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Talquetamab: latest updates from the FDA and European Commission

Aug 24, 2023
Learning objective: After reading this article, learners will be able to cite a new clinical development in relapsed/refractory MM

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On August 10, 2023, the U.S. Food and Drug Administration (FDA) granted accelerated approval for the use of talquetamab in the treatment of relapsed/ refractory multiple myeloma (RRMM) for patients who have been treated with four or more prior lines of therapy. Following this, on August 22, 2023, the European Commission granted conditional marketing authorization for patients with RRMM, treated with three or more prior lines of therapy. For both the FDA and European Commission approvals, patients must have been treated with a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 antibody.1 Talquetamab is the first GPRC5D/CD3-targeted BsAb to be approved for use.

Talquetamab is an investigational bispecific T-cell engaging antibody that targets both GPRC5D and CD3. CMA has been recommended for talquetamab as a monotherapy for the treatment of patients with relapsed/refractory multiple myeloma (RRMM), who have been treated with three or more prior therapies, including an immunomodulatory agent, a proteasome inhibitor, and an anti-CD38 antibody, with observed disease progression.


The EMA’s CHMP recommendation for CMA is based on data from the phase I/II MonumenTAL-1 trial (NCT03145181; NCT04557098), which was presented at the 2023 European Hematology Association (EHA) Hybrid Congress. A summary of MonumenTAL-1, including its trial design has been published previously on the Multiple Myeloma Hub and can be found here.


The latest response data in patients treated with 0.4 mg/kg and 0.8 mg/kg of talquetamab as well as in those with prior exposure to T-cell redirection therapy (TCR; which includes bispecific antibodies and CAR T-cell therapy) is shown in Figure 1.

Figure 1. Response rates for patients by dosing strategy and prior exposure to T-cell redirection therapy* 

CR, complete response; ORR, overall response rate; PR, partial response; sCR, stringent complete response; SQ, subcutaneous; TCR, T-cell redirection; VGPR, very good partial response.
*Adapted from Touzeau.2


Safety data for the 0.4 mg/kg weekly, 0.8 mg/kg every other week, and prior TCR dosing regimens, respectively:

  • Adverse events leading to discontinuation: 4.9%, 8.3%, and 7.8%
  • Cytokine-release syndrome, any grade: 79%, 74.5%, and 76.5%
  • Immune effector cell-associated neurotoxicity syndrome, any grade: 10.7%, 11%, and 2.9%
  • Neutropenia, Grade 3/4: 30.8%, 22.1%, 52.9%
  • Infections, any grade: 58.7%, 66.2%, and 72.5%
    • Infections, Grade 3/4: 19.6%, 14.5%, 27.5%

  1.  U.S. FDA approves TALVEY™ (talquetamab-tgvs), a first-in-class bispecific therapy for the treatment of patients with heavily pretreated multiple myeloma. Published August 10, 2023. Accessed August 15, 2023.
  2. Cyrille Touzeau. Pivotal phase 2 MONUMENTAL-1 results of talquetamab (tal), a GPRC5DXCD3 bispecific antibody (bsAb), for relapsed/refractory multiple myeloma (RRMM). Oral abstract #S191. European Hematology Association 2023 Hybrid Congress; June 10, 2023; Frankfurt, DE.


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