Encouraging results for the addition of acalabrutinib to lenalidomide and rituximab in follicular lymphoma

Adding acalabrutinib to the combination of lenalidomide and rituximab appeared a safe and efficacious treatment option for participants with newly diagnosed follicular lymphoma (FL), results of a phase 2 study indicated.

Lenalidomide plus rituximab is an efficacious first-line therapy in patients with FL [1,2]. “However, it is hypothesised that adding the BTK inhibitor acalabrutinib to lenalidomide and rituximab increases the efficacy due to beneficial effects on the immune microenvironment,” introduced speaker Dr Paolo Strati (MD Anderson Cancer Center, TX, USA).

Dr Strati and co-researchers investigated the safety and efficacy of the combination of the BTK inhibitor acalabrutinib with lenalidomide and rituximab in a phase 2 study (NCT04404088) among 24 participants with previously untreated FL [3]. Enrolled participants received a daily dose of 100 mg acalabrutinib for 13 x 28-day cycles and lenalidomide plus rituximab for 12 cycles. The primary endpoint was a complete response (CR) rate of more than 80%.

The best observed CR rate was 92%, meeting the primary endpoint (see Figure). “We already noticed a CR rate of 62.5% at 3 months, increasing to 92% at 6 months,” added Dr Strati. The 2-year progression-free survival rate was 79% and the 2-year overall survival rate was 92%. “We also observed favourable biological changes in multiple circulating immune cells by adding acalabrutinib to lenalidomide and rituximab,” emphasised Dr Strati.

Figure: Response rates over time, at the end of treatment and timepoint of best response [3]



BEST, best response timepoint; CR, complete response; EOT, end of treatment; M, months; PR, partial response.

The most common grade 3–4 treatment-emergent adverse events were neutropenia (58%), ALT elevation (17%), AST elevation (12.5%), and infections (12.5%).

Upon this finding, the study included another 26 participants to further explore this promising treatment option as first-line therapy for participants with FL. The results of this extended study have not been analysed yet.

1. Morschhauser F, et al. N Eng J Med 2018;379(10):934-947.
2. Strati P, et al. Blood. 2021;137(8):1124-1129.
3. Strati P, et al. Addition of acalabrutinib to lenalidomide and rituximab induces high complete response rates in patients with previously untreated follicular lymphoma: results of a phase 2 study. Abstract 983, 65^th ASH Annual Meeting, 9–12 December 2023, San Diego, CA, USA.

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Posted on 7 February, 20247 February, 2024