WCLC 2025 - Posters & ePosters-P3.12.25 First-Line HLX07 Plus Serplulimab With or Without Chemotherapy in Squamous Non-Small Cell Lung Cancer: A Phase 2 Study

P3.12.25 First-Line HLX07 Plus Serplulimab With or Without Chemotherapy in Squamous Non-Small Cell Lung Cancer: A Phase 2 Study

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This randomized, multicenter phase 2 study evaluated the efficacy and safety of the tri-combination regimen HLX07 (a novel humanized anti-EGFR monoclonal antibody), serplulimab (an anti-PD-1 antibody), and chemotherapy as first-line treatment for advanced squamous non-small cell lung cancer (NSCLC). The study enrolled 27 patients, assigned to two groups receiving different HLX07 doses alongside serplulimab and chemotherapy. Patients had stage IIIB/IIIC or IV squamous NSCLC, ECOG performance status 0 or 1, and confirmed EGFR expression (H-score ≥150).<br /><br />Tumor response was assessed using RECIST v1.1 by blinded independent central review (BICR). Primary endpoints were objective response rate (ORR) and progression-free survival (PFS). Secondary endpoints included duration of response (DOR), disease control rate (DCR), overall survival (OS), safety, pharmacokinetics, immunogenicity, and quality of life.<br /><br />Results showed encouraging antitumor activity in both groups, with BICR-assessed ORRs of 69.2% (group A) and 71.4% (group B), and DCRs of 92.3% and 100%, respectively. Median PFS was not reached in group A and was 17.4 months in group B. Median DOR and OS were not reached in either group, indicating sustained responses. Adverse events (AEs) were common, with all patients experiencing treatment-emergent AEs and grade 3 AEs reported in over 90%. Immune-related adverse events occurred in approximately 46% (group A) and 57% (group B) of patients. The most frequent grade 3 treatment-emergent AEs included decreased neutrophil and white blood cell counts, anemia, pneumonia, and hypokalemia.<br /><br />The study concludes that HLX07 combined with serplulimab and chemotherapy offers a manageable safety profile and promising antitumor efficacy in advanced squamous NSCLC, warranting further investigation as a potential first-line treatment option.

Asset Subtitle

Yi-Long Wu

Meta Tag

Speaker Yi-Long Wu

Topic Metastatic Non-small Cell Lung Cancer – Targeted Therapy

Keywords

HLX07

serplulimab

anti-EGFR monoclonal antibody

anti-PD-1 antibody

chemotherapy

advanced squamous non-small cell lung cancer

phase 2 study

objective response rate

progression-free survival

treatment-emergent adverse events