The U.S. Food and Drug Administration (FDA) has granted priority review to Dizal's new drug application (NDA) for sunvozertinib, an oral EGFR inhibitor, for the treatment of locally advanced or metastatic non-small cell lung cancer (NSCLC) in patients with epidermal growth factor receptor (EGFR) exon 20 insertion mutations (exon20ins) whose disease has progressed on or after platinum-based chemotherapy. This decision aims to expedite the availability of a potentially significant improvement in safety and effectiveness for a serious condition.
The FDA's priority review is based, in part, on data from the multinational pivotal WU-KONG1 Part B study, which included patients from Asia, Europe, North America, and South America. The study demonstrated statistically significant clinical benefits in patients with relapsed or refractory NSCLC harboring EGFR exon20ins mutations. These results were presented at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting.
Clinical Significance of Sunvozertinib
"Patients with EGFR exon20ins NSCLC face a poor prognosis and limited treatment options," said Xiaolin Zhang, PhD, CEO of Dizal. "Sunvozertinib's Priority Review designation marks an important regulatory milestone in Dizal's efforts to address unmet medical needs worldwide. If approved, sunvozertinib as a single oral drug would offer a convenient and safe treatment option with superior efficacy for NSCLC patients with EGFR exon20ins."
Sunvozertinib is an irreversible EGFR inhibitor that targets a wide spectrum of EGFR mutations with wild-type EGFR selectivity. It has already received accelerated approval from the National Medical Products Administration (NMPA) of China in August 2023 for treating advanced NSCLC with EGFR exon20ins after platinum-based chemotherapies. This approval was based on the results of the WU-KONG6 study.
Ongoing Clinical Trials
Dizal is currently conducting two global pivotal studies: WU-KONG1 Part B (≥ 2nd line) and WU-KONG28 (1st line setting), both focusing on NSCLC patients with EGFR exon20ins. Pre-clinical and clinical results of sunvozertinib have been published in peer-reviewed journals such as Cancer Discovery and The Lancet Respiratory Medicine.
Efficacy Data from WU-KONG1 Part B Trial
The phase 2 WU-KONG1 Part B trial (NCT03974022) investigated sunvozertinib in patients with relapsed/refractory NSCLC harboring EGFR exon 20 insertion mutations. Data from the trial, which were presented at the 2024 ASCO Annual Meeting, showed that evaluable patients who received sunvozertinib at 300 mg once daily (n = 107) achieved a best overall response rate (ORR) of 53.3% (97.5% CI, 42.0%-64.3%) and a confirmed ORR of 44.9% (97.5% CI, 34.0%-56.1%).
Best responses included complete response (CR; 2.8%), confirmed CR (1.9%), partial response (PR; 50.5%), confirmed PR (43.0%), PR pending confirmation (3.7%) stable disease (36.4%), and progressive disease (7.5%). Three patients were not evaluable for response.
Safety Profile
Sunvozertinib has demonstrated a well-tolerated and manageable safety profile in clinical trials. The most common drug-related treatment-emergent adverse events (TEAEs) were Grade 1/2 in nature and clinically manageable.
