SOHO 2026 | Phase III CARES: survival and cardiovascular outcomes with anselamimab in cardiac AL amyloidosis

So on the safety side, there were no additional safety signals seen in this trial with anselamimab versus placebo. There were a number of adverse events seen, but that’s to be expected in a population of patients with advanced cardiac amyloidosis treated with chemotherapy. Three quarters of the patients had two or three adverse events, but none of them were directly attributable to the trial. There were minor infusion-related reactions that were attributable to the drug. So as far as safety is concerned, there were no additional safety signals with this drug. In terms of adopting this therapy in clinical practice, I think we need to be very clear when and where we are using this drug and in what setting we are planning to use this drug. So this trial was primarily designed to look for survival benefit in cardiac patients. This trial was not designed to look for benefit in renal patients. And what it showed was improvement in overall survival, but also a marked reduction in cardiovascular hospitalizations, which to me would suggest that this drug has a benefit in the cardiac population. Now, the traditional biomarker response with anti-proBNP was not seen in this patient subgroup, and we don’t really understand why. However, we have to remember that anti-proBNP responses were defined and validated with anti-plasma cell therapies. And our understanding of how the biomarkers change when we actually remove the amyloid deposits remains much less clear. We also know that the light chains are directly proteotoxic. They induce production of anti-proBNP within the cardiac myocyte by the p38 and MEK kinase-dependent pathway. So when you use an anti-plasma cell therapy and stop the light chain production, the anti-proBNP will automatically drop. Now, how much additional the anselamimab will cause the reduction of proBNP, or will it do something completely different when the protein deposits are cleared, we need to understand more. And as we accumulate more data and treat more patients, we’ll get further clarifications. Again, we did not formally assess renal responses in this trial. We did not see many, but this trial was not designed to assess renal responses and will need to be studied formally in patients with renal amyloidosis.

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