The FDA has granted accelerated approval to sunvozertinib (Zegfrovy) for adults with locally advanced or metastatic non-small cell lung cancer (NSCLC) that has EGFR exon 20 insertion mutations and has progressed after platinum-based chemotherapy. These mutations are found in about 2% of NSCLC cases and have historically responded poorly to standard EGFR tyrosine kinase inhibitors (TKIs), resulting in limited effective therapies and a poor prognosis for affected patients.
Alongside the drug approval, the FDA also cleared the Oncomine Dx Express Test to help identify patients with these specific EGFR mutations who may benefit from Zegfrovy.
In a clinical trial, patients taking sunvozertinib showed a confirmed overall response rate of 46% and a median duration of response of 11.1 months. Common side effects and warnings include risks for interstitial lung disease (ILD)/pneumonitis, gastrointestinal and skin reactions, eye toxicity, and embryo-fetal toxicity.
This new treatment offers an important option for patients with this hard-to-treat form of lung cancer, providing hope for improved outcomes where few therapies are available.
About Sunvozertinib
Sunvozertinib is a selective, irreversible EGFR inhibitor specifically designed to target exon 20 insertion mutations. In clinical trials, it has demonstrated notable anti-tumor activity and higher response rates compared to previous therapies for this subgroup. For example, in pivotal studies, sunvozertinib showed an overall response rate (ORR) of up to 79% in the first-line setting and 46% in previously treated patients, with a median progression-free survival (PFS) of up to 12 months. This is a significant improvement over conventional treatments, where patients with these mutations typically have shorter survival times and fewer options.
Additionally, sunvozertinib has shown activity across different subtypes of EGFR exon 20 insertions and even in patients with prior treatments or brain metastases. Its approval provides a targeted therapy option for patients whose disease has progressed after platinum-based chemotherapy, offering hope for better disease control and longer survival.
More Reading
In Depth Overview of Tyrosine Kinase Inhibitor Treatment of EGFR + Lung Cancer
Reference
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
