The EGFR-targeting tyrosine kinase inhibitor sunvozertinib was more effective than standard platinum-based chemotherapy as a first-line treatment for patients with advanced non–small cell lung cancer (NSCLC) driven by EGFR exon 20 insertion mutations (EGFR exon20ins).
Results from the phase III WU-KONG28 trial revealed that sunvozertinib significantly extended progression-free survival to more than 10 months, compared to 7.5 months with chemotherapy alone. Patients receiving sunvozertinib had an objective response rate of 58.9%, compared with 31.1% in the patients receiving platinum-based chemotherapy.
The findings were presented at the 2026 ASCO Annual Meeting (Abstract LBA8500) by lead author John Heymach, MD, PhD, Chair of Thoracic/Head and Neck Medical Oncology at The University of Texas MD Anderson Cancer Center, and published simultaneously in The New England Journal of Medicine.
“For years, patients with lung cancer harboring EGFR exon 20 insertion mutations have faced poor outcomes because available treatments simply didn’t work well, or have substantial toxicities,” Dr. Heymach said. “These results show that sunvozertinib can control the disease longer and shrink tumors more often than chemotherapy, offering a new, much-needed option for those starting treatment.”
EGFR exon20ins mutations occur in a small group of patients with NSCLC, and these cancers are especially difficult to treat because they do not respond well to earlier generations of targeted therapies. Sunvozertinib is a next‑generation EGFR inhibitor designed specifically to block the abnormal signaling caused by these exon20ins mutations.
Sunvozertinib is taken as an oral pill, which can make treatment more convenient for patients and reduce the amount of time needed in the clinic or hospital.
In August 2023, sunvozertinib was granted accelerated approval by the U.S. Food and Drug Administration for patients with advanced NSCLC with EGFR exon20ins who had previously been treated with platinum-based chemotherapy.
Other Key Findings
WU-KONG28 researchers enrolled 324 patients who were randomly assigned to receive either sunvozertinib once daily or standard chemotherapy with carboplatin and pemetrexed, followed by pemetrexed maintenance. Patients receiving chemotherapy were allowed to switch to sunvozertinib if their cancer progressed.
Responses lasted a median of 11.2 months with sunvozertinib vs 7.1 months with chemotherapy. Side effects were consistent with earlier studies; only 7.4% of patients stopped treatment due to drug-related side effects, and no treatment‑related deaths occurred.
Limitations of the study include that the overall survival results aren’t detailed yet. Also, because most patients on chemotherapy switched to sunvozertinib once their cancer progressed, it makes long‑term comparisons between the two groups difficult.
DISCLOSURE: For full disclosures of the study authors, visit coi.asco.org.
