Darzalex for Amyloidosis – pro
Daratumumab is a monoclonal antibody that targets CD38. The frequent association of CD38 expression in plasma cell dyscrasias provided a rationale for evaluating daratumumab for treatment of light chain amyloidosis. Late last year, the FDA granted accelerated approval of daratumumab for myeloma that has relapsed or progressed on at least 3 prior regimens.The approval of single-agent daratumumab for heavily pretreated myeloma was primarily based on data from 2 trials. In the phase II MMY2002 study, daratumumab demonstrated a 65% one-year overall survival (OS) rate and a 29.2% objective response rate (ORR). In the phase I/II GEN501 study, the ORR was 36%, median progression-free survival was 5.6 months, and the 1-year OS rate was 77%.
The use is supported by clinical research in two articles from major peer-reviewed medical journals that present data supporting the proposed off-label use or uses as generally safe and effective unless there is clear and convincing contradictory evidence presented in a major peer-reviewed medical journal.
Chakra P. Chaulagain, MD, Raymond L. Comenzo, MD, How We Treat Systemic Light-Chain Amyloidosis, How we treat amyloidosis, Clinical Advances in Hematology & Oncology May 2015, Volume 13, Issue 5
08 A Prospective Phase II of Daratumumab in Previously-Treated Systemic Light-Chain (AL) Amyloidosis
Program: Oral and Poster Abstracts
Type: Oral
Session: 653. Myeloma: Therapy, excluding Transplantation: Immunotherapy in Myeloma and Amyloid
Sunday, December 10, 2017: 5:15 PM
NCCN, Amyloidosis 2017A recent study suggests that Darzalex maybe very effective for AL Amyloidosis in a recent small study. Overall, 16 of 18 patients achieved objective responses, including complete responses in a third of patients. None of the patients had achieved a complete response with prior therapies,
More study is needed with larger numbers of patients to confirm and better assess these results.