SHANGHAI, April 24, 2024 /PRNewswire/ -- Dizhe Therapeutics (stock code: 688192. SH) announced that it will present two latest research results of its self-developed class I lung cancer targeted drug suvotinib ® (generic name: suvotinib tablets) for epidermal growth factor receptor (EGFR) exon 20 insertion (exon20ins)-mutated advanced non-small cell lung cancer (NSCLC) at the American Society of Clinical Oncology (ASCO) Annual Meeting to be held in Chicago from May 31 to June 4, 2024.
At this conference,
Shu Wozhe®
For economic treatment EGFR exon20ins Mutant NSCLC Global registry clinical studies " Goku 1 B part " （ WU-KONG1 Part B The data from the study will be presented in an oral presentation for the first time in the world。 The study is a phase II, open-label, international multicenter clinical study to evaluate the efficacy and safety of Suvozer ® in patients with EGFR exon20ins mutant NSCLC who have failed or are intolerant to platinum-based chemotherapy, and is currently being conducted in 10 countries and regions around the world, including the United States, Europe, and China.
Dr. Xiaolin Zhang, Founder, Chairman and CEO of Digi Therapeutics, said, "We are delighted that the first global registrational clinical study of Sulvozer ® has been successfully selected for the ASCO oral presentation, which is an important milestone in the 'Global Innovation' journey of Digi Therapeutics. In the long-term lack of effective standard treatment options for EGFR exon20ins mutant NSCLC, Shuwozhe ® broke through the bottleneck of previous treatments in this field with the latest research results of the Chinese registration clinical study "WU-KONG6" and launched its first launch in China. We believe that the positive data from WU-KONG1 Part B will further provide evidence for the significant clinical benefit of this product." We will work closely with overseas drug regulatory authorities such as the United States and the European Union to accelerate the submission of New Drug Application (NDA). It is expected that as the first national innovative drug for EGFR exon20ins mutant NSCLC in the past 20 years, Suvozhe ® will benefit more patients around the world as soon as possible. "
Previous studies have shown that Suvozhe ® has high efficacy and low toxicity in the treatment of EGFR exon20ins mutant NSCLC, and has the potential to be best-in-class in the world. As the field of lung cancer currently
The only one in the worldApproved and accessible small molecule TKIs for EGFR exon20ins mutant NSCLC, Schwozhe ® is still in this field
The only one in the world that has won the whole line FDA Breakthrough Therapy Designationtherapeutic drugs. At present, the ® global multi-center phase III clinical study "Wukong 28" (WU-KONG28) in the first-line treatment of EGFR exon20ins mutant advanced NSCLC is also underway, which is expected to further consolidate its advantages in the first-line treatment of EGFR exon20ins mutant NSCLC.
In addition, a study of plasma circulating tumor DNA (ctDNA) biomarkers in patients with EGFR exon20ins-mutant NSCLC treated with Suvozer ® will be presented as a poster presentation at the conference. This study explored the correlation between the EGFR exon20ins mutation and the anti-tumor activity and ctDNA of Suvoze, as well as the mechanism and potential solutions of Suvozer ® ® resistance.
Oral presentation-
Abstract Title:
Preliminary results from an international multicenter registry clinical study of suvotinib in EGFR exon 20 insertion-mutated non-small cell lung cancer (NSCLC) that has failed platinum-based chemotherapy
A multinational pivotal study of sunvozertinib in platinum pretreated non-small cell lung cancer with EGFR exon20 insertion mutations: Primary analysis of WU-KONG1 study
- Prof. Zhixin Yang, National Taiwan University Cancer Center Hospital
- Abstract No. 8513
- Parallel Session: Lung Cancer – Metastatic Non-Small Cell Lung Cancer
- Report Period: 6/1/2024, 4:30PM-6:00PM (CDT)
- Location of the report: S406
-
Abstract Title:
A Study of Suvotinib in the Treatment of Plasma ctNDA Biomarkers in Patients With EGFR Exon 20 Insertion Mutation Non-Small Cell Lung Cancer
Plasma ctDNA biomarker study in patients with non-small cell lung cancer with EGFR exon 20 insertion mutation treated with sunvozertinib
- Presenter: Prof. Mengzhao Wang, Peking Union Medical College Hospital
- Abstract Number: 8563
- Parallel Session: Lung Cancer – Metastatic Non-Small Cell Lung Cancer
- Show time: 6/3/2024, 1:30PM-4:30PM (CDT)
- Venue: Hall A
Bibliography:
[1] Wang, Mengzhao, et al. The Lancet Respiratory Medicine 12.3 (2024): 217-224.
About Suvozer (Suvotinib) Suvozer ® ® is an oral, irreversible, The first indication of a highly selective EGFR tyrosine kinase inhibitor (TKI) targeting multiple EGFR mutant subtypes was approved by the NMPA in August 2023 through priority review in China for patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) who have progressed on prior platinum-based chemotherapy or who have not tolerated platinum-based chemotherapy and have been tested to confirm the presence of epidermal growth factor receptor (EGFR) exon 20 insertion (exon20ins) mutations.
About Dizhe Pharmaceutical Dizhe Pharmaceutical (Stock Code: 688192. SH) is an innovative biopharmaceutical company focusing on the research, development and commercialization of innovative therapies in the fields of malignant tumors and immune diseases. The company adheres to the R&D concept of source innovation, with the goal of launching first-in-class drugs and treatments with breakthrough potential, aiming to fill the unmet clinical needs around the world. Based on the industry-leading translational science and new drug molecule design and screening technology platforms, the company has established a globally competitive product pipeline, with two leading products in the global pivotal clinical trial stage, one of which has been approved for marketing.
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