Dizal 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.