AstraZeneca's Calquence Improves Survival in Phase 3 Mantle Cell Lymphoma Study

AstraZeneca’s Bruton’s tyrosine kinase (BTK) inhibitor, Calquence (acalabrutinib), has shown promising results in enhancing progression-free survival (PFS) for patients with previously untreated mantle cell lymphoma (MCL). This breakthrough comes from the late-stage phase 3 ECHO trial, unveiled by AstraZeneca, which evaluated the effectiveness of Calquence in combination with standard chemoimmunotherapy, specifically bendamustine and rituximab, against the standard chemoimmunotherapy alone. The study focused on adults over 65 years old who had not received prior treatment for MCL.

The findings, presented at the European Hematology Association Hybrid Congress, revealed that the Calquence combination significantly lowered the risk of disease progression or death by 27% compared to the chemoimmunotherapy group. Patients treated with Calquence plus chemoimmunotherapy reported a median PFS of 66.4 months, as opposed to 49.6 months for those who received only chemoimmunotherapy.

Additionally, an encouraging trend emerged regarding the secondary endpoint of overall survival (OS), suggesting that Calquence might be the first BTK inhibitor to demonstrate a favorable impact on OS compared to standard chemoimmunotherapy in this context. However, this data was not mature at the time of analysis, and the trial will continue to further evaluate OS.

AstraZeneca noted that the ECHO trial was conducted during the COVID-19 pandemic. A pre-specified analysis that excluded COVID-19-related deaths indicated an even greater improvement in PFS, with the Calquence combination reducing the risk of disease progression or death by 36%.

Susan Galbraith, executive vice president of oncology research and development at AstraZeneca, remarked, “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.”

Mantle cell lymphoma, which affects more than 27,500 people globally, is a rare and aggressive form of non-Hodgkin lymphoma, often diagnosed at a late stage. Calquence is already approved in the United States and several other countries for treating adults with MCL who have had at least one prior therapy. Additionally, it holds authorizations for treating certain patients with chronic lymphocytic leukemia and small lymphocytic lymphoma.

Michael Wang, the principal investigator of the ECHO trial from MD Anderson Cancer Center, emphasized, “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.”

In summary, the phase 3 ECHO trial demonstrates that Calquence, when combined with standard chemoimmunotherapy, offers significant benefits in prolonging the progression-free survival of patients with previously untreated mantle cell lymphoma. These findings suggest that Calquence could become a crucial new option for first-line treatment, potentially setting a new standard of care for this challenging disease.