2023WCLC Oral Presentation | Molecular Analysis Validates the Effectiveness of Tumor Tissue-Based and Plasma ctDNA Testing in Identifying NSCLC Patients with EGFR Exon20ins Eligible for Treatment with Sunvozertinib

• A high concordance was observed between tumor tissue-based and plasma circulating tumor DNA (ctDNA) testing in detecting EGFR exon 20 insertion (Exon20ins) mutations.
• Both tumor tissue-based and plasma ctDNA testing can be used to identify patients who may benefit from treatment with sunvozertinib.
• Plasma ctDNA testing can be used as a complementary tool to tumor tissue-based testing, especially in clinical scenarios where tumor tissue is limited or unavailable.

SHANGHAI, Aug. 17, 2023 /PRNewswire/ -- Dizal (688192.SH) will present the results of a molecular analysis on EGFR Exon20ins mutations in tumor tissue and plasma ctDNA using next-generation sequencing, and their correlation with clinical activity observed in patients treated with sunvozertinib, in a mini oral presentation at the 2023 World Conference on Lung Cancer (WCLC), taking place September 9 – 12, 2023 in Singapore.

Sunvozertinib, a highly selective EGFR tyrosine kinase inhibitor (TKI) targeting a wide spectrum of EGFR mutations, is the first and only Chinese Category-I Innovative Drug for the treatment of lung cancer that has received breakthrough therapy designations from both the China National Medical Products Administration (NMPA) and the U.S. Food and Drug Administration (FDA). The NMPA has accepted new drug application (NDA) and granted priority review for sunvozertinib for the treatment of advanced non-small cell lung cancer (NSCLC) with EGFR Exon20ins mutations after platinum-based chemotherapies. Topline readouts of the first pivotal study, known as WU-KONG6, demonstrates sunvozertinib's potential as the best-in-class therapy in the ≥second line setting of NSCLC with EGFR Exon20ins mutations.

Tumor tissue-based and plasma ctDNA testing is an important tool for diagnosing EGFR Exon20ins NSCLC. In the WU-KONG6 study, tumor tissue and plasma samples were collected at the baseline and analyzed using next generation sequencing-based assay. And the results of the molecular analysis are as follows:

• A high concordance was observed between tumor tissue-based and plasma ctDNA testing in detecting EGFR Exon20ins mutation. 
  The positive agreement between tumor tissue-based and plasma ctDNA tests was high (69.1%). Moreover, the EGFR Exon20ins mutation subtypes identified in both tumor tissue-based and plasma ctDNA testing were identical.
• Patients whose tumor tissues or plasma ctDNA tested positive for EGFR Exon20ins mutation may benefit from sunvozertinib therapy.
  The objective response rates (ORRs) in subjects with EGFR Exon20ins mutations in tumor tissue and plasma ctDNA were 59.8% and 63.0% respectively, which were comparable to the ORR of 60.8% in the whole efficacy population.

These findings suggest that both tumor tissue-based and plasma ctDNA testing can be used to identify patients who may benefit from treatment with sunvozertinib. Plasma ctDNA testing can serve as complementary tool, particularly in clinical scenarios when access to tumor tissue is limited or unavailable.

About sunvozertinib (DZD9008)

Sunvozertinib is an irreversible EGFR inhibitor discovered by Dizal scientists targeting a wide spectrum of EGFR mutations with wild-type EGFR selectivity. The first pivotal study of sunvozertinib, known as WU-KONG6, has achieved its primary endpoint, demonstrating superior anti-tumor efficacy in pretreated NSCLC patients with EGFR Exon20ins. In January 2023, the Center for Drug Evaluation (CDE) of the China National Medical Products Administration (NMPA) granted priority review status to sunvozertinib and accepted the New Drug Application (NDA) for sunvozertinib for the treatment of advanced NSCLC with EGFR Exon20ins mutations after platinum-based chemotherapies. As assessed by the Independent Review Committee (IRC), the primary endpoint of cORR at RP2D of 300mg QD reached 60.8%. Anti-tumor efficacy was observed across a broad range of EGFR Exon20ins subtypes, and in patients with pretreated and stable brain metastasis. In addition, sunvozertinib also demonstrated encouraging anti-tumor activity in NSCLC patients with EGFR sensitizing, T790M and uncommon mutations (such as G719X, L861Q, etc.), as well as HER2 Exon20ins mutations.

Sunvozertinib showed a well-tolerated and manageable safety profile in the clinic. The most common drug related TEAEs (treatment emergent adverse event) were Grade 1/2 in nature and clinically manageable.

Two global pivotal studies are ongoing in ≥ 2nd line (WU-KONG1 PART B) and 1st line setting (WU-KONG28), respectively, in NSCLC patients with EGFR Exon20ins mutations.

Pre-clinical and Phase 1 clinical results of sunvozertinib were published in peer-reviewed journal Cancer Discovery (IF:39.397) in April 2022.

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.

To learn more about Dizal, please visit www.dizalpharma.com, or follow us at Linkedin or Twitter.

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 turnout to be incorrect.

Contacts

Investor Relations: ir@dizalpharma.com

Business Development: bd@dizalpharma.com

SOURCE Dizal Pharmaceutical

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