# MajesTEC-3

Source: https://onco.cc/trials/majestec-3/  
OnCo record `majestec-3` (Trial). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

A bispecific plus daratumumab cut the risk of progression by more than 80% versus standard doublets, bringing bispecifics to second line.

## Summary

MajesTEC-3, trial NCT05083169 sponsored by Janssen and reported in 2025, showed that the BCMA bispecific teclistamab plus daratumumab cut the risk of progression by more than eighty percent versus daratumumab-based doublets in relapsed or refractory myeloma after one to three prior lines, bringing bispecifics into the second line. It randomised 587 patients and met its primary progression-free survival endpoint with the median not reached against about eighteen months, leading to FDA approval on 5 March 2026 for patients with at least one prior line, with EU approval following and infection prophylaxis mandatory. OnCo links it to multiple myeloma, teclistamab, daratumumab, Philippe Moreau and the MajesTEC-1 paper. How bispecifics and CAR-T should be sequenced against each other in early relapse is the open question.

## Fields

- Kind: Trial
- Status: positive
- Last checked: 2026-09-07
- Registry id: NCT05083169
- Phase: 3
- Setting: Relapsed/refractory myeloma after 1-3 prior lines: teclistamab + daratumumab vs Dara-Pd or Dara-Vd
- Sponsor: Janssen
- Enrolled: 587
- Result: 36-month PFS 83.4% vs 29.7%; HR ~0.17.
- Outcomes: Progression-free survival at 36 months: Teclistamab + daratumumab 83.4% vs Dara-Pd / Dara-Vd 29.7%, HR 0.17

## Sources

- ClinicalTrials.gov NCT05083169: https://clinicaltrials.gov/study/NCT05083169
- FDA approval (J&J): https://www.jnj.com/media-center/press-releases/johnson-johnson-announces-u-s-fda-approval-of-tecvayli-plus-darzalex-faspro-for-relapsed-refractory-multiple-myeloma-offering-a-potential-new-standard-of-care-as-early-as-second-line

## Connected records

- cancers: [Multiple myeloma](https://onco.cc/cancers/multiple-myeloma/), [Relapsed or refractory multiple myeloma](https://onco.cc/cancers/myeloma-relapsed-refractory/)
- technologies: [T-cell engagers (bispecific)](https://onco.cc/technologies/t-cell-engager/)
- drugs: [Daratumumab](https://onco.cc/drugs/daratumumab/), [Teclistamab](https://onco.cc/drugs/teclistamab/)
- companies: [Johnson & Johnson](https://onco.cc/companies/johnson-johnson/)
- people: [Philippe Moreau](https://onco.cc/people/philippe-moreau/)
- key papers: [MajesTEC-1: teclistamab, an off-the-shelf BCMA bispecific antibody, in heavily pretreated myeloma](https://onco.cc/key-papers/paper-majestec-1-teclistamab-nejm-2022/)

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