Dizal announced the latest research findings on the efficacy and safety of sunvozertinib in treatment-naïve patients with advanced or metastatic NSCLC with EGFR Exon20ins mutations at the 2023 European Society for Medical Oncology (ESMO) Congress. The pooled analysis is based on the treatment-naïve NSCLC patients with EGFR Exon20ins mutations from the global multi-center phase I/II study (WU-KONG1) and the phase II study initiated by Chinese investigators (WU-KONG15). As of September 15, 2023, 28 patients were included in the efficacy analysis and 57 patients were included in the safety analysis.

The research findings revealed that among the 28 patients included in the efficacy analysis, 100% of them exhibited a reduction in target lesions. The confirmed objective response rate (cORR) by investigator assessment reached an impressive 78.6%. Notably, the 300mg cohort demonstrated a median progression-free survival (mPFS) of 12.4 months, surpassing previous research findings.

Sunvozertinib showcased potent and durable anti-tumor efficacy, demonstrating favorable efficacy across various subtypes of EGFR Exon20ins mutations. These results highlight its potential as a leading treatment option for treatment-naïve NSCLC patients with EGFR Exon20ins mutations.Additionally, sunvozertinib is well tolerated with overall safety profile consistent with previous reports in the later-line settings and similar to traditional EGFR-TKIs.