REALiTEC: a multi-country observational retrospective study of teclistamab in patients with relapsed/refractory multiple myeloma outside of clinical trials - PubMed
2 hours ago
- #multiple myeloma
- #teclistamab
- #retrospective study
- Teclistamab is the first approved anti-BCMA bispecific antibody for triple-class exposed relapsed/refractory multiple myeloma (RRMM).
- REALiTEC is a retrospective observational study of teclistamab use outside clinical trials in Europe and Israel, involving 113 patients from 23 sites.
- Most patients (88.5%) accessed teclistamab through pre-approval access programs.
- Patients had a median age of 66 years and a median of 6 prior lines of therapy.
- 78.8% were triple-class refractory, 44.2% penta-class refractory, and 35.4% had prior anti-BCMA treatment.
- Overall response rate (ORR) was 60.2%, with 52.2% achieving very good partial response or better (≥VGPR).
- Median duration of response (DoR) was 20.3 months, progression-free survival (PFS) 9.7 months, and overall survival (OS) 26.3 months.
- Patients with ≥VGPR had longer DoR (26.1 months) and higher 12-month PFS (71.2%) and OS (83.1%) rates.
- Common adverse events included infections (70.8%), cytokine release syndrome (55.8%), neutropenia (35.4%), and anemia (25.7%).
- Infection rates decreased over time, and immunoglobulin replacement therapy was used in up to 60% of patients.
- REALiTEC supports teclistamab's efficacy in heavily pre-treated RRMM patients, aligning with MajesTEC-1 trial results.