Dizal has completed subject enrolment for the randomised Phase III WU-KONG28 trial of oral sunvozertinib for treating non-small cell lung cancer (NSCLC) patients.
This multinational study is designed to assess the safety and efficacy of the therapy compared to platinum-based doublet chemotherapies as a first-line treatment for NSCLC with epidermal growth factor receptor (EGFR) exon 20 insertion mutations (exon20ins).
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WU-KONG28 is being carried out in 16 nations and regions, including Asia, North America, Europe, and South America.
At the 2023 European Society for Medical Oncology (ESMO) Annual Meeting, the company announced that the therapy showed a complete decrease of target lesions, a median progression-free survival of 12.4 months, and a confirmed objective response rate of 78.6% in advanced or metastatic NSCLC subjects who are treatment-naïve.
In addition, the therapy showed a well-tolerated safety profile against other EGFR tyrosine kinase inhibitors (TKIs).
Furthermore, the therapy claims to have shown positive anti-tumour activity in NSCLC subjects, including EGFR sensitising, T790M, and uncommon mutations, and also HER2 exon20ins.
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By GlobalDataIt received the breakthrough therapy designation from the China National Medical Products Administration’s (NMPA) Center for Drug Evaluation (CDE) and the US Food and Drug Administration (FDA) for EGFR exon20ins NSCLC treatment.
It has also been approved in China for the treatment of relapsed and refractory NSCLC with EGFR exon20ins.
The FDA has granted priority review for its new drug application (NDA) for the same indication, with a Prescription Drug User Fee Act (PDUFA) date set for 7 July 2025.
Discovered by the scientists of the company, the oral therapy is an irreversible EGFR inhibitor that targets a broad EGFR mutation spectrum with selectivity for wild-type EGFR.
In 2022, the company reported positive safety and pharmacokinetic findings from the Phase I trial of DZD1516 in HER2-positive metastatic breast cancer patients who relapsed, following multiple previous therapies.
