Anselamimab offers significant reduction in all-cause mortality and cardiovascular hospitalization risk for kappa AL amyloidosis

The addition of anselamimab, a novel anti-fibril monoclonal antibody, to standard chemotherapy significantly reduced all-cause mortality and cardiovascular hospitalizations for patients with newly diagnosed kappa amyloid light chain (AL) amyloidosis, according to a study presented at the Fourteenth Annual Meeting of the Society of Hematologic Oncology in Houston, Texas.

The study, led by Ashutosh Wechalekar, MD, of National Amyloidosis Centre and University College London Hospitals in the United Kingdom, analyzed a combined population of patients with stage 3a or 3b AL amyloidosis from two phase 3 randomized trials in the Cardiac Amyloid Reaching for Extended Survival (CARES) program.

The pooled cohort included 271 patients randomized to receive anselamimab and 135 randomized to receive placebo in addition to cyclophosphamide, bortezomib, and dexamethasone with or without daratumumab. Baseline characteristics were similar between arms. The median duration of treatment was 21.4 months in the anselamimab arm and 21.1 months in the placebo arm, and daratumumab was used in 79.3% and 83.7% of patients, respectively. Patients were divided by kappa or lambda free light chain involvement for subgroup analysis.

For patients with kappa AL amyloidosis, treatment with anselamimab yielded a 62% reduction in all-cause mortality (HR, 0.38; 95% CI, 0.17-0.86; P=.012) and a 71% reduction in risk for cardiovascular hospitalization (estimated rate ratio, 0.29; 95% CI, 0.1-0.87; P=.028) compared with placebo. Patients with lambda AL amyloidosis had a 10% reduction in cardiovascular hospital risk but no reduction in all-cause mortality with anselamimab compared with placebo.

Anselamimab, a kappa light chain-directed anti-fibril mAb used alongside standard-of-care chemotherapy, offers a first-in-class, new therapeutic option for patients with newly diagnosed kappa AL amyloidosis, Dr. Wechalekar and colleagues stated.

Reference
Wechalekar A, Dispenzieri A, Sanchorawala V, et al. Phase 3 randomized trial of anselamimab demonstrates improvement in all-cause mortality in κ light-chain amyloidosis. Abstract MM-218. Presented at the 2026 Society of Hematologic Oncology Annual Meeting; September 9-12, 2026; Houston.