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    DRUG:

    Haiyitan (gumarontinib)

    i
    Other names: SCC244, SCC-244, SCC 244
    Company:
    HaiHe Biopharma, Otsuka
    Drug class:
    c-MET inhibitor
    Related drugs:
    9d
    Remarkable response to Osimertinib plus Gumarontinib for EGFR mutation and concomitant MET exon 14 skipping in a patient with lung adenocarcinoma: A case report. (PubMed, Oncol Lett)
    The present study marks the initial discovery of MET exon 14 skipping and EGFR Del19 in a single patient, who achieved partial response through a treatment plan involving Osimertinib and Gumarontinib. These findings provide valuable perspectives on treatment approaches for individuals sharing similar genetic profiles.
    Journal
    |
    EGFR (Epidermal growth factor receptor) • MET (MET proto-oncogene, receptor tyrosine kinase)
    |
    EGFR mutation • MET exon 14 mutation • MET mutation
    |
    Tagrisso (osimertinib) • Haiyitan (gumarontinib)
    29d
    A Concise Review of the Approved MET TKIs (Savolitinib, Gumarontinib, Vebreltinib, Tepotinib, Capmatinib) in China for MET Exon 14 Splice Site Mutated (METex14+) NSCLC Circa 2025. (PubMed, Lung Cancer (Auckl))
    Splice site mutations around or within exon 14 of MET (METex14+) are rare, but are one of the common actionable driver mutations in elderly patients with non-small cell lung cancer (NSCLC). On June 30, 2025, vebreltinib has been approved for NSCLC with MET amplification while combination of savoltinib and osimertinib has been approved for EGFR+ post EGFR TKINSCLC with MET amplification post EGFR TKI based on the SACHI trial (NCT05015608). We discuss the current unmet clinical need (need to develop Type II MET TKI to overcome acquired resistance MET mutations at D1228 and Y1230) and future optimal treatment approaches.
    Review • Journal
    |
    MET (MET proto-oncogene, receptor tyrosine kinase)
    |
    MET amplification • MET exon 14 mutation • MET mutation
    |
    Tagrisso (osimertinib) • Orpathys (savolitinib) • Tepmetko (tepotinib) • Tabrecta (capmatinib) • Haiyitan (gumarontinib) • bozitinib (APL-101)
    1m
    Long-term follow-up results from the GLORY study: phase II study of gumarontinib in East Asian patients with MET exon 14 skipping mutated non-small cell lung cancer. (PubMed, Transl Lung Cancer Res)
    Treatment-related adverse events leading to permanent discontinuation occurred in 8.3% (7/84) of patients. Gumarontinib showed promising efficacy and acceptable toxicities in East Asian population, with a rapid onset of action, substantial and durable response, which can be converted into a long-term survival benefit.
    P2 data • Journal
    |
    MET (MET proto-oncogene, receptor tyrosine kinase)
    |
    MET exon 14 mutation
    |
    Haiyitan (gumarontinib)
    3ms
    Safety and Efficacy of Glumetinib Combined With Docetaxel for Injection (Albumin-bound) in Patients With Advanced Gastric Cancer/Gastroesophageal Junction Adenocarcinoma and Other Solid Tumors (clinicaltrials.gov)
    P2, N=350, Recruiting, CSPC ZhongQi Pharmaceutical Technology Co., Ltd. | Not yet recruiting --> Recruiting
    Enrollment open
    |
    Haiyitan (gumarontinib) • albumin-bound docetaxel (CPO100)
    4ms
    Glumetinib for MET Overexpression and/or Amplification in Advanced Gastric Cancer: A Phase II Clinical Study‌ (ChiCTR2500104368)
    P2, N=112, Not yet recruiting, Zhejiang Cancer Hospital; Zhejiang Cancer Hospital
    New P2 trial
    |
    MET (MET proto-oncogene, receptor tyrosine kinase)
    |
    HER-2 positive • HER-2 expression • MET amplification • MET overexpression
    |
    albumin-bound paclitaxel • Haiyitan (gumarontinib) • albumin-bound docetaxel (CPO100)
    7ms
    Safety and Efficacy of Glumetinib Combined With Docetaxel for Injection (Albumin-bound) in Patients With Advanced Gastric Cancer/Gastroesophageal Junction Adenocarcinoma and Other Solid Tumors (clinicaltrials.gov)
    P2, N=350, Not yet recruiting, CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
    New P2 trial
    |
    Haiyitan (gumarontinib) • albumin-bound docetaxel (CPO100)
    8ms
    SYH2065-002: A Study to Evaluate the Efficacy and Safety of Glumetinib Combined With Osimertinib Mesylate Versus Platinum-based Doublet Chemotherapy in Non-Small Cell Lung Cancer Patients After Resistance to EGFR-TKIs (clinicaltrials.gov)
    P3, N=350, Recruiting, Shanghai JMT-Bio Inc. | Not yet recruiting --> Recruiting
    Enrollment open
    |
    cisplatin • Tagrisso (osimertinib) • carboplatin • pemetrexed • Haiyitan (gumarontinib)
    8ms
    Glumetinib Combined With Osimertinib Treatment for Non-Small Cell Lung Cancer Patients (clinicaltrials.gov)
    P2/3, N=390, Not yet recruiting, Shanghai JMT-Bio Inc.
    New P2/3 trial
    |
    Tagrisso (osimertinib) • Haiyitan (gumarontinib)
    9ms
    Case report: Aumolertinib plus gumarontinib in a patient with EGFR mutated non-small-cell lung cancer harboring acquired MET amplification following progression on afatinib plus crizotinib. (PubMed, Front Pharmacol)
    This case underscores the importance of re-challenge using third-generation EGFR-TKI with novel MET-TKI after the failure of second-generation EGFR-TKI plus crizotinib in EGFR-TKI resistant NSCLC patients with MET amplification, especially in patients with brain metastases. The successful application of aumolertinib plus gumarontinib highlights its potential in overcoming MET amplification-induced EGFR-TKI resistance, which warrants further investigation in future large-scale clinical trials.
    Journal
    |
    EGFR (Epidermal growth factor receptor) • MET (MET proto-oncogene, receptor tyrosine kinase)
    |
    EGFR mutation • EGFR L858R • MET amplification
    |
    Xalkori (crizotinib) • Gilotrif (afatinib) • Ameile (aumolertinib) • Haiyitan (gumarontinib)
    10ms
    A Study to Evaluate the Efficacy and Safety of Glumetinib Combined With Osimertinib Mesylate Versus Platinum-based Doublet Chemotherapy in Non-Small Cell Lung Cancer Patients After Resistance to EGFR-TKIs (clinicaltrials.gov)
    P3, N=350, Not yet recruiting, Shanghai JMT-Bio Inc.
    New P3 trial
    |
    cisplatin • Tagrisso (osimertinib) • carboplatin • pemetrexed • Haiyitan (gumarontinib)
    10ms
    Cost-effectiveness analysis of gumarontinib versus savolitinib for the treatment of advanced or metastatic NSCLC with MET exon 14 skipping mutations in China using partitioned survival model. (PubMed, Front Pharmacol)
    Sensitivity and scenario analyses confirmed the robustness of the base-case results. Gumarontinib is a cost-effective option compared to savolitinib for METex14 skipping NSCLC in China.
    Journal • HEOR • Cost-effectiveness
    |
    MET (MET proto-oncogene, receptor tyrosine kinase)
    |
    MET exon 14 mutation
    |
    Orpathys (savolitinib) • Haiyitan (gumarontinib)
    11ms
    To evaluate the efficacy and safety of glumetinib in elderly patients with advanced non-small cell lung cancer with MET amplification or protein overexpression (ChiCTR2400092808)
    P4, N=20, Beijing Hospital; Beijing Hospital
    New P4 trial
    |
    MET (MET proto-oncogene, receptor tyrosine kinase)
    |
    MET amplification • MET overexpression • MET expression
    |
    Haiyitan (gumarontinib)