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Peer-reviewedCC BY-NC-NDSignal transduction and targeted therapy

Efficacy and safety of ifupinostat in relapsed or refractory diffuse large B-cell lymphoma: a multicenter, single-arm phase 2 study.

  • Yuankai Shi1
  • Peng Liu2
  • Yufu Li3
  • Wenyu Li4
  • Hui Zhou5
  • Yu Yang6
  • Jie Jin7
  • Yuhuan Gao8
  • Weijie Xu9
  • Meifang Zheng10
  • Haiyan Yang11
  • Hongwei Xue12
19 more authors
  • Zhigang Peng13
  • Ou Bai14
  • Fei Li15
  • Fangfang Lv16
  • Liling Zhang17
  • Ning Huang18
  • Yi Luo19
  • Chunhong Hu20
  • Yajing Xu21
  • Huilai Zhang22
  • Xiuhua Sun23
  • Xin Li24
  • Kaiyang Ding25
  • Linjuan Zeng26
  • Haiyan Zhu27
  • Yajie Cao28,29
  • Yonglong Yang29
  • Kegang Jiang29
  • Changgeng Qian29
29 affiliations
  1. 1Department of Medical Oncology, Beijing Key Laboratory of Key Technologies for Early Clinical Trial Evaluation of Innovative Drugs for Major Diseases, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College, Beijing, PR China. [email protected].
  2. 2Department of Medical Oncology, Beijing Key Laboratory of Key Technologies for Early Clinical Trial Evaluation of Innovative Drugs for Major Diseases, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College, Beijing, PR China.
  3. 3Hematology Department, Henan Cancer Hospital, Henan, PR China.
  4. 4Lymphoma Department, Guangdong Provincial People's Hospital, Guangdong, PR China.
  5. 5Lymphoma Hematology Department, Hunan Cancer Hospital, Hunan, PR China.
  6. 6Lymphoma and Head and Neck Tumor Department, Fujian Cancer Hospital, Fujian, PR China.
  7. 7Hematology Department, The First Affiliated Hospital, Zhejiang University School of Medicine, Zhejiang, PR China.
  8. 8Hematology Department, Hebei Cancer Hospital, Hebei, PR China.
  9. 9Oncology Department, Jilin Cancer Hospital, Jilin, PR China.
  10. 10Internal Medicine Department, Linyi Cancer Hospital, Shandong, PR China.
  11. 11Lymphoma Department, Zhejiang Cancer Hospital, Zhejiang, PR China.
  12. 12Hematology Department, The Affiliated Hospital of Qingdao University, Shandong, PR China.
  13. 13Oncology Department, The First Affiliated Hospital of Guangxi Medical University, Guangxi, PR China.
  14. 14Hematology Department, The First Hospital of Jilin University, Jilin, PR China.
  15. 15Hematology Department, The First Affiliated Hospital of Nanchang University, Jiangxi, PR China.
  16. 16Oncology Department, Fudan University Shanghai Cancer Center, Shanghai, PR China.
  17. 17Lymphoma Department, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Hubei, PR China.
  18. 18Hematology Department, Shandong Provincial Qianfoshan Hospital, Shandong, PR China.
  19. 19Oncology Department, Changsha Kexin Cancer Hospital, Hunan, PR China.
  20. 20Oncology Department, The Second Xiangya Hospital of Central South University, Hunan, PR China.
  21. 21Hematology Department, Xiangya Hospital of Central South University, Hunan, PR China.
  22. 22Lymphoma Department, Tianjin Medical University Cancer Institute & Hospital, Tianjin, PR China.
  23. 23Oncology Department, The Second Hospital of DaLian Medical University, Liaoning, PR China.
  24. 24Oncology Department, The First Affiliated Hospital of Zhengzhou University, Henan, PR China.
  25. 25Hematological Oncology Department, Anhui Provincial Cancer Hospital, Anhui, PR China.
  26. 26Oncology Department, The Fifth Affiliated Hospital Sun Yat-san University, Guangdong, PR China.
  27. 27Radiation Injury Treatment Department, The Fifth Medical Center of Chinese PLA General Hospital, Beijing, PR China.
  28. 28Center of Clinical Pharmacology, The Third Xiangya Hospital, Central South University, Changsha, PR China.
  29. 29BeBetter Med Inc., Guangzhou, Guangdong, PR China.
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Abstract

Ifupinostat (BEBT-908) is a novel dual-targeted inhibitor of histone deacetylase (HDACs) and phosphatidylinositol 3-kinase alpha (PI3Kα). We evaluated the efficacy and safety of ifupinostat monotherapy in patients with relapsed or refractory (r/r) diffuse large B-cell lymphoma (DLBCL) after at least 2 prior lines of systemic therapy. Eligible participants received intravenous ifupinostat at 22.5 mg/m² on days 1, 3, 5, 8, 10, and 12 of a 21-day cycle. The primary endpoint was objective response rate (ORR) assessed by blinded independent central review (BICR). Secondary endpoints included disease control rate (DCR), duration of response (DoR), progression-free survival (PFS), overall survival (OS) and safety. From June 2020 to July 2022, 128 patients were enrolled and included in the safety set (SS), and 115 patients were in the efficacy analysis set (EAS). At the data cutoff (July 2023), the median follow-up was 19.58 months (95% confidence interval [CI] 16.82-21.95). The ORR was 36.5% (42/115, 95% CI 27.7-46.0), with a complete response rate of 11.3% (13/115). The median DoR was 6.2 months (95% CI 3.5-14.5), median PFS was 2.7 months (95% CI 1.6-3.7), and median OS was 9.9 months (95% CI 7.8-14.8). Treatment-related adverse events (TRAEs) occurred in 99.2% (127/128) of patients, and ≥grade 3 TRAEs in 86.7% (111/128). The most common ≥grade 3 TRAEs were thrombocytopenia (75.8%, 97/128), neutropenia (33.6%, 43/128), and leukopenia (22.7%, 29/128). No treatment-related deaths occurred. Ifupinostat demonstrated promising efficacy and a manageable safety profile as a new therapeutic alternative for patients with r/r DLBCL. Clinical Trial Registry Number: ChiCTR1900028179.

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Cite

BibTeXRIS
BibTeX
@article{shi2026efficacy,
  title = {{Efficacy and safety of ifupinostat in relapsed or refractory diffuse large B-cell lymphoma: a multicenter, single-arm phase 2 study.}},
  author = {Yuankai Shi and Peng Liu and Yufu Li and Wenyu Li and Hui Zhou and Yu Yang and Jie Jin and Yuhuan Gao and Weijie Xu and Meifang Zheng and Haiyan Yang and Hongwei Xue and Zhigang Peng and Ou Bai and Fei Li and Fangfang Lv and Liling Zhang and Ning Huang and Yi Luo and Chunhong Hu and Yajing Xu and Huilai Zhang and Xiuhua Sun and Xin Li and Kaiyang Ding and Linjuan Zeng and Haiyan Zhu and Yajie Cao and Yonglong Yang and Kegang Jiang and Changgeng Qian},
  journal = {Signal transduction and targeted therapy},
  year = {2026},
  month = oct,
  doi = {10.1038/s41392-026-02926-8},
  url = {https://europepmc.org/article/MED/42893991},
  note = {CC BY-NC-ND},
}
RIS
TY  - JOUR
TI  - Efficacy and safety of ifupinostat in relapsed or refractory diffuse large B-cell lymphoma: a multicenter, single-arm phase 2 study.
AU  - Yuankai Shi
AU  - Peng Liu
AU  - Yufu Li
AU  - Wenyu Li
AU  - Hui Zhou
AU  - Yu Yang
AU  - Jie Jin
AU  - Yuhuan Gao
AU  - Weijie Xu
AU  - Meifang Zheng
AU  - Haiyan Yang
AU  - Hongwei Xue
AU  - Zhigang Peng
AU  - Ou Bai
AU  - Fei Li
AU  - Fangfang Lv
AU  - Liling Zhang
AU  - Ning Huang
AU  - Yi Luo
AU  - Chunhong Hu
AU  - Yajing Xu
AU  - Huilai Zhang
AU  - Xiuhua Sun
AU  - Xin Li
AU  - Kaiyang Ding
AU  - Linjuan Zeng
AU  - Haiyan Zhu
AU  - Yajie Cao
AU  - Yonglong Yang
AU  - Kegang Jiang
AU  - Changgeng Qian
PY  - 2026
DA  - 2026/10/19
JO  - Signal transduction and targeted therapy
DO  - 10.1038/s41392-026-02926-8
UR  - https://europepmc.org/article/MED/42893991
AB  - Ifupinostat (BEBT-908) is a novel dual-targeted inhibitor of histone deacetylase (HDACs) and phosphatidylinositol 3-kinase alpha (PI3Kα). We evaluated the efficacy and safety of ifupinostat monotherapy in patients with relapsed or refractory (r/r) diffuse large B-cell lymphoma (DLBCL) after at least 2 prior lines of systemic therapy. Eligible participants received intravenous ifupinostat at 22.5 mg/m² on days 1, 3, 5, 8, 10, and 12 of a 21-day cycle. The primary endpoint was objective response rate (ORR) assessed by blinded independent central review (BICR). Secondary endpoints included disease control rate (DCR), duration of response (DoR), progression-free survival (PFS), overall survival (OS) and safety. From June 2020 to July 2022, 128 patients were enrolled and included in the safety set (SS), and 115 patients were in the efficacy analysis set (EAS). At the data cutoff (July 2023), the median follow-up was 19.58 months (95% confidence interval [CI] 16.82-21.95). The ORR was 36.5% (42/115, 95% CI 27.7-46.0), with a complete response rate of 11.3% (13/115). The median DoR was 6.2 months (95% CI 3.5-14.5), median PFS was 2.7 months (95% CI 1.6-3.7), and median OS was 9.9 months (95% CI 7.8-14.8). Treatment-related adverse events (TRAEs) occurred in 99.2% (127/128) of patients, and ≥grade 3 TRAEs in 86.7% (111/128). The most common ≥grade 3 TRAEs were thrombocytopenia (75.8%, 97/128), neutropenia (33.6%, 43/128), and leukopenia (22.7%, 29/128). No treatment-related deaths occurred. Ifupinostat demonstrated promising efficacy and a manageable safety profile as a new therapeutic alternative for patients with r/r DLBCL. Clinical Trial Registry Number: ChiCTR1900028179.
SN  - 2095-9907
SN  - 2059-3635
ER  -