ASCO20: Venetoclax Combination Therapy for Resistant Myeloma
Posted: Friday, June 5, 2020
According to an ongoing phase I/II study (ClinicalTrials.gov identifier NCT03314181) presented during the ASCO20 Virtual Scientific Program (Abstract 8511), combination therapy consisting of venetoclax, daratumumab, and dexamethasone with or without bortezomib appears to be a safe treatment for patients with relapsed or refractory multiple myeloma. In fact, Jonathan L. Kaufman, MD, of Winship Cancer Institute of Emory University, Atlanta, and colleagues noted the tolerable safety profile and activity particularly in patients with t(11;14).
The multicenter study enrolled 48 patients with multiple myeloma. Part 1 of the trial included patients with t(11;14) treated with venetoclax, daratumumab, dexamethasone, and bortezomib, whereas part 2 included patients irrespective of t(11;14) treated with combination therapy that did not include bortezomib.
The researchers compared the adverse events between parts 1 and 2 of the trial, with the most common events including fatigue (71%/25%), diarrhea (58%/46%), nausea (46%/50%), insomnia (33%/50%), upper respiratory tract infection (33%/21%), cough (42%/9%), and dyspnea (25%/25%). There were four frequent grade 3 or greater adverse events in the arm without bortezomib: neutropenia (17%), hypertension (12%), fatigue, and hyperglycemia (8% each). Grade 3 or greater adverse events in the group treated with all four drugs were insomnia (21%), diarrhea, and thrombocytopenia (8% each).
The authors reported the overall response rate was 96% without bortezomib and 92% with bortezomib, with a median follow-up of 10 and 9 months, respectively. Lastly, pharmacokinetic analysis revealed the addition of daratumumab and bortezomib did not appear to affect venetoclax exposure.
Disclosure: For full disclosures of the study authors, visit coi.asco.org.
