REALiTEC: a multi-country observational retrospective study of teclistamab in patients with relapsed/refractory multiple myeloma outside of clinical trials

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.

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Journal
Haematologica
Published
2026-03-05
DOI
https://doi.org/10.3324/haematol.2025.289281
Primary Topic
Multiple Myeloma Research and Treatments
Type
article
Field-Weighted Citation Impact
0.00

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article

REALiTEC: a multi-country observational retrospective study of teclistamab in patients with relapsed/refractory multiple myeloma outside of clinical trials

Moshe E. Gatt, MARIA CASANOVA, Peter Hu, Mathew Streetly et al.
Haematologica
Multiple Myeloma Research and Treatments
article

REALiTEC: a multi-country observational retrospective study of teclistamab in patients with relapsed/refractory multiple myeloma outside of clinical trials

Moshe E. Gatt, MARIA CASANOVA, Peter Hu, Mathew Streetly, Diptendu Santra, Katarina Uttervall, Hila Magen, Pavel Smirnov, Caroline Jacquet, Carmine Liberatore, Tamir Shragai, M. Cavo, Markus Hansson, Claire Albrecht, Martin K. Kortüm, S. Manier, Aurore Perrot, Katja Weisel, Bhuvan Kishore, Matteo Claudio Da Via, Sarah Leeth Farmer, Teresa De Soto Alvarez, Rakesh Popat, Marc S. Raab, Jesper Aegesen, Eva Rubio-Azpeitia
article en

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.

Haematologica
University Hospitals Birmingham NHS Foundation Trust (GB), Johnson & Johnson (United States) (US), Karolinska University Hospital (SE), University College London Hospitals NHS Foundation Trust (GB), Universität Hamburg (DE), PAREXEL International (United Kingdom) (GB), Guy's and St Thomas' NHS Foundation Trust (GB), Heidelberg University (DE), Tel Aviv Sourasky Medical Center (IL), Sheba Medical Center (IL), Hadassah Medical Center (IL), Sahlgrenska University Hospital (SE), Odense University Hospital (DK), University Hospital Heidelberg (DE), Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico (IT), Centre Hospitalier Universitaire de Lille (FR), Centre Hospitalier Universitaire de Toulouse (FR), University of Chieti-Pescara (IT), Hospital Costa del Sol (ES), Vejle Sygehus (DK), Johnson & Johnson (France) (FR), Centre Hospitalier Régional et Universitaire de Nancy (FR), Hospital La Paz Institute for Health Research (ES), Thomas Foundation (AU), University Medical Center Hamburg-Eppendorf (DE), Universitätsklinikum Würzburg (DE), Johnson & Johnson (Italy) (IT), Klinik und Poliklinik für Neurologie (DE), Ryhov Hospital Jönköping (SE), University College London (GB), University of Bologna (IT)
Amgen, Pfizer, Sanofi
No poverty
Openalex Percentile: Top 32%
Multiple Myeloma Research and Treatments
DOIOpen Access PDFOpenAlex
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