Johnson & Johnson announced positive Phase 3 data showing that Tecvayli (teclistamab-cqyv) monotherapy significantly improved progression-free survival (PFS) and overall survival (OS) in multiple myeloma (MM) patients refractory to anti-CD38 therapy. In J&J’s view, the data supports the use of Tecvayli against MM as early as first relapse patients from second-line onwards.
The Phase 3 MajesTEC-9 trial enrolled 614 patients who had received 1 to 3 prior lines of therapy, including a prior anti-CD38 monoclonal antibody and lenalidomide.
At the first pre-specified interim analysis, Tecvayli reduced the risk of progression or death by 71% and the risk of death by 40% versus pomalidomide-, bortezomib- or carfilzomib-based regimens. J&J noted that the MajesTEC-9 data follows positive results from the MajesTEC-3 trial, which showed Tecvayli plus Darzalex Faspro (daratumumab and hyaluronidase-fihj) produced significant PFS and OS benefits in MM patients naïve or sensitive to an anti-CD38 therapy.
About Tecvayli
Tecvayli is a bispecific T-cell engager (TCE) that binds CD3 on T cells and BCMA on myeloma cells, redirecting the immune system to drive targeted killing of malignant plasma cells. This off-the-shelf, T-cell-redirecting approach has helped establish bispecific antibodies as a major new therapeutic class in multiple myeloma, offering a more accessible alternative to autologous CAR T-cell therapies that require complex, patient-specific manufacturing.
Tecvayli’s development has so far focused on heavily pretreated patients. The therapy received conditional approvals in the US and EU in 2022, for fourth-line or fifth-line or later use respectively. The MajesTEC-9 data indicate that Tecvayli may move out of its original late-line niche and into earlier lines of therapy, where competition is intensifying and expectations for durable disease control are higher.
Competitive context
In the relapsed setting, BCMA-directed approaches now span CAR T-cell therapies, antibody-drug conjugates (ADCs), and bispecific antibodies. CAR T products such as Bristol Myers Squibb’s Abecma (idecabtagene vicleucel) and J&J’s own Carvykti (ciltacabtagene autoleucel) have set a high bar for depth of response, although their use is constrained by manufacturing timelines and access limitations. J&J is aiming to further strengthen its dominance of the MM treatment field, where it offers Tecvayli, Carvykti, Darzalex Faspro, and Talvey (talquetamab), a GPRC5D/CD3-targeted TCE approved in 2023 for fourth-line or later relapsed/refractory (R/R) MM.
Other competitor products include:
Pfizer’s Elrexfio (elranatamab-bcmm), a BCMA x CD3 TCE approved in 2023 (fourth-line or later); Regeneron Pharmaceutical’s Lynozyfic (linvoseltamab-gcpt), a BCMA x CD3 TCE approved in 2025; and GSK’s Blenrep (belantamab mafodotin-blmf), a BCMA-targeted ADC first approved in 2020 for fourth-line, extended to second-line or later stages in combination with bortezomib/dexamethasone in 2025.