Calquence Regimen Improves Outcomes in Frontline Mantle Cell Lymphoma

Calquence (acalabrutinib) plus standard-of-care chemoimmunotherapy led to improved progression-free survival (PFS) compared to standard of care for the frontline treatment of patients with mantle cell lymphoma (MCL), according to an interim analysis of the phase 3 ECHO trial announced by AstraZeneca, the manufacturer of Calquence.

PFS describes the time patients live until their disease worsens. Additionally, researchers on the study observed a trend of improved overall survival (OS; time patients live before death of any cause) in the Calquence-containing group. However, not enough survival data is available to calculate an exact average.

“These positive progression-free survival results from the ECHO phase 3 trial could provide a new standard of care for patients with mantle cell lymphoma. Incorporating Calquence into the first-line mantle cell lymphoma setting would give many more patients the opportunity to benefit from the robust efficacy and strong safety profile we’ve seen with this medicine,” Dr. Michael Wang, Puddin Clarke Endowed Professor, Director of Mantle Cell Lymphoma Program of Excellence, co-director of Clinical Trials at MD Anderson Cancer Center and principal investigator in the trial, said in the press release.

About the ECHO Trial

ECHO is a multicenter trial that includes 598 patients aged 65 or older with previously untreated MCL. Half of the participants were randomly assigned to receive Calquence plus Bendeka/Treanda (bendmustine) and Rituxan (rituximab). The other half were assigned to receive a placebo (inactive drug) plus Bendeka/Treanda and Rituxan.

All patients on the trial had to have documentation of a chromosome translocation t(11;14)(q13;q32) and/or overexpression of cyclin D1 in association with other relevant markers. They also must have had an Eastern Cooperative Oncology Group (ECOG) score of 2 or lower. This means that, at the very least, patients are ambulatory and able to carry out all of their self-care activities.

The main goal of the trial is to determine differences in PFS among the two groups. Researchers also plan on evaluating OS, overall response rate, duration of response and time to response.

According to the listing for the ECHO trial on ClinicalTrials.gov, researchers plan to complete the study in October 2025.

Calquence for Mantle Cell Lymphoma

Calquence was previously approved in the MCL space in October 2017 for patients with previously treated disease, based on findings from the ACE-LY-004 trial that showed promising objective response rates. Then in 2022, The Food and Drug Administration approved a tablet version of Calquence.

Calquence works by inhibiting Bruton tyrosine kinase (BTK), which is a protein found on MCL cells that helps activate the pathways that promote cancerous B cells from growing and proliferating, according to AstraZeneca.

MCL, the company explained, is a rare and aggressive subtype of non-Hodgkin lymphoma and occurs when B-lymphocytes turn into cancerous cells in the mantle zone of lymph nodes.

“These impactful results in mantle cell lymphoma show that bringing Calquence to the first-line setting significantly delays disease progression and, for the first time, shows potential to extend survival. The improvement in progression-free survival together with the differentiated safety profile of Calquence are both important as we strive to transform outcomes earlier in the course of disease treatment,” Susan Galbraith, executive vice president, Oncology R&D, AstraZeneca, said in the release.

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