Calquence Combo Shows Significant Progression-Free Survival Boost in 1st-Line Mantle Cell Lymphoma: ECHO Phase III Study

Encouraging findings emerge from an interim analysis of the ECHO Phase III trial, indicating that AstraZeneca’s Calquence (acalabrutinib), when paired with standard-of-care chemoimmunotherapy—bendamustine and rituximab—achieved a significant improvement in progression-free survival (PFS) compared to standard treatment in previously untreated adults with mantle cell lymphoma (MCL).

The analysis showed a statistically significant and clinically meaningful enhancement in PFS with the Calquence combination regimen, offering promising prospects for patients battling MCL. Although overall survival (OS) data were not fully matured at the time of this assessment, a favorable trend towards Calquence plus chemoimmunotherapy was observed for this secondary endpoint, underscoring the potential for extended survival benefits.

MCL, a relatively rare and typically aggressive form of non-Hodgkin lymphoma, poses significant challenges, often being diagnosed at advanced stages. With over 27,500 patients worldwide estimated to be affected, innovative treatment approaches are crucial.

Dr. Michael Wang, Principal Investigator in the trial and Director of Mantle Cell Lymphoma Program of Excellence at MD Anderson Cancer Center, expressed optimism regarding these findings, suggesting that integrating Calquence into the frontline MCL treatment could establish a new standard of care, widening the scope of patients benefiting from its robust efficacy and favorable safety profile.

Susan Galbraith, Executive Vice President of Oncology R&D at AstraZeneca, echoed this sentiment, emphasizing the potential of Calquence to delay disease progression significantly and potentially extend survival. The positive impact on progression-free survival, coupled with the differentiated safety profile of Calquence, holds promise for improving outcomes in earlier stages of disease management.

The safety and tolerability profile of Calquence remained consistent with previous observations, with no new safety concerns identified during the trial. These findings are expected to be presented at upcoming medical meetings and shared with regulatory authorities globally.

As part of its comprehensive clinical development program, AstraZeneca continues to explore the potential of Calquence as a monotherapy and in combination across various B-cell blood cancers, including chronic lymphocytic leukemia (CLL), MCL, and diffuse large B-cell lymphoma.

With a track record of treating over 80,000 patients worldwide, Calquence has secured approvals for CLL and small lymphocytic lymphoma (SLL) in the US and EU, as well as for relapsed or refractory CLL and SLL in Japan and China. Additionally, it is approved in several countries, including the US and China, for adult patients with MCL who have received at least one prior therapy, though not yet in Japan or the EU for MCL treatment.

MCL, constituting a small fraction of non-Hodgkin lymphomas, presents unique therapeutic challenges, with patients often experiencing relapses despite initial responses to treatment.

The ECHO trial, a randomized, double-blind, placebo-controlled, multicenter Phase III study, evaluated the efficacy and safety of Calquence in combination with bendamustine and rituximab compared to standard chemoimmunotherapy in previously untreated MCL patients aged 65 or older. The trial, spanning 27 countries, focused on primary and key secondary endpoints such as PFS, OS, overall response rate (ORR), duration of response (DoR), and time to response (TTR).

Conducted from 2017 to 2023 amidst the COVID-19 pandemic, the ECHO trial underscores the persistent risks faced by blood cancer patients, who remain disproportionately vulnerable to severe outcomes from COVID-19.

Calquence, a next-generation BTK inhibitor, disrupts signaling pathways crucial for B-cell proliferation, offering a targeted approach in treating hematologic malignancies.

AstraZeneca’s commitment to advancing care in hematology extends beyond oncology, encompassing rare diseases through the acquisition of Alexion. With a focus on delivering innovative therapies, AstraZeneca aims to transform patient outcomes in malignant, rare, and related hematologic conditions.

In oncology, AstraZeneca is driving innovation to redefine cancer care, with a diverse portfolio and pipeline aimed at addressing some of the most challenging cancers. With a vision to eliminate cancer as a cause of death, AstraZeneca remains dedicated to pioneering breakthroughs in oncology and beyond.

AstraZeneca, a global biopharmaceutical company headquartered in Cambridge, UK, operates in over 100 countries, with a mission to discover, develop, and commercialize prescription medicines across various therapeutic areas, including Oncology, Rare Diseases, and BioPharmaceuticals.

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