AstraZeneca’s CALQUENCE demonstrates enhanced efficacy in mantle cell lymphoma trial

AstraZeneca has announced significant outcomes from the ECHO Phase III trial, highlighting the effectiveness of its drug CALQUENCE (acalabrutinib) when combined with bendamustine and rituximab in treating previously untreated patients with mantle cell lymphoma (MCL). Presented at the European Hematology Association (EHA) 2024 Hybrid Congress in Madrid, Spain, the findings reveal a statistically significant and clinically meaningful improvement in progression-free survival (PFS) and a favorable trend in overall survival (OS) compared to the standard-of-care chemoimmunotherapy.

Clinical Trial Insights

The CALQUENCE combination regimen was shown to reduce the risk of disease progression or death by 27% compared to the standard chemoimmunotherapy (hazard ratio [HR] 0.73; 95% confidence interval [CI] 0.57-0.94; p=0.016), with a median PFS of 66.4 months versus 49.6 months in the control group. Although the data for OS are not yet mature, initial trends indicate potential benefits, which will continue to be a focus of ongoing analysis.

Strategic Impact and Market Potential

This trial’s results are pivotal for AstraZeneca, showcasing CALQUENCE’s potential to change the standard care landscape for MCL, particularly in cases where patients are over 65—demographically the most affected group. Dr. Michael Wang of MD Anderson Cancer Center, a principal investigator in the trial, noted the significant impact this could have on patient care, offering a new and effective treatment option for a typically aggressive cancer.

Development and Safety Profile

CALQUENCE, a next-generation BTK inhibitor, is already recognized for its efficacy in various conditions but is particularly noted here for its role in MCL treatment. The trial also confirmed CALFUNCTION’s safety profile, consistent with previous findings, and no new safety signals were identified. Adverse events were comparable between the treatment and control groups, with manageable side effects.

Executive Insights

Susan Galbraith, Executive Vice President of Oncology R&D at AstraZeneca, remarked on the trial’s success, “The ECHO trial data demonstrate important progress in improving outcomes for patients with mantle cell lymphoma. We are excited about the potential to offer these patients an additional 16.8 months without disease progression and possibly extending their overall survival.”

Regulatory Status and Future Prospects

CALQUENCE is approved under accelerated approval for MCL based on overall response rate and is currently indicated for various other B-cell blood cancers in multiple regions, including the US, China, and the EU. It is under further evaluation in several other hematological conditions, promising extensive future applications.

The positive results from the ECHO Phase III trial represent a significant advance in the treatment of mantle cell lymphoma, positioning CALQUENCE as a potential new standard in first-line therapy. With ongoing studies and strategic development, AstraZeneca continues to enhance its portfolio in oncology, addressing critical needs in cancer treatment across the globe.