Dizal Pharmaceuticals announced that the Center for Drug Evaluation (CDE) of China’s National Medical Products Administration (NMPA) has granted Breakthrough Therapy Designation (BTD) to sunvozertinib for the first-line treatment of locally advanced or metastatic non-small cell lung cancer (NSCLC) harboring epidermal growth factor receptor (EGFR) exon 20 insertion mutations (exon20ins) in patients who have not received prior systemic therapies. This marks the fourth BTD for sunvozertinib in this indication, including a previous designation from the U.S. FDA.
The BTD is designed to expedite the development and review of promising medicines for serious conditions. According to Dizal, sunvozertinib is the first and only oral drug approved for lung cancer patients with EGFR exon20ins.
Clinical Efficacy and Safety
The CDE's decision was based on pooled data from the global multi-center Phase I/II WU-KONG1 study and the Phase II WU-KONG15 study, which focused on Chinese patients. The results showed that sunvozertinib, administered as a single oral agent, achieved a confirmed objective response rate (cORR) of 78.6% and a median progression-free survival (mPFS) of 12.4 months in treatment-naïve patients with advanced or metastatic NSCLC with EGFR exon20ins. The company also reported that sunvozertinib was well-tolerated, with an overall safety profile similar to classic EGFR-TKIs.
Ongoing Phase III Trial
Currently, sunvozertinib is being evaluated in the Phase III WU-KONG28 study, a multinational, randomized trial comparing sunvozertinib to platinum doublet chemotherapies in treatment-naive patients globally.
Addressing Unmet Needs in NSCLC
NSCLC with EGFR exon20ins mutations presents a significant challenge due to the unique spatial conformation, diverse mutation subtypes, and high heterogeneity of these mutations. According to Dizal, in some regions, an antibody with platinum-containing chemotherapies is the only treatment option available in the first-line setting.
Prior Approvals and Further Studies
Sunvozertinib received approval in China in 2023 for the treatment of relapsed or refractory NSCLC with EGFR exon20ins, based on the results of the WU-KONG6 study. Dizal presented results from the WU-KONG1 Part B study, a multinational trial, at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting, where it met its primary endpoint. Regulatory submissions for market approvals are ongoing.
About Sunvozertinib
Sunvozertinib (DZD9008) is an irreversible EGFR inhibitor discovered by Dizal scientists. It targets a wide spectrum of EGFR mutations with selectivity for wild-type EGFR. It was approved in China in August 2023 for advanced NSCLC with EGFR exon20ins after platinum-based chemotherapies, based on the WU-KONG6 study, where the confirmed overall response rate (cORR) reached 60.8% as assessed by the Independent Review Committee (IRC).
