On June 24, 2024 Haihe Biopharma Co., Ltd. (referred as "Haihe") reported that Ministry of Health, Labor and Welfare of Japan 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 (Press release, Shanghai HaiHe Pharmaceutical, JUN 24, 2024, View Source [SID1234646873]).
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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.
Dr. Ruiping Dong, Chief Executive Officer of Haihe, stated,
"The approval of Gumarontinib in Japan is another significant milestone for the company, highlighting the company’s commitment to developing and providing innovative oncology therapies to meet the unmet medical needs of patients in China and around the world. Following the international strategy of "From China to the World",the company will continue to bring innovative and high-quality drugs to patients worldwide. Also，we would like to express our gratitude to all researchers, patients, family members of patients, and clinical staffs who have worked hard on the clinical research of Gumarontinib!"
Prof. Shun Lu, the global leading principal investigator of the GLORY study, from the Oncology Department of Shanghai Chest Hospital, commented,
"The approval of Gumarontinib in Japan will provide a new treatment option for the Japanese NSCLC patients. It also confirms that the GLORY study of Gumarontinib, led by Chinese and Japanese researchers, has gained international recognition and affirmation. It is a new milestone in the journey of China’s bio-innovative drugs onto the global stage. We look forward to seeing more innovative drugs from China, such as Gumarontinib, go global to meet the unmet medical needs of patients."
About NSCLC and METex14 Skipping Mutations
Primary lung cancer is the second most common malignant cancer and the first in terms of mortality in the world. 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 2.51%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 ALK2. Most patients were elderly, with a median age of 72 years2. 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% in second-line chemotherapy4. 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 expression5-6. In Japan, the number of new lung cancer patients is 120,000/year (2020) and the number of deaths is 70,000 /year 7. The proportion of non-small cell lung cancer among lung cancer patients in Japan is 88%, and the frequency of METex 14 skipping mutation-positive expression is about 3%2. Therefore, in Japan, the estimated number of patients who may need to receive this type of drug treatment is around 1,800 per 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. 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).