Dizal Seeks FDA Approval for Sunvozertinib in EGFR Exon20ins NSCLC
Key Insights
Dizal (search) has submitted an NDA to the FDA for sunvozertinib to treat NSCLC (search) patients with EGFR (search) exon 20 insertion mutations.
The application is supported by the WU-KONG1 Part B study, which showed a statistically significant and clinically meaningful objective response rate.
Sunvozertinib is already approved in China for the same indication, making it the first oral drug for NSCLC (search) patients with EGFR (search) exon20ins.
Dizal (search), a biopharmaceutical company, has announced the submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for sunvozertinib. The application seeks approval for the treatment of locally advanced or metastatic non-small cell lung cancer (NSCLC (search)) patients with epidermal growth factor receptor (EGFR (search)) exon 20 insertion mutations (exon20ins), specifically in cases where the disease has progressed on or after platinum-based chemotherapy. This submission marks a significant step for Dizal in addressing unmet medical needs in NSCLC treatment.
Clinical Trial Data Supporting the NDA
The NDA is supported by data from the pivotal WU-KONG1 Part B study, a multinational trial that evaluated the efficacy and safety of sunvozertinib in relapsed or refractory EGFR (search) exon20ins NSCLC (search) patients across Asia, Europe, North America, and South America. The study demonstrated that sunvozertinib met its primary endpoint, achieving a statistically significant and clinically meaningful objective response rate (ORR) as assessed by an independent review committee (IRC), while also maintaining a manageable safety profile. These findings were presented at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting.
Sunvozertinib: An Irreversible EGFR Inhibitor
Sunvozertinib is an irreversible EGFR (search) inhibitor designed to target a broad spectrum of EGFR mutations with selectivity for wild-type EGFR. It has already received accelerated approval in China, making it the world’s first and only oral drug for NSCLC (search) patients with EGFR exon20ins. The China approval was based on the results of the WU-KONG6 study, where the confirmed overall response rate (cORR) reached 60.8% as assessed by the Independent Review Committee (IRC).
Impact on NSCLC Treatment
NSCLC (search) accounts for approximately 80%-85% of all lung cancers, with EGFR (search) exon20ins mutations associated with poorer prognosis compared to other EGFR sensitizing mutations. Sunvozertinib offers enhanced efficacy, safety, and ease of administration due to its innovatively designed molecular structure. According to Xiaolin Zhang, PhD, CEO of Dizal (search), the company is encouraged by the potential of sunvozertinib as a single oral agent to improve outcomes for patients with EGFR exon20ins NSCLC.
Ongoing Studies and Future Directions
Dizal (search) continues to investigate sunvozertinib in two global pivotal studies: WU-KONG1 Part B (≥ 2nd line) and WU-KONG28 (1st line setting), both focusing on NSCLC (search) patients with EGFR (search) exon20ins. Pre-clinical and clinical results of sunvozertinib have been published in peer-reviewed journals, including Cancer Discovery and The Lancet Respiratory Medicine.