Talquetamab
- Generic Name
- Talquetamab
- Brand Names
- Talvey
- Drug Type
- Biotech
- 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
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
- Conditions
- Relapsed or Refractory Multiple Myeloma
- Interventions
- First Posted Date
- 2022-07-13
- Last Posted Date
- 2025-04-27
- Lead Sponsor
- Janssen Research & Development, LLC
- Target Recruit Count
- 810
- Registration Number
- NCT05455320
- Locations
- 🇯🇵
Chiba Cancer Center, Chiba, Japan
🇪🇸Hosp Univ Hm Sanchinarro, Madrid, Spain
🇪🇸Hosp Virgen de La Victoria, Malaga, Spain
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
- Conditions
- Relapsed/ Refractory Multiple Myeloma
- Interventions
- First Posted Date
- 2022-04-21
- Last Posted Date
- 2025-04-03
- 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
A Study of Talquetamab With Other Anticancer Therapies in Participants With Multiple Myeloma
- Conditions
- Multiple Myeloma
- Interventions
- First Posted Date
- 2021-09-20
- Last Posted Date
- 2025-05-04
- 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
A Study of JNJ-64407564 in Japanese Participants With Relapsed or Refractory Multiple Myeloma
- First Posted Date
- 2021-02-26
- Last Posted Date
- 2025-04-27
- Lead Sponsor
- Janssen Pharmaceutical K.K.
- Target Recruit Count
- 15
- Registration Number
- NCT04773522
- Locations
- 🇯🇵
Shonan Kamakura General Hospital, Kamakura-shi, Japan
🇯🇵Nagoya City University Hospital, Nagoya, Japan
🇯🇵National Hospital Organization Okayama Medical Center, Okayama, Japan
A Study of Talquetamab in Participants With Relapsed or Refractory Multiple Myeloma
- First Posted Date
- 2020-11-18
- Last Posted Date
- 2025-04-27
- Lead Sponsor
- Janssen Research & Development, LLC
- Target Recruit Count
- 510
- Registration Number
- NCT04634552
- Locations
- 🇧🇪
UCL - Saint Luc, Brussels, Belgium
🇧🇪UZ Antwerpen, Edegem, Belgium
🇧🇪UZ Leuven, Leuven, Belgium
A Study of the Combination of Talquetamab and Teclistamab in Participants With Relapsed or Refractory Multiple Myeloma
- Conditions
- Multiple Myeloma
- Interventions
- First Posted Date
- 2020-10-14
- Last Posted Date
- 2025-04-03
- 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
A Study of Subcutaneous Daratumumab Regimens in Combination With Bispecific T Cell Redirection Antibodies for the Treatment of Participants With Multiple Myeloma
- Conditions
- Multiple Myeloma
- Interventions
- First Posted Date
- 2019-09-30
- Last Posted Date
- 2025-05-04
- 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
An Efficacy and Safety Study of bb2121 in Subjects With Relapsed and Refractory Multiple Myeloma and in Subjects With High-Risk Multiple Myeloma
- Conditions
- Multiple Myeloma
- Interventions
- First Posted Date
- 2018-07-26
- Last Posted Date
- 2025-03-12
- Lead Sponsor
- Celgene
- Target Recruit Count
- 264
- Registration Number
- NCT03601078
- Locations
- 🇺🇸
Mayo Clinic in Arizona - Scottsdale, Scottsdale, Arizona, United States
🇺🇸University Of California San Francisco Medical Center, San Francisco, California, United States
🇺🇸Moffitt Cancer Center, Tampa, Florida, United States
Dose Escalation Study of Talquetamab in Participants With Relapsed or Refractory Multiple Myeloma
- First Posted Date
- 2018-01-16
- Last Posted Date
- 2025-04-25
- Lead Sponsor
- Janssen Research & Development, LLC
- Target Recruit Count
- 279
- Registration Number
- NCT03399799
- Locations
- 🇪🇸
Hosp. Univ. Germans Trias I Pujol, Badalona, Spain
🇺🇸University of Alabama Birmingham, Birmingham, Alabama, United States
🇺🇸City of Hope, Duarte, California, United States
Drug Development Updates
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