WCLC 2025 - Posters & ePosters-P1.11.76 Bevacizumab Plus Serplulimab and Chemotherapy for EGFR-TKI-Resistant Non-Squamous Non-Small Cell Cancer: A Phase2Study

P1.11.76 Bevacizumab Plus Serplulimab and Chemotherapy for EGFR-TKI-Resistant Non-Squamous Non-Small Cell Cancer: A Phase2Study

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Pdf Summary

This multicenter, single-arm phase 2 study (NCT06334757) evaluated the feasibility, efficacy, and safety of a quadruple regimen combining bevacizumab (HLX04), serplulimab (HLX10), and platinum-based doublet chemotherapy in patients with EGFR-TKI-resistant non-squamous non-small-cell lung cancer (nsq-NSCLC). The study enrolled 46 patients aged 18-70 years with EGFR-mutated nsq-NSCLC who had progressed after first- to third-generation EGFR-TKI therapy, had ECOG performance status 0-1, and no prior immunochemotherapy exposure.<br /><br />Treatment consisted of dose-reduced bevacizumab (7.5 mg/kg), serplulimab (300 mg), and chemotherapy (pemetrexed 500 mg/m² and carboplatin AUC5) every three weeks for 4-6 cycles, followed by maintenance with all three agents until progression or unacceptable toxicity, for up to 2 years.<br /><br />The primary endpoint, objective response rate (ORR), was 47.8% (95% CI: 32.9-63.0%), surpassing the predefined target of 45.0%. Secondary endpoints showed a median progression-free survival (PFS) of 7.7 months and immature overall survival (OS) data at the time of analysis. Median time to response (TTR) and duration of response (DoR) were 1.5 and 6.2 months, respectively. Patients without brain metastases demonstrated better outcomes (ORR 52.4% vs. 44.0%; median PFS 9.5 vs. 7.1 months). PFS did not significantly differ based on prior EGFR-TKI therapy lines or regimens.<br /><br />Safety was manageable, with 80.4% experiencing any-grade adverse events (AEs) and 37.0% experiencing grade 3 AEs, predominantly hematologic toxicities including neutrophil count decrease (26.1%), white blood cell count decrease (19.6%), and platelet count decrease (17.4%).<br /><br />In conclusion, the combination of dose-reduced bevacizumab with serplulimab and chemotherapy demonstrated promising efficacy and tolerable safety in EGFR-TKI-resistant nsq-NSCLC, supporting further investigation of this regimen in this difficult-to-treat population.

Asset Subtitle

Qiming Wang

Meta Tag

Speaker Qiming Wang

Topic Metastatic Non-small Cell Lung Cancer – Immunotherapy

Keywords

EGFR-TKI-resistant non-squamous NSCLC

bevacizumab HLX04

serplulimab HLX10

platinum-based doublet chemotherapy

phase 2 clinical trial

objective response rate ORR

progression-free survival PFS

adverse events hematologic toxicity

non-small-cell lung cancer treatment

immunochemotherapy efficacy