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This information is intended for US healthcare professionals to access current scientific information about J&J Innovative Medicine products. It is prepared by Medical Information and is not intended for promotional purposes, nor to provide medical advice.

TECVAYLI® (teclistamab-cqyv)

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TECVAYLI - MajesTEC-3 (MMY3001) Study

Last Updated: 03/18/2025

SUMMARY

Janssen does not recommend the use of TECVAYLI in a manner inconsistent with the approved labeling.
MajesTEC-3 (MMY3001) is a phase 3, randomized, open-label study evaluating the efficacy and safety of TECVAYLI in combination with DARZALEX FASPRO^® (daratumumab and hyaluronidase) vs investigator’s choice of DARZALEX FASPRO, pomalidomide, and dexamethasone (DPd) or DARZALEX FASPRO, bortezomib, and dexamethasone (DVd) in patients with relapsed/refractory multiple myeloma (RRMM) after 1-3 prior lines of therapy (LOT). Enrollment of this study is ongoing, and results have not been published at this time.¹^,²

PRODUCT LABELING

TECVAYLI (teclistamab-cqyv) [Prescribing Information]. Horsham, PA: Janssen Biotech, Inc.; https://www.janssenlabels.com/package-insert/product-monograph/prescribing-information/TECVAYLI-pi.pdf.
DARZALEX FASPRO (daratumumab and hyaluronidase-fihj) [Prescribing Information]. Horsham, PA: Janssen Biotech, Inc.; https://www.janssenlabels.com/package-insert/product-monograph/prescribing-information/DARZALEX+Faspro-pi.pdf.

CLINICAL DATA - MAJESTEC-3 STUDY

MajesTEC-3 (MMY3001; clinicaltrials.gov identifier NCT05083169) is a phase 3, randomized, open-label study evaluating the efficacy and safety of TECVAYLI in combination with DARZALEX FASPRO vs DPd or DVd (investigator’s choice) in patients with RRMM after 1-3 prior LOT.¹^,²

Study Design/Methods

The study design is presented in Figure: MajesTEC-3 Study Design.¹^,²

MajesTEC-3 Study Design¹^,²

Abbreviations: ADA, anti-drug antibody; AE, adverse event; BCMA, B-cell maturation antigen; CR, complete response; DOR, duration of response; DPd, daratumumab + pomalidomide + dexamethasone; DVd, daratumumab + bortezomib + dexamethasone; ECOG PS, Eastern Cooperative Oncology Group performance status; HRQoL, health-related quality of life; ISS, International Staging System; IV, intravenous; LOT, line of therapy; mAb, monoclonal antibody; MM, multiple myeloma; MRD, minimal residual disease; OS, overall survival; PD, pharmacodynamics; PFS2, progression-free survival on next-line therapy; PFS, progression-free survival; PI, proteasome inhibitor; PK, pharmacokinetics; PO, by mouth; PR, partial response; PRO, patient-reported outcome; R, randomization; SC, subcutaneous; SUD, step-up dose; TTNT, time to next treatment; VGPR, very good partial response.
^aRandomization will be stratified by choice of DPd or DVd, ISS stage, previous anti-CD38 exposure, and the number of prior LOTs.
^bStep-up doses of teclistamab will be given before the first-full dose.
^cDexamethasone was administered at a dose of 40 mg for patients ≤75 years or 20 mg for patients >75 years.
^dInvestigator’s choice of DPd/DVd.

Literature Search

A literature search of MEDLINE^®, Embase^®, BIOSIS Previews^®, and Derwent Drug File databases (and/or other resources, including internal/external databases) was conducted on 14 March 2025.

References

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Mateos M, Bahlis N, Costa L, et al. MajesTEC-3: randomized phase 3 study of teclistamab plus daratumumab versus investigator‚Äôs choice of daratumumab, pomalidomide, and dexamethasone or daratumumab, bortezomib, and dexamethasone in patients with relapsed/refractory multiple myeloma. Poster presented at: 2022 American Society of Clinical Oncology (ASCO) Annual Meeting; June 3-7, 2022; Chicago, IL/Virtual Meeting.

Janssen Research & Development, LLC. A phase 3 randomized study comparing teclistamab in combination with daratumumab SC (Tec-Dara) versus daratumumab SC, pomalidomide, and dexamethasone (DPd) or daratumumab SC, bortezomib, and dexamethasone (DVd) in participants with relapsed or refractory multiple myeloma. In: ClinicalTrials.gov [Internet]. Bethesda (MD): National Library of Medicine (US). 2000- [cited 2025 March 14]. Available from: https://clinicaltrials.gov/ct2/show/NCT05083169 NLM Identifier: NCT05083169.