AstraZeneca highlights data insights from Cares clinical programme

(Alliance News) - AstraZeneca PLC on Friday announced that the CARES phase 3 clinical programme did not meet a primary endpoint, but noted insightful data.

The Cambridge, England-based pharmaceutical company said the programme did not meet the primary endpoint in the overall light chain amyloidosis population. The primary endpoint was defined as a hierarchical combination of time to all-cause mortality and frequency of cardiovascular hospitalisations.

The company said in a prespecified subgroup analysis of patients with kappa predominant light chain isotype, anselamimab improved survival by 62% and reduced the frequency of cardiovascular hospitalisations by 71%, compared to placebo in the subgroup with kappa AL amyloidosis.

Further, AstraZeneca said the global clinical programme showed that treatment with anselamimab resulted in nominally statistically significant and highly clinically meaningful benefit in adults with advanced kappa light chain amyloidosis as first-line therapy added to standard of care plasma cell dyscrasia treatments, compared to placebo.

Anselamimab is a potential first-in-class anti-fibril therapy, designed to improve organ function by reducing or depleting amyloid deposits in tissues and organs of patients living with AL amyloidosis, a rare, systemic and progressive disorder caused by defective plasma cells in the bone marrow.

Gianluca Pirozzi, Senior Vice President, head of Development, Regulatory & Safety, Alexion, AstraZeneca Rare Disease, said: "The CARES Phase III programme is the first to show that targeting existing deposits of amyloid fibrils could deliver clinically meaningful survival and cardiovascular benefit in adults with kappa light chain amyloidosis, underscoring anselamimab's potential as a first-line therapy on top of standard of care.

"With anselamimab and our leading amyloidosis portfolio, we are advancing pioneering science with the goal of addressing critical treatment gaps. We look forward to continued engagement with health authorities to advance this potential first-in-class anti-fibril therapy."

AstraZeneca shares rose 1.0% to 13,870.00 pence each on Friday afternoon in London.

By Tom Budszus, Alliance News slot editor

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