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EHA 2025 | Results of the Phase III AFFIRM-AL trial of birtamimab in AL amyloidosis
Ashutosh Wechalekar, MBBS, MD, FRCP, FRCPath, DM, University College London Hospitals NHS Foundation Trust, London, UK, comments on the disappointing results of the Phase III AFFIRM-AL clinical trial (NCT04973137) of birtamimab for patients with light chain (AL) amyloidosis. Despite this, he believes that anti-fibril strategies remain important in amyloidosis, and mentions plans for another Phase III trial. This interview took place at the 30th Congress of the European Hematology Association (EHA) in Milan, Italy.
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Transcript
Yes, so recently there was a press release from Prothena that they analyzed the final results of the Phase III AFFIRM clinical trial and it was extremely disappointing for all of us that the Phase III trial did not meet any of its primary endpoints. Clearly this is a huge disappointment for all the doctors and patients involved in the program. I mean, AL amyloidosis is a very challenging disease and this particular trial was looking at a subset of patients based on an ad hoc analysis of a previous Phase III clinical trial...
Yes, so recently there was a press release from Prothena that they analyzed the final results of the Phase III AFFIRM clinical trial and it was extremely disappointing for all of us that the Phase III trial did not meet any of its primary endpoints. Clearly this is a huge disappointment for all the doctors and patients involved in the program. I mean, AL amyloidosis is a very challenging disease and this particular trial was looking at a subset of patients based on an ad hoc analysis of a previous Phase III clinical trial. So clearly they were looking at a challenging endpoint but we were disappointed that the trial results were negative. Anti-fibril strategies in amyloidosis still remain important and I do believe that they will help patients to improve their organ function quickly. There is another Phase III clinical trial from Alexion looking at the Kalem antibody for patients with stage 3a and stage 3b amyloidosis and we are hoping to see some results on that trial in the next few months.
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