On September 8, 2023 Haihe Biopharma K. K. (referred as "Company"), fully owned affiliate of Shanghai Haihe Biopharma Co., Ltd (China) reported that the New Drug Application ("NDA") of Gumarontinib (SCC244) for the treatment of locally advanced or metastatic non-small cell lung cancer (NSCLC) with MET exon 14 (METex14) skipping mutation, has been filed to Ministry of Health, Labour and Welfare(厚生労働省) (Press release, Shanghai HaiHe Pharmaceutical, SEP 8, 2023, View Source [SID1234646872]).
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The indication application is based on the data from the SCC244-108 a pivotal Phase II study (GLORY study), a global multi-center, open-label, single-arm clinical trial 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 at Shanghai Chest Hospital，China.
Dr. Ruiping Dong, Chief Executive Officer of Haihe Biopharma, stated,
"The file in Japan for Gumarontinib, demonstrates Haihe’s mission for the global development of the innovative drugs to bring more effective and much safer treatment options for cancer patients around the world, and marks a historic step of Haihe Biopharma’s innovative drug into the global market. We deeply appreciated the contribution from the patients and the efforts from the investigators, and the recognition of Gumarontinib. Haihe Biopharma will continue to file more global New Drug Applications to benefit cancer patients in the world."
Prof. Shun Lu, the global leading principal investigator of the GLORY study, from the Oncology Department of Shanghai Chest Hospital, commented,
"Gumarontinib is an oral, potent and highly selective MET inhibitor. The GLORY study data demonstrated that Gumarontinib has solid efficacy and good safetyin the treatment naive or previously treated NSCLC patients harboring METex14 skipping mutations, even those with brain metastases. We expect Gumarontinib with better efficacy and acceptable safety could address the unmet needs of patients in China and globally."
About NSCLC and METex14 Skipping Mutations
Primary lung cancer is the malignant tumor with the highest morbidity and mortality in China. NSCLC accounts for approximately 85% of all lung cancers1. The total incidence of METex14 skipping mutations in NSCLC is about 3%2, and the incidence in Chinese NSCLC population is about 1.3%3.
METex14 skipping mutations is a primary oncogenic driver gene, which usually does not coexist with other lung cancer mutations such as EGFR, KRAS and ALK4. Most patients were elderly, with a median age of 72.5 years5. METex14 skipping mutations predicted poor prognosis, with progression-free survival (PFS) of only 2.9 months, overall survival (OS) of 7.9 – 8.3 months, and objective response rate (ORR) of 8.8% — 9.1%6 in second-line chemotherapy. NSCLC patients with METex14 skipping mutations were insensitive to PD-1 therapy with ORR ranged from 16 to 17%, median PFS ranged from 1.9 to 3.4 months, and there was no increase in response rate among tumor patients with high PD-L1 expression7,8 In Japan, the number of new lung cancer patients is 120,000/year (2020) and the number of deaths is 70,000 /year 1. The proportion of non-small cell lung cancer among lung cancer patients in Japan is 88%, and the frequency of METex14 skipping mutation-positive expression is about 3%3. Thus, in Japan, the number of patients that may be eligible for treatment with this drug is estimated to be around 3,000/year.
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. As of today, compared with its competitors, Gumarontinib has long half-life to achieve sustained target inhibition, low DDI potential withless 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.