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Teclistamab receives positive CHMP opinion for reduced, biweekly dosing schedule in patients with relapsed/refractory multiple myeloma

On July 21, 2023, teclistamab received a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) for a reduced, biweekly dosing schedule of 1.5mg/kg every other week in patients who have achieved a complete response or better for six months or longer.1  

Despite the tremendous progress made in the field of multiple myeloma in recent years, there remains a large unmet need in patients with advanced disease, whose responses tend to decrease after each successive line of treatment.2 The emergence of bispecific antibodies offers newfound hope as a highly promising treatment option for patients with relapsed/refractory (R/R) myeloma.

Teclistamab was the first BCMAxCD3 bispecific antibody to be licensed in Europe for the treatment of adults with R/R multiple myeloma who have received at least three prior lines of treatment, including an immunomodulatory agent (IMiD), a proteasome inhibitor, and an anti-CD38 monoclonal antibody.3

The CHMP recommendation is based on data from the Phase I/II MajesTEC-1 study (NCT03145181; NCT04557098), which investigates the safety and efficacy of teclistamab in R/R multiple myeloma. An update was presented at this year’s ASCO meeting, focusing on the feasibility of transitioning from a once-weekly dosing schedule (QW) to every other week (Q2W) in patients who achieved a confirmed partial response or better after ≥4 cycles of treatment (Phase I) or a confirmed complete response (CR) or better for ≥6 months (Phase II). The study reported that at the time of switch, 82% of patients achieved a CR or better and 18% had a very good partial response (VGPR). After a median follow-up of 11.1 months after switching, the median duration of response (DOR) from the date of switch was 20.5 months, and approximately 67% of patients are still in response, indicating that transition to Q2W teclistamab dosing allows patients to maintain a sustained remission.4

During the ASCO conference, Surbhi Sidana, MD, Stanford University, Stanford, CA, discussed the latest findings from the MajesTEC-1 study, revealing that a less frequent dosing schedule is also associated with a lower rate of infections.5

Overall, this updated teclistamab dosing recommendation, tailored to patient response, will benefit not only patients but also physicians and caregivers4, and marks an important step in the utilization of bispecific antibodies in multiple myeloma.  

  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 (Accessed 26/07/2023).
  2. Yong K, Delforge M, Driessen C, et al. Multiple myeloma: patient outcomes in real-world practice. British Journal of Haematology. 2016 Jul 13; 175(2):252-264.
  3. European Medicines Agency. TECVAYLI Summary of Product Characteristics. Available here (Accessed 26/07/2023).
  4. Usmani SZ, Karlin L, Benboubker L, et al. Durability of responses with biweekly dosing of teclistamab in patients with relapsed/refractory multiple myeloma achieving a clinical response in the majesTEC-1 study. Journal of Clinical Oncology. 2023 May 31; 41(suppl 16):8034.
  5. Van de Donk NWCJ, Moreau P, Garfall AL, et al. Long-term follow-up from MajesTEC-1 of teclistamab, a B-cell maturation antigen (BCMA) x CD3 bispecific antibody, in patients with relapsed/refractory multiple myeloma (RRMM). Journal of Clinical Oncology. 2023 May 31; 41(suppl 16):8011-8011.

Written by Elitsa Kamberska

Edited by Thomas Southgate