REALiTEC: a multi-country observational retrospective study of teclistamab in patients with relapsed/refractory multiple myeloma outside of clinical trials
Uttervall, Katarina Kortum, Martin K Perrot, Aurore Farmer, Sarah Leeth Cavo, Michele Kishore, Bhuvan Jacquet, Caroline Casanova, Maria Hansson, Markus Weisel, Katja
Uttervall, Katarina
Kortum, Martin K
Perrot, Aurore
Farmer, Sarah Leeth
Cavo, Michele
Kishore, Bhuvan
Jacquet, Caroline
Casanova, Maria
Hansson, Markus
Weisel, Katja
Abstract
Teclistamab is the first approved anti-BCMA bispecific antibody for patients with triple-class exposed relapsed/refractory multiple myeloma (RRMM), based on the results of MajesTEC-1 clinical trial. Here, we first report the findings from REALiTEC, a retrospective observational study of patients who received teclistamab outside of clinical trials in Europe and Israel. The study included 113 patients from 23 sites in eight countries, with most (88.5%) accessing the medication through pre-approval access programs. The median age was 66 years, and patients had a median of 6 prior lines of therapy. Notably, 78.8% were triple-class refractory, 44.2% penta-class refractory, and 35.4% had previous anti-BCMA treatment. Overall response rate (ORR) was 60.2%, with 52.2% of patients achieving a very good partial response or better (≥VGPR). After a median follow-up of 20.7 months, median duration of response (DoR) was 20.3 months, median progression-free survival (PFS) was 9.7 months, and median overall survival (OS) was 26.3 months. Patients attaining ≥VGPR experienced longer DOR (median 26.1 months), with 12-month PFS and OS rates of 71.2% and 83.1%, respectively. Subgroup analyses demonstrated consistent outcomes across different patient groups, even in those with historically poorer outcomes. Most common adverse events were infections (all grade: 70.8%), cytokine release syndrome (55.8%), neutropenia (35.4%), and anaemia (25.7%), with no new safety signals identified. Infection rates decreased over time, and immunoglobulin replacement therapy was used in up to 60% of patients. REALiTEC corroborates the efficacy observed in MajesTEC-1, supporting teclistamab as an effective treatment option in heavily pre-treated RRMM patients.
MIDER Authors
Date
2026-03-05
Type
Article
Subject
Multiple myeloma
Collections
Citation
Uttervall K, Kortum MK, Perrot A, Farmer SL, Cavo M, Kishore B, Jacquet C, Casanova M, Hansson M, Weisel K, Magen H, Liberatore C, Hansen CT, Gatt ME, Shragai T, Da Via MC, Alvarez TS, Streetly M, Raab MS, Manier S, Aegesen J, Albrecht C, Hu P, Smirnov P, Santra D, Rubio-Azpeitia E, Popat R. REALiTEC: a multi-country observational retrospective study of teclistamab in patients with relapsed/refractory multiple myeloma outside of clinical trials. Haematologica. 2026 Mar 5. doi: 10.3324/haematol.2025.289281. Epub ahead of print.
Journal / Source Title
haematologica
DOI
10.3324/haematol.2025.289281
PMID
41784028
Publisher
Ferrata Storti Foundation
Publisher’s URL
https://haematologica.org/index