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

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

Gumarontinib for NSCLC harboring MET exon 14 skipping (METex14) mutations: GLORY Japan subset (JLCS 2024) - No abstract available

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

A Phase I Study of SCC244 in Patients With Advanced MET Alterations Solid Tumors (clinicaltrials.gov) - P1 | N=177 | Completed | Sponsor: Haihe Biopharma Co., Ltd. | Unknown status ➔ Completed | N=75 ➔ 177

Enrollment change • Metastases • Trial completion • Breast Cancer • Oncology • Solid Tumor

Study to Evaluate the Safety and Anti-tumor Activity of SCC244 (clinicaltrials.gov) - P1 | N=56 | Completed | Sponsor: Haihe Biopharma Co., Ltd. | Unknown status ➔ Completed | N=113 ➔ 56

Enrollment change • Metastases • Trial completion • Hepatocellular Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • ALK • KRAS • MET • ROS1

Taiho Pharmaceutical and Haihe Biopharma Announce the Launch of MET Inhibitor HAIYITAN Tablets 50mg in Japan (Taiho Press Release) - "Taiho Pharmaceutical...and Haihe Biopharma...announced today that the MET inhibitor, HAIYITAN tablets 50mg (generic name: gumarontinib hydrate), is schedule for launch on October 11, 2024, in Japan. In June 2024, Haihe Biopharma K. K., a fully owned affiliate of Haihe, obtained approval to manufacture and market HAIYITAN in Japan for the treatment of unresectable, advanced or recurrent non-small cell lung cancer with MET exon 14 skipping mutations."

Launch Japan • Non Small Cell Lung Cancer

MAIC of OS and TRAE Comparing Capmatinib with Other MET Inhibitors for Treatment of Ansclc with MET Exon 14 Skipping Mutations (IASLC-WCLC 2024) - P1/2, P2 | "At the time of this analysis (Aug 2023), 4 MET inhibitors (Capmatinib (CAP), savolitinib (SAV), glumetinib (GLU), and tepotinib (TEP)) had clinical data published based on respective single arm trials. 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."

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

AmoyDx Pan Lung Cancer PCR Panel Approved in Japan as a Companion Diagnostic for Haiyitan tablets (gumarontinib) (AmoyDx Press Release) - "Riken Genesis Co., Ltd., Amoy Diagnostics Co., Ltd., ('AmoyDx') and Precision Medicine Asia Co., Ltd. ('PREMIA') today announced that the Japanese Ministry of Health, Labour and Welfare (MHLW) has approved the AmoyDx Pan Lung Cancer PCR Panel (the 'AmoyDx PLC Panel') as a companion diagnostic for Haiyitan (gumarontinib), a product of Haihe Biopharma K.K. Haiyitan in 50 mg tablet form, was approved by MHLW in June 2024 for patients with unresectable advanced or recurrent non-small cell lung cancer (NSCLC) with MET exon 14 (METex14) skipping mutations."

Approval • Diagnostic • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

A pooled analysis of clinical outcome in driver-gene negative non-small cell lung cancer patients with MET overexpression treated with gumarontinib. (PubMed, Ther Adv Med Oncol) - 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."

Clinical data • Journal • Retrospective data • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • EGFR

A Study to Evaluate the Efficacy and Safety of the Combination of Glumetinib and Docetaxel（Albumin Bound）Verse Docetaxel for the Treatment of MET-overexpressed Non-small Cell Lung Cancer (clinicaltrials.gov) - P2 | N=256 | Not yet recruiting | Sponsor: CSPC ZhongQi Pharmaceutical Technology Co., Ltd.

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

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... (PubMed, Int J Clin Oncol) - No abstract available

Japanese regulatory • Journal • Adult T-Cell Leukemia-Lymphoma • Hematological Malignancies • Leukemia • Lung Cancer • Lymphoma • Mantle Cell Lymphoma • Myelofibrosis • Non Small Cell Lung Cancer • Non-Hodgkin’s Lymphoma • Oncology • Peripheral T-cell Lymphoma • Solid Tumor • T Cell Non-Hodgkin Lymphoma • MET • RET

Gumarontinib Combined With 3rd EGFR-TKI in Patients With Non-small Cell Lung Cancer. (clinicaltrials.gov) - P2 | N=91 | Not yet recruiting | Sponsor: Cancer Institute and Hospital, Chinese Academy of Medical Sciences

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

Pyrazolopyridine-based kinase inhibitors for anti-cancer targeted therapy. (PubMed, RSC Med Chem) - "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."

Journal • Review • Oncology

Clinical characteristics and prognosis analysis of pulmonary sarcomatoid carcinoma (PubMed, Zhonghua Jie He He Hu Xi Za Zhi) - "Seventeen patients received immunotherapy, and 1 patient received targeted therapy with the MET inhibitor glumetinib. PSC has a higher incidence in the elderly, smokers, and males, is highly malignant and has a poor prognosis. Based on its molecular biological characteristics, PD-L1 expression and tumor molecular detection can be performed to guide treatment options."

IO biomarker • Journal • Oncology • Sarcoma • Solid Tumor • KRAS • PD-L1 • TP53

Taiho Pharma Enters Exclusive License Agreement with Haihe Biopharma for Gumarontinib (SCC244), an Agent for Non-Small Cell Lung Cancer (Taiho Press Release) - "Taiho Pharmaceutical...and Haihe Biopharma...announced today that two companies have entered into an exclusive license agreement regarding the development, manufacturing and commercialization of gumarontinib (development code : SCC244), agent for non-small cell lung cancer, which application for marketing authorization has been submitted and is currently being reviewed in Japan by Haihe Biopharma K. K., fully owned affiliate of Haihe. Under the license agreement, Taiho will obtain exclusive rights in Japan, Asia (excluding China) and Oceania to develop, manufacture and commercialize, gumarontinib, Haihe will receive an upfront payment, development and sales milestones, and royalty based on sales revenue from Taiho."

Licensing / partnership • Non Small Cell Lung Cancer