprising a heavy and light chain. Talquetamab binds to GPRC5D, a cell surface receptor expressed predominantly on multiple myeloma cells, and CD3 on T cells. It works to recruit CD3-expressing T cells to GPRC5D-expressing multiple myeloma cells to induce T-cell–mediated cytotoxicity.

The Committee for Medicinal Products for Human Use (CHMP) of the EMA recommended conditional marketing authorization for talquetamab for the treatment of relapsed or refractory multiple myeloma on July 21, 2023. On August 9, 2023, talquetamab was granted FDA accelerated approval.

Indication: In the US, talquetamab is indicated for the treatment of adult patients with relapsed or refractory multiple myeloma who have received at least four prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 monoclonal antibody. In Europe, talquetamab is indicated in patients who received at least three prior therapies and have demonstrated disease progression on the last therapy.

These indications are contingent, as talquetamab is only approved under accelerated approval in the US and conditional marketing authorization in Europe. Continued approval for these indications may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).

Associated Conditions: Refractory Multiple Myeloma, Relapsed Multiple Myeloma

Associated Therapies: -

Clinical Trials

A Study of Different Sequences of Cilta-cel, Talquetamab in Combination With Daratumumab and Teclistamab in Combination With Daratumumab Following Induction With Daratumumab, Bortezomib, Lenalidomide and Dexamethasone in Participants With Standard-risk Newly Diagnosed Multiple Myeloma

Phase 2

Recruiting

Conditions: Multiple Myeloma

Interventions: Drug: Cilta-cel
Drug: Talquetamab
Drug: Daratumumab
Drug: Bortezomib
Drug: Teclistamab
Drug: Lenalidomide
Drug: Dexamethasone
Drug: Cyclophosphamide
Drug: Fludarabine

First Posted Date: 2024-08-29

Last Posted Date: 2025-01-09

Lead Sponsor: Janssen Research & Development, LLC

Target Recruit Count: 40

Registration Number: NCT06577025

Locations: 🇪🇸
Hosp Clinico Univ de Salamanca, Salamanca, Spain
🇪🇸
Hosp. Univ. Marques de Valdecilla, Santander, Spain
🇺🇸
City of Hope, Duarte, California, United States

and more 5 locations

A Study to Evaluate Preventive Treatments for Talquetamab-related Oral Toxicity

Phase 2

Recruiting

Conditions: Relapse Multiple Myeloma
Refractory Multiple Myeloma

Interventions: Drug: Talquetamab
Drug: Prophylaxis A
Drug: Prophylaxis B
Drug: Prophylaxis C

First Posted Date: 2024-07-15

Last Posted Date: 2025-01-09

Lead Sponsor: Janssen Research & Development, LLC

Target Recruit Count: 130

Registration Number: NCT06500884

Locations: 🇺🇸
Icahn School of Medicine at Mt. Sinai, New York, New York, United States
🇧🇷
Instituto D Or de Pesquisa e Ensino IDOR, Sao Paulo, Brazil
🇰🇷
Seoul National University Hospital, Seoul, Korea, Republic of

and more 4 locations

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

Phase 3

Recruiting

Conditions: Relapsed or Refractory Multiple Myeloma

Interventions: Drug: Talquetamab
Drug: Pomalidomide
Drug: Teclistamab
Drug: Elotuzumab
Drug: Dexamethasone
Drug: Bortezomib

First Posted Date: 2024-01-17

Last Posted Date: 2025-01-09

Lead Sponsor: Janssen Research & Development, LLC

Target Recruit Count: 795

Registration Number: NCT06208150

Locations: 🇨🇳
The First Affiliated Hospital of Wenzhou Medical University, Wenzhou, China
🇨🇳
Tongji Hospital, Tongji Medical College of HUST, Wuhan, China
🇮🇱
Carmel Medical Center, Haifa, Israel

and more 192 locations

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

Phase 3

Recruiting

Conditions: Multiple Myeloma

Interventions: Drug: Teclistamab
Drug: Daratumumab
Drug: Lenalidomide
Drug: Talquetamab
Drug: Dexamethasone

First Posted Date: 2022-09-23

Last Posted Date: 2025-01-09

Lead Sponsor: Janssen Research & Development, LLC

Target Recruit Count: 1590

Registration Number: NCT05552222

Locations: 🇨🇳
The Second Xiangya Hospital of Central South Hospital, Changsha, China
🇨🇳
The First Affliated Hospital Of Nanchang University, Nanchang, China
🇦🇹
SCRI CCCIT gem GmbH, Salzburg, Austria

and more 162 locations

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

Phase 3

Recruiting

Conditions: Relapsed or Refractory Multiple Myeloma

Interventions: Drug: Talquetamab
Drug: Daratumumab
Drug: Pomalidomide
Drug: Dexamethasone

First Posted Date: 2022-07-13

Last Posted Date: 2025-01-09

Lead Sponsor: Janssen Research & Development, LLC

Target Recruit Count: 810

Registration Number: NCT05455320

Locations: 🇺🇸
University of Kansas, Westwood, Kansas, United States
🇺🇸
The Ohio State University Wexner Medical Center - James Cancer Hospital, Columbus, Ohio, United States
🇺🇸
OhioHealth, Columbus, Ohio, United States

and more 213 locations

A Study of Talquetamab and Teclistamab Each in Combination With a Programmed Cell Death Receptor-1 (PD-1) Inhibitor for the Treatment of Participants With Relapsed or Refractory Multiple Myeloma

Phase 1

Active, not recruiting

Conditions: Relapsed/ Refractory Multiple Myeloma

Interventions: Drug: Talquetamab
Drug: Teclistamab
Drug: PD-1 Inhibitor

First Posted Date: 2022-04-21

Last Posted Date: 2025-01-09

Lead Sponsor: Janssen Research & Development, LLC

Target Recruit Count: 74

Registration Number: NCT05338775

Locations: 🇺🇸
Wake Forest Baptist Medical Center, Winston-Salem, North Carolina, United States
🇺🇸
Memorial Sloan Kettering Cancer Center, New York, New York, United States
🇺🇸
Colorado Blood Cancer Institute, Denver, Colorado, United States

and more 16 locations

A Study of Talquetamab With Other Anticancer Therapies in Participants With Multiple Myeloma

Phase 1

Active, not recruiting

Conditions: Multiple Myeloma

Interventions: Drug: Talquetamab
Drug: Carfilzomib
Drug: Pomalidomide
Drug: Daratumumab SC
Drug: Lenalidomide

First Posted Date: 2021-09-20

Last Posted Date: 2025-01-09

Lead Sponsor: Janssen Research & Development, LLC

Target Recruit Count: 166

Registration Number: NCT05050097

Locations: 🇺🇸
University of Pittsburgh Medical Center, Pittsburgh, Pennsylvania, United States
🇺🇸
Indiana University, Indianapolis, Indiana, United States
🇺🇸
Tennessee Oncology, Nashville, Tennessee, United States

and more 28 locations

A Study of Talquetamab in Participants With Relapsed or Refractory Multiple Myeloma

Phase 2

Recruiting

Conditions: Hematological Malignancies

Interventions: Drug: Talquetamab

First Posted Date: 2020-11-18

Last Posted Date: 2025-01-09

Lead Sponsor: Janssen Research & Development, LLC

Target Recruit Count: 480

Registration Number: NCT04634552

Locations: 🇺🇸
University of Alabama Birmingham, Birmingham, Alabama, United States
🇺🇸
University of Arkansas for Medical Sciences, Little Rock, Arkansas, United States
🇺🇸
City of Hope, Duarte, California, United States

and more 74 locations

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

Phase 1

Active, not recruiting

Conditions: Multiple Myeloma

Interventions: Drug: Talquetamab
Drug: Teclistamab
Drug: Daratumumab

First Posted Date: 2020-10-14

Last Posted Date: 2025-01-09

Lead Sponsor: Janssen Research & Development, LLC

Target Recruit Count: 228

Registration Number: NCT04586426

Locations: 🇨🇦
Arthur J E Child Comprehensive Cancer Centre, Calgary, Alberta, Canada
🇺🇸
University of Alabama at Birmingham, Comprehensive Cancer Center, Birmingham, Alabama, United States
🇺🇸
University of Arkansas for Medical Sciences, Little Rock, Arkansas, United States

and more 37 locations

A Study of Subcutaneous Daratumumab Regimens in Combination With Bispecific T Cell Redirection Antibodies for the Treatment of Participants With Multiple Myeloma

Phase 1

Active, not recruiting

Conditions: Multiple Myeloma

Interventions: Drug: Daratumumab
Drug: Talquetamab
Drug: Teclistamab
Drug: Pomalidomide

First Posted Date: 2019-09-30

Last Posted Date: 2025-01-09

Lead Sponsor: Janssen Research & Development, LLC

Target Recruit Count: 290

Registration Number: NCT04108195

Locations: 🇨🇦
Arthur J E Child Comprehensive Cancer Centre, Calgary, Alberta, Canada
🇺🇸
City of Hope National Medical Center, Duarte, California, United States
🇺🇸
City of Hope Orange County Lennar Foundation Cancer Center, Irvine, California, United States

and more 21 locations

Drug Development Updates

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