Subgroup Analysis of WU-KONG1B Shows Strong Efficacy of Sunvozertinib in EGFR Exon 20 NSCLC

Dizal, a Shanghai-based biopharmaceutical company, revealed the subgroup analysis findings from its WU-KONG1 Part B (WU-KONG1B) study at the 2024 European Society for Medical Oncology (ESMO) Congress. This open-label, multinational study assesses the efficacy and safety of sunvozertinib in treating relapsed or refractory non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 20 insertion mutations (exon20ins). The study spans across 10 countries in Asia, Europe, North America, and South America. Sunvozertinib has shown promising anti-tumor efficacy across various baseline characteristics, suggesting its significant clinical value for patients worldwide.

As of March 22, 2024, the study involved 107 patients with at least 33 EGFR exon20ins subtypes. The key findings were promising:
- Independent review committee (IRC) assessed target lesion shrinkage in 92.4% of patients.
- The best objective response rate (ORR) was 53.3%, including three complete responses.
- By EGFR exon20ins region classification, ORR was 51.9% for near loop, 59.1% for far loop, 66.7% for C-helix, and 40% for unknown regions.
- ORR was consistent across different subgroups irrespective of race, region, baseline characteristics, and prior treatments.
- With a median follow-up of seven months, the duration of response (DoR) was not reached, and 66.7% of responders were still responding.
- The safety profile was consistent with previous reports and clinically manageable.

The WU-KONG1B study enrolled over 40% of non-Asian patients, and the analysis suggested superior anti-tumor efficacy and manageable safety profiles of sunvozertinib across different demographics and clinical characteristics. Xiaolin Zhang, PhD, CEO of Dizal, emphasized the company's commitment to advancing global studies and regulatory submissions for sunvozertinib, aiming to make this effective and safe oral treatment available to more patients worldwide.

In addition to the WU-KONG1B study, Dizal is conducting the WU-KONG28 study, a phase III multinational randomized trial comparing sunvozertinib with platinum-based doublet chemotherapy as a first-line treatment for NSCLC patients. This study involves patients from 16 countries across Asia, Europe, North America, and South America, and its results are expected to enhance patient outcomes further.

Sunvozertinib, also known as DZD9008, is an irreversible EGFR inhibitor developed by Dizal targeting a wide range of EGFR mutations while maintaining selectivity for wild-type EGFR. In August 2023, the drug received approval from the National Medical Products Administration (NMPA) for treating advanced NSCLC with EGFR exon20ins after platinum-based chemotherapies. This approval was based on the WU-KONG6 study, which showed a confirmed overall response rate (cORR) of 60.8%.

Sunvozertinib has demonstrated significant anti-tumor activity across various EGFR exon20ins subtypes and has been effective in patients with pretreated and stable brain metastasis. It has also shown efficacy in NSCLC patients with EGFR sensitizing, T790M, and uncommon mutations, as well as HER2 exon20ins. The drug's safety profile is well-tolerated and manageable, with most treatment-emergent adverse events being Grade 1/2.

Dizal is committed to discovering, developing, and commercializing innovative therapeutics for cancer and immunological diseases. With a strong focus on translational science and molecular design, the company has built a competitive portfolio with two leading assets in global pivotal studies, both launched in China.