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TECVAYLI®

(teclistamab-cqyv)

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TECVAYLI® (teclistamab-cqyv)

Medical Information

TECVAYLI - MajesTEC-9 Study

Last Updated: 03/18/2026

SUMMARY

  • Johnson & Johnson does not recommend the use of TECVAYLI in a manner inconsistent with the approved labeling.
  • MajesTEC-9 is an ongoing, phase 3, randomized, open-label, multicenter study comparing TECVAYLI with investigator’s choice of pomalidomide, bortezomib and dexamethasone (PVd) or carfilzomib and dexamethasone (Kd) in patients with relapsed or refractory multiple myeloma (RRMM) who previously received 1-3 prior lines of therapy (LOTs) including an anti-CD38 monoclonal antibody (mAb) and lenalidomide. The study is currently ongoing, and results have not been published.1

CLINICAL DATA - MajeSTEC-9 Study

MajesTEC-9 (NCT05572515) is an ongoing, phase 3, randomized, open-label, multicenter study comparing TECVAYLI with investigator’s choice of PVd or Kd in patients with RRMM who previously received 1-3 prior LOTs including an anti-CD38 mAb and lenalidomide.1

Study Design/Methods

MajesTEC-9 Study Design1

Abbreviations: AE, adverse event; BCMA, B-cell maturation antigen; CR, complete response; ECOG PS, Eastern Cooperative Oncology Group performance status; EOT, end of treatment; HRQoL, health-related quality of life; IMWG, International Myeloma Working Group; Kd, carfilzomib and dexamethasone; LOT, line of therapy; mAb, monoclonal antibody; ORR, overall response rate; OS, overall survival; PFS2, progression-free survival on next-line therapy; PFS, progression-free survival; PR, partial response; PRO, patient-reported outcome; PVd, pomalidomide, bortezomib and dexamethasone; R, randomization; RRMM, relapsed or refractory multiple myeloma; TTNT, time to next treatment; VGPR, very good partial response.
aRandomization will be stratified by choice of PVd or Kd, stage of disease, anti-CD38 mAb-refractory status, and the number of prior LOTs.
bInvestigator’s choice of PVd or Kd.

LITERATURE SEARCH

A literature search of Ovid MEDLINE®, Embase®, BIOSIS Previews®, and Derwent Drug File databases (and/or other resources, including internal/external databases) was conducted on 18 March 2026.

 

References

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1 Touzeau C, Hungria V, Bhutani D, et al. MajesTEC-9: a randomized phase 3 study of teclistamab versus pomalidomide, bortezomib, and dexamethasone or carfilzomib and dexamethasone in patients with relapsed/refractory multiple myeloma. Poster presented at: The 2023 American Society of Clinical Oncology (ASCO) Annual Meeting; June 2-6, 2023; Chicago, IL & Virtual.