![]() At the 3-, 4-, and 5-year follow-up of ELOQUENT-2, the PFS benefit with ERd was sustained and durable, and no new relevant safety information was identified 7, 16, 17. Based on these results, ERd received approval for the treatment of patients with RRMM and 1–3 prior therapies in the United States and ≥1 prior therapy in the European Union. In addition, ERd was associated with an improved overall response rate (ORR) versus Rd (ERd, 79% Rd, 66% odds ratio: 1.9 95% CI, 1.4–2.8 P < 0.001) 15. At the primary analysis of ELOQUENT-2, patients treated with ERd had a 30% reduction in the risk of progression or death versus Rd (median PFS, 19.4 months vs 14.9 months hazard ratio, 0.70 95% confidence interval, 0.57–0.85 P < 0.001) 15. The phase 3 ELOQUENT‑2 study assessed the efficacy and safety of elotuzumab plus lenalidomide and dexamethasone (ERd) versus lenalidomide and dexamethasone (Rd) alone in patients with RRMM and 1–3 prior lines of therapy 15. Lenalidomide, an immunomodulatory drug, synergizes with elotuzumab by increasing cytokine production (e.g., interleukin-2 and tumor necrosis factor α) and enhancing the elotuzumab-mediated NK cell killing of MM cells 14. ![]() Elotuzumab has multiple mechanisms of action against MM cells, including direct NK cell activation, NK cell–mediated antibody-dependent cellular cytotoxicity and macrophage-mediated antibody-dependent cellular phagocytosis 10, 11, 12, 13. ![]() SLAMF7 is a cellular glycoprotein that is highly expressed on MM cells, natural killer (NK) cells, and some other immune cells, but has minimal expression on normal tissues 10. Treatment regimens that incorporate monoclonal antibodies have demonstrated durable responses and extended progression-free survival (PFS) however, final OS analyses for these therapies have not yet been reported 7, 8, 9.Įlotuzumab is a first-in-class humanized immunoglobulin G1 immunostimulatory monoclonal antibody that targets signaling lymphocytic activation molecule family member 7 (SLAMF7) 10. Therefore, identifying therapeutic options that prolong OS in RRMM remains critical. Outcomes are particularly poor for patients with relapsed or refractory (RR) MM, as durability of response decreases with successive lines of therapy 2, 3, 4, 5, 6. As such, the 5-year overall survival (OS) rate remains low, at ~50% 1. The magnitude of OS benefit was greatest among patients with adverse prognostic factors, including older age, ISS stage III, IMWG high-risk disease, and 2–3 prior LoTs.ĭespite the introduction of novel and highly effective front-line therapies, nearly all patients with multiple myeloma (MM) eventually relapse and become refractory to treatment. ERd is the first antibody-based triplet regimen shown to significantly prolong OS in patients with RRMM and 1–3 prior LoTs. No additional safety signals with ERd at extended follow-up were reported. ERd demonstrated a statistically significant 8.7-month improvement in OS versus Rd (median, 48.3 vs 39.6 months hazard ratio, 0.82 P = 0.0408 ), which was consistently observed across key predefined subgroups. OS was a key secondary endpoint, with the final analysis planned after 427 deaths. PFS and overall response rate were co-primary endpoints. Overall, 646 patients with RRMM and 1–3 prior LoTs were randomized 1:1 to ERd or Rd. We report results from the pre-planned final OS analysis after a minimum follow-up of 70.6 months, the longest reported for an antibody-based triplet in RRMM. In ELOQUENT-2 (NCT01239797), elotuzumab plus lenalidomide/dexamethasone (ERd) significantly improved progression-free survival (PFS) versus lenalidomide/dexamethasone (Rd) in patients with RRMM and 1–3 prior lines of therapy (LoTs). Prolonging overall survival (OS) remains an unmet need in relapsed or refractory multiple myeloma (RRMM). Elotuzumab, lenalidomide, and dexamethasone in RRMM: final overall survival results from the phase 3 randomized ELOQUENT-2 study
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