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- | Japanese regulatory, Journal: PMDA regulatory update on approval and revision of the precautions for use of anticancer drugs: approval selpercatinib for solid tumor with RET fusion, gumarontinib for non-small cell lung cancer with MET gene exon 14 skipping mutation, momelotinib for myelofibrosis, bexarotene for adult T-cell leukemia/lymphoma, valemetostat for peripheral T-cell lymphoma, and pirtobrutinib for mantle cell lymphoma in Japan. (Pubmed Central) - Aug 26, 2024
No abstract available
- || gumarontinib (SCC244) / HaiHe Biopharma
Clinical data, Retrospective data, Journal: A pooled analysis of clinical outcome in driver-gene negative non-small cell lung cancer patients with MET overexpression treated with gumarontinib. (Pubmed Central) - Aug 2, 2024
P1, P1/2
Gumarontinib showed promising antitumour activity in driver-gene negative locally advanced or metastatic NSCLC patients with MET overexpression, which warranted a further clinical trial. ClinicalTrials.gov identifier: NCT03457532; NCT04270591.
- Tabrecta (capmatinib) / Novartis
MAIC of OS and TRAE Comparing Capmatinib with Other MET Inhibitors for Treatment of Ansclc with MET Exon 14 Skipping Mutations (Exhibit Hall) - Jul 24, 2024 - Abstract #IASLCWCLC2024IASLC_WCLC_2190;
P1/2, P2
In the Asian population, CAP showed the lowest rate of any grade TRAEs against all comparators (Risk difference CAP vs SAV: -11.4%, GLU: -12.6%, TEP: -11.1%). Conclusions : Considering all comparators, CAP showed numerical OS advantage trend in the first line setting and a lower incidence of TRAEs in both the overall population and the Asian population.
- || Review, Journal: Pyrazolopyridine-based kinase inhibitors for anti-cancer targeted therapy. (Pubmed Central) - May 24, 2024
Notably, selpercatinib, glumetinib, camonsertib and olverembatinib have either received approval or are in late-phase clinical studies. This review presents the success stories employing pyrazolopyridine scaffolds as hinge-binding cores to address various challenges in kinase-targeted drug discovery research.
- Tabrecta (capmatinib) / Incyte, Novartis, Tepmetko (tepotinib) / EMD Serono, Orpathys (savolitinib) / AstraZeneca, Hutchmed
MET TKIs in Asian patients (pts) with MET exon 14 skipping NSCLC: A matching-adjusted indirect comparison (MAIC) (Exhibition area) - Oct 6, 2023 - Abstract #ESMOAsia2023ESMO_Asia_1086;
P2
Improvements with tepotinib vs comparators were also seen in VISION pts overall and pts in Asia, regardless of T+ status. Conclusions Based on available evidence (with limited capmatinib subgroup size), the MAICs show no clinically relevant differences in ORR and trends for longer PFS and/or OS with tepotinib vs savolitinib, gumarontinib, or capmatinib in pts in Asia in 1L and 2L+.
- || gumarontinib (SCC244) / HaiHe Biopharma
P1/2 data, Journal: Gumarontinib in patients with non-small-cell lung cancer harbouring MET exon 14 skipping mutations: a multicentre, single-arm, open-label, phase 1b/2 trial. (Pubmed Central) - May 7, 2023
P1/2
Haihe Biopharma Co., Ltd. Supported in part by grants from the National Science and Technology Major Project of China for "Clinical Research of Gumarontinib, a highly selective MET inhibitor" (2018ZX09711002-011-003); the National Natural Science Foundation of China (82030045 to S.L. and 82172633 to YF.Y); Shanghai Municipal Science & Technology Commission Research Project (19411950500 to S.L.); Shanghai Shenkang Action Plan (16CR3005A to S.L.) and Shanghai Chest Hospital Project of Collaborative Innovation (YJXT20190105 to S.L.).
- | glumetinib (SCC244) / HaiHe Biopharma
Preclinical, Journal: Possible role of combined therapy targeting MET and pro-HGF activation for renal cell carcinoma: analysis by human HGF-producing SCID mice. (Pubmed Central) - Feb 27, 2023
The cells were cultured with pro-HGF, and inhibitory effect of MET inhibitor (SCC244) and HAI-2 was evaluated by phosphorylation of MET and cell proliferation...Although in vivo analysis also showed apparent downregulation of MET phosphorylation and growth inhibition in combined treatment, statistical significance was not observed compared with single use of MET inhibitor. Combined treatment with MET-TKI and HAI-2 suggested to consider as a candidate for new strong therapy for RCC.
- glumetinib (SCC244) / HaiHe Biopharma
A pool analysis of MET TKI SCC244 in NSCLC patients with MET overexpression (Exhibition / Poster Area) - Oct 9, 2022 - Abstract #ESMOAsia2022ESMO_Asia_813;
P1, P1/2
Conclusions SCC244 demonstrated promising anti-tumor activity with durable response across treatment lines in NSCLC patients with MET overexpression. Further larger scale prospective studies are warranted to confirm these findings.
- Tagrisso (osimertinib) / AstraZeneca, glumetinib (SCC244) / HaiHe Biopharma
SCC244 plus osimertinib in patients with stage IIIB/IIIC or IV, EGFR TKI resistant EGFR-mutant NSCLC harboring MET amplification (Hall 406) - Oct 1, 2022 - Abstract #ESMOAsia2022ESMO_Asia_290;
Conclusions SCC244 plus Osimertinib demonstrated clinical activity in EGFR-mutant NSCLC pts with METamp and resistant to EGFR TKI. The safety profile was acceptable and manageable.
- || gumarontinib (SCC244) / HaiHe Biopharma
New P1 trial: Single Dose Glumetinib in Healthy Chinese Male Subjects (clinicaltrials.gov) - Aug 18, 2022
P1, N=18, Completed, Sponsor: Haihe Biopharma Co., Ltd.
- ||| gumarontinib (SCC244) / HaiHe Biopharma
Enrollment open, Metastases: GLORY: Assessment of Anti-tumor and Safety in Glumetinib in Patients With c-MET-positive Non-Small Cell Lung Cancer (clinicaltrials.gov) - Aug 1, 2022
P1/2, N=183, Recruiting, Sponsor: Haihe Biopharma Co., Ltd.
The safety profile was acceptable and manageable. Active, not recruiting --> Recruiting
- || gumarontinib (SCC244) / HaiHe Biopharma
Enrollment closed, Trial completion date, Trial primary completion date, Metastases: GLORY: Assessment of Anti-tumor and Safety in Glumetinib in Patients With c-MET-positive Non-Small Cell Lung Cancer (clinicaltrials.gov) - Apr 14, 2022
P1/2, N=183, Active, not recruiting, Sponsor: Haihe Biopharma Co., Ltd.
Active, not recruiting --> Recruiting Trial primary completion date: Sep 2021 --> Oct 2023 | Recruiting --> Active, not recruiting | Trial completion date: Dec 2021 --> Dec 2023
- |||| glumetinib (SCC244) / HaiHe Biopharma
Clinical: SCC244 Elicits Responses in METex14 Skipping–Mutated NSCLC https://t.co/D8VfYXnd5H via @onclive Impressive OR=66.7%. Safety? (Twitter) - Apr 12, 2022
- glumetinib (SCC244) / HaiHe Biopharma
Phase II study of SCC244 in NSCLC patients harboring MET exon 14 skipping (METex14) mutations (GLORY study) (Great Hall BC, Convention Center) - Mar 9, 2022 - Abstract #AACR2022AACR_1727;
The safety profile was favorable with manageable toxicity. The data supports SCC244 as a valuable targeted treatment option for METex14 NSCLC patients.
- ||| gumarontinib (SCC244) / HaiHe Biopharma
Enrollment change, Metastases: GLORY: Assessment of Anti-tumor and Safety in Glumetinib in Patients With c-MET-positive Non-Small Cell Lung Cancer (clinicaltrials.gov) - Sep 23, 2021
P1/2, N=210, Recruiting, Sponsor: Haihe Biopharma Co., Ltd.
The data supports SCC244 as a valuable targeted treatment option for METex14 NSCLC patients. N=68 --> 210
- | Loqtorzi (toripalimab-tpzi) / Shanghai Junshi Biosci, Coherus Biosci
New P1/2 trial, Metastases: CT32: Glumetinib Combined With Toripalimab in the Treatment of Relapsed or Metastatic Non-small Cell Lung Cancer. (clinicaltrials.gov) - Mar 15, 2021
P1/2, N=67, Recruiting, Sponsor: Shanghai Junshi Bioscience Co., Ltd.
- || gumarontinib (SCC244) / HaiHe Biopharma
Trial completion date, Trial primary completion date, Metastases: GLORY: Assessment of Anti-tumor and Safety in Glumetinib in Patients With c-MET-positive Non-Small Cell Lung Cancer (clinicaltrials.gov) - Feb 9, 2021
P1/2, N=68, Recruiting, Sponsor: ShangHai HaiHe Pharmaceutical
N=68 --> 210 Trial completion date: Jun 2021 --> Dec 2021 | Trial primary completion date: Feb 2021 --> Sep 2021
- glumetinib (SCC244) / HaiHe Pharma
[VIRTUAL] First-in-human (FIH) study of SCC244, a novel potent and highly selective c- MET inhibitor, in patients (pts) with Advanced non-small cell lung cancer (NSCLC) (Channel 1) - Feb 8, 2021 - Abstract #TAT2021TAT_95;
P1
The long T1/2 supports once daily dosing. Studies with SCC44 in patients with METex14 skipping mutation in NSCLC are ongoing to further explore the safety and efficacy in larger populations.
- glumetinib (SCC244) / HaiHe Pharma
[VIRTUAL] A phase I clinical trial to assess the safety, pharmacokinetics, and antitumor activity of glumetinib (SCC244) in patients with advanced non-small cell lung cancers (NSCLCs). () - Apr 29, 2020 - Abstract #ASCO2020ASCO_5645;
Glumetinib is used in ongoing clinical trials to further explore safety and efficacy in NSCLC. Research Funding: Shanghai Haihe Pharmaceutical Co., Ltd.
- |||| Tagrisso (osimertinib) / AstraZeneca, glumetinib (SCC244) / HaiHe Biopharma
New P1/2 trial, Metastases: Glumetinib Combined With Osimertinib in the Treatment of Relapsed and Metastatic Non-small Cell Lung Cancer Patients Who Failed to Receive EGFR Inhibitors (clinicaltrials.gov) - Apr 8, 2020
P1/2, N=70, Recruiting, Sponsor: ShangHai HaiHe Pharmaceutical
- | gumarontinib (SCC244) / HaiHe Biopharma
Phase classification, Metastases: A Phase I Study of SCC244 (clinicaltrials.gov) - Apr 5, 2018
P1, N=75, Recruiting, Sponsor: ShangHai HaiHe Pharmaceutical
Research Funding: Shanghai Haihe Pharmaceutical Co., Ltd. Phase classification: P1a/1b --> P1
- ||| gumarontinib (SCC244) / HaiHe Biopharma
New P1 trial, Metastases: A Phase I Study of SCC244 (clinicaltrials.gov) - Mar 9, 2018
P1, N=75, Recruiting, Sponsor: ShangHai HaiHe Pharmaceutical
- ||| gumarontinib (SCC244) / HaiHe Biopharma
New P1 trial, Metastases: A Phase I Study of SCC244 (clinicaltrials.gov) - Mar 7, 2018
P1a/1b, N=75, Recruiting, Sponsor: ShangHai HaiHe Pharmaceutical