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Trial result
Multiple myeloma

Etentamig BCMA×CD3 Bispecific Hits 66% ORR with Half-the-Usual CRS in Triple-Class–Exposed Myeloma

Trial ID
NCT03933735 on ClinicalTrials.gov
Cancer type
Multiple Myeloma
Related trial IDs
NCT05650632
Published in
New in Oncology - June 16, 2025

Etentamig, a bivalent BCMA×CD3 T-cell engager engineered with low-affinity CD3 and a silenced Fc, was pooled across two Phase 1/1b studies (NCT03933735; NCT05650632) in relapsed/refractory multiple myeloma after ≥3 lines (n = 146; median 4 lines). Dosing 60 mg Q4W or 40 mg Q3W plus step-up yielded a 66% ORR and ≥VGPR in 54%, with mDOR and mPFS not reached for a median duration of follow-up of 13 months. The 12-month estimatesof mDOR was 71% and of mPFS was 55%. Grade ≥3 toxicities (79%; neutropenia 38%, anemia 23%) led to discontinuation in 9%, yet CRS (cytokine release syndrome) occurred in just 30% (no ≥G3), roughly half the 54–72% seen with the first-in-class bispecific teclistamab, whose real-world ORR sits at 63-67% and 6-month PFS at 53%.

Take home

In patients with relapsed/refractory multiple myeloma, etentamig offers similar efficacy to teclistamab with an ORR of 66.00% (compared to 63.0% for teclistamab). While mPFS data is not yet mature, the mPFS was not reached for etentamiig at 12 months, which is longer than the 11.3-month mPFS for teclistamab. If these low-grade CRS and durable responses translate in Phase 3, etentamig could offer community clinics an outpatient BCMA bispecific that matches teclistamab’s efficacy while sparing many patients the inpatient CRS watch.

Source: Read the original publication

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