Dizal Submits NDA to FDA for Sunvozertinib in EGFR Exon20ins NSCLC
核心洞察
Dizal has submitted an NDA to the FDA for sunvozertinib to treat NSCLC (搜索) patients with EGFR (搜索) exon 20 insertion mutations after platinum-based chemotherapy.
The application is supported by the WU-KONG1 Part B study, which showed statistically significant and clinically meaningful objective response rate (ORR).
Sunvozertinib is an irreversible EGFR (搜索) inhibitor and has already received accelerated approval in China for the same indication.
Dizal (Jiangsu) Pharmaceutical Co., Ltd. has announced the submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) seeking approval of sunvozertinib for the treatment of locally advanced or metastatic non-small cell lung cancer (搜索) (NSCLC (搜索)) patients with epidermal growth factor receptor (EGFR (搜索)) exon 20 insertion mutations (exon20ins), as detected by an FDA-approved test, whose disease has progressed on or after platinum-based chemotherapy. This submission marks a significant step toward providing a new treatment option for a subset of NSCLC patients with limited therapeutic alternatives.
Supporting Data from WU-KONG1 Part B Study
The NDA is supported by data from the WU-KONG1 Part B study, a multinational pivotal trial evaluating the efficacy and safety of sunvozertinib in relapsed or refractory EGFR (搜索) exon20ins NSCLC (搜索) 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. Detailed findings were presented at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting.
Sunvozertinib: A Targeted EGFR Inhibitor
Sunvozertinib is an irreversible EGFR (搜索) inhibitor developed by Dizal scientists, designed to target a broad spectrum of EGFR mutations with selectivity for wild-type EGFR. It received accelerated approval in China in August 2023 for treating advanced NSCLC (搜索) with EGFR exon20ins mutations after platinum-based chemotherapies, 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%. Anti-tumor efficacy was observed across a broad range of EGFR exon20ins subtypes, including in patients with pretreated and stable brain metastasis. The most common drug-related treatment-emergent adverse events (TEAEs) were Grade 1/2 in nature and clinically manageable.
Clinical Significance and Market Landscape
Lung cancer (搜索) remains the leading cause of cancer incidence and mortality worldwide, with NSCLC (搜索) accounting for approximately 80%-85% of all lung cancers. Patients with NSCLC harboring EGFR (搜索) exon20ins mutations typically face a poorer prognosis compared to those with other EGFR sensitizing mutations. Sunvozertinib has also been granted Breakthrough Therapy Designations (BTDs) by both the U.S. FDA and the China Center for Drug Evaluation (CDE) for treating EGFR exon20ins NSCLC, highlighting its potential to address a significant unmet need.
Ongoing Clinical Trials
Two global pivotal studies are currently underway, evaluating sunvozertinib in the 2nd line (WU-KONG1 Part B) and 1st line (WU-KONG28) settings, respectively, for NSCLC (搜索) patients with EGFR (搜索) exon20ins mutations. Pre-clinical and clinical results of sunvozertinib have been published in peer-reviewed journals such as Cancer Discovery and The Lancet Respiratory Medicine.