Treatment with ententamig significantly improved overall response rate and progression-free survival compared with standard available therapies for heavily pretreated patients with triple-class exposed relapsed or refractory multiple myeloma, according to data from the phase 3 CERVINO trial presented at the 23rd Annual Meeting and Exposition of the International Myeloma Society in Glasgow, Scotland.
Ententamig is a second-generation bispecific T-cell engager targeting CD3 and B-cell maturation antigen with a low-affinity CD3 binding domain, potentially reducing rates of cytokine release syndrome and infection, wrote the study’s authors, led by Peter Voorhees, MD, of Atrium health Levine Cancer Institute in Charlotte, North Carolina.
This prespecified interim analysis of CERVINO covered 196 patients randomized to ententamig and 197 to standard therapy. The cohort had a median age of 70 years, including 68.2% ages 65 years or older, and 14.5% were enrolled in the United States. Among US patients randomized to ententamig, 41.7% were treated in community settings and 45.8% started treatment in outpatient settings.
The cohort had a median time from diagnosis of 5.2 years and a median of three prior lines of therapy. Overall, 51.9% of patients were triple-class refractory, 90.1% were refractory to their last line of therapy, 86% were refractory to anti-CD38 monoclonal antibodies and 23.4% had high-risk cytogenetics.
After a median follow-up of 11.4 months, the ORR was 74% (95% CI, 67.25-79.97) with ententamig and 45.7% (95% CI, 38.59-52.91; P<.0001) with standard therapy. The median PFS was not reached (95% CI, 14.55-not estimable) with ententamig and 6.2 months (95% CI, 4.63-7.26) with standard therapy HR, 0.4; 95% CI, 0.29-0.54; P<.0001). The PFS benefit was observed across all prespecified subgroups, according to the presentation.
The 12-month overall survival rates were 87.9% and 72% (HR, 0.48; 95% CI, 0.29-0.77; nominal P=.0012) for ententamig and standard therapy, respectively. The efficacy boundary for OS was not crossed by the time of presentation.
The safety analysis included 195 patients in the ententamig arm and 193 in the standard therapy arm. Overall, treatment-emergent adverse events occurred in 97.9% and 95.3%, grade 3 or 4 TEAEs in 73.3% and 64.2%, and serious TEAEs in 51.8% and 40.4% of the ententamig and standard therapy arms, respectively. Compared with standard therapy, the ententamig arm had fewer TEAE–related discontinuations or fatal TEAEs, and lower rates of grade 3 or higher infections.
In the ententamig group, the rates of CRS and immune effector cell–associated neurotoxicity syndrome were 39.5% and 3.6%, respectively, both predominantly grade 1 or 2. Rates of CRS and ICANS were both lower in patients who received a single step-up dose.
Ultimately, the data support ententamig monotherapy as a new standard of care with convenient dosing suitable for global outpatient and community use, Dr. Voorhees and colleagues wrote.
Reference
Voorhees P, Manteca MVM, Costa L, et al. CERVINO: Phase (Ph) 3 Results of Etentamig vs Investigator’s Choice of Standard Available Therapies (SAT) in Patients (Pts) With Triple-Class Exposed Relapsed or Refractory Multiple Myeloma (RRMM). Abstract LB-01. Presented at the 23rd Annual Meeting and Exposition of the International Myeloma Society; September 23-26, 2026; Glasgow.
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