NMPA Approves First NGS-Based Companion Diagnostic for Lung Cancer with Sunvozertinib
核心洞察
The NMPA has approved the first co-developed NGS-based companion diagnostic (CDx) for lung cancer (搜索) in China, LungCure CDx, developed by Burning Rock and Dizal (搜索).
LungCure CDx is designed to identify EGFR (搜索) exon 20 insertion mutations in NSCLC (搜索) patients, guiding the use of Dizal (搜索)'s targeted therapy, sunvozertinib.
Sunvozertinib, an irreversible EGFR (搜索) inhibitor, has already received approval in China for advanced NSCLC (搜索) patients with EGFR exon20ins mutations after platinum-based chemotherapy.
The National Medical Products Administration (NMPA) of China has granted marketing approval to LungCure CDx, the first co-developed next-generation sequencing (NGS)-based companion diagnostic for lung cancer (搜索). Developed through a collaboration between Burning Rock Biotech Limited (搜索) and Dizal (搜索), this diagnostic tool is designed to identify EGFR (搜索) exon 20 insertion mutations (exon20ins) in patients with non-small cell lung cancer (NSCLC (搜索)), facilitating the use of Dizal's targeted therapy, sunvozertinib.
This approval marks a significant advancement in precision oncology in China, providing a comprehensive solution for identifying and treating NSCLC (搜索) patients with specific EGFR (搜索) mutations. The simultaneous development of LungCure CDx and sunvozertinib offers an innovative approach to personalized medicine in lung cancer (搜索) treatment.
LungCure CDx: A Comprehensive Diagnostic Tool
LungCure CDx is a multi-gene tumor mutation co-detection test kit that allows for in vitro detection of mutations in genes such as EGFR (搜索), MET, ERBB2, KRAS, BRAF, PIK3CA, ALK, ROS1, and RET in NSCLC (搜索) patients. This comprehensive detection capability enhances the identification of rare mutation types, enabling more precise treatment decisions. Approved as a Class III medical device product by the NMPA on March 11, 2022, LungCure CDx has undergone rigorous clinical validation to ensure its accuracy and reliability.
Sunvozertinib: A Targeted Therapy for EGFR Exon20ins Mutations
Sunvozertinib is an irreversible EGFR (搜索) inhibitor developed by Dizal (搜索), targeting a wide spectrum of EGFR mutations with selectivity for wild-type EGFR. In August 2023, sunvozertinib received approval from the NMPA for the treatment of advanced NSCLC (搜索) with EGFR exon20ins mutations after platinum-based chemotherapies. The approval was based on the results of the WU-KONG6 study, a pivotal trial demonstrating a confirmed objective response rate (cORR) of 61% as assessed by the Independent Review Committee (IRC).
Clinical Efficacy and Safety of Sunvozertinib
The WU-KONG6 study demonstrated that sunvozertinib exhibited anti-tumor efficacy across a broad range of EGFR (搜索) exon20ins subtypes, including in patients with pretreated and stable brain metastasis. Additionally, sunvozertinib showed encouraging anti-tumor activity in NSCLC (搜索) patients with EGFR sensitizing, T790M, and uncommon mutations such as G719X and L861Q. The drug has a well-tolerated and manageable safety profile, with most treatment-emergent adverse events (TEAEs) being Grade 1/2 in nature and clinically manageable.
Ongoing Clinical Trials
Two global pivotal studies are currently underway to further evaluate sunvozertinib in NSCLC (搜索) patients with EGFR (搜索) exon20ins mutations: WU-KONG1 Part B (≥ second-line setting) and WU-KONG28 (first-line setting). These trials aim to solidify the role of sunvozertinib as a key treatment option for this patient population.
Industry Collaboration and Future Implications
The collaboration between Burning Rock and Dizal (搜索) exemplifies a standardized and high-quality benchmark for the concurrent development of companion diagnostics for anti-tumor drugs. Yusheng Han, Founder and CEO of Burning Rock, stated, "Burning Rock is strategically positioned to drive companion diagnostic development on a global scale for pharmaceutical companies. By integrating our resources and experience in the field of oncology diagnosis and treatment, we are confident that we can offer more precise treatment options for Chinese cancer patients."
Dr. Xiaolin Zhang, Founder, Chairman, and CEO of Dizal (搜索), added, "This achievement can be attributed to the collaborative innovation of the professional teams from both sides and reflects our unremitting pursuit of creating clinical value for the benefit of patients. Precision therapy is one of the core strategies of Dizal. Dizal will continue to adhere to the discovery and development of groundbreaking new medicines, and work with our partners to bring new hope of precision treatment to more patients."