Efficacy and Safety of Frontline Acalabrutinib, Lenalidomide and Rituximab for Follicular Lymphoma

Strategic Insights -

Research conducted at the University of Texas MD Anderson Cancer Center has shown promising results for the treatment of follicular lymphoma using acalabrutinib, lenalidomide, and rituximab. The phase II trial involved 24 patients with previously untreated follicular lymphoma and high tumor burden, who were treated with the combination of drugs. The primary endpoint was the best complete response (CR) rate, while secondary endpoints included overall response rate (ORR), duration of response, progression of disease, progression-free survival (PFS), overall survival, and safety.

Key Takeaways:

  • The combination of frontline acalabrutinib, lenalidomide, and rituximab resulted in a best ORR of 100% and best CR rate of 92% in patients with follicular lymphoma.
  • The CR30 rate was 65% and POD24 rate was 17%.
  • After a median follow-up of 43 months, the median PFS was not reached, but the 2-year PFS rate was 79% and the 2-year OS rate was 92%.
  • The most common grade 3-4 adverse events were neutropenia (58%) and liver function test elevation (17%).
  • The study concluded that the addition of acalabrutinib to R2 is a safe and effective frontline regimen for FL patients.

Statistics:

  • Best ORR (Overall Response Rate): 100%
  • Best CR (Complete Response) rate: 92%
  • CR30 rate (Complete Response at 30 months): 65%
  • POD24 rate (Progression of Disease at 24 months): 17%
  • Median follow-up time: 43 months
  • Median PFS (Progression-Free Survival): not reached
  • 2-year PFS rate: 79%
  • 2-year OS (Overall Survival) rate: 92%
  • Number of patients in the study: 24
  • Grade 3-4 adverse events:

+ Neutropenia: 58%

+ Liver function test elevation: 17%

Sources:

  • NewsRx. Data on Follicular Lymphoma Discussed by Researchers at University of Texas MD Anderson Cancer Center (Frontline acalabrutinib, lenalidomide and rituximab for advanced stage follicular lymphoma with high tumor burden: phase II trial). Hematology Week. September 1, 2025; p 827.
  • Nature Communications. Frontline acalabrutinib, lenalidomide and rituximab for advanced stage follicular lymphoma with high tumor burden: phase II trial. 2025,16(1):1-10. (DOI: 10.1038/s41467-025-62509-z)