Acalabrutinib Plus Chemotherapy Provides Cover for High-Risk Patients in MCL

During an interview with CancerNetwork® prior to the FDA’s decision to approve acalabrutinib (Calquence) in combination with bendamustine and rituximab (Rituxan) for the treatment of patients with previously untreated mantle cell lymphoma (MCL), Tycel Phillips, MD, spoke on what the approval could mean for the landscape.¹

Phillips, an associate professor in the Division of Lymphoma, Department of Hematology and Hematopoietic Cell Transplantation at City of Hope in Duarte, California, referenced the data from the randomized, double-blind phase 3 ECHO trial (NCT02972840) that analyzed the indicated drug combination and found that the patient group that received acalabrutinib had a median progression-free survival of 66.4 months vs 49.6 months in the standard-of-care (SOC) group.²

The newly approved regimen, according to Phillips, will particularly help physicians who operate in the community setting because testing isn’t as widely available and physicians who practice in academic settings have access to clinical trials and other regimens.

Adding acalabrutinib to bendamustine and rituximab will also provide more benefit for high-risk patients who, historically, don’t perform well on chemotherapy alone, and should help alleviate some of the additional risks that community physicians deal with due to the limited testing recourses.

Transcript:

The approval [would] be based on results from the [ECHO] study looking at this in combination with chemotherapy in patients 65 years and older. If you look at this patient population and the results, [this means] it would provide a new quasi SOC for community physicians who would tend to use a lot more bendamustine and rituximab in this patient population vs what we would typically see in an academic setting, where there is a mixture of clinical trials vs other regimens utilized for this patient population—because of the BTK inhibitor acalabrutinib, in this instance. Some of the early data that came out of the clinical trial that led to this approval does suggest that it may be beneficial in some high-risk patients who historically have performed very poorly with just chemotherapy. This does give them a bit more of a [benefit] in that situation because testing is a little bit more limited in the community setting and some of these more high-risk patient populations may not be readily identified in the community space.

References:

1. FDA approves acalabrutinib with bendamustine and rituximab for previously untreated mantle cell lymphoma. January 16, 2024. Accessed January 16, 2024. https://shorturl.at/fTW0O
2. CALQUENCE (acalabrutinib) granted priority review in the US for patients with untreated mantle cell lymphoma. News release. AstraZeneca. October 3, 2024. Accessed December 16, 2024. https://tinyurl.com/bdspu2np