Journal: Blood cancer journal
This publication reports a comparative effectiveness analysis of linvoseltamab, a BCMA×CD3 bispecific antibody, versus real-world standard-of-care (SOC) regimens in heavily pretreated relapsed/refractory multiple myeloma.
Study design:
- Phase 2 cohort (LINKER-MM1 trial): 105 patients with triple-class exposed and/or triple-class refractory disease, with ≥3 prior lines of therapy.
- External control arm: 149 patients from two US EHR databases (COTA, Guardian Research Network) treated with real-world SOC.
- Eligibility and data quality: Key trial eligibility criteria were applied to the real-world cohort; an independent committee confirmed data relevance, quality, and comparability.
- Adjustment method: Inverse probability of treatment weighting was used to balance baseline characteristics.
Comparators:
- Most common SOC regimens: carfilzomib–pomalidomide–dexamethasone (8.6%) and daratumumab–pomalidomide–dexamethasone (8.2%).
- Advanced therapies: No patients in the SOC arm received CAR T-cell therapy or bispecific antibodies.
Main outcomes (linvoseltamab vs weighted SOC):
- Objective response rate: substantially higher with linvoseltamab (weighted OR 3.8; 95% CI 2.5–6.6).
- Progression-free survival: improved (weighted HR 0.29; 95% CI 0.23–0.39).
- Time to next treatment: improved (weighted HR 0.20; 95% CI 0.15–0.26).
- Overall survival: improved (weighted HR 0.41; 95% CI 0.32–0.52).
Conclusion:
In a rigorously adjusted comparison against contemporary real-world regimens (excluding CAR T and other bispecifics), linvoseltamab demonstrated markedly higher response rates and superior PFS, time to next therapy, and OS in patients with ≥3 prior lines and triple-class exposed/refractory multiple myeloma, supporting its potential as an effective option in this setting.