AstraZeneca : Calquence plus chemoimmunotherapy reduced the risk of disease progression or death by 27% vs. standard of care in patients with untreated mantle cell lymphoma in ECHO Phase III trial

Positive results from the ECHO Phase III trial showed AstraZeneca's Calquence (acalabrutinib) in combination with bendamustine and rituximab demonstrated a statistically significant and clinically meaningful improvement in progression-free survival (PFS) and showed a favourable trend in overall survival (OS) compared to standard-of-care chemoimmunotherapy (bendamustine plus rituximab) in previously untreated patients with mantle cell lymphoma (MCL).

These results will be presented today in a late-breaking oral presentation at the European Hematology Association (EHA) 2024 Hybrid Congress in Madrid, Spain (#LBA3439).

Results showed the Calquence combination regimen reduced the risk of disease progression or death by 27% compared to standard-of-care chemoimmunotherapy (hazard ratio [HR] 0.73; 95% confidence interval [CI] 0.57-0.94; p=0.016). Median PFS was 66.4 months for patients treated with the Calquence combination (n=299) versus 49.6 months with standard-of-care chemoimmunotherapy (n=299).

The secondary endpoint of OS showed a favourable trend for the Calquence combination compared to standard-of-care chemoimmunotherapy, further supporting the clinical benefit of this combination (HR 0.86; 95% CI 0.65-1.13; p=0.2743). The OS data were not mature at the time of this analysis and the trial will continue to assess OS as a key secondary endpoint.

The ECHO trial enrolled during the pandemic period, and a pre-specified analysis censoring for COVID-19-related deaths was conducted to assess the impact. PFS was further improved in both arms, with the Calquence combination reducing the risk of disease progression or death by 36% (HR 0.64; 95% CI; 0.48-0.84; p=0.0017). Median PFS was not reached among patients treated with the Calquence combination versus 61.6 months for standard-of-care chemoimmunotherapy (HR 0.64, 95% CI, 0.48-0.84; p=0.0017). A favourable trend was seen for OS in this analysis for the Calquence combination (HR 0.75; 95% CI 0.53-1.04; p=0.0797).

Michael Wang, MD, Puddin Clarke Endowed Professor, Director of Mantle Cell Lymphoma Program of Excellence, Co-Director of Clinical Trials at MD Anderson Cancer Center in Houston, US and principal investigator in the trial, said: "For people living with mantle cell lymphoma, a typically aggressive form of non-Hodgkin's lymphoma, the ECHO results offer promise of a new, effective treatment option for adults older than 65, who represent the majority of MCL patients. The improved progression-free survival seen in patients treated with the Calquence combination compared to chemoimmunotherapy demonstrate its potential to change the standard of care as the only BTK inhibitor in this first-line setting."

Susan Galbraith, Executive Vice President, Oncology R&D, AstraZeneca, said: "The ECHO trial data demonstrate important progress in improving outcomes for patients with mantle cell lymphoma. The 16.8 months of additional time patients can live without their disease progressing is highly clinically meaningful, together with a trend to improvement in overall survival. We therefore believe Calquence plus chemoimmunotherapy will be an important new option for patients living with this disease."

Summary of Results: ECHO