June 24, 2024, Haihe Biopharma Co., Ltd. (referred as “Haihe”) announced that Ministry of Health, Labor and Welfare of Japan (厚生労働省) approved New Drug Application (“NDA”) of Gumarontinib (SCC244) for the treatment of unresectable advanced or recurrent non-small cell lung cancer (NSCLC) with MET exon 14 (METex14) skipping mutation.
The indication application is based on the data from the successful SCC244-108 (GLORY study, NCT04270591), a pivotal Phase II study, to evaluate the efficacy and safety of Gumarontinib in locally advanced or metastatic NSCLC patients with METex14 skipping mutations. This indication has been approved by NMPA in China on March 7, 2023. The global leading principal investigator is Prof. Shun Lu of Shanghai Chest Hospital, China.
A total of 79 patients with MET exon 14 skipping mutations confirmed by the central laboratory were enrolled in the GLORY study with a data cut-off date of April 28, 2022. The confirmed overall objective response rate (ORR) per Blinded Independent Review Committee (IRC) was 65.8%, including 70.5% ORR for treatment-naïve patients and 60.0% ORR for previously-treated patients at 12-months follow-up. The median progression-free survival (PFS) was 8.5 months, 11.7 months and 7.6 months for overall population, treatment-naïve and previously treated patients respectively. Additionally, the median overall survival (OS) was 17.3 months and 16.2 months for overall population and previously-treated patients respectively, and it has not reached in treatment-naïve patients to the date of this report.
About Gumarontinib (SCC244)
Gumarontinib (code: SCC244) is an oral, potent and highly selective small molecule MET inhibitor. Gumarontinib has shown excellent pharmacokinetic characteristics, highly effective and durable efficacy and favorable safety profile in NSCLC patients with MET alterations. Gumarontinib has long half-life to achieve sustained target inhibition, low DDI potential to enable less co-medication restrictions, convenient QD regimen. Gumarontinib has been approved by the NMPA in China with breakthrough designation for the treatment of non-small cell lung cancer (NSCLC) with MET genomic aberration. A few clinical trials are ongoing, such as one phase III clinical trial for patients with non-small cell lung cancer (NSCLC) who have MET overexpression and are negative for driver mutations (this indication has been granted breakthrough therapy designation by the CDE).
1] Retrieved July 03，2024, From
https://www.haihepharma.com/en/news/details/423
2] Retrieved July 03，2024, From
https://kk.haihepharma.com/news/news_2024062401.html
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