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The expert discussed key details from the phase 3 ANDROMEDA trial presented at the 2021 ASCO Annual Meeting.
CancerNetwork® spoke with Efstathios Kastritis, MD, professor of medical oncology at the National and Kapodistrian University of Athens, in Athens, Greece, at the 2021 American Society for Clinical Oncology (ASCO) Annual Meeting, to discuss some of the key outcomes from the phase 3 ANDROMEDA trial (NCT03201965) investigating subcutaneous daratumumab (DARA; Darzalex) plus bortezomib (Velcade), cyclophosphamide, and dexamethasone (VCd) for patients with newly diagnosed light chain (AL) amyloidosis.
In the ANDROMEDA study, patients with newly diagnosed AL amyloidosis [who] had stage 1, 2, or 3 cardiac disease were randomized to receive either the standard therapy, which is a combination of bortezomib, cyclophosphamide, and dexamethasone—also called VCd—compared [with] VCd plus subcutaneous daratumumab (DARA) for 6 cycles, followed by daratumumab maintenance for up to 24 cycles.
In the updated analysis that will [be presented at] ASCO, the complete hematologic response rate in the DARA-VCd arm has further improved to 59% versus 19% for the old standard VCd. There has been a substantial improvement in the complete hematologic response rates across all the subgroups of patients [who] were evaluated, including patients with more advanced cardiac disease, and also patients with translocation (11;14), or older or younger patients.
In the updated analysis that we present [at] ASCO, we see that at [the] 12-month landmark, the organ response rates have also improved.We have a significant improvement in the cardiac response rates with DARA-VCd, which increased from 42% to 57% versus 28% for the VCd arm, so we have a doubling of the cardiac responses. Also, we see a doubling of renal responses, both at 6- and at 12-month [mark] for DARA-VCd versus VCd. These are very important outcomes for our patients with AL amyloidosis.
Kastritis E, Sanchorawala V, Merlini G, et al. Subcutaneous daratumumab + bortezomib, cyclophosphamide, and dexamethasone (VCd) in patients with newly diagnosed light chain (AL) amyloidosis: Updated results from the phase 3 ANDROMEDA study. J Clin Oncol. 2021;39(suppl 15):8003. doi: 10.1200/JCO.39.15_suppl.8003