New England Journal of Medicine· 2015Q1
Elotuzumab Therapy for Relapsed or Refractory Multiple Myeloma
- 1,328citations
- Q1SCImago
- 2015year
Short summary
Adding elotuzumab to lenalidomide and dexamethasone significantly improved progression-free survival (PFS) in patients with relapsed or refractory multiple myeloma, extending median PFS by 4.5 months (19.4 vs. 14.9 months) and reducing the risk of progression or death by 30%.
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Key points
- Elotuzumab in combination with lenalidomide and dexamethasone improved median progression-free survival from 14.9 to 19.4 months in relapsed/refractory multiple myeloma patients.
- The elotuzumab regimen reduced the hazard of progression or death by 30% (hazard ratio 0.70, P<0.001).
- Overall response rates were significantly higher with elotuzumab (79%) compared to the control group (66%).
- Common adverse events included lymphocytopenia, neutropenia, fatigue, and pneumonia; infusion reactions were infrequent and mild.
AI-generated from the title and abstract; the full text is not read.
Abstract
BACKGROUND: Elotuzumab, an immunostimulatory monoclonal antibody targeting signaling lymphocytic activation molecule F7 (SLAMF7), showed activity in combination with lenalidomide and dexamethasone in a phase 1b-2 study in patients with relapsed or refractory multiple myeloma. METHODS: In this phase 3 study, we randomly assigned patients to receive either elotuzumab plus lenalidomide and dexamethasone (elotuzumab group) or lenalidomide and dexamethasone alone (control group). Coprimary end points were progression-free survival and the overall response rate. Final results for the coprimary end points are reported on the basis of a planned interim analysis of progression-free survival. RESULTS: Overall, 321 patients were assigned to the elotuzumab group and 325 to the control group. After a median follow-up of 24.5 months, the rate of progression-free survival at 1 year in the elotuzumab group was 68%, as compared with 57% in the control group; at 2 years, the rates were 41% and 27%, respectively. Median progression-free survival in the elotuzumab group was 19.4 months, versus 14.9 months in the control group (hazard ratio for progression or death in the elotuzumab group, 0.70; 95% confidence interval, 0.57 to 0.85; P<0.001). The overall response rate in the elotuzumab group was 79%, versus 66% in the control group (P<0.001). Common grade 3 or 4 adverse events in the two groups were lymphocytopenia, neutropenia, fatigue, and pneumonia. Infusion reactions occurred in 33 patients (10%) in the elotuzumab group and were grade 1 or 2 in 29 patients. CONCLUSIONS: Patients with relapsed or refractory multiple myeloma who received a combination of elotuzumab, lenalidomide, and dexamethasone had a significant relative reduction of 30% in the risk of disease progression or death. (Funded by Bristol-Myers Squibb and AbbVie Biotherapeutics; ELOQUENT-2 ClinicalTrials.gov number, NCT01239797.).
The authors' abstract, as published at the source. New England Journal of Medicine, 2015 · DOI ↗
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Field: Hematology
HematologyMedicine