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Jeremy S. Abramson, MD, MMSc
Jeremy S. Abramson, MD, MMSc
Posted: Tuesday, January 21, 2025
According to Nina D. Wagner-Johnston, MD, of Sidney Kimmel Comprehensive Cancer Center, Johns Hopkins Hospital, Baltimore, and colleagues, the addition of the Bruton’s tyrosine kinase (BTK) inhibitor acalabrutinib to chemotherapy with high-dose cytarabine yielded improved remission among patients with mantle cell lymphoma. These investigators conducted the ECOG-ACRIN EA4181 trial to evaluate the efficacy of fixed-duration acalabrutinib to chemotherapy regimens, and they presented their data during the 2024 American Society of Hematology (ASH) Annual Meeting & Exposition (Abstract 236).
“[The] addition of acalabrutinib to the standard arm added toxicity without improvement in efficacy, suggesting acalabrutinib should be avoided during [cytarabine] cycles,” the researchers concluded. “However, it is the least toxic arm with similar efficacy and represents an appealing option to avoid high-dose cytarabine.”
The study authors enrolled 359 patients with mantle cell lymphoma (≤ age 70); the median patient age was 61. Participants were randomly assigned 1:1:1 to receive six cycles of bendamustine and rituximab (BR) followed by three cycles of cytarabine and rituximab (CR), with (n = 129) or without (n = 128) acalabrutinib, or BR plus acalabrutinib (n = 102).
The median follow-up was 27.9 months. Of 308 patients with baseline clonal sequencing data available, 281 were treated, and 260 had measurable residual disease (MRD) at treatment completion. Most patients in the BR/CR (94%), BR/CR/acalabrutinib (91%), and BR/acalabrutinib (90%) arms completed six cycles of protocol therapy.
Rates of complete metabolic response or undetectable MRD were 85%, 82%, and 78% with BR/CR, BR/CR/acalabrutinib, and BR/acalabrutinib, respectively; rates in the sensitivity analysis set were 74%, 76%, and 74%, respectively. The objective response rate was the highest with BR/CR/acalabrutinib (99%), followed by BR/CR and BR/acalabrutinib (94%). Of note, estimated 12-month progression-free and overall survivals were highest in the BR/CR/acalabrutinib arm.
Disclosure: For full disclosures of the study authors, visit ash.confex.com.
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