Fourth Breakthrough Therapy Designation for sunvozertinib in NSCLC with EGFR exon20ins

Dizal (SSE:688192), a biopharmaceutical company committed to developing novel medicines for the treatment of cancer and immunological diseases, announced that the Center for Drug Evaluation (CDE) of China's National Medical Products Administration (NMPA) has granted Breakthrough Therapy Designation (BTD) for sunvozertinib for the first-line treatment of patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) harboring epidermal growth factor receptor (EGFR) exon 20 insertion mutations (exon20ins) who have not received prior systemic therapies.

This designation is the fourth BTD that Dizal has received for sunvozertinib in EGFR exon20ins NSCLC. It follows the grant by the U.S. Food and Drug Administration (FDA) for the first-line setting in April this year. Sunvozertinib was previously granted BTDs by both the U.S. FDA and the China CDE for relapsed or refractory patients.

BTD procedures in the US and China are designed to expedite the development and regulatory review of new medicines that are intended to treat serious or life-threatening conditions with preliminary clinical evidence indicating substantial improvement over available therapies. Drug candidates with BTD can be considered for priority review when submitting a New Drug Application (NDA).

"The total of four Breakthrough Therapy Designations by both the U.S. and China's regulatory agencies, reflects not only sunvozertinib's transformative potential in EGFR exon20ins NSCLC, but also Dizal's commitment to developing groundbreaking new medicines to address unmet medical needs globally." said Xiaolin Zhang, PhD, CEO of Dizal, "Sunvozertinib is the world first and only oral drug approved for the treatment of lung cancer patients with EGFR exon20ins. We are accelerating ongoing clinical studies and regulatory submissions, hoping to bring this new treatment option to more patients as quickly as possible."

The CDE granted the BTD based on results from the pooled analysis of the global multi-center phase I/II study (WU-KONG1) and the phase II study (WU-KONG15) focused on patients from China. Results from these studies showed that sunvozertinib, as a single oral agent, produced 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. Additionally, sunvozertinib is well tolerated with overall safety profile similar to classic EGFR-TKIs.

Currently, sunvozertinib is being evaluated in the WU-KONG28 study, a phase III, multinational, randomized study to compare sunvozertinib vs. platinum doublet chemotherapies in treatment naive patients globally.

NSCLC with EGFR exon20ins are difficult to treat due to their unique spatial conformation, diverse mutation subtypes, and high heterogeneity. In some parts of the world, an antibody with platinum containing chemotherapies is the only treatment option in the first line setting.

Sunvozertinib was approved in China for the treatment of relapsed or refractory NSCLC with EGFR exon20ins in 2023 based on WU-KONG6 study results. In an oral presentation at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting, Dizal revealed its WU-KONG1 Part B study results, a multinational study with patients from Asia, Europe, North America, and South America. The study met its primary endpoint. Regulatory submissions for market approvals are ongoing.

References：
[1] Yan Xu, et al. 2023ASCO Abstract#9073.
[2] Bazhenova L, et al. Lung Cancer. 2021 Dec,162154-161.
[3] James Chih-Hsin Yang,et al. 2024ASCO #8513.