Combination of acalabrutinib with lenalidomide and rituximab in relapsed/refractory aggressive B-cell non-Hodgkin lymphoma: a single-arm phase II trial

Changhee Park, Ho Sup Lee, Ka-Won Kang, Won-Sik Lee, Young Rok Do, Jae-Yong Kwak, Ho-Jin Shin, Sung-Yong Kim, Jun Ho Yi, Sung-Nam Lim, Jeong-Ok Lee, Deok-Hwan Yang, Hun Jang, Byoungsan Choi, Jiwoo Lim, Choong Hyun Sun, Ja Min Byun, Sung-Soo Yoon and Youngil Koh ()
Additional contact information
Changhee Park: Seoul National University Hospital
Ho Sup Lee: Kosin University College of Medicine, Gospel Hospital
Ka-Won Kang: Korea University College of Medicine, Anam Hospital
Won-Sik Lee: Busan Paik Hospital
Young Rok Do: Keimyung University Dongsan Medical Center
Jae-Yong Kwak: Jeonbuk National University Medical School
Ho-Jin Shin: Pusan National University
Sung-Yong Kim: KonKuk University
Jun Ho Yi: Chung-Ang University
Sung-Nam Lim: Inje University Haeundae Paik Hospital
Jeong-Ok Lee: Seoul National University Bundang Hospital
Deok-Hwan Yang: Chonnam National University Hwasun Hospital
Hun Jang: PROTEINA Co., Ltd
Byoungsan Choi: PROTEINA Co., Ltd
Jiwoo Lim: GenomeOpinion Inc.
Choong Hyun Sun: GenomeOpinion Inc.
Ja Min Byun: Seoul National University Hospital
Sung-Soo Yoon: Seoul National University Hospital
Youngil Koh: Seoul National University Hospital

Nature Communications, 2024, vol. 15, issue 1, 1-11

Abstract: Abstract Potential synergism between Bruton’s tyrosine kinase (BTK) inhibitor and lenalidomide in treating aggressive B-cell lymphoma has been suggested. Here, the authors report a single-arm phase II clinical trial of combination of acalabrutinib, lenalidomide and rituximab (R2A) in patients with aggressive relapsed/refractory aggressive (R/R) B-cell non-Hodgkin lymphoma (NHL). The primary endpoint of this study is objective response rate (ORR), and the secondary endpoints are complete remission (CR) rate, duration of response (DoR), progression-free survival (PFS) and overall survival (OS). A total of 66 patients are enrolled mostly with diffuse large B-cell lymphoma. The ORR is 54.5% and CR rate is 31.8% meeting the primary end point. The median DoR is 12.9 months, and 1-year PFS and OS rate is 33.1% and 67.5% respectively. Adverse events (AE) are manageable with the most frequent AE being neutropenia (31.8%). Patients with MYD88 mutations, subtypes known for NF-κB activation, and high BTK expression by immunohistochemistry respond well. Overall, these results show a significant efficacy of the R2A regimen in patients with aggressive R/R B-cell NHL, with exploratory biomarkers suggesting potential associations with response. (ClinicalTrials.gov 51 identifier: NCT04094142)

Date: 2024
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DOI: 10.1038/s41467-024-47198-4

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