Zie ook in gerelateerde artikelen

14 december 2025: Bron: The New Journal of Medicine d.d. 9 december 2025

Uit een gerandomiseerde fase III studie bij totaal 587 patiënten met gevorderde botkanker - Multiple Myeloma (ziekte van Kahler) die 1 tot 3 eerdere behandelingen hadden gehad blijkt dat immuuntherapie met de combinatie van TECVAYLI / Teclistamab plus DARZALEX / daratumumab in vergelijking met de standaard behandeling van DARZALEX / daratumumab gecombineerd met dexamethason plus de door de onderzoeker gekozen pomalidomide of bortezomib, statistisch significant veel betere ziektevrije overleving en overall overleving geeft. Na drie jaar studie follow-up waren de overlevingspercentages respectievelijk 83,3 procent versus 65,0 procent.

Uit het abstract vertaalde resultaten:

TECVAYLI / Teclistamab plus DARZALEX / daratumumab subcutaan gegeven behaalde significant hogere algehele responspercentages van 89,0 procent versus 75,3 procent;
Ook werden hogere percentages van een complete remissie gezien of betere gedeeltelijke remissies ≥CR van 81,8 procent versus 32,1 procent;
De percentages MRD-negativiteit = restziekte bij ≥CR 10-5 in de evalueerbare populatie waren 89,3 procent versus 63,0 procent.b
Bij ≥CR 10-6 waren de percentages MRD-negativiteit = restziekte 87,5 procent versus 41,8 procent vergeleken met de standaardbehandeling na bijna drie jaar follow-up.
De algehele overleving (OS) was ook beter voor TECVAYLI / Teclistamab plus DARZALEX / daratumumab in alle vooraf gespecificeerde subgroepen. Na drie jaar waren de overlevingspercentages respectievelijk 83,3% en 65,0%.
Bovendien ervaarden patiënten met TECVAYLI / Teclistamab plus DARZALEX / daratumumab twee keer zo lang minder eernstige bijwerkingen vergeleken met de standaardbehandeling, wat een significante verbetering van de door patiënten gerapporteerde kwaliteit van leven onderstreept.

"Met deze gegevens betreden we een nieuw tijdperk in de behandeling van botkanker - Multiple Myeloma (ziekte van Kahler) met de eerste immunotherapiecombinatie die al in de tweede lijn een superieure algehele overleving laat zien vergeleken met de standaardbehandeling", aldus dr. Sen Zhuang, Vice President, Oncology Clinical Research, Johnson & Johnson Innovative Medicine, de producent van deze medicijnen. “Met teclistamab plus daratumumab SC hebben we opnieuw de potentie om een nieuwe standaard te zetten voor de behandeling van deze ziekte. We blijven onderzoeken hoe behandelingen met onze bispecifieke antilichamen de toekomst voor patiënten kunnen herdefiniëren.”

Teclistamab is een kant-en-klaar (of gebruiksklaar) bispecifiek antilichaam. Teclistamab, een subcutane injectie, stuurt T-cellen via twee cellulaire doelen (BCMA en CD3) om het immuunsysteem van het lichaam te activeren en kanker te bestrijden. Teclistamab wordt momenteel geëvalueerd in verschillende combinatiestudies. Zie ook referenties onderaan dit artikel die ik heb gekopieerd van de website van Johnson & Johnson Innovative Medicine, de producent van deze medicijnen uit dit artikel.

Het volledige studierapport is onder bepaalde voorwaarden gratis in te zien, zie in het abstract:

Teclistamab plus Daratumumab in Relapsed or Refractory Multiple Myeloma

Authors: Luciano J. Costa, M.D. https://orcid.org/0000-0001-5362-2469, Nizar J. Bahlis, M.D., Aurore Perrot, M.D., Ph.D. https://orcid.org/0000-0003-0131-8689, Ajay K. Nooka, M.D., M.P.H., Jin Lu, M.D., Charlotte Pawlyn, M.B., B.Chir., Ph.D., Roberto Mina, M.D., +37 , for the MajesTEC-3 Trial Investigators*Author Info & Affiliations

Published December 9, 2025

DOI: 10.1056/NEJMoa2514663

Abstract

Background

In a phase 1–2 trial, teclistamab, a bispecific antibody targeting CD3 on T-cell surfaces and B-cell maturation antigen on myeloma cells, showed durable responses in heavily pretreated patients with relapsed or refractory multiple myeloma. Daratumumab, a monoclonal antibody targeting CD38 protein, has shown survival benefit in patients with multiple myeloma.

Methods

In this phase 3 trial, we randomly assigned patients with one to three previous lines of therapy to receive combination therapy with teclistamab–daratumumab or daratumumab combined with dexamethasone plus the investigator’s choice of pomalidomide (DPd) or bortezomib (DVd) — the DPd or DVd group. The primary end point was progression-free survival, as assessed by an independent review committee.

Results

A total of 587 patients underwent randomization (291 to receive teclistamab-daratumumab and 296 to receive DPd or DVd). At a median of 34.5 months, progression-free survival was significantly longer with teclistamab-daratumumab than with DPd or DVd. The estimated 36-month progression-free survival was 83.4% in the teclistamab–daratumumab group and 29.7% in the DPd or DVd group (hazard ratio, 0.17; 95% confidence interval, 0.12 to 0.23; P<0.001). More patients in the teclistamab-daratumumab group than in the DPd or DVd group had a complete response or better (81.8% vs. 32.1%), an overall response (89.0% vs. 75.3%), and minimal residual disease negativity (10-5; 58.4% vs. 17.1%) (P<0.001 for all comparisons). Serious adverse events occurred in 70.7% of the patients in the teclistamab–daratumumab group and in 62.4% of those in the DPd or DVd group; death from adverse events occurred in 7.1% and 5.9%, respectively.

Conclusions

In patients with multiple myeloma who had received one to three previous lines of therapy, those in the teclistamab–daratumumab group had significantly longer progression-free survival than those in the DPd or DVd group. (Funded by Johnson & Johnson; ClinicalTrials.gov number, NCT05083169.)

This article was published on December 9, 2025, at NEJM.org.

A data sharing statement provided by the authors is available with the full text of this article at NEJM.org.

Supported by Johnson & Johnson.

Disclosure forms provided by the authors are available with the full text of this article at NEJM.org.

We thank the patients who participated in the trial, along with their families and caregivers; the physicians, nurses, and staff members at each site; the members of the study safety committee; Caren Minadeo and Arpan Patel, who assisted with data management and programming, respectively, and additional team members who were involved in the collection and analysis of the data; and Holly Clarke and Bethany Reinecke of Lumanity Communications for their writing assistance.

Supplementary Material

Protocol (nejmoa2514663_protocol.pdf)

12.21 MB

Supplementary Appendix (nejmoa2514663_appendix.pdf)

638.74 KB

Disclosure Forms (nejmoa2514663_disclosures.pdf)

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4.65 MB

Data Sharing Statement (nejmoa2514663_data-sharing.pdf)

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70.84 KB

December 2025
CP-554346

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