Venetoclax in Combination With Dexamethasone for Resistant Multiple Myeloma
Posted: Wednesday, January 22, 2020
An ongoing study of venetoclax (a small-molecule inhibitor of antiapoptosis protein BCL2) in combination with dexamethasone shows the combination to be safe and effective in some patients with relapsed or refractory multiple myeloma. Jonathan L. Kaufman, MD, of Emory University School of Medicine, and colleagues, presented results from their interim analysis at the 2019 American Society for Hematology (ASH) Annual Meeting & Exposition (Abstract 926).
In phase I of this trial, 20 and with multiple myeloma harboring a t(11;14) translocation were enrolled; in phase II, 31 were. Patients received venetoclax with dexamethasone every 7 days. In the phase I and phase II patient cohorts, the median number of prior therapies was 2.5 and 5, respectively. At the time of analysis, 19 and 8 patients had discontinued participation in the study.
Overall response rates were achieved by 65% and 45% of the patients in the phase I and phase II cohorts, respectively. Partial response rates were achieved by 35% and 13%, and stable disease was achieved by 20% and 26% of patients. The median time to first response was 1.4 months and 0.7 months.
The most common treatment-emergent adverse events in the phase I cohort were insomnia, hypophosphatemia, hyperglycemia, diarrhea, and thrombocytopenia (45%, 40%, 35%, 35%, and 30% of patients). Grade 3 and 4 treatment-emergent adverse events included neutropenia (lymphopenia) and hypophosphatemia. Tumor-lysis syndrome was the most frequently reported serious treatment-emergent adverse event, affecting 10% of patients.
In the phase II patient cohort, treatment-emergent adverse events included diarrhea, nausea, and lymphopenia (32%, 26%, and 32% of patients, respectively). Grade 3 or 4 treatment-emergent adverse events included lymphopenia, thrombocytopenia, and hypertension. Sepsis was the most frequently reported serious treatment-emergent adverse event, affecting 10% of patients. Five patients died of progressive disease, and one patient died due to an adverse event.
Disclosure: For full disclosures of the study authors, visit ash.confex.com.