Company: AZN
Filing Date: 2025-07-16
Form Type: 6-K
Source: 0001654954-25-008111
Chunk: 2

Company: ASTRAZENECA PLC
Filing Date: 2025-07-16
Form: 6-K
Chunk 2
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 are produced abnormally by defective plasma cells in the bone marrow. These abnormal proteins misfold, aggregate and form amyloid fibrils that deposit and accumulate in tissues or organs, particularly in the heart and kidneys. The deposition can cause progressive damage and may lead to premature death, most commonly due to cardiac failure. 1,2

In the early stages of the disease, people with AL amyloidosis may experience a range of vague signs and symptoms that mimic other diseases, which can often delay the diagnosis. Worldwide, there are an estimated 74,000 patients living with AL amyloidosis. 4,5

#### CARES Phase III Clinical Programme
The Cardiac Amyloid Reaching for Extended Survival (CARES) clinical programme consists of two parallel global, Phase III, randomised, double-blind, placebo-controlled, multicentre trials evaluating the efficacy and safety of anselamimab plus standard of care (SoC) in patients with stage IIIa and stage IIIb light chain (AL) amyloidosis, respectively. 6,7

The primary endpoint is a hierarchical combination of time to all-cause mortality and frequency of cardiovascular hospitalisations in the overall patient population across both trials.

The CARES clinical programme is the largest prospective investigation in cardiac AL amyloidosis to date with a total of 406 patients enrolled from 19 countries globally, including 281 patients with stage IIIa and 125 patients with stage IIIb disease per European modification of the Mayo 2004 staging system. 6,7

In CARES, newly diagnosed patients planning first-line plasma cell dyscrasia (PCD) treatment with cyclophosphamide, bortezomib and dexamethasone were randomised 2:1 to receive either anselamimab or placebo once weekly for the first four weeks and then every two weeks until study completion. Daratumumab was permitted but not required as part of the PCD regimen, and approximately 80% of patients in CARES received daratumumab as part of their treatment.

Following the primary evaluation treatment period, which concluded 18 months after the last patient was randomised, all patients had the option to participate in an open-label extension period receiving anselamimab plus SoC for up to 24 months. 6,7

#### Anselamimab
Anselamimab is an investigational, potentially first-in-class anti-fibril monoclonal antibody designed to improve organ function by reducing or eliminating