Haiyitan (gumarontinib) / HaiHe Biopharma, Otsuka - LARVOL DELTA

New Onset Heart Failure Induced By Glumetinib: A Case Report. (PubMed, Clin Ther) - No abstract available

Journal • Cardiovascular • Congestive Heart Failure • Heart Failure

COST-EFFECTIVENESS ANALYSIS OF SAVOLITINIB VERSUS GLUMETINIB IN THE FIRST-LINE TREATMENT OF CHINESE ADULT PATIENTS WITH LOCALLY ADVANCED OR METASTATIC NON-SMALL CELL LUNG CANCER HARBORING MET EXON 14 SKIPPING MUTATION (ISPOR 2026) - P1/2, P3 | "Savolitinib is a dominant and cost-effective option compared to glumetinib for first-line treatment of MET exon 14-mutated advanced NSCLC in China, demonstrating both improved health outcomes and cost savings, which was verified in sensitivity analyses."

Clinical • Cost effectiveness • HEOR • Metastases • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • MET

Glumetinib combined with platinum-based chemotherapy for the treatment of MET-overexpressing locally advanced or metastatic non-small cell lung cancer: A single-arm, multicenter study (ChiCTR) - P1 | N=48 | Not yet recruiting | Sponsor: West China Hospital of Sichuan University; West China Hospital of Sichuan University

New P1 trial • Lung Cancer • Lung Non-Squamous Non-Small Cell Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • ALK • BRAF • EGFR • HER-2 • MET • NTRK • RET • ROS1

SCC244 plus osimertinib in patients with stage IIIB/IIIC or IV, EGFR TKI resistant EGFR-mutant NSCLC harboring MET amplification (ESMO Asia 2022) - "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."

Clinical • Hematological Disorders • Lung Cancer • Neutropenia • Non Small Cell Lung Cancer • Oncology • Solid Tumor • Thrombocytopenia • EGFR • MET

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, EClinicalMedicine) - 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.)."

Journal • P1/2 data • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Renal Disease • Solid Tumor • MET

Challenges and Limitations of Sequential MET-TKI Therapy in METex14- Positive NSCLC With a Focus on Non-ILD Toxicities: A Case Report. (PubMed, Cancer Rep (Hoboken)) - "Although all three MET-TKIs share similar mechanisms of action, they exhibit differing toxicity profiles. In this case, treatment discontinuation was not due to ILD recurrence but rather to distinct non-ILD adverse events. Furthermore, the toxicities experienced by the patient varied between agents, suggesting that rechallenge may remain a viable strategy depending on individual tolerance. Careful toxicity monitoring and personalized risk assessment are essential when considering sequential MET-TKI therapy."

IO biomarker • Journal • Interstitial Lung Disease • Lung Cancer • Mucositis • Non Small Cell Lung Cancer • Oncology • Pulmonary Disease • Respiratory Diseases • Solid Tumor

Glumetinib plus albumin-bound docetaxel (HB1801) in patients with MET overexpression, actionable genetic alteration- (AGA-) negative non-small cell lung cancer (Gleam Study) (ESMO Asia 2025) - P2 | "Glumetinib plus HB1801 exhibits a tolerable safety profile and a promising efficacy in MET overexpressed, AGA-negative, locally advanced or metastatic NSCLC."

Clinical • IO biomarker • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

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 • Lung Adenocarcinoma • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Pain • Solid Tumor • EGFR • MET

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)) - P3 | "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."

Journal • Review • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • MET

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) - P1/2 | "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."

Journal • P2 data • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • MET

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 | Sponsor: CSPC ZhongQi Pharmaceutical Technology Co., Ltd. | Not yet recruiting ➔ Recruiting

Enrollment open • Esophageal Cancer • Gastric Cancer • Gastroesophageal Cancer • Gastroesophageal Junction Adenocarcinoma • Oncology • Solid Tumor

Glumetinib for MET Overexpression and/or Amplification in Advanced Gastric Cancer: A Phase II Clinical Study‌ (ChiCTR) - P2 | N=112 | Not yet recruiting | Sponsor: Zhejiang Cancer Hospital; Zhejiang Cancer Hospital

New P2 trial • Esophageal Cancer • Gastric Cancer • Gastroesophageal Cancer • Gastroesophageal Junction Adenocarcinoma • Neutropenia • Oncology • Solid Tumor • MET

Glumetinib Combined With Fruquintinib in the Treatment of MET Amplification or Protein Overexpression in Third-Line Unresectable Metastatic Colorectal Cancer (clinicaltrials.gov) - P1/2 | N=42 | Recruiting | Sponsor: Liu Huang

New P1/2 trial • Colorectal Cancer • Oncology • Solid Tumor

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 | Sponsor: CSPC ZhongQi Pharmaceutical Technology Co., Ltd.

New P2 trial • Esophageal Cancer • Gastric Cancer • Gastroesophageal Cancer • Gastroesophageal Junction Adenocarcinoma • Oncology • Solid Tumor

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 | Sponsor: Shanghai JMT-Bio Inc. | Not yet recruiting ➔ Recruiting

Enrollment open • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

Glumetinib Combined With Osimertinib Treatment for Non-Small Cell Lung Cancer Patients (clinicaltrials.gov) - P2/3 | N=390 | Not yet recruiting | Sponsor: Shanghai JMT-Bio Inc.

New P2/3 trial • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

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 • Cardiovascular • Lung Adenocarcinoma • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Respiratory Diseases • Solid Tumor • EGFR • MET

Gumarontinib for NSCLC harboring MET exon 14 skipping (METex14) mutations: Updated Japanese subgroup of the GLORY study (JSMO 2025) - No abstract available

Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • MET

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 | Sponsor: Shanghai JMT-Bio Inc.

New P3 trial • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

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) - P2 | "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."

HEOR • Journal • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • MET

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 (Front Pharmacol) - "Gumarontinib gained an additional 0.10 QALYs at an incremental cost of $1,893 compared to savolitinib, resulting in the ICERs of $19,243/QALY, which is below the threshold of 3 times the GDP per capita in China ($35,007 per capita in 2022). Sensitivity and scenario analyses confirmed the robustness of the base-case results."

HEOR • Non Small Cell Lung Cancer

To evaluate the efficacy and safety of glumetinib in elderly patients with advanced non-small cell lung cancer with MET amplification or protein overexpression (ChiCTR) - P4 | N=20 | Sponsor: Beijing Hospital; Beijing Hospital

New P4 trial • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • MET

A Phase II, Single-Arm Study Evaluating the Efficacy and Safety of Sunvozertinib in Combination with Glumetinib in Locally Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC) with MET Amplification or Overexpression Following EGFR-TKI Treatment Failure (WUKONG-37) (ChiCTR) - P4 | N=40 | Sponsor: Jiangsu Cancer Hospital; Jiangsu Cancer Hospital

New P4 trial • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • MET

A Case Report of EGFR-TKIs Resistant Secondary MET Gene Amplified Lung Squamous Cell Carcinoma and Literature Review (PubMed, Zhongguo Fei Ai Za Zhi) - "At present, some selective tyrosine kinase inhibitors (TKIs) of MET has been approved for non-small cell lung cancer with MET gene 14 exon skipping mutation, such as Glumetinib, Savolitinib, Tepotinib, Capmatinib, etc. Drugs that target secondary MET amplification are still in clinical trials. This paper retrospectively analyzed the clinical data of a female patient with EGFR-TKIs resistant secondary MET amplified squamous cell lung cancer, and reviewed relevant literature to explore how to optimize the treatment of lung squamous cell carcinoma patients with EGFR mutation, so as to provide clinical reference for the diagnosis and treatment of such patients.."

Journal • Review • Lung Adenocarcinoma • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • Squamous Cell Carcinoma • MET

Efficacy and safety outcomes of Phase II study of SCC244 in NSCLC patients harboring MET exon 14 skipping (METex14) mutations (GLORY study): Long-term follow-up analysis (ESMO Asia 2024) - P1/2 | "Conclusions Gumarontinib provided significant clinical benefits for pts with exon 14 skipping locally advanced or metastatic NSCLC, which can translate into long-term survival benefits. The latest data shows that the median OS of treatment-naïve population reached 25.4 months, and Gumarontinib had acceptable and manageable safety profiles."

Clinical • P2 data • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • MET