The FDA has granted accelerated approval to sunvozertinib (Zegfrovy) for the treatment of adult patients with locally advanced or metastatic non–small cell lung cancer (NSCLC) harboring EGFR exon 20 insertion mutations, as detected by an FDA-approved test, whose disease has progressed on or following platinum-based chemotherapy.1
The efficacy of the agent was examined in the multinational, open-label WU-KONG1b trial (NCT03974022). Data showed that sunvozertinib elicited an objective response rate of 46% (95% CI, 35%-57%), with a duration of response of 11.1 months (95% CI, 8.2-not evaluable).
About the Trial
WU-KONG1 Part B enrolled patients with locally advanced or metastatic NSCLC with EGFR exon 20 insertion mutations confirmed in tumor tissue.2 Patients needed to have an ECOG performance status of 0 or 1 and have received prior treatment with platinum-based chemotherapy.
Patients were randomly assigned 1:1 to receive sunvozertinib at 200 mg daily or 300 mg daily. At the interim analysis, 111 patients went on to receive continuous dosing of the agent at 300 mg daily until trial discontinuation criteria were met.
Independent review committee (IRC)–assessed ORR served as the trial’s primary end point. IRC-assessed duration of response (DOR) was a key secondary end point. Other secondary end points included investigator-assessed ORR and DOR.
Safety Spotlight
The most common grade 3 or higher treatment-related adverse effects (TRAEs) observed with the agent at the 300-mg dose included diarrhea (17.1%), increased blood creatinine phosphokinase levels (10.8%), anemia (3.6%), rash (3.6%), increased lipase levels (3.6%), decreased neutrophil counts (2.7%), hypokalemia (2.7%), decreased appetite (2.7%), and asthenia (2.7%). TRAEs led to dose reduction and treatment discontinuation in 36.0% and 6.3% of patients, respectively. Investigators noted that most of the common TRAEs were grade 1 or 2 in severity and clinically manageable. No TRAEs led to fatal outcomes.
What Came Before
Previously, in April 2024, the FDA granted breakthrough therapy designation to sunvozertinib for patients with treatment-naive NSCLC harboring an EGFR exon 20 insertion mutation.3
References
- FDA grants accelerated approval to sunvozertinib for metastatic non-small cell lung cancer with EGFR exon 20 insertion mutations. FDA. July 2, 2025. Accessed July 2, 2025. https://www.fda.gov/drugs/resources-information-approved-drugs/fda-grants-accelerated-approval-sunvozertinib-metastatic-non-small-cell-lung-cancer-egfr-exon-20
- Yang J CH, 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. 2024;42(suppl 16)8513. doi:10.1200/JCO.2024.42.16_suppl.8513
- 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 Pharma. April 7, 2024. Accessed July 2, 2025. https://www.dizalpharma.com/news/detail?id=70&search=¤tPage=1