The global CARES phase 3 clinical programme has shown 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 hospitalisations (CVH), as previously disclosed.
In a prespecified subgroup analysis of patients with kappa predominant light chain isotype, anselamimab improved survival by 62 percent, 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 percent (incidence risk ratio 0.29; 95 percent CI 0.10, 0.87; nominal p=0.028), compared to placebo in the subgroup with kappa AL amyloidosis.