Abstract | PURPOSE: This is a phase II multicenter, single-arm, open-label study assessing the efficacy, safety, and pharmacokinetics (PK) of ripretinib in Chinese patients with advanced gastrointestinal stromal tumor (GIST) as a fourth- or later-line therapy. It was designed to show consistency with the phase III INVICTUS study. PATIENTS AND METHODS: Patients with disease progression on (or intolerance to) prior imatinib, sunitinib, and at least one other drug were recruited to receive ripretinib 150 mg once daily continuously in 28-day cycles. The primary endpoint was progression-free survival (PFS) based on independent radiologic review ( IRR). Secondary efficacy endpoints included objective response rate (ORR) based on IRR and overall survival. Safety endpoints included the incidence and severity of adverse events (AE). RESULTS: Between April 2020 and August 2020, 39 patients were enrolled. All were included in the safety analysis while 38 were included in the efficacy analysis. By primary data cut-off (February 26, 2021), the median PFS [90% confidence interval (CI)] was 7.2 (2.9-7.3) months; the lower bound of the 90% CI exceeded 1 month, fulfilling the standard of bridging success. The ORR (95% CI) based on IRR was 18.4% (7.7%-34.3%). Treatment-related treatment-emergent AEs (TRAE) were reported in 37 (94.9%) patients. The majority of TRAEs were of grade 1/2. A total of 6 patients (15.4%) experienced grade 3/4 TRAEs. CONCLUSIONS: The results demonstrated that ripretinib can clinically improve the outcomes of Chinese patients with advanced GIST as a fourth- or later-line therapy. The efficacy, safety, and PK profiles of ripretinib are consistent with those in the global patient population.
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Authors | Jian Li, Shirong Cai, Yongjian Zhou, Jun Zhang, Ye Zhou, Hui Cao, Xin Wu, Yanhong Deng, Zhao Huang, Juan Dong, Lin Shen |
Journal | Clinical cancer research : an official journal of the American Association for Cancer Research
(Clin Cancer Res)
Vol. 28
Issue 16
Pg. 3425-3432
(08 15 2022)
ISSN: 1557-3265 [Electronic] United States |
PMID | 35686969
(Publication Type: Clinical Trial, Phase II, Journal Article, Multicenter Study, Research Support, Non-U.S. Gov't)
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Copyright | ©2022 The Authors; Published by the American Association for Cancer Research. |
Chemical References |
- Naphthyridines
- Imatinib Mesylate
- Urea
- ripretinib
- Sunitinib
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Topics |
- China
- Gastrointestinal Stromal Tumors
(pathology)
- Humans
- Imatinib Mesylate
- Naphthyridines
- Sunitinib
- Urea
(analogs & derivatives)
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