Sunvozertinib's Pivotal WU-KONG1B Study Succeeds in NSCLC with EGFR Exon 20 Insertions

Dizal, a biopharmaceutical company specializing in innovative cancer and immunology treatments, has revealed encouraging results from its WU-KONG1 Part B (WU-KONG1B) study of sunvozertinib in patients with relapsed or refractory non-small cell lung cancer (NSCLC) harboring EGFR exon 20 insertion mutations (exon20ins). These findings were presented at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting. The study's primary objective was met with a manageable safety profile, emphasizing the drug’s significant global clinical value.

Sunvozertinib, an oral EGFR inhibitor, targets a broad range of EGFR mutations while maintaining wild-type EGFR selectivity. It has received Breakthrough Therapy designations from both the US FDA and China’s CDE for its efficacy in treating NSCLC with EGFR exon20ins. Having obtained conditional approval in China through the WU-KONG6 study, sunvozertinib stands as the first and only oral medication specifically approved for NSCLC patients with EGFR exon20ins.

WU-KONG1B, an international pivotal study akin to WU-KONG6, evaluated sunvozertinib in patients from 10 countries across Asia, Europe, North America, and South America. The primary endpoint was the objective response rate (ORR), and the key secondary endpoint was the duration of response (DoR), both assessed by an Independent Review Committee (IRC).

By March 22, 2024, 111 patients were enrolled to receive a 300mg dosage of sunvozertinib, with 107 meeting the criteria for efficacy analysis. The demographic breakdown included 57.9% Asian, 40.2% White, and 1.9% Black or African American participants. Key results revealed a best ORR of 53.3%, with a 9-month DoR rate of 57%, showcasing durable efficacy. Efficacy was consistent regardless of prior treatment with amivantamab, with ORRs of 50% in previously treated and 53.8% in treatment-naïve patients. The study also highlighted a manageable safety profile.

Prof. James Chih-Hsin Yang from National Taiwan University Hospital, the principal investigator of WU-KONG1B, noted the significance of enrolling over 40% non-Asian patients and the impressive anti-tumor efficacy of sunvozertinib. Safety findings were consistent with previous studies, with most adverse events being reversible and manageable.

Xiaolin Zhang, CEO of Dizal, expressed optimism about the clinical benefits of sunvozertinib, emphasizing its convenience, safety, and superior efficacy as a single oral drug. He also highlighted the ongoing global Phase III study, WU-KONG28, which is comparing sunvozertinib to platinum-based doublet chemotherapy in first-line NSCLC patients with EGFR exon20ins. This study involves participants from 14 countries, reinforcing the global interest and potential impact of sunvozertinib.

Sunvozertinib, known as DZD9008, was developed by Dizal scientists as an irreversible EGFR inhibitor. It has shown efficacy against a wide spectrum of EGFR mutations and received approval in China for advanced NSCLC following platinum-based treatments. The approval was based on the WU-KONG6 study, which reported a confirmed overall response rate (cORR) of 60.8%. Sunvozertinib exhibited anti-tumor activity across various EGFR exon20ins subtypes and was effective even in patients with brain metastasis. It was also well-tolerated, with most treatment-emergent adverse events (TEAEs) being mild and manageable.

Dizal's commitment to advancing sunvozertinib includes two ongoing global pivotal studies—WU-KONG1 Part B for second-line treatment and WU-KONG28 for first-line treatment. Preclinical and clinical findings have been published in reputable journals such as Cancer Discovery and The Lancet Respiratory Medicine.

Dizal, driven by translational science and molecular design, aims to address unmet medical needs worldwide through groundbreaking therapeutics for cancer and immunological diseases. The company continues to develop and commercialize first-in-class medicines, making significant strides in global healthcare.

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