Michael Wang, MD
Responses, progression-free and overall survival (OS) with single-agent acalabrutinib (Calquence) remained consistent during long-term follow-up, confirming efficacy in patients with relapsed/refractory mantle cell lymphoma (MCL), according to data presented at the 2018 ASH Annual Meeting.
during the 2018 ASH Annual Meeting, Wang, a professor in the Department of Lymphoma and Myeloma at The University of Texas MD Anderson Cancer Center, discussed the promise of single-agent acalabrutinib in the treatment of patients with relapsed/refractory MCL.
OncLive: Please provide an overview of this study.
: At this meeting, I presented data pertaining to the use of single-agent acalabrutinib in patients with relapsed/refractory MCL. This was the pivotal trial [that led to] the FDA approval, and the initial data were published in Lancet Oncology. At the time of the initial reporting, follow-up was only 15 months. At this meeting, we presented a longer follow-up of over 26 months.
What were the long-term data?
I would like to say the results were very good. The efficacy actually improved with the CR improving to 43%; the ORR remained the same. Long-term toxicity data were even more favorable because all categories of AEs, such as bleeding and rash, decreased over time. Acalabrutinib is a very well-tolerated agent, especially in the longer-term.
In addition to the efficacy and toxicity data, we presented brand-new data on minimal residual disease (MRD). Out of 29 patients, many achieved a CR in terms of MRD. This further demonstrated that single-agent acalabrutinib, with a very favorable toxicity profile, is very effective; it can also drive a CR into a molecular CR, based on MRD.
What are the next steps for acalabrutinib?
The next steps [is the ECHO study, which] we are accruing very rapidly on; this is a massive international clinical trial with over 100 centers. We are [evaluating the use of] bendamustine and rituximab (Rituxan) plus acalabrutinib versus placebo. It is an ongoing phase III clinical trial in previously untreated elderly patients. This is a frontline trial that we hope will change the way that patients with MCL are treated worldwide.
Is there anything you would like to add?
As an academic hematologic oncologist [who has been working in the space] for over 2 decades, I have witnessed the therapy for hematologic malignancies expand from just toxic chemotherapy to targeted therapy. We are now rapidly getting into the peak of cellular immunotherapy. We are seeing a lot of data on chimeric antigen receptor T cells, which is very exciting. By the 2019 ASH Annual Meeting, we will see a much greater precision medicine approach. MRD is becoming a more important endpoint in trials, which is also exciting. We need to prepare for the genomic medicine era.
Wang M, Rule S, Zinzani PL, et al. Long-term follow-up of acalabrutinib monotherapy in patients with relapsed/refractory mantle cell lymphoma. In: Proceedings from the 2018 ASH Annual Meeting; December 1-4, 2018; San Diego, California. Abstract 2876. ash.confex.com/ash/2018/webprogram/Paper110327.html.
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