Sunvozertinib

(Zegfrovy®)

Zegfrovy®

Drug updated on 8/13/2025

Dosage FormTablet (oral; 150 mg, 200 mg)
Drug ClassKinase inhibitors
Ongoing and
Completed Studies
ClinicalTrials.gov

Indication

  • Indicated for the treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with 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

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Summary
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  • This summary is based on the review of one systematic review/meta-analysis. [1]
  • Population and outcomes: patients with non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 20 insertion mutations; outcomes included overall response rate (ORR), disease control rate (DCR), progression-free survival (PFS), and overall survival (OS).
  • Pooled effectiveness: ORR 0.486 (95% confidence interval [CI], 0.369-0.602); DCR 0.843 (95% CI, 0.740-0.946); median PFS 10.11 months (95% CI, 9.58-10.64 months); median OS 23.00 months (95% CI, 20.30-25.69 months).
  • Drug-specific ORR: YK-029A 0.731 (95% CI, 0.560-0.901), sunvozertinib 0.608 (95% CI, 0.511-0.705), furmonertinib 0.602 (95 % CI, 0.440-0.764), befotertinib 0.602 (95% CI, 0.486-0.718), amivantamab 0.566 (95% CI, 0.236-0.896), BEBT-109 0.444 (95% CI, 0.215-0.674), poziotinib 0.256 (95% CI, 0.178-0.334); only ORR was compared across drugs, as DCR, PFS, and OS were not detailed per drug.
  • In patients with NSCLC harboring EGFR exon 20 insertions, the pooled incidence of grade >= 3 treatment-related adverse events (TRAEs) was 0.458 (95% CI, 0.336-0.580; I-squared [I^2] = 96.9%; P < 0.001).
  • Most reported TRAEs: diarrhoea 0.112 (95% CI, 0.060-0.164), thrombocytopenia 0.065 (95% CI, -0.012-0.141), anaemia 0.040 (95% CI, 0.005-0.076); studies did not provide specific safety outcomes for other drugs, precluding direct comparisons.
  • Patients had NSCLC with EGFR exon 20 insertion mutations; no subgroup-specific findings or differential effects were reported beyond this population.

Product Monograph / Prescribing Information

Document TitleYearSource
Zegfrovy (sunvozertinib) Prescribing Information2025Dizal Pharmaceutical Co., Ltd. Shanghai, China

Systematic Reviews / Meta-Analyses