Zai Lab Qingle second-line treatment of gastrointestinal stromal tumor phase 3 clinical failure

Recently, Zai Lab's partner Deciphera announced the targeted anticancer drug Qinlock (Chinese product name: Qingle®, generic name: ripretinib, Ripetinib) for the second-line treatment of gastrointestinal stromal tumor (GIST) INTRIGUE Phase 3 clinical trial Top-line results of the study
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INTRIGUE is a randomized, global, multi-center, open-label phase 3 study, carried out in GIST patients who have previously been treated with imatinib, and evaluated the efficacy and efficacy of Qinlock and sunitinib.
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In the study, 453 patients were randomly divided into 2 groups at a ratio of 1:1.
One group received Qinlock (150 mg orally once a day), and the other group received sunitinib (50 mg orally once a day for 4 consecutive treatments).
Week, then stop the drug for 2 weeks)
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The main endpoints of the study are: the use of modified solid tumor efficacy evaluation criteria (RECIST), progression-free survival (PFS) determined by independent radiological review, and pre-designation of KIT exon 11 mutations (exon 11) A subgroup of patients and all patients with intention to treat (AP) were evaluated
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Secondary endpoints include: objective response rate (ORR) and overall survival (OS) determined by independent radiological review using modified RECIST, assessed in the exon 11 subgroup and AP group, respectively
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The research is being carried out in 122 research centers in 22 countries around the world
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The results showed that the study did not reach the primary efficacy endpoint of PFS
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In the subgroup of patients with primary mutations in KIT exon 11 (n=327), the median PFS in the Qinlock group was 8.
3 months, while that in the sunitinib group was 7.
0 months (HR=0.
88; p= 0.
360)
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Although no formal test was performed due to the rules of the stratified test order, in the AP population, the median PFS in the Qinlock group was 8.
0 months, while that in the sunitinib group was 8.
3 months (HR=1.
05; nominal p=0.
715) )
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The complete results of the study will be announced at an upcoming medical conference
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As of now, Qinlock is still the standard of care drug and the only approved treatment for fourth-line GIST
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Qinlock's active pharmaceutical ingredient is ripretinib, which is a KIT/PDGFRα kinase switch regulator inhibitor, used to treat KIT/PDGFRα-driven GIST, systemic mastocytosis (SM) and other cancers
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In June 2019, Zai Lab obtained the exclusive license for the development and promotion of ripretinib in Greater China (Mainland China, Hong Kong, Macau and Taiwan) from Deciphera
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ripretinib is specifically designed to improve the treatment of GIST patients by inhibiting a broad spectrum of KIT and PDGFRα mutations
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Ripretinib can block the initial and secondary KIT mutations in exons 9, 11, 13, 14, 17, and 18 involved in GIST and the primary exon 17 D816V mutation found in SM
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Ripretinib also inhibits primary PDGFRα mutations in exons 12, 14, and 18, including GIST involving the D842V mutation in exon 18
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In May 2020, ripretinib was approved by the US FDA (brand name Qinlock) for the fourth-line treatment of advanced GIST
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Qinlock is suitable for adult patients who have previously been treated with 3 or more kinase inhibitors, including: imatinib, sunitinib, and regorafenib
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In China, the National Medical Products Administration (NMPA) approved Qingle® (ripretinib) in March this year for the treatment of those who have received 3 or more kinase inhibitors including imatinib Of adult patients with advanced GIST
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Reference source: Deciphera Pharmaceuticals Announces Top-Line Results from the INTRIGUE Phase 3 Clinical Study