ADMYRE: Matched ECA analysis of plitidepsin + LD‑DXM vs Pom + LD‑DXM for RRMM

A matched external control arm (ECA) analysis of the randomized, multicenter, phase III ADMYRE trial (NCT01102426) evaluated plitidepsin (P) + low-dose dexamethasone (LD-DXM) vs pomalidomide (Pom) + LD‑DXM for the treatment of patients with relapsed/refractory multiple myeloma (RRMM) and ≥3–6 prior lines of therapy (LoT). Patient-level data from ADMYRE (n = 171) were matched to patients treated with Pom + LD‑DXM from eight contemporary trials (n = 557) to assess overall survival (OS). Results were published in Annals of Hematology by Ludwig et al.

Key data: In the primary ECA analysis (ECA1), median OS was comparable between P + LD‑DXM and Pom + LD‑DXM (11.8 vs 13.9 months, respectively; hazard ratio [HR], 1.009; 95% confidence interval [CI], 0.812–1.254; p = 0.9336), demonstrating non-inferiority. P + LD‑DXM was associated with lower rates of Grade ≥3 hematologic treatment-related adverse events (TRAEs), including neutropenia (2.5% vs 37.1%) and thrombocytopenia (2.5% vs 13.2%), and fewer Grade ≥3 infections (8.1% vs 18.7%). In a secondary analysis (ECA2), a numerically higher OS was observed with Pom + LD‑DXM vs LD‑DXM alone (HR, 0.762; 95% CI, 0.566–1.026; p = 0.0733), consistent with that observed in ADMYRE.

Key learning: P + LD-DXM demonstrated non-inferior overall survival to Pom + LD‑DXM, alongside fewer Grade ≥3 hematologic TRAEs, supporting P + LD‑DXM as a clinically relevant alternative treatment option in patients with heavily pretreated RRMM.