The recent results from the ECHO Phase III trial showed AstraZeneca’s CALQUENCE (acalabrutinib) in combination with bendamustine and rituximab demonstrated an 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 were presented on June 16, 2024, in a late-breaking oral presentation at the European Hematology Association (EHA) 2024 Hybrid Congress in Madrid, Spain.
According to its statement, the results showed the CALQUENCE combination regimen reduced the risk of disease progression or death by 27 per cent compared to standard-of-care chemoimmunotherapy (hazard ratio [HR] 0.73; 95 per cent 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 per cent 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 per cent (HR 0.64; 95 per cent 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 per cent 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 per cent CI 0.53-1.04; p=0.0797).