MajesTEC-9 phase III: Teclistamab monotherapy vs PVd/Kd for RRMM

Results from the phase III, randomized MajesTEC-9 trial (NCT05572515), evaluating teclistamab monotherapy (n = 296) vs investigator’s choice of pomalidomide + bortezomib + dexamethasone or carfilzomib + dexamethasone (PVd/Kd; n = 297) in patients with relapsed/refractory multiple myeloma (RRMM) after 1–3 prior lines of therapy (LoT), were presented by Cyrille Touzeau at the European Hematology Association (EHA) 2026 Congress, June 11–14, 2026, Stockholm, SE. The primary endpoint was progression-free survival (PFS) as assessed by an independent review committee (IRC). 

Key data: At a median follow-up of 17.3 months, median PFS was not reached (NR) with teclistamab vs 8.2 months with PVd/Kd (hazard ratio [HR], 0.29; 95% confidence interval [CI], 0.23–0.38; p < 0.0001); the 18-month PFS rates were 69.8% vs 26.9%, respectively. PFS favored teclistamab across all subgroups. The overall response rate (ORR) was 84.5% with teclistamab vs 54.2% with PVd/Kd (odds ratio [OR], 4.62; p < 0.0001), with complete response or better (≥CR) in 65.9% vs 16.8%, respectively (OR, 10.42; p < 0.0001). Teclistamab also demonstrated improved overall survival (OS, HR, 0.60; p = 0.0020) and a longer time to worsening of symptoms (HR, 0.50; p < 0.0001). Cytokine release syndrome (CRS) and immune effector cell-associated neurotoxicity syndrome (ICANS) were infrequent and mostly low grade. Grade 3/4 infections were more frequent with teclistamab vs PVd/Kd (41.6% vs 29.0%). 

Key learning: Teclistamab demonstrated superior survival outcomes, deeper responses, and improved symptom control vs PVd/Kd, supporting its use as a potential new standard of care (SoC) in the second-line or later setting, with proactive infection prophylaxis and monitoring remaining important.