Haiyitan (gumarontinib)

P1, N=177, Completed, Haihe Biopharma Co., Ltd. | Unknown status --> Completed | N=75 --> 177

P1, N=56, Completed, Haihe Biopharma Co., Ltd. | Unknown status --> Completed | N=113 --> 56

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.

P2, N=256, Not yet recruiting, CSPC ZhongQi Pharmaceutical Technology Co., Ltd.

P4, N=200, Recruiting, Beijing Cancer Hospital; Beijing Cancer Hospital

P4, N=40, Recruiting, Beijing Tiantan Hospital, Capital Medical University; Beijing Tiantan Hospital, Capital Medical University

No abstract available

P2, N=91, Not yet recruiting, Cancer Institute and Hospital, Chinese Academy of Medical Sciences

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.

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+.

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.).

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.

The data shows high and robust efficacy of SCC244 in NSCLC patients with METex14 mutations across treatment lines and encouraging intracranial anti-tumor activity. The safety profile was favorable with manageable toxicity. The data supports SCC244 as a valuable targeted treatment option for METex14 NSCLC patients.

P1/2, N=67, Recruiting, Shanghai Junshi Bioscience Co., Ltd.

Glumetinib was well tolerated at doses up to 400 mg once daily and demonstrated clinical activity in advanced NSCLC with MET alterations. Glumetinib is used in ongoing clinical trials to further explore safety and efficacy in NSCLC. Research Funding: Shanghai Haihe Pharmaceutical Co., Ltd.