Is Ixazomib/Dexamethasone a New Option for Treating AL Amyloidosis?
Posted: Tuesday, January 7, 2020
When comparing physician’s choice of treatment with ixazomib/dexamethasone, researchers found that ixazomib/dexamethasone prolonged the duration of composite survival and vital organ functioning in patients with primary systemic AL (amyloid light-chain) amyloidosis. Angela Dispenzieri, MD, of the Mayo Clinic in Rochester, Minnesota, and colleagues presented these findings at the 2019 American Society of Hematology (ASH) Annual Meeting & Exposition in Orlando, Florida (Abstract 139).
“TOURMALINE-AL1 is the first phase III trial in relapsed/refractory AL amyloidosis to show significant outcome improvements, suggesting ixazomib/dexamethasone represents a new option for relapsed/refractory AL amyloidosis patients, who have limited access to therapies,” concluded the authors.
This study enrolled 168 patients who had relapsed or refractory AL amyloidosis with measurable disease and major organ management. Patients were randomly assigned to receive either ixazomib/dexamethasone or a physician’s choice of treatment (dexamethasone alone or with melphalan, cyclophosphamide, thalidomide, or lenalidomide) in 28-day cycles.
Hematologic responses were seen in 53% and 51% of patients receiving ixazomib/dexamethasone and physician’s choice, respectively. The rates of complete response were higher with the combination therapy than with the physician’s choice, with 26% and 18% achieving complete responses. Further data favored ixazomib/dexamethasone therapy, including overall survival, time to organ deterioration or death, time to treatment failure, and duration of hematologic response.
The median duration of treatment for patients in the combination group was 11.7 months, and 21% remained on treatment, whereas patients in the physician’s-choice group were on therapy for 4.9 months and 6% of patients remained on treatment. Common grade 3 adverse events included fatigue, anemia, cardiac failure, dyspnea, peripheral edema, and pneumonia in both groups.
Disclosure: For full disclosures of the study authors, visit ash.confex.com.