AstraZeneca Announces Positive Phase III ECHO Trial Results for Calquence (acalabrutinib) in First-Line Mantle Cell Lymphoma

On May 2, AstraZeneca announced that the interim analysis results of the Phase III ECHO study showed that, compared with standard chemoimmunotherapy, the BTK inhibitor Calquence (acalabrutinib) in combination with standard chemoimmunotherapy (bendamustine and rituximab) significantly improved progression-free survival (PFS) with both statistical and clinical significance in patients with previously untreated mantle cell lymphoma (MCL).

For the secondary endpoint of overall survival (OS), a favorable trend was observed with Calquence in combination with chemoimmunotherapy. At the time of this analysis, the OS data were not yet mature, and the trial will continue to evaluate OS.

Notably, Johnson & Johnson withdrew the new indication marketing application for ibrutinib (Imbruvica) in combination with bendamustine and rituximab as a first-line treatment for MCL patients from the European Medicines Agency.

The Phase III SHINE study of ibrutinib enrolled 523 previously untreated MCL patients aged ≥65 years. The study showed that 39.8% of patients in the ibrutinib group and 40.8% in the placebo group died, with similar OS between the two groups (hazard ratio for death = 1.07). The 7-year overall survival rate was 55.0% in the ibrutinib group and 56.8% in the placebo group.

ECHO Study"The positive PFS results from the Phase III ECHO study can provide a new treatment standard for MCL patients," said Dr. Michael Wang, the principal investigator and Puddin Clarke Distinguished Endowed Professor at The University of Texas MD Anderson Cancer Center in Houston. "Incorporating Calquence into first-line treatment for MCL will allow more patients to benefit from the powerful efficacy and safety profile of this drug."

Susan Galbraith, Executive Vice President of Oncology R&D at AstraZeneca, said: "These important results show that using Calquence for first-line MCL treatment can significantly delay disease progression and, for the first time, demonstrate the potential to extend OS. The improvement in PFS and Calquence’s distinct safety profile are both crucial as we strive to change treatment outcomes in the early stages of the disease."

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