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.

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.

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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