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MajesTEC-9 — Teclistamab monotherapy, relapsed/refractory multiple myeloma, 2nd–4th line (1–3 prior lines)

Abstract: 7507 · Session: Hematologic Malignancies — Plasma Cell Dyscrasia, Fri May 29, 2026 · Presenter: Roberto Mina, MD (Winship Cancer Institute, Emory University, Atlanta, GA) · Embargo: May 29, 2026

At a glance

  • Sponsor: Johnson & Johnson (Janssen)
  • PI / presenter: Roberto Mina, MD (Emory/Winship) presenting; C. Ola Landgren, MD, PhD (Sylvester, Univ. Miami) lead/corresponding author on simultaneous NEJM publication
  • NCT ID: NCT05572515
  • Phase: 3, randomized, open-label
  • Design: Teclistamab monotherapy vs investigator's choice of PVd (pomalidomide/bortezomib/dexamethasone) or Kd (carfilzomib/dexamethasone)
  • N: 593 (296 teclistamab; 297 SOC) across 24 countries
  • Primary endpoint(s): Progression-free survival (PFS)
  • Comparator: PVd or Kd (investigator's choice)
  • Indication: Relapsed/refractory multiple myeloma
  • Line: 1–3 prior lines, including lenalidomide and an anti-CD38 monoclonal antibody (len/dara-exposed population)

Headline result

Teclistamab monotherapy reduced the risk of progression or death by 71% vs SOC: median PFS not reached vs 8.2 months (HR 0.29; 95% CI 0.23–0.38; P<.0001), with 18-month PFS 69.8% vs 26.9%. Overall survival also favored teclistamab (HR 0.60; 95% CI 0.43–0.83; P=.0020; medians not reached in either arm). Responses were deeper: ORR 84.5% vs 54.2% and ≥CR 65.9% vs 16.8% (P<.0001). Cytokine release syndrome occurred in 66.0% (predominantly grade 1/2); grade 3/4 AEs 84.9% vs 76.3%; median treatment duration 13.1 vs 7.0 months. Results published simultaneously in NEJM (DOI 10.1056/NEJMoa2603870).

Mechanism / class

Teclistamab (TECVAYLI) is a BCMA × CD3 bispecific T-cell engager that links T cells to BCMA on myeloma cells, driving T-cell–mediated lysis. First-in-class BCMA bispecific; previously FDA/EMA approved for triple-class–exposed RRMM after ≥4 prior lines (MajesTEC-1). MajesTEC-9 extends teclistamab into earlier relapse (2L–4L).

Discussant takeaway

Framed alongside MajesTEC-3 as the second positive phase 3 to show significant PFS and OS benefit for teclistamab-based therapy in the second-line-and-beyond setting, supporting a chemotherapy-free, off-the-shelf BCMA bispecific as a new SOC option after anti-CD38/lenalidomide exposure.

Practice-changing?

Yes. Statistically significant PFS and OS gains with a deep ≥CR rate over active triplet/doublet comparators, plus simultaneous NEJM publication, position teclistamab monotherapy to move BCMA bispecific therapy into early relapse (as early as first relapse) and likely support a label expansion.

  • Other ASCO 2026 trials: ./majestec-3-teclistamab-rrmm.md (teclistamab + daratumumab/lenalidomide, prior-line RRMM)
  • JPM 2026: ../../jpm-2026/index.md (Johnson & Johnson oncology pipeline)

Sources

  • ASCO Meeting Library: https://www.asco.org/abstracts-presentations/260439/
  • EurekAlert (NEJM/ASCO release): https://www.eurekalert.org/news-releases/1130063
  • OncLive: https://www.onclive.com/view/teclistamab-monotherapy-tops-soc-in-myeloma-with-phase-3-data-to-be-presented-at-asco-2026
  • CancerNetwork: https://www.cancernetwork.com/view/teclistamab-monotherapy-improves-pfs-and-os-in-relapsed-refractory-myeloma
  • Medscape: https://www.medscape.com/viewarticle/teclistamab-alone-ups-previously-treated-myeloma-survival-2026a1000i2u
  • J&J press release (GlobeNewswire): https://www.globenewswire.com/news-release/2026/05/29/3303568/0/en/New-TECVAYLI-teclistamab-data-demonstrate-superior-progression-free-and-overall-survival-versus-standard-of-care-as-early-as-first-relapse-in-multiple-myeloma.html