The Oral PI3Kδ Inhibitor Linperlisib for the Treatment of Relapsed and/or Refractory Follicular Lymphoma: A Phase II, Single-Arm, Open-Label Clinical Trial

Author:

Wang Tingyu12ORCID,Sun Xiuhua3ORCID,Qiu Lihua4ORCID,Su Hang5ORCID,Cao Junning6ORCID,Li Zhiming7ORCID,Song Yuqin8ORCID,Zhang Li9ORCID,Li Dengju10ORCID,Wu Huijing11ORCID,Zhang Wei12ORCID,Li Junmin13ORCID,Zhou Keshu14ORCID,Zhou Hui15ORCID,Yang Yu16ORCID,Li Zhifeng17ORCID,Cen Hong18ORCID,Cai Zhen19ORCID,Zhang Zhihui20ORCID,Fu Weijun21ORCID,Jin Jie19ORCID,Li Fei22ORCID,Wu Weixin23ORCID,Gu Xuekui24ORCID,Zhu Weiliang25ORCID,Liu Lihong26ORCID,Li Zengjun12ORCID,Yi Shuhua12ORCID,Bao Hanying27ORCID,Xu Zusheng27ORCID,Qiu Lugui12ORCID

Affiliation:

1. 1State Key Laboratory of Experimental Hematology, National Clinical Research Center for Blood Diseases, Haihe Laboratory of Cell Ecosystem, Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College, Tianjin, China.

2. 2Tianjin Institutes of Health Science, Tianjin, China.

3. 3Department of Medical Oncology, The Second Hospital of Dalian Medical University, Dalian, China.

4. 4Department of Lymphoma, Tianjin's Clinical Research Center for Cancer, Key Laboratory of Cancer Prevention and Therapy, National Clinical Research Center for Cancer, Tianjin Medical University Cancer Institute and Hospital, Tianjin Medical University, Tianjin, China.

5. 5Department of Lymphoma, Senior Department of Hematology, The Fifth Medical Center of PLA General Hospital, Beijing, China.

6. 6Department of Medical Oncology, Fudan University Shanghai Cancer Center, Shanghai, China.

7. 7Department of Medical Oncology, Sun Yat-sen University Cancer Center, Guangzhou, China.

8. 8Key Laboratory of Carcinogenesis and Translational Research (Ministry of Education), Department of Lymphoma, Peking University School of Oncology, Beijing Cancer Hospital and Institute, Beijing, China.

9. 9Department of Hematology, West China Hospital, Sichuan University, Chengdu, China.

10. 10Department of Hematology, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China.

11. 11Department of Medical Oncology, Hubei Cancer Hospital, Wuhan, China.

12. 12Department of Hematology, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College, Beijing, China.

13. 13Shanghai Institute of Hematology, State Key Laboratory of Medical Genomics, National Research Center for Translational Medicine at Shanghai, Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine, Shanghai, China.

14. 14Department of Hematology, The Affiliated Cancer Hospital of Zhengzhou University and Henan Cancer Hospital, Zhengzhou, China.

15. 15Department of Lymphoma & Hematology, Hunan Cancer Hospital, The Affiliated Cancer Hospital of Xiangya School of Medicine, Central South University, Changsha, China.

16. 16Department of Lymphoma and Head and Neck Cancer, Fujian Provincial Cancer Hospital, The Affiliated Tumor Hospital of Fujian Medical University, Fuzhou, China.

17. 17Department of Hematology, The First Affiliated Hospital of Xiamen University and Institute of Hematology, School of Medicine, Xiamen University, Xiamen, China.

18. 18Department of Haematology/Oncology and Paediatric Oncology, Guangxi Medical University Affiliated Cancer Hospital, Nanning, China.

19. 19Department of Hematology, The First Affiliated Hospital, Zhejiang University School of Medicine, Hangzhou, China.

20. 20Department of Medical Oncology, Sichuan Cancer Hospital and Institute, Chengdu, China.

21. 21Department of Hematology, Shanghai Fourth People's Hospital, School of Medicine, Tongji University, Shanghai, China.

22. 22Department of Hematology, The First Affiliated Hospital of Nanchang University, Nanchang, China.

23. 23Department of Internal Medicine and Oncology, Zhongshan Hospital, Xiamen University, Xiamen, China.

24. 24Department of Hematology, The First Affiliated Hospital of Guangzhou University of Chinese Medicine, Guangzhou, China.

25. 25Department of Oncology, Zhujiang Hospital of Southern Medical University, Guangzhou, China.

26. 26Department of Hematology, The Fourth Hospital of Hebei Medical University, Shijiazhuang, China.

27. 27Clinical Development Department, Shanghai Yingli Pharmaceutical Co., Ltd., Shanghai, China.

Abstract

AbstractPurpose:To investigate the efficacy and safety of the novel orally active PI3Kδ inhibitor in relapsed and/or refractory patients with follicular lymphoma (FL) who had received at least two prior systemic treatments.Patients and Methods:Histologically confirmed relapsed and/or refractory patients with FL with disease progression after receiving second-line or greater systemic therapy were enrolled. Linperlisib was administered at 80 mg every day, orally in a 28-day cycle until disease progression or intolerable toxicity occurred. The primary outcome for the study was the objective response rate (ORR), with secondary outcomes including the duration of response (DOR), progression-free survival (PFS), overall survival (OS), disease control rate, and drug safety profile.Results:Of 114 screened relapsed and/or refractory patients with FL, 84 were enrolled in the full analysis set (FAS). The ORR of the 84 FAS patients was 79.8% [95% confidence interval (CI), 69.6–87.8, 67 patients], with 13 patients (15.5%) achieving a complete response and 54 patients (64.3%) with a partial response. The median DOR was 12.3 months (95% CI, 9.3–15.9). The median PFS was 13.4 months (95% CI, 11.1–16.7). The 12-month OS rate was 91.4% (95% CI, 82.7–95.8) and a median OS not reached by 42 months. The most frequent (>3%) treatment-related adverse events Grade ≥3 were infectious pneumonia (19.0%), neutropenia (15.5%), decreased lymphocyte count (4.8%), decreased leukocyte count (4.8%), increased lipase (3.6%), decreased platelet count (3.6%), hypertriglyceridemia (3.6%), and interstitial lung disease (3.6%).Conclusions:Linperlisib demonstrated compelling clinical activity and manageable tolerability for relapsed and/or refractory patients with FL who had received at least two prior systemic therapies.

Funder

Chinese Academy of Medical Sciences Innovation Fund for Medical Sciences

Shanghai Yingli Pharmaceutical Co., Ltd.

Publisher

American Association for Cancer Research (AACR)

Subject

Cancer Research,Oncology

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