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Efficacy and Safety of Avapritinib in Treating Unresectable or Metastatic GIST: A Phase I/II, Open-Label, Multicenter Study

The oncologist (Dayton, Ohio), 2023-02, Vol.28 (2), p.187 [Peer Reviewed Journal]

COPYRIGHT 2023 Oxford University Press ;ISSN: 1083-7159 ;EISSN: 1549-490X ;DOI: 10.1093/oncolo/oyac242

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  • Title:
    Efficacy and Safety of Avapritinib in Treating Unresectable or Metastatic GIST: A Phase I/II, Open-Label, Multicenter Study
  • Author: Li, Jian ; Zhang, Xinhua ; Deng, Yanhong ; Wu, Xin ; Zheng, Zhichao ; Zhou, Yongjian ; Cai, Shirong ; Zhang, Yanqiao ; Zhang, Jun ; Tao, Kaixiong ; Cui, Yuehong ; Cao, Hui ; Shen, Kuntang ; Yu, Jiren ; Zhou, Ye ; Ren, Wenxiao ; Qu, Chenglin ; Zhao, Wanqi ; Hu, Jin ; Wang, Wei ; Yang, Jason ; Shen, Lin
  • Subjects: Anemia ; Bilirubin ; Blood cell count ; Care and treatment ; Drug therapy ; Gastrointestinal tumors ; Labels ; Medical research ; Medicine, Experimental ; Metastasis ; Patient outcomes ; Platelet-derived growth factor ; Tyrosine
  • Is Part Of: The oncologist (Dayton, Ohio), 2023-02, Vol.28 (2), p.187
  • Description: Background: Avapritinib is a type 1 kinase inhibitor designed to potently and selectively inhibit oncogenic KIT/PDGFRA mutants by targeting the kinase active conformation. This multicenter, single-arm, open-label, phase I/II bridging study of NAVIGATOR in Chinese patients evaluated the safety and the antineoplastic activity of avapritinib in Chinese patients with unresectable/metastatic gastrointestinal stromal tumors (GIST). Methods: Phase I comprised dose escalation for safety and phase II dose determination. Phase II comprised dose expansion for safety/efficacy evaluations in patients with PDGFRA D842V mutations or patients having received at least 3 lines of therapy without PDGFRA D842V mutations. The primary endpoints were recommended phase II dose, safety, and Independent Radiology Review Committee (IRRC)-assessed objective response rate (ORR). Results: No dose-limiting toxicities occurred (n = 10); the recommended phase II dose was avapritinib 300 mg once daily orally. Fifty-nine patients initially received avapritinib 300 mg. Common grade [greater than or equal to] 3 treatment-related adverse events were anemia, decreased white blood cell count, increased blood bilirubin levels, and decreased neutrophil count. In patients with PDGFRA D842V mutations, IRRC- and investigator-assessed ORRs were 75% and 79%, respectively; clinical benefit rates were both 86%. Median duration of response/progression-free survival were not reached. IRCC- and investigator-assessed ORRs in patients in the fourth- or later-line setting were 22% and 35%, respectively. Median progression-free survivals were 5.6 months for both. Overall survival data were immature and not calculated. Conclusion: Avapritinib was generally well tolerated and showed marked anti- tumor activity in Chinese patients with GIST bearing PDGFRA D842V mutations and notable efficacy as fourth- or later-line monotherapy (ClinicalTrials.gov Identifier: NCT04254939). Key words: tyrosine kinase inhibitor; avapritinib; gastrointestinal stromal tumors; PDGFRA D842V; fourth-line therapy.
  • Publisher: Oxford University Press
  • Language: English
  • Identifier: ISSN: 1083-7159
    EISSN: 1549-490X
    DOI: 10.1093/oncolo/oyac242
  • Source: PubMed Central
    Alma/SFX Local Collection
    DOAJ Directory of Open Access Journals
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