FDA Reviewing Sunvozertinib for EGFR Exon 20 Insertion-Mutated NSCLC
核心洞察
The FDA is reviewing sunvozertinib for relapsed/refractory NSCLC (搜索) with EGFR (搜索) exon 20 insertion mutations after platinum-based chemotherapy.
The application is supported by the phase 2 WU-KONG1 part B study, which showed a 54.3% overall response rate.
Sunvozertinib, an oral single agent, has demonstrated a manageable safety profile, with mostly grade 1 or 2 adverse events.
Dizal Pharmaceutical's new drug application (NDA) for sunvozertinib has been submitted to the FDA for the treatment of relapsed/refractory non-small cell lung cancer (NSCLC (搜索)) harboring EGFR (搜索) exon 20 insertion mutations. This submission marks a significant step forward for patients who have progressed on or after platinum-based chemotherapy, addressing a critical unmet need in this specific patient population. The FDA is currently evaluating the application.
The NDA is based on data from the pivotal phase 2 WU-KONG1 part B study (NCT03974022), which evaluated the efficacy and safety of sunvozertinib in this patient population. Key findings from the WU-KONG1 part B study, presented at the 2024 ASCO Annual Meeting, demonstrated a best overall response rate (ORR) of 54.3% per independent review committee, meeting the primary endpoint of the study. Furthermore, 2.9% of patients achieved a confirmed complete response, and the disease control rate was 90.8%. With a median follow-up of 5.5 months, the duration of response was not yet met, and 74.6% of responders had ongoing response.
Safety Profile
The safety profile of sunvozertinib observed in the WU-KONG1 part B study was consistent with previous reports. The most common treatment-emergent adverse events (AEs) included diarrhea, skin rash, and increased creatine phosphokinase. The majority of these AEs were grade 1 or 2 and were manageable. According to Xiaolin Zhang, PhD, chief executive officer of Dizal, the adverse events observed are consistent with previous data, and the agent is considered tolerable due to its oral administration and lack of requirement for intravenous access or combination with chemotherapy.
Regulatory Status and Breakthrough Therapy Designation
In April 2024, the FDA granted breakthrough therapy designation to sunvozertinib for the treatment of patients with relapsed/refractory NSCLC (搜索) with EGFR (搜索) exon 20 insertion mutations. Sunvozertinib is already approved in China, based on data from the WU-KONG6 clinical trial.