NMPA Grants Marketing Approval to NGS-Based Companion Diagnostic for Sunvozertinib in EGFR Exon 20+ NSCLC

China’s National Medical Products Administration (NMPA) has granted marketing approval to LungCure CDx, a next generation sequencing (NGS)–based companion diagnostic, to guide the use of sunvozertinib (DZD9008) in EGFR exon 20 insertion mutation–positive non–small cell lung cancer (NSCLC).¹

This regulatory decision serves as the first NMPA approval of a co-developed NGS-based companion diagnostic since the release of the companion diagnostic guidelines in China, according to Burning Rock Biotech Limited and Dizal, the drug’s developers.

LungCure CDx is a multi-gene tumor mutation co-detection test kit utilized for in vitro detection of EGFR, MET, ERBB2, KRAS, BRAF, PIK3CA, ALK, ROS1, and RET mutations or alterations in NSCLC. The diagnostic test is vital for comprehensive navigation of targeted therapy selection for patients harboring alterations in any of these genes.

The NMPA approved the registration of LungCure CDx as a Class III medical device product on March 11, 2022.

“We are thrilled to have carried out a deep companion diagnostic collaboration with the global biopharmaceutical company Dizal,” Yusheng Han, founder and chief executive officer of Burning Rock Biotech, stated in a news release. “This collaboration sets a standardized and high-quality benchmark for the concurrent development of companion diagnostics for anti-tumor drugs. 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 patients [with cancer]."

On August 23, 2023, sunvozertinib received NMPA approval for use in adult patients with locally advanced or metastatic NSCLC who harbor an EGFR exon 20 insertion mutation and whose disease has progressed on or following platinum-based chemotherapy.²

Findings from the phase 2 WO-KONH6 trial (NCT05712902) supported this regulatory decision, showing that patients treated with this irreversible EGFR inhibitor at the recommended phase 2 dose of 300 mg daily achieved an objective response rate (ORR) of 60.8% (95% CI, 50.4%-70.6%; P < .0001). Additionally, 26.8% of patients achieved stable disease, 6.2% had progressive disease, and 6.2% were not evaluable for response. The disease control rate was 87.6% (95% CI, 79.4%-93.4%).³

Sunvozertinib was also granted FDA breakthrough therapy designation for patients with relapsed/refractory locally advanced or metastatic NSCLC harboring EGFR exon 20 insertion mutations in January 2022, and as frontline treatment for this patient population in April, 2024.^4,5

The agent’s frontline approval was supported by results from the global, multi-center, phase 1/2 WU-KONG1 trial (NCT03974022), which were presented at the 2023 ESMO Congress. At a median follow-up of 10.8 months, the confirmed ORR with sunvozertib (n = 9) was 78.6% and the median progression-free survival was 12.4 months.⁶

“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,” Xiaolin Zhang, PhD, founder, chairman, and chief executive officer of Dizal concluded. “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.”

References

1. NMPA grants marketing approval to the first co-developed NGS-based companion diagnostic for lung cancer in China.News release. Burning Rock Biotech. October 11, 2024. Accessed October 11, 2024. https://us.brbiotech.com/news/2024/nmpa-grants-marketing-approva/
2. Dizal’s sunvozertinib approved in China NMPA with potential best-in-class therapy in NSCLC with EGFR exon20ins mutations. News release. Dizal. August 23, 2023. Accessed October 11, 2024. http://www.dizalpharma.com/news/detail?id=59
3. Wang M, Fan Y, Sun M, et al. Sunvozertinib for the treatment of NSCLC with EGFR exon20 insertion mutations: the first pivotal study results. J Clin Oncol. 2023;41(suppl 16):9002. doi:10.1200/JCO.2023.41.16_suppl.9002
4. FDA grants breakthrough therapy designation for Dizal Pharmaceutical’s DZD9008 in patients with locally advanced or metastatic non-small cell lung cancer harboring EGFR exon20 insertion. News release. Dizal Pharmaceutical Co. Ltd. January 28, 2022. Accessed October 11, 2024. https://www.dizalpharma.com/news/detail?id=19
5. FDA grants breakthrough therapy designation to sunvozertinib for the first-line treatment of patients with advanced non-small cell lung cancer harboring EGFR exon 20 insertion mutations. News Release. Dizal Pharma. April 7, 2024. Accessed October 11, 2024. https://www.dizalpharma.com/news/detail?id=70&search=&currentPage=1
6. Yang JCH, Wang M, Chiu CH, et al. Sunvozertinib as first-line treatment in NSCLC patients with EGFR exon20 insertion mutations. Ann Oncol. 2023;34(suppl 2):S765. doi:10.1016/j.annonc.2023.09.2358