Source: MPR
URL: https://www.empr.com/news/fda-greenlights-oral-therapy-for-nsclc-with-egfr-exon20-insertion-mutations/
The FDA has granted accelerated approval to sunvozertinib (Zegfrovy®), the first oral targeted therapy for NSCLC patients with EGFR exon 20 insertion mutations who have progressed on platinum-based chemotherapy. This once-daily oral medication achieved a 46% confirmed overall response rate with a median duration of response of 11.1 months, providing a convenient treatment option for a previously difficult-to-treat patient population.
Study Design & Population
- Single-arm trial (WU-KONG1B) supporting accelerated approval
- 85 patients in primary efficacy population
- Locally advanced or metastatic NSCLC with EGFR exon 20 insertion mutations
- Disease progression on or after platinum-based chemotherapy
- Dosing: 200mg orally once daily with food until progression or intolerable toxicity
Key Findings:
- Primary endpoint: Confirmed overall response rate 46% (95% CI: 35-57%)
- Duration of response: 11.1 months (95% CI: 8.2 months to not evaluable)
- Consistent efficacy demonstrated across Asian and non-Asian populations
- First-in-class oral irreversible EGFR inhibitor for this specific mutation
Clinical Implications:
- Fills critical treatment gap for EGFR exon 20 insertion mutations, previously lacking targeted oral options
- Once-daily oral dosing improves patient convenience and adherence compared to IV therapies
- FDA-approved companion diagnostic (Oncomine™ Dx Express Test) required for patient selection
- Represents paradigm shift toward chronic disease management in lung cancer care
Limitations:
- Accelerated approval based on single-arm trial without comparator arm
- Safety profile includes warnings for interstitial lung disease/pneumonitis, GI/dermatologic reactions, and ocular toxicity
- Long-term survival data pending from ongoing studies
- Limited to post-platinum therapy setting
