Evidence map›Paper›PMID 36735519›Full record

Trial reportClinical cancer research : an official journal of the American Association for Cancer Research2023

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

Tingyu Wang, Xiuhua Sun, Lihua Qiu, Hang Su, Junning Cao, Zhiming Li, Yuqin Song, Li Zhang, Dengju Li, Huijing Wu and 21 more

Abstract readClinical Trial, Phase II
In one paragraph

Trial report in Clinical cancer research : an official journal of the American Association for Cancer Research, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 31 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
31citing papers in PubMed, 2 pooled it
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

31 citing papers in PubMed, 2 syntheses or guidelines pooled it.

  1. Pooled it
  2. [The guideline for the diagnosis and treatment of marginal zone lymphoma in China (2025)].Zhonghua xue ye xue za zhi = Zhonghua xueyexue zazhi · 2025
    Guideline
  3. Trial
  4. Trial
  5. Review
  6. Article
  7. Article
  8. Review
  9. Article
  10. Review
  11. Article
  12. Article
  13. Review
  14. Article
  15. Article
  16. Article
  17. Article
  18. Article
  19. Article
  20. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

31 authors.

Tingyu Wang *State 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.ORCID 0000-0003-4542-3587
Xiuhua Sun *Department of Medical Oncology, The Second Hospital of Dalian Medical University, Dalian, China.ORCID 0000-0002-5957-0505
Lihua QiuDepartment 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.ORCID 0000-0003-4637-1811
Hang SuDepartment of Lymphoma, Senior Department of Hematology, The Fifth Medical Center of PLA General Hospital, Beijing, China.ORCID 0000-0003-1831-0640
Junning CaoDepartment of Medical Oncology, Fudan University Shanghai Cancer Center, Shanghai, China.ORCID 0000-0002-3146-9413
Zhiming LiDepartment of Medical Oncology, Sun Yat-sen University Cancer Center, Guangzhou, China.ORCID 0000-0001-9730-9917
Yuqin SongKey Laboratory of Carcinogenesis and Translational Research (Ministry of Education), Department of Lymphoma, Peking University School of Oncology, Beijing Cancer Hospital and Institute, Beijing, China.ORCID 0000-0003-3067-5554
Li ZhangDepartment of Hematology, West China Hospital, Sichuan University, Chengdu, China.ORCID 0000-0001-5389-7550
Dengju LiDepartment of Hematology, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China.ORCID 0000-0001-7629-2642
Huijing WuDepartment of Medical Oncology, Hubei Cancer Hospital, Wuhan, China.ORCID 0000-0003-3224-1733
Wei ZhangDepartment of Hematology, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College, Beijing, China.ORCID 0000-0001-9489-5965
Junmin LiShanghai 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.ORCID 0000-0002-9761-891X
Keshu ZhouDepartment of Hematology, The Affiliated Cancer Hospital of Zhengzhou University and Henan Cancer Hospital, Zhengzhou, China.ORCID 0000-0001-5467-1377
Hui ZhouDepartment of Lymphoma & Hematology, Hunan Cancer Hospital, The Affiliated Cancer Hospital of Xiangya School of Medicine, Central South University, Changsha, China.ORCID 0000-0001-9909-5051
Yu YangDepartment of Lymphoma and Head and Neck Cancer, Fujian Provincial Cancer Hospital, The Affiliated Tumor Hospital of Fujian Medical University, Fuzhou, China.ORCID 0000-0002-3513-8865
Zhifeng LiDepartment of Hematology, The First Affiliated Hospital of Xiamen University and Institute of Hematology, School of Medicine, Xiamen University, Xiamen, China.ORCID 0000-0001-5161-3040
Hong CenDepartment of Haematology/Oncology and Paediatric Oncology, Guangxi Medical University Affiliated Cancer Hospital, Nanning, China.ORCID 0000-0003-2232-9213
Zhen CaiDepartment of Hematology, The First Affiliated Hospital, Zhejiang University School of Medicine, Hangzhou, China.ORCID 0000-0001-6026-3804
Zhihui ZhangDepartment of Medical Oncology, Sichuan Cancer Hospital and Institute, Chengdu, China.ORCID 0000-0001-6326-7624
Weijun FuDepartment of Hematology, Shanghai Fourth People's Hospital, School of Medicine, Tongji University, Shanghai, China.ORCID 0000-0002-5908-0207
Jie JinDepartment of Hematology, The First Affiliated Hospital, Zhejiang University School of Medicine, Hangzhou, China.ORCID 0000-0002-8166-9915
Fei LiDepartment of Hematology, The First Affiliated Hospital of Nanchang University, Nanchang, China.ORCID 0000-0002-7765-5975
Weixin WuDepartment of Internal Medicine and Oncology, Zhongshan Hospital, Xiamen University, Xiamen, China.ORCID 0000-0001-8964-1901
Xuekui GuDepartment of Hematology, The First Affiliated Hospital of Guangzhou University of Chinese Medicine, Guangzhou, China.ORCID 0000-0001-8166-114X
Weiliang ZhuDepartment of Oncology, Zhujiang Hospital of Southern Medical University, Guangzhou, China.ORCID 0000-0002-1024-4389
Lihong LiuDepartment of Hematology, The Fourth Hospital of Hebei Medical University, Shijiazhuang, China.ORCID 0000-0003-1430-7620
Zengjun LiState 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.ORCID 0000-0003-0787-8089
Shuhua YiState 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.ORCID 0000-0002-6291-812X
Hanying BaoClinical Development Department, Shanghai Yingli Pharmaceutical Co., Ltd., Shanghai, China.ORCID 0000-0002-0846-2774
Zusheng XuClinical Development Department, Shanghai Yingli Pharmaceutical Co., Ltd., Shanghai, China.ORCID 0000-0002-7266-6202
Lugui QiuState 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.ORCID 0000-0002-9948-1662

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

purposeTo 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

methodsHistologically 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.

resultsOf 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%).

conclusionsLinperlisib demonstrated compelling clinical activity and manageable tolerability for relapsed and/or refractory patients with FL who had received at least two prior systemic therapies.

Indexed as

Lymphoma, FollicularAngiogenesis InhibitorsAntineoplastic Combined Chemotherapy ProtocolsDisease ProgressionHumansProtein Kinase InhibitorsTreatment OutcomeAngiogenesis InhibitorsProtein Kinase Inhibitors

Identifiers

PMID36735519
PMCPMC10102838

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-ND
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.