The phase II ERASMM trial: Elranatamab for high-risk smoldering MM

First results from the phase II ERASMM trial (EMN34; NCT06183489), evaluating fixed-duration (2 years) subcutaneous elranatamab monotherapy as early intervention in patients with high-risk (HR) smoldering multiple myeloma (SMM) (N = 50), were presented by Cyrille Touzeau at the European Hematology Association (EHA) 2026 Congress, June 11–14, 2026, Stockholm, SE. The primary endpoint was complete response (CR) rate after 6 cycles, with safety as a key secondary endpoint.

Key data: After 6 cycles, the overall response rate (ORR) was 90% and the CR rate was 30%. After a median follow-up of 14 months, the best ORR was 92%, the CR rate was 72%, and undetectable measurable residual disease (MRD) by next-generation sequencing (NGS; 10⁻⁶) was reported in 90% of evaluable patients with suspected CR (n = 29). The progression-free survival (PFS) rate was 96%, all patients were alive, and no patients progressed to active myeloma. Grade 3–4 neutropenia occurred in 40% of patients, while Grade 3 infections occurred in 14%; no Grade ≥4 infections were reported. Cytokine release syndrome (CRS) occurred in 70% of patients (Grade 3, 4%), with no immune effector cell-associated neurotoxicity syndrome (ICANS) reported. No new safety signals were observed compared with the known safety profile of elranatamab in relapsed/refractory multiple myeloma (RRMM).

Key learning: Fixed-duration elranatamab demonstrated deep responses with a manageable safety profile in HR-SMM, supporting further evaluation of elranatamab in this setting.