Dizal has announced the submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for sunvozertinib, an oral drug intended for the treatment of locally advanced or metastatic non-small cell lung cancer (NSCLC) patients with epidermal growth factor receptor (EGFR) exon 20 insertion mutations (exon20ins). The application targets patients whose disease has progressed on or after platinum-based chemotherapy.
The NDA submission is supported by data from the pivotal WU-KONG1 Part B study, a multinational trial evaluating the efficacy and safety of sunvozertinib in relapsed or refractory EGFR exon20ins NSCLC patients across Asia, Europe, North America, and South America. The study met its primary endpoint, demonstrating a statistically significant and clinically meaningful objective response rate (ORR) as assessed by an independent review committee (IRC), alongside a manageable safety profile. These data were presented at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting.
Clinical Efficacy and Safety
Sunvozertinib has already received accelerated approval in China for the treatment of advanced NSCLC with EGFR exon20ins mutations, making it the world’s first and only oral drug approved for this indication. It has also been granted Breakthrough Therapy Designations (BTDs) by both the U.S. FDA and the China Center for Drug Evaluation (CDE) for the same indication.
Addressing Unmet Needs in NSCLC
Lung cancer remains the leading cause of cancer incidence and mortality worldwide, with NSCLC accounting for approximately 80%-85% of all lung cancers. Patients with NSCLC harboring EGFR exon20ins mutations typically have a poorer prognosis compared to those with other EGFR sensitizing mutations. Sunvozertinib, with its innovatively designed molecular structure, aims to provide enhanced efficacy, safety, and ease of administration.
About Sunvozertinib
Sunvozertinib (DZD9008) is an irreversible EGFR inhibitor discovered by Dizal scientists, targeting a wide spectrum of EGFR mutations with wild-type EGFR selectivity. The approval in China was based on the results of the WU-KONG6 study, where the confirmed overall response rate (cORR) as assessed by the Independent Review Committee (IRC) reached 60.8%. The drug has shown anti-tumor efficacy across a broad range of EGFR exon20ins subtypes, including in patients with pretreated and stable brain metastasis. It has also demonstrated encouraging anti-tumor activity in NSCLC patients with EGFR sensitizing, T790M, and uncommon mutations (such as G719X, L861Q, etc.), as well as HER2 exon20ins.
Ongoing Clinical Trials
Two global pivotal studies are ongoing in ≥ 2nd line (WU-KONG1 Part B) and 1st line setting (WU-KONG28), respectively, in NSCLC patients with EGFR exon20ins.
