Dizal Pharmaceutical has announced a major breakthrough in the treatment of platinum-pretreated non-small-cell lung cancer (NSCLC) patients with EGFR exon 20 insertion mutations. The results of a pivotal phase 2 study of sunvozertinib, a selective EGFR TKI, were published in The Lancet Respiratory Medicine, reinforcing its potential as a best-in-class treatment. The study’s success positions sunvozertinib as the first Chinese innovative drug approved for NSCLC patients with EGFR exon 20 insertion mutations.
Lung cancer is a prevalent and deadly disease in China, with NSCLC being the leading type. EGFR mutations, especially exon 20 insertion mutations, pose a significant challenge due to their unique spatial configuration and high heterogeneity. Despite various treatment modalities, the objective response rate (ORR) in platinum-pretreated NSCLC patients with EGFR exon 20 insertion mutations has historically been below 50%.
Sunvozertinib, a selective EGFR TKI, has demonstrated its efficacy in a pivotal phase 2 study (WU-KONG6). The study’s primary endpoint, the ORR assessed by the Independent Review Committee (IRC), reached an impressive 61%. This marked improvement over existing treatment options is a significant development for patients with EGFR exon 20 insertion mutations.
The unique chemical design and flexible compound of sunvozertinib allowed it to bind to different subtype proteins, showcasing potent anti-tumor activities across various subtypes in cell lines. More than 100 different subtypes of EGFR exon 20 insertion mutations have been reported in NSCLC, making the treatment with a single agent challenging. Sunvozertinib’s ability to address this diversity and its translatable activity to humans contribute to its potential as an innovative treatment option.
Dr. Yun Fan, the first author of the paper and affiliated with the Cancer Hospital of the University of Chinese Academy of Sciences, emphasized the challenge presented by EGFR exon 20 insertion mutations. Despite multiple treatment modalities, the ORR has historically been limited. Sunvozertinib’s success in achieving a high ORR offers a new ray of hope for patients facing this challenging mutation.
Dr. Mengzhao Wang of Peking Union Medical College Hospital, the first and corresponding author of the paper, highlighted sunvozertinib’s superior efficacy, safety, and convenience profile. Being the first Category-I Innovative Drug approved for the treatment of EGFR exon 20 insertion mutations NSCLC in China, sunvozertinib represents a significant advancement in addressing the existing treatment challenges for advanced NSCLC patients.
Xiaolin Zhang, PhD, Chairman and CEO of Dizal, expressed the company’s excitement at the increasing recognition of sunvozertinib’s potential as the best-in-class therapy for NSCLC patients with EGFR exon 20 insertion mutations. As the first approved innovative drug from Dizal, sunvozertinib marks a crucial milestone, and the company is committed to expediting global clinical research to explore additional treatment possibilities.
Sunvozertinib’s approval by the National Medical Products Administration (NMPA) was based on the results of the WU-KONG6 study, and the drug has demonstrated encouraging anti-tumor activity not only in EGFR exon 20 insertion mutations but also in patients with other EGFR mutations and HER2 exon 20 insertion mutations.
With ongoing global pivotal studies in both ≥ 2nd line (WU-KONG1 PART B) and 1st line setting (WU-KONG28) for NSCLC patients with EGFR exon 20 insertion mutations, sunvozertinib holds promise as a groundbreaking therapy that could change the landscape of treatment options for a wide range of EGFR mutations in NSCLC. Dizal aims to collaborate with experts to further explore and deliver life-changing treatment options for patients worldwide.