Teclistamab Outperforms Standard of Care in Early Refractory Myeloma

Roberto Mina, MD, associate professor of hematology at the Winship Cancer Institute at Emory University, discussed the significance of the early outcomes that were reported from the MajesTEC-9 trial (NCT05572515) in patients with relapsed/refractory multiple myeloma.

In the phase 3 trial, teclistamab (Tecvayli), a bispecific antibody targeting CD3 on T cells and B-cell maturation antigen on malignant plasma cells, was compared with standard-of-care treatment in patients who had received 1 to 3 prior lines of treatment.¹ Teclistamab previously received accelerated approval based on the efficacy seen in a single-arm study in patients who received 4 prior lines of therapy. Following the MajesTEC-1 trial (NCT03145181; NCT04557098), which enrolled patients who were heavily pretreated, investigators proceeded to studying teclistamab in earlier lines of therapy after relapse where there is a need for effective treatments.

Importantly, patients were previously exposed to both lenalidomide (Revlimid) and an anti-CD38 monoclonal antibody. This is representative of the modern patient population who commonly receive these agents in the first line of treatment, Mina says, and many patients are refractory to these agents, giving them a greater need for an effective agent with a different mechanism of action in the next line.

Patients were randomly assigned on a 1:1 basis to receive teclistamab as monotherapy or physician’s choice of standard-of-care carfilzomib (Kyprolis) plus dexamethasone or pomalidomide (Pomalyst), bortezomib (Velcade), and dexamethasone.

According to Mina, the announced results include that the primary end point of progression-free survival (PFS) was met, with a HR of 0.29 favoring teclistamab translating to a 71% reduction in progression or death.² Additionally, it showed an improvement in overall survival of 40% with an HR of 0.60. Mina says this is particularly important in this patient population where both efficacy and tolerability are high priorities for newer agents. Full results from this trial are forthcoming and will show more about the usage of teclistamab’s performance in less heavily pretreated patients.

REFERENCES

1. A Study Comparing Teclistamab Monotherapy Versus Pomalidomide, Bortezomib, Dexamethasone (PVd) or Carfilzomib, Dexamethasone (Kd) in Participants With Relapsed or Refractory Multiple Myeloma (MajesTEC-9). ClinicalTrials.gov. Updated December 19, 2025. Accessed January 15, 2026. https://clinicaltrials.gov/study/NCT05572515

2. TECVAYLI® monotherapy demonstrates superior progression-free and overall survival versus standard of care as early as first relapse in patients with multiple myeloma predominantly refractory to anti-CD38 therapy and lenalidomide. News release. Johnson & Johnson. January 14, 2026. Accessed January 15, 2026. https://tinyurl.com/kvppbavu