Dizal announced that the results of a phase 2 pivotal study of sunvozertinib for the treatment of platinum-pretreated non-small-cell lung cancer (NSCLC) patients with EGFR exon 20 insertion mutations (exon20ins) (WU-KONG6) were published in the peer-reviewed journal The Lancet Respiratory Medicine (IF: 76.2). The publication of these research results further reinforces sunvozertinib's leading position as a potential best-in-class treatment option, following its selection for an oral presentation at this year's ASCO Annual Meeting. Lung cancer is the leading type of cancer with the highest incidence and mortality rates in China.

In NSCLC, EGFR represents the most common driver gene mutation, with exon20ins mutations being the most prevalent rare subtype, accounting for approximately 12% of all EGFR mutations. However, due to its unique spatial configuration and high heterogeneity, there has been a persistent lack of safe and effective targeted treatment options for this mutation, leading to limited survival benefits for patients. Yun Fan, MD, PhD from the Department of Thoracic Oncology at the Cancer Hospital of the University of Chinese Academy of Sciences, and the first author of the paper, emphasized the significant challenge presented by EGFR exon20ins mutations in drug development.

Despite various treatment modalities including chemotherapy, traditional EGFR-TKIs, immunotherapy and other targeted therapies, the objective response rate (ORR) in platinum-pretreated NSCLC patients with EGFR exon20ins mutations has not exceeded 50%. Sunvozertinib is a selective EGFR TKI developed to target a wide spectrum of EGFR mutations. It is the first Chinese innovative drug approved for NSCLC patients with EGFR exon20ins mutations.

The National Medical Products Administration (NMPA) granted approval based on the results from the WU-KONG6 study, a single-arm, multicenter phase 2 pivotal study, conducted to evaluate the antitumor efficacy of sunvozertinib in platinum-pretreated advanced stage NSCLC patients with EGFR exon20ins mutations. The study's primary endpoint, the independent review committee (IRC) -assessed ORR reached 61%, indicating a significant improvement over existing treatment options. With more than 100 different subtypes of EGFR exon20ins reported in NSCLC so far, thus making the treatment with a single agent even more challenging due to the diversified protein structure of different subtypes.

However, owing to its unique chemical design and flexible compound, sunvozertinib was able to bind to different subtype proteins, and showed potent anti-tumor activities in cell lines expressing a broad variety of subtypes. More importantly, its activity was translatable to human. The ORRs were higher than 50% among different subtypes enrolled into this study.

Additionally, the overall safety is similar to other EGFR TKIs and clinically manageable, which can be well managed in the clinic.