AstraZeneca's Acalabrutinib Combination Therapy Shows 27% Risk Reduction in MCL Trial

AstraZeneca has received approval from the European Union for its BTK inhibitor, acalabrutinib, in combination with bendamustine and rituximab, for the treatment of adult patients with mantle cell lymphoma (MCL) who have not received prior treatment and are not eligible for autologous stem cell transplant. This approval marks a significant milestone as it is the first and only BTK inhibitor approved in the EU for this specific indication.

The approval is grounded in the positive outcomes from the Phase III clinical trial known as ECHO. This trial was designed as a randomized, double-blind, placebo-controlled, multicenter study. Its primary objective was to assess the efficacy and safety of acalabrutinib in combination with bendamustine and rituximab, compared to the standard of care (SoC) chemotherapy-immunotherapy, which includes bendamustine and rituximab. The trial focused on adult MCL patients aged 65 and above who had not received prior treatment. The primary endpoint measured was progression-free survival (PFS).

The results of the ECHO trial were compelling. The combination therapy of acalabrutinib with bendamustine and rituximab demonstrated a 27% reduction in the risk of disease progression or death compared to the standard chemotherapy-immunotherapy. Patients who received the combination therapy had a median PFS of 66.4 months, whereas those who received only the standard chemotherapy-immunotherapy had a median PFS of 49.6 months. These findings underscore the potential of acalabrutinib in enhancing treatment outcomes for MCL patients.

This approval reflects AstraZeneca's dedication to advancing innovative treatments for patients with hematological malignancies. The combination therapy provides a new treatment option for MCL patients who are not eligible for autologous stem cell transplant, offering them a potentially more effective and safer treatment regimen. The positive results from the ECHO trial highlight the potential of acalabrutinib in improving outcomes for patients with MCL, a rare and aggressive form of non-Hodgkin lymphoma.