AstraZeneca’s (AZ) Bruton’s tyrosine kinase (BTK) inhibitor Calquence (acalabrutinib) has been shown to improve progression-free survival (PFS) in patients with previously untreated mantle cell lymphoma (MCL), according to late-stage results presented by the company.
The phase 3 ECHO trial has been evaluating the drug plus standard-of-care chemoimmunotherapy, bendamustine and rituximab, compared to chemoimmunotherapy alone in adults aged over 65 years with previously untreated MCL.
The results shared at this year’s European Hematology Association Hybrid Congress showed that the Calquence combination reduced the risk of disease progression or death by 27% compared to chemoimmunotherapy.
Median PFS was 66.4 months for patients treated with the Calquence combination versus 49.6 months for those receiving chemoimmunotherapy.
A trend was also observed in favour of the combination for the secondary endpoint of overall survival (OS), making Calquence the first BTK inhibitor to demonstrate a favourable OS trend versus standard-of-care chemoimmunotherapy in this setting. This data was not mature at the time of the analysis and the trial will continue to further assess OS, AZ said.
The company added that ECHO enrolled during the COVID-19 pandemic and a pre-specified analysis that censored COVID-19-related deaths demonstrated a further improvement in PFS, with the Calquence combination reducing the risk of disease progression or death by 36%.
Susan Galbraith, executive vice president, oncology research and development, AZ, said: “The ECHO trial data demonstrates important progress in improving outcomes for patients with MCL… We therefore believe Calquence plus chemoimmunotherapy will be an important new option for patients living with this disease.”
Estimated to affect more than 27,500 people globally, MCL is a rare and typically aggressive form of non-Hodgkin lymphoma that is often diagnosed as a late-stage disease.
Calquence is already approved in the US and several other countries to treat adults with MCL who have received at least one prior therapy, and also holds authorisations to treat certain patients with chronic lymphocytic leukaemia and small lymphocytic lymphoma.
ECHO principal investigator, Michael Wang, MD Anderson Cancer Center, said: “The improved PFS seen in patients treated with the Calquence combination compared to chemoimmunotherapy demonstrates its potential to change the standard of care as the only BTK inhibitor in this first-line setting.”