WCLC 2025 - Posters & ePosters-P3.12.43 A Phase II Study of Sunvozertinib Combined With Anlotinib in NSCLC Patients Harboring EGFR Ex20Ins and Uncommon EGFR Mutations

P3.12.43 A Phase II Study of Sunvozertinib Combined With Anlotinib in NSCLC Patients Harboring EGFR Ex20Ins and Uncommon EGFR Mutations

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This Phase II open-label study evaluates the efficacy and safety of combining sunvozertinib, a selective oral EGFR tyrosine kinase inhibitor approved for NSCLC with EGFR exon 20 insertion mutations, with anlotinib, an anti-angiogenic VEGF inhibitor, in patients harboring EGFR exon 20 insertions and uncommon EGFR mutations.<br /><br />The trial enrolled 40 patients divided into two cohorts: previously untreated EGFR exon20ins patients (Cohort 1) and previously treated patients with uncommon EGFR mutations (Cohort 2). Part A assessed dose-limiting toxicities (DLTs) and safety with an initial sunvozertinib dose of 300 mg daily plus anlotinib 8 mg daily on days 1-14 of a 21-day cycle. No DLTs or serious adverse events occurred at this dose, establishing it as the recommended combination dose (RCD). Part B is an expansion phase at the RCD.<br /><br />By May 2025, 13 patients had been treated (12 exon20ins, 1 uncommon mutation). The combination yielded an objective response rate (ORR) of 84.6% and disease control rate (DCR) of 100%. Notably, the patient with uncommon EGFR mutations G719S and L861Q experienced complete remission of intracranial lesions. Safety profile was manageable: common treatment-emergent adverse events (≥30%) included rash, diarrhea, oral mucositis, and hypertension, mostly low grade. Only one patient required dose reduction for diarrhea; no treatment-related discontinuations or deaths occurred.<br /><br />In conclusion, sunvozertinib combined with anlotinib shows promising efficacy and tolerability in NSCLC patients with EGFR exon20ins and uncommon mutations, supporting further clinical investigation. The trial is registered under ClinicalTrials ID ChiCTR2400084053.

Asset Subtitle

Huiyang Shi

Meta Tag

Speaker Huiyang Shi

Topic Metastatic Non-small Cell Lung Cancer – Targeted Therapy

Keywords

sunvozertinib

anlotinib

EGFR exon 20 insertion mutations

uncommon EGFR mutations

non-small cell lung cancer

Phase II clinical trial

objective response rate

disease control rate

dose-limiting toxicities

treatment-emergent adverse events