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Talquetamab receives conditional marketing authorization for patients with relapsed/refractory multiple myeloma

On July 21, 2023, talquetamab received conditional marketing authorization (CMA) from the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) for patients with relapsed/refractory (R/R) multiple myeloma.1

Talquetamab is recommended as monotherapy for adult patients with R/R myeloma who have received at least three prior lines of therapy, including an immunomodulatory agent (IMiD), a proteasome inhibitor (PI), and an anti-CD38 antibody.1 Talquetamab is a bispecific antibody (BsAb) that targets GPRC5D on myeloma cells and CD3 on T-cells, mediating the killing of GPRC5D-expressing myeloma cells.2

The recommendation for talquetamab is based on data from the Phase I/II MonumenTAL-1 trial (NCT03399799; NCT04634552), which is evaluating the safety and efficacy of this agent in patients with R/R myeloma. Updated results were presented at the 2023 American Society of Clinical Oncology (ASCO) Meeting held in Chicago, IL. In this trial, patients were treated with talquetamab at a dose of 0.8 mg/kg biweekly or 0.4 mg/kg weekly with step-up doses.3 At a median follow-up of 12.7 months, 71.7% of patients treated with the 0.8 mg/kg biweekly dose achieved a response, with 60.7% of patients achieving a very good partial response (VGPR) or better. At a median follow-up of 18.8 months, 74.1% of patients treated with a dose of 0.4 mg/kg weekly achieved a response, with 59.4% achieving a VGPR or better.3 Responses were durable, and the 12-month overall survival (OS) rates were 77.4% in the 0.8 mg/kg biweekly cohort, and 76.4% in the 0.4 mg/kg cohort.

The discontinuation rate due to adverse events (AEs) was low in all cohorts, with cytokine release syndrome (CRS), dysgeusia, and skin-related AEs being the most common AEs observed.3

At the 2022 American Society for Hematology (ASH) Annual Meeting, Ajai Chari, MD, PhD, Mount Sinai School of Medicine, New York City, NY, shared some updates from the MonumenTAL-1 trial, commenting on the promise of talquetamab in the myeloma treatment armamentarium. Dr Chari states, “…and I think that’s what’s exciting about talquetamab – it’s a non-BCMA target, and as I alluded to the safety profile, makes it a really good agent to combine with other things.”

This recommendation by the CHMP for talquetamab provides a valuable novel option for patients with R/R disease, who represent a high unmet medical need.

  1. Johnson & Johnson. Janssen Receives Positive CHMP Opinions for Novel Bispecific Antibodies TALVEY®▼ (talquetamab) and TECVAYLI®▼ (teclistamab) for the Treatment of Patients with Relapsed and Refractory Multiple Myeloma. Available here. (Last accessed 26/07/2023).
  2. Chari A, Minnema MC, Berdeja JG, et al. Talquetamab, a T-Cell-Redirecting GPRC5D Bispecific Antibody for Multiple Myeloma. New England Journal of Medicine. 2022 Dec 15;387(24):2232-2244.
  3. Janssen. Janssen Presents Longer-Term Talquetamab Follow-Up Data Showing Overall Response Rates of More Than 70 Percent in Heavily Pretreated Patients with Multiple Myeloma. Available here. (Last accessed 26/07/2023).

Written by Anya Dragojlovic-Kerkache

Edited by Thomas Southgate