The Phase 3 WU-KONG28 trial shows that sunvozertinib (Zegfrovy) is more effective than standard chemotherapy for patients with advanced non-small cell lung cancer (NSCLC) carrying EGFR exon 20 insertion mutations.
Sunvozertinib significantly delayed cancer growth, offering superior progression-free survival compared with traditional platinum-based chemotherapy. It also outperformed chemotherapy in overall response and disease control rates, providing a potential oral, chemotherapy-free first-line treatment option.
EGFR exon 20 insertion mutations are difficult to treat because of their many subtypes, natural resistance to older EGFR inhibitors, and generally poor prognosis, with median survival around 16 months. Patients with this mutation are often younger non-smokers.
Sunvozertinib is an irreversible inhibitor that targets these diverse mutations while sparing healthy cells. It received accelerated FDA approval in July 2025 based on prior studies showing a 46% response rate. The success of the WU-KONG28 trial, conducted across 16 countries, supports sunvozertinib as a promising new standard of care for newly diagnosed patients.