Dizal Submits Sunvozertinib NDA to FDA for EGFR Exon 20 Mutant NSCLC

Dizal, a biopharmaceutical firm based in Shanghai, has recently applied for approval from the U.S. Food and Drug Administration (FDA) for their drug, sunvozertinib. This new drug targets patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) characterized by epidermal growth factor receptor (EGFR) exon 20 insertion mutations (exon20ins). The disease in these patients has typically progressed after platinum-based chemotherapy. Sunvozertinib has already been granted accelerated approval in China, making it the first and only oral medication globally for NSCLC patients with EGFR exon20ins.

The application for FDA approval is backed by data from the WU-KONG1 Part B study, a critical international study that examines the effectiveness and safety of sunvozertinib in patients from various regions including Asia, Europe, North America, and South America who have relapsed or are refractory to standard treatments. The drug achieved its primary goal by showing a statistically significant and clinically meaningful objective response rate (ORR) as evaluated by an independent review committee. Importantly, the drug maintained a manageable safety profile. Findings from this study were highlighted during an oral session at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting.

Dr. Xiaolin Zhang, CEO of Dizal, expressed optimism about sunvozertinib's potential to improve outcomes for patients with this specific type of NSCLC. He highlighted that this submission marks Dizal's first New Drug Application (NDA) to the FDA, a significant milestone in their mission to address unmet medical needs on a global scale. Zhang emphasized the company's commitment to collaborating closely with the FDA during the review process.

Lung cancer remains the leading cause of cancer-related deaths worldwide, with NSCLC making up about 80%-85% of all lung cancer cases. Patients with NSCLC harboring EGFR exon20ins mutations generally face a worse prognosis compared to those with other EGFR mutations. Sunvozertinib, designed with a novel molecular structure, promises better efficacy, safety, and ease of administration.

Sunvozertinib is an irreversible EGFR inhibitor developed by Dizal to target a broad range of EGFR mutations while sparing the wild-type EGFR. In August 2023, the drug received approval from the National Medical Products Administration (NMPA) in China to treat advanced NSCLC with EGFR exon20ins after platinum-based chemotherapies. This approval was based on the WU-KONG6 study, which demonstrated a confirmed overall response rate (cORR) of 60.8% as assessed by an independent review committee. The drug showed anti-tumor efficacy across various EGFR exon20ins subtypes, including patients with pretreated and stable brain metastasis. Additionally, it exhibited promising activity in NSCLC patients with other EGFR mutations such as T790M and uncommon mutations like G719X and L861Q, as well as HER2 exon20ins.

Sunvozertinib has been well-tolerated in clinical settings, with most treatment-emergent adverse events being Grade 1/2 and clinically manageable. Two pivotal global studies are currently ongoing, one in the second-line setting (WU-KONG1 Part B) and another in the first-line setting (WU-KONG28), both targeting NSCLC patients with EGFR exon20ins.

Dizal continues to dedicate itself to the development and commercialization of innovative therapeutics for cancer and immunological diseases. With a focus on creating first-in-class and groundbreaking medicines, the company is committed to addressing unmet medical needs worldwide. Their robust research and development pipeline, grounded in translational science and molecular design, positions them as a competitive player on the international stage.