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Anselamimab demonstrated 62% improvement in survival and 71% reduction in cardiovascular hospitalizations in prespecified kappa light-chain amyloidosis subgroup
Results published in the Journal of Clinical Oncology and will be presented at 2026 American Society of Clinical Oncology Annual Meeting
The global CARES Phase III clinical program showed that treatment with anselamimab, a potential first-in-class anti-fibril therapy, resulted in nominally statistically significant and highly clinically meaningful benefit in adults with advanced kappa light chain (AL) amyloidosis as first-line therapy added to standard of care plasma cell dyscrasia (PCD) treatments, compared to placebo. In the overall population of patients with AL amyloidosis, treatment with anselamimab did not meet the primary endpoint, defined as a hierarchical combination of time to all-cause mortality (ACM) and frequency of cardiovascular hospitalizations (CVH), as previously disclosed.1
In a prespecified subgroup analysis of patients with kappa predominant light chain isotype, anselamimab improved survival by 62%, measured by ACM (hazard ratio 0.38; 95% confidence interval [CI] 0.17, 0.86; nominal p=0.012), and reduced the frequency of CVH by 71% (incidence risk ratio 0.29; 95% CI 0.10, 0.87; nominal p=0.028), compared to placebo in the subgroup with kappa AL amyloidosis.1
The reduction in the risk of ACM in the kappa subgroup was also observed in both trials comprising the CARES Phase III clinical program among patients with kappa isotype with Mayo stage IIIa disease (75%) and Mayo stage IIIb disease (48%). No differences in ACM and CVH were observed among patients with lambda predominant light chain isotype.1
