Talquetamab

Overview

Talquetamab (JNJ-64407564) is a bispecific antibody binds to both CD3 on T cells and GPRC5D expressed on certain tumor cells.

SparkCures ID 306
Developed By Janssen Research & Development
Generic Name Talquetamab
Additional Names JNJ-64407564
Treatment Classifications
Treatment Targets

Clinical Trials

All Clinical Trials

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Early Relapse Multiple Myeloma

The following is a listing of clinical trials for patients with multiple myeloma who have received one to two prior lines of therapy.

A Study of Subcutaneous Daratumumab Regimens in Combination With Bispecific T Cell Redirection Antibodies f...
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Dose Escalation Study of Talquetamab in Participants With Relapsed or Refractory Multiple Myeloma
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Late Relapse Multiple Myeloma

The following is a listing of clinical trials for patients with multiple myeloma who have received three or more prior lines of therapy.

A Study of Talquetamab in Participants With Relapsed or Refractory Multiple Myeloma
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A Study of Subcutaneous Daratumumab Regimens in Combination With Bispecific T Cell Redirection Antibodies f...
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Dose Escalation Study of Talquetamab in Participants With Relapsed or Refractory Multiple Myeloma
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Smoldering Myeloma
Monoclonal Gammopathy of Undetermined Significance (MGUS)

Published Results

Updated results of a phase 1, first-in-human study of talquetamab, a G protein-coupled receptor family C group 5 member D (GPRC5D) × CD3 bispecific antibody, in relapsed/refractory multiple myeloma (MM)

May 28, 2021

  • As of Feb 8, 2021, 174 pts received talquetamab, 102 by IV and 72 by SC; in parts 1 and 2, 28 pts were treated at the RP2D, identified as weekly SC 405 µg/kg, with 10.0 and 60.0 µg/kg step-up doses.
  • Patients treated at the RP2D had a median age of 61.5 y (range 46–80) and a median of 5.5 prior lines of therapy (range 2–14; 100%/79% triple-class/penta-drug exposed; 71%/18% triple-class/penta-drug refractory; 86% refractory to last line of therapy; 21% with prior B-cell maturation antigen–directed therapy).
  • No dose-limiting toxicities occurred at the RP2D in part 1.
  • Most common AEs at the RP2D were:
    • CRS (79%; grade 3 4%; median time to onset: day after SC injection),
    • neutropenia (64%; grade 3/4 54%),
    • anemia (57%; grade 3/4 29%) and
    • dysgeusia (57%; all grade 1/2);
    • infections were reported in 32% of patients (grade 3/4 4%) and neurotoxicity in 7% (grade 3/4 0).
  • In all, 75% of pts dosed at the RP2D had skin-related AEs (grade 3/4 0), including 18% with nail disorders.
  • The overall response rate at the RP2D in response-evaluable pts (n = 24) was 63%, with 50% reaching very good partial response or better; 9/17 (53%) evaluable triple-class refractory pts and 3/3 (100%) penta-drug refractory pts had a response.
  • Median time to first confirmed response at the RP2D was 1.0 mo (range 0.2–3.8); responses were durable and deepened over time (median follow-up 6.2 mo [range 2.7–9.7+] for responders at the RP2D).
  • At the RP2D, exposure was maintained over the maximum EC90 target level from an ex vivo cytotoxicity assay, and consistent T cell activation was seen.
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