Astrazeneca’s provides update on CARES Phase III clinical programme of anselamimab in light chain amyloidosis

Astrazeneca announces their new high-level results from the Cardiac Amyloid Reaching for Extended Survival Phase III clinical programme showed that anselamimab, did not achieve statistical significance for the primary endpoint compared to placebo in patients with Mayo stages IIIa and IIIb light chain amyloidosis. The endpoint were defined as a hierarchical combination of time to all-cause mortality and frequency of cardiovascular hospitalisations. All patients in the clinical programme received background standard of care for plasma cell dyscrasia.

Ashutosh Wechalekar, MBBS, MD, FRCP, FRCPath, DM, Consultant Haematologist at University College London Hospitals NHS Foundation Trust, Professor of Medicine and Haematology at University College London and lead principal investigator of the programme, said: “While the study did not meet the primary endpoint in the overall patient population, results from a pre-defined subgroup suggest that anselamimab, by targeting and clearing amyloid deposits, may address a leading cause of organ damage and functional impairment in these patients. The potential to extend survival and reduce cardiovascular hospitalisations would represent a practice-changing advancement for this patient group.”

Marc Dunoyer, Chief Executive Officer, Alexion, AstraZeneca Rare Disease, said: “Alexion is pioneering a novel mechanism of action to address organ damage from existing amyloid deposits in patients with AL amyloidosis, a devastating disease often diagnosed in advanced stages with poor prognosis. Anselamimab is the first and only investigational fibril depleter to show clinical benefit in AL amyloidosis, and these results underscore its potential to address a critical treatment gap in a prespecified subgroup of patients.”

---

---

Related Topics and Keywords

light chain amyloidosis