Dizal to Present Latest Scientific Advancements across its Fast-growing Innovative Pipeline at 2022 CSCO
2022-11-02 · Dizal Pharmaceuticals · original dizalpharma.com ↗
Oral Presentations: Sunvozertinib Sunvozertinib, which was granted dual Breakthrough Therapy Designation by both US FDA and China CDE, is an oral, potent, irreversible and selective ErbB inhibitor showing activity against EGFR/HER2 exon20ins mutations and other common mutations. Data to be presented include the positive topline results from the first pivotal study of sunvozertinib (DZD9008) in platinum-pretreated NSCLC Patients with EGFR exon20ins mutations, and the researching findings in the correlation between theEGFR exon20ins mutations changes in ctDNA and antitumor efficacy in patients with the therapy of sunvozertinib. Efficacy results with a data cut-off date of July 31, 2022 were as follows: Parameter Results in 300 mg cohort (N=97) Confirmed ORR per BICR 59.8% (58/97) ORR in patients with baseline brain metastasis 48.4% (15/31) C-helical ORR 100% (2/2) C-helical DCR 100% (2/2) Near loop ORR 62.0% (44/71) Near loop DCR 88.7% (63/71) Far loop ORR 50.0% (12/24) Far loop DCR 83.3% (20/24) DZD1516 Nearly 60% of patients with advanced HER2-positive breast cancer develop brain metastasis and the prognosis is extremely poor. DZD1516 is an oral, full blood-brain barrier (BBB) penetrant selective HER2 inhibitor for the treatment of HER2-positive metastatic breast cancer (HER2+ MBC). The Phase I study is enrolling HER2+ MBC patients who relapsed from or were intolerant to the standard of care (SoC). The primary objective is to evaluate the safety of DZD1516 and to define maximum tolerated dose (MTD). As of February 20, 2022, DZD1516 was explored in 22 HER2+ MBC patients from the US and China, among whom nearly 70% had CNS metastases at baseline. Key findings are as follows: DZD1516 was well tolerated at doses ≤ 250 mg, and in consistent with its high selectivity, no wild-type EGFR-related AEs have been reported. Thus, 250 mg was defined as MTD. In patients, mean Kpuu,CSF was 2.1 for DZD1516 across the dose range, indicating full penetration of DZD1516 through human BBB. 18 patients had completed ≥ 1 post treatment RECIST assessment. With a median of 7 lines of prior systemic treatment (86% treated with HER2 TKI), the best antitumor efficacy in intracranial, extracranial and overall lesions was stable disease. Poster presentation: Golidocitinib (DZD4205) Golidocitinib (DZD4205), which was granted Fast Track Designation by US FDA, is an oral, potent, JAK1-specific inhibitor. Results from the Phase 1/2 trial, which is evaluating the efficacy and safety of golidocitinib in patients with r/r PTCL, showed golidocitinib yielded an ORR of 42.9% and longest DoR of > 14 months. Dizal presentations at CSCO 2022: Presenter Abstract title Presentation details Prof. Mengzhao, Wang Preliminary results from the pivotal study of sunvozertinib (DZD9008) in NSCLC patients with EGFR exon20ins mutations Time: 14:15-14:25, 5 November 2022 Location: Hall 2, China World Hotel Prof. Yan, Xu Correlation between the EGFR exon20ins mutations changes in ctDNA and antitumor efficacy in patients with the therapy of sunvozertinib Time: 14:15-14:30, 9 November 2022 Location: Online conference room 3, oral session, NSCLC, CSCO Prof. Jian Zhang Preliminary data of DZD 1516, an oral, full blood-brain barrier (BBB) penetrant selective HER2 inhibitor, from a phase I clinical study in the treatment of HER2-positive metastatic breast cancer Time: 15:45-15:55, 5 November 2022 Location: Hall 2, China World Hotel About Dizal Dizal is a clinical-stage, biopharmaceutical company, dedicated to the discovery and development of differentiated therapeutics for the treatment of cancer and immunological diseases. Deep-rooted in translational science and molecular design, it has established an internationally competitive portfolio of five clinical-stage assets with two leading assets in global pivotal studies. About CSCO The Chinese Society of Clinical Oncology (hereinafter referred to as "CSCO"), established in 1997, is committed to carrying out continuing education and multi-center collaborative research in clinical oncology, promoting the standardization of tumor diagnosis and treatment, and improving the quality of academic level in clinical oncology in China. Forward-Looking Statements This news release may contain certain forward-looking statements that are, by their nature, subject to significant risks and uncertainties. The words "anticipate", "believe", "estimate", "expect", and "intend" and similar expressions, as they relate to Dizal, are intended to identify certain forward-looking statements. Dizal does not intend to update these forward-looking statements regularly. These forward-looking statements are based on the existing beliefs, assumptions, expectations, estimates, projections, and understandings of the management of Dizal with respect to future events at the time these statements are made. These statements are not a guarantee of future developments and are subject to risks, uncertainties, and other factors, some of which are beyond Dizal's control and are difficult to predict. Consequently, actual results may differ materially from information contained in the forward-looking statements as a result of future changes or developments in our business, Dizal's competitive environment, and political, economic, legal, and social conditions. Dizal, the Directors, and the employees of Dizal assume (a) no obligation to correct or update the forward-looking statements contained on this site; and (b) no liability in the event that any of the forward-looking statements does not materialize or turn out to be incorrect. 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