Sunvozertinib Approved for EGFR Exon 20 Insertion Mutation–Positive NSCLC
Expert Perspectives · Lyn Brook · 2025-07-08
The FDA has granted accelerated approval to sunvozertinib (Zegfrovy®, Dizal (Jiangsu) Pharmaceutical Co., Ltd.) for the treatment of adult patients with locally advanced or metastatic non–small cell lung cancer (NSCLC) harboring epidermal growth factor receptor (EGFR) exon 20 insertion mutations, as detected by an FDA-approved test, whose disease has progressed on or after platinum-based chemotherapy.
In conjunction with this approval, the FDA also approved the Oncomine Dx Express Test (Life Technologies Corporation) as a companion diagnostic to aid in the detection of EGFR exon 20 insertion mutations in patients with NSCLC who may be eligible for treatment with sunvozertinib.
Why This Approval Matters
The accelerated approval of sunvozertinib introduces a novel, oral EGFR inhibitor specifically for patients with NSCLC harboring EGFR exon 20 insertion mutations, a subgroup historically associated with poor response to standard therapies. This approval offers a new treatment option for patients whose disease has progressed following platinum-based chemotherapy, addressing an unmet need in advanced NSCLC.
Breaking Down the WU-KONG1B Trial
Efficacy was evaluated in the WU-KONG1B trial (NCT03974022), a multinational, open-label, dose randomization study, which enrolled patients with locally advanced or metastatic NSCLC with EGFR exon 20 insertion mutations and who had disease progression on or after platinum-based chemotherapy. The primary efficacy population consisted of 85 patients who received sunvozertinib 200 mg orally, once daily with food, until disease progression or intolerable toxicity.
The primary efficacy end point was confirmed overall response rate (ORR) as assessed by a blinded independent review committee (BIRC) according to RECIST v1.1. An additional efficacy end point was duration of response (DOR) by BIRC. Sunvozertinib achieved an ORR of 46% with a median DOR of 11.1 months.
Managing Adverse Events
The prescribing information for sunvozertinib includes warnings and precautions for interstitial lung disease (ILD)/pneumonitis, gastrointestinal adverse reactions, dermatologic adverse reactions, ocular toxicity, and embryo-fetal toxicity. Clinicians should monitor for these potential adverse events and manage patients accordingly.
Conclusion
“Sunvozertinib demonstrated promising antitumor efficacy in platinum-pretreated NSCLC with EGFR exon 20 insertion mutations, with a tolerable safety profile,” concluded James Chih-Hsin Yang, MD, PhD, the Director and a Professor at the Graduate Institute of Oncology at the National Taiwan University Cancer Center and University Hospital, and colleagues, in their published results of the WU-KONG1B trial.
Dosing and Administration
The recommended dose of sunvozertinib is 200 mg orally, once daily with food, to be continued until disease progression or unacceptable toxicity.