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Brad S. Kahl, MD, discusses the evolving role of BTK inhibitors in the mantle cell lymphoma treatment paradigm.
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“The combination [of acalabrutinib plus BR] definitely improved disease control. Patients were more likely to go into complete remission, and their MCL was more likely to be in remission at 2, 3, and 4 years with the combination.”
Brad S. Kahl, MD, a professor in the John T. Milliken Department of Oncology in the Division of Oncology at the Washington University School of Medicine, explained the evolving role of BTK inhibitors in the management of mantle cell lymphoma (MCL).
In January 2025, the FDA approved acalabrutinib (Calquence) plus bendamustine and rituximab (Rituxan; BR) for the treatment of adults with previously untreated MCL who are ineligible to receive autologous hematopoietic stem cell transplantation (HSCT). The approval was supported by data from the randomized, double-blind, placebo-controlled, multicenter phase 3 ECHO trial (NCT02972840).
Patients on the ECHO trial were 65 years of age or older and were randomly assigned to receive either BR induction followed by 2 years of maintenance rituximab plus placebo, or BR and maintenance rituximab plus acalabrutinib during the induction, 2 years of maintenance, and until disease progression, Kahl began. He noted that the data from the ECHO trial were positive, as it met its primary end point of progression-free survival (PFS).
Results from the study revealed that 110 patients in the acalabrutinib arm (n = 299) and 137 patients in the placebo arm (n = 299) either died or experienced disease progression. At a median follow-up of 49.8 months, the median PFS by independent review committee was at 66.4 months (95% CI, 55.1-not evaluable) compared with 49.6 months (95% CI, 36.0-64.1) in the acalabrutinib and placebo arms, respectively (HR, 0.73; 95% CI, 0.57-0.94; P = .0160).
Although the acalabrutinib/BR combination demonstrated PFS improvements compared with placebo plus BR, no overall survival (OS) benefits were shown, Kahl continued. The median OS was not reached in either arm and was not different between the arms (HR, 0.86; 95% CI, 0.65-1.13; P = .2743). These outcomes were likely associated with the number of infections observed in the acalabrutinib arm, which mostly comprised COVID-19–related deaths, he explained. The acalabrutinib combination likely weakens patients’ immune systems more than placebo plus BR. This should be considered when making treatment decisions for patients, he concluded.
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