Journal: Blood cancer journal
This publication reports an external control comparison of linvoseltamab, a BCMA×CD3 bispecific antibody, in heavily pretreated relapsed/refractory multiple myeloma.
Design:
- Phase 1/2 study cohort: 105 patients receiving linvoseltamab 200 mg, all triple-class exposed with ≥3 prior lines of therapy and/or triple-class refractory.
- External control arm: 203 patients from international myeloma centers, selected via chart review to match key eligibility criteria and representing real-world standard-of-care treatments.
- Adjustment for baseline differences: Baseline differences between groups were adjusted using inverse probability of treatment weighting.
- Independent review: Independent committees reviewed data quality, cohort comparability, and centrally assessed responses.
Key findings (linvoseltamab vs real-world standard-of-care after weighting):
- Objective response rate: Significantly higher with linvoseltamab (weighted odds ratio 3.0; 95% CI 1.9–4.1).
- Progression-free survival: Markedly improved (weighted hazard ratio [wHR] 0.33; 95% CI 0.28–0.40).
- Time to next treatment: Longer with linvoseltamab (wHR 0.34; 95% CI 0.29–0.44).
- Overall survival: Modest but statistically significant improvement (wHR 0.72; 95% CI 0.58–0.98).
Interpretation:
In a population with advanced, heavily pretreated disease, linvoseltamab was associated with substantially better response and disease control, and a survival advantage compared with contemporary real-world regimens. These data support linvoseltamab as a promising option for triple-class exposed/refractory, late-line multiple myeloma.