Repretinib for treatment of gastrointestinal stromal tumors
A technology for gastrointestinal stromal tumors and ripretinib, which is applied in antineoplastic drugs, medical preparations containing active ingredients, and pharmaceutical formulas, etc.
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Embodiment 1
[0113] Study Design. Approximately 358 eligible patients were randomized 1:1 into two groups, one of which underwent continuous 42-day cycles of ripretinib (179 patients) at a dose of 150 mg daily; Sunitinib doses were received at a dose of 50 mg daily for 4 weeks in a 42-day cycle followed by a 2-week rest period (179 patients).
[0114]Given the mutation-driven natural history of GIST and the well-described relationship between secondary mutations and the emergence of resistance to first- and second-line TKIs, the results of this study will evaluate ripratinib compared with sunitinib as Second-line treatment of patients with GIST after imatinib therapy.
[0115] The primary endpoint of the study was progression-free survival (PFS) of ripretinib as assessed by blinded independent central review (BICR) using the modified Response Evaluation Criteria in Solid Tumors version 1.1 (mRECIST v1.1). Key secondary efficacy endpoints included ORR assessed by BICR using mRECIST v1.1 an...
Embodiment 2
[0118] This study was a randomized (2:1), double-blind, placebo-controlled, international multicentre study to evaluate the efficacy of ripretinib compared with placebo in patients who had previously received at least imatinib, sunitinib, and rifatinib. Safety, tolerability and efficacy of gorfenib in 129 patients with advanced GIST. Patients were randomized 2:1 to receive ripretinib 150 mg once daily or placebo. The primary efficacy endpoint was progression-free survival (PFS) as determined by independent radiological review using the Modified Response Evaluation Criteria in Solid Tumors (RECIST). Secondary endpoints determined by independent radiologic review using modified RECIST included objective response rate (ORR), time to tumor progression (TTP), and overall survival (OS).
[0119] Results. This study achieved the primary endpoint of improved PFS as determined by blinded independent central radiology review using the Revised Response Evaluation Criteria in Solid Tumor...
Embodiment 3
[0150] Results. Table 2 presents data for 178 GIST patients who received ripretinib at >100 mg daily. The table includes investigator-assessed objective response rate (ORR), disease control rate (DCR) and median progression-free survival (mPFS) based on best response, all of which were determined by the Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 Sure.
[0151] Table 2. Results / clinical studies of ripretinib
[0152]
[0153] In Table 2, (1) represents the overall patient population (n=178), which is the same as the previous data presented at ESMO 2018; based on additional data cleaning, one patient each in the second-line and fourth-line / ≥four-line Reclassified as third-line patients; (2) refers to the median treatment duration: second-line = 44 weeks, third-line = 48 weeks, fourth-line = 46 weeks, greater than or equal to fourth-line = 29 weeks; (3) refers to patients who choose to 60 patients with dose escalation from 150 mg QD to 150 mg BID; (4) ...
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