SOHO 2021 | Frontline therapy for amyloidosis
Angela Dispenzieri, MD, of the Mayo Clinic, Rochester, MN, discusses potential novel frontline treatments for amyloidosis, highlighting key data from pivotal clinical trials. Dr Dispenzieri discusses the results from the most awaited Phase III ANDROMEDA trial (NCT03201965) investigating daratumumab plus cyclophosphamide, bortezomib and dexamethasone (CyBorD) compared to CyBorD alone in newly diagnosed patients with amyloid light-chain amyloidosis. The study yielded a complete remission rate of 53% with the addition of daratumumab to CyBorD as opposed to 18%. Dr Dispenzieri also comments on the Phase III EMN-03 trial (NCT01277016) comparing the efficacy and safety of bortezomib, melphalan, and dexamethasone with melphalan and dexamethasone. This interview took place during the ninth annual meeting of the Society of Hematologic Oncology (SOHO 2021) congress.
Transcript (edited for clarity)
What I’m going to be talking about is the exciting new results of the ANDROMEDA trial, which basically has made it possible that there’s the FDA approval for daratumumab upfront for patients with newly diagnosed AL Amyloid. And so again, many of us are well familiar with that trial, but it basically it was a randomized trial. Patients were either treated with dara CyBorD or CyBorD alone...
What I’m going to be talking about is the exciting new results of the ANDROMEDA trial, which basically has made it possible that there’s the FDA approval for daratumumab upfront for patients with newly diagnosed AL Amyloid. And so again, many of us are well familiar with that trial, but it basically it was a randomized trial. Patients were either treated with dara CyBorD or CyBorD alone. And it was six cycles of the CyBorD in both arms. And then the dara carried through for about two years. And the results were really extraordinary.
Basically CR rates, 53% versus 18%. VGPR rates, 81 versus 51%. Organ response twice as good in the dara CyBorD arm as compared to the CyBorD alone. So, cardiac response is in 40% of patients versus about 20% in the control arm. And for renal responses, 53 versus 27%. So really exciting. Other things we’ll touch on is the role of PRD in AL patients. Talking about some sort of retrospective data from Greece and also the BMD trial versus the MD trial. So there is some really exciting new therapies and in AL, and I’m so happy to have an FDA approved regimen for AL amyloidosis.
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