Sunvozertinib New Drug Application in EGFR-Mutant NSCLC Submitted to FDA

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• The new drug application (NDA) of sunvozertinib in relapsed/refractory non–small cell lung cancer (NSCLC) with EGFR exon 20 insertion mutations has been submitted to the FDA.
• The application is supported by data from the phase 2 WU-KONG1 part B study (NCT03974022).
• Data from WU-KONG1 part B were presented at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting.

The NDA of sunvozertinib for the treatment of patients with relapsed/refractory NSCLC with EGFR exon 20 insertion mutations whose disease has progressed on or after platinum-based chemotherapy has been submitted to the FDA, according to Dizal Pharmaceutical, the drug’s developer.¹

The submission is supported by the pivotal phase 2 WU-KONG1 part B study. Data presented at the 2024 ASCO Annual Meeting showed that the best overall response rate (ORR) was 54.3% per independent review committee, meeting the primary end point of the study, and 2.9% of patients had a confirmed complete response. 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.²

Regarding safety, the observed adverse events (AEs) were similar to previous reports of sunvozertinib in other studies. The most common treatment-emergent AEs included diarrhea, skin rash, and increased creatine phosphokinase. Most AEs were grade 1 or 2 and manageable.

“In terms of safety, it is an oral single agent, and the AEs we have found from part B are consistent with WU-KONG6 [NCT05668988] data we have reported previously. The diarrhea increased a few percentages and partly reflect [that this] is a global study. And we have different regions, they have different levels of experience to manage that AE,” said Xiaolin Zhang, PhD, chief executive officer of Dizal, in an interview with Targeted Oncology^TM. “Still, that is a very tolerable agent, because it is a single agent, oral, you do not need [intravenous (IV) access], you do not have any IV-related injection site adverse effects. And you do not have to combine with the chemo[therapy], because once you have to combine with chemo[therapy], there are a lot of issues.”

In April 2024, the FDA granted breakthrough therapy designation to sunvozertinib in this patient population. Further, the agent is already approved in China, supported by data from the WU-KONG6 clinical trial.³

REFERENCES:

1. Dizal submits new drug application to the U.S. FDA for sunvozertinib in treating relapsed or refractory non-small cell lung cancer with EGFR exon 20 insertion mutations. News release. Dizal Pharmaceutical. November 8, 2024. Accessed November 8, 2024. https://tinyurl.com/3tevwmpw

2. Yang JCH, Doucet L, Wang M, et al. A multinational pivotal study of sunvozertinib in platinum pretreated non-small cell lung cancer with EGFR exon 20 insertion mutations: Primary analysis of WU-KONG1 study. J Clin Oncol. 42, 2024 (suppl 16):abstr 8513. doi:10.1200/JCO.2024.42.16_suppl.8513

3. 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 Pharmaceutical. April 7, 2024. Accessed November 8, 2024. https://tinyurl.com/bdfy2j53