- Regardless of the patient's mutant subtype, ethnicity, region, baseline brain metastases, prior treatment with evantumab, or immunotherapy, Suvozhe ® has good antitumor efficacy
- The overall safety profile of Suwozhe ® is consistent with that reported in previous studies and is clinically manageable
SHANGHAI, Sept. 17, 2024 /PRNewswire/ -- Dizhe Therapeutics (stock code: 688192. SH) announced that the company's first self-developed novel targeted drug for lung cancer, suvozhe ® (generic name: suvotinib tablets)
International multi-center registered clinical study "Wukong 1 B "（ WU-KONG1 Part B 、 WU-KONG1B The latest global subgroup data are available at 2024 European Society for Medical Oncology ( RANDOM General Assembly debut.The study showed that the benefits of the ® second/posterior treatment of EGFR exon 20 insertion mutation (exon20ins) non-small cell lung cancer (NSCLC) in each subgroup were consistent with the global population, adding new evidence to the "high efficiency, low toxicity, and best-in-class" of the company ®.
WU-KONG1B is currently being carried out in 10 countries and regions around the world, including Europe, the United States, Australia, and Asia, to evaluate the efficacy and safety of WU-KONG1B ® in patients with EGFR exon20ins NSCLC. The study has met the primary endpoint, the preliminary analysis was presented in an oral presentation at the 2024 United States Society of Clinical Oncology (ASCO) Annual Meeting, and the latest global subgroup analysis data was presented at the 2024 ESMO Congress in Barcelona, Spain, on September 14 local time.
As of March 22, 2024, a total of 107 patients were enrolled in the efficacy analysis set, covering at least 33 subtypes of EGFR exon20ins. The results of the study showed that:
- According to the Independent Imaging Evaluation Committee (IRC) assessment, 92.4% (98/106) of patients observed shrinkage of target lesions
-
The best objective response rate (ORR) as assessed by IRC was 53.3%, with 3 patients achieving complete response (CR)
- The best ORRs for the proximal ring, distal ring, C-helix and unknown isoforms were 51.9%, 59.1%, 66.7% and 40%, respectively
- The best ORR in the different subgroups as assessed by IRC demonstrated favorable anti-tumor efficacy regardless of race, region, baseline disease characteristics, and prior treatment history, consistent with the optimal ORR benefit in the global population as a whole
| race | region | Baseline brain metastases | ||||
| Optimal relief , n (%) | Asian (n=62) | Non-Asian (n = 45) | Asia (n=58) | Non-Asian (n=49) | With (n=27) | Not accompanied (n = 80) |
| Complete Response (CR) | 3 (4.8) | 0 (0.0) | 3 (5.2) | 0 (0.0) | 0 (0.0) | 3 (3.8) |
| Partial Response (PR) | 32 (51.6) | 22 (48.9) | 29 (50.0) | 25 (51.0) | 18 (66.7) | 36 (45.0) |
| Previous treatment with avantumab | Previous immunotherapy for oncology | |||
| Optimal relief , n (%) | be (n=14) | not (n=93) | be (n=52) | not (n=55) |
| Complete Response (CR) | 0 (0.0) | 3 (3.2) | 2 (3.8) | 1 (1.8) |
| Partial Response (PR) | 7 (50.0) | 47 (50.5) | 26 (50.0) | 28 (50.9) |
- The median follow-up was 7 months, the median duration of response (DoR) had not yet been reached, and 66.7% of patients who had tumor response continued to respond
- The overall safety profile is consistent with previous studies and is clinically manageable
Dr. Xiaolin Zhang, Founder, Chairman and CEO of Digi Therapeutics, said, "More than 40% of the subjects enrolled in the WU-KONG1B study are non-Asian patients. The latest subgroup analysis data further validates the ® strong and long-lasting anti-tumor efficacy and good safety profile of EGFR exon20ins NSCLC patients with different races, regions and other baseline characteristics, and the results of the study are representative worldwide. With the in-depth advancement of the global registration clinical study of Suwozhe ®, we will further accelerate the overseas layout, so that the Chinese source innovation results can benefit more patients around the world as soon as possible." "
At present, WU-KONG28 ®, a randomized controlled, international multi-center phase III clinical study of EGFR exon20ins NSCLC compared with platinum-doublet chemotherapy, is being actively promoted in 16 countries and regions in the Americas, Europe and Asia, and is expected to provide breakthrough innovative therapy for more patients with EGFR exon20ins NSCLC around the world.
About Suvozer ® (Suvotinib)
Suvozer ® is an oral, irreversible, highly selective EGFR tyrosine kinase inhibitor (TKI) targeting multiple EGFR mutant subtypes, the first indication approved by the NMPA in August 2023 through priority review in China, for patients who have progressed on prior platinum-based chemotherapy or who have intolerant platinum-based chemotherapy. Patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 20 insertion mutations (exon20ins) have been confirmed by testing. In April 2024, as the only level I recommended regimen for the posterior treatment of EGFR exon20ins NSCLC, Suwozhe ® was included in the "Chinese Society of Clinical Oncology (CSCO) Guidelines for the Diagnosis and Treatment of Non-small Cell Lung Cancer (2024 Edition)".
About Dizhe Pharmaceutical
Dizhe Pharmaceutical (stock code: 688192.HK) 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 its industry-leading translational science and new drug molecule design and screening technology platforms, the Company has established six globally competitive product pipelines, two of which are in the global pivotal clinical trial stage, both of which have been approved for marketing in China. For more information, please follow the WeChat account: Dizal, or visit.
Forward-Looking Statements
Certain forward-looking statements may be included in the information contained in this press release. These statements are inherently subject to considerable risks and uncertainties. The use of words such as "anticipates," "believes," "predicts," "expects," "intends," "probabs" and other similar words is intended to identify forward-looking statements as those relating to the Company.
Forward-looking statements are based on the Company's management's current beliefs, assumptions, expectations, estimates, projections and understandings of future events at the time of making such statements. These statements are not guarantees of future development and are subject to risks, uncertainties and other factors, some of which are beyond the Company's control and are difficult to predict. As a result, actual results may differ materially from those contained in the forward-looking statements due to future changes and developments in our business, competitive environment, political, economic, legal and social conditions.
Neither the Company, nor any of its directors nor employees undertakes any obligation to (a) correct or update the forward-looking statements contained in this website; and (b) any liability arising from the failure or inaccuracy of any forward-looking statements.
For more information, please contact: Investor Relations: Business Cooperation: Media Contact: