WCLC 2025 - Posters & ePosters-EP.18.10 Phase II Study: Efficacy and Biomarker Exploration of Anlotinib Plus Penpulimab in ES-SCLC After Failure of Platinum-Based Chemotherapy

EP.18.10 Phase II Study: Efficacy and Biomarker Exploration of Anlotinib Plus Penpulimab in ES-SCLC After Failure of Platinum-Based Chemotherapy

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Pdf Summary

This Phase II, open-label, single-arm, multicenter study evaluated the efficacy, safety, and biomarkers of combining penpulimab, a novel PD-1 inhibitor, with anlotinib, a multi-target tyrosine kinase inhibitor, in patients with extensive-stage small cell lung cancer (ES-SCLC) whose disease progressed after platinum-based chemotherapy. The rationale stemmed from the Phase II ALTER1202 trial, which showed anlotinib alone improved progression-free survival (PFS) and overall survival (OS) versus placebo in similar patients.<br /><br />Sixty-five ES-SCLC patients were enrolled and treated with penpulimab (200 mg IV every 3 weeks) plus oral anlotinib (10 mg daily, 2 weeks on/1 week off) until progression, intolerable toxicity, or withdrawal. The primary endpoint was objective response rate (ORR) per RECIST v1.1; secondary endpoints included disease control rate (DCR), PFS, OS, and safety.<br /><br />Results showed an ORR of 43.1% (28/65) and DCR of 75.4% (49/65). Median PFS was 4.27 months (95% CI: 3.66–4.88), with a 6-month PFS rate of 35.6%. Median OS was 10.7 months (95% CI: 4.64–16.71), with 6- and 12-month OS rates of 48.7% and 31.5%, respectively. Safety analysis revealed that all patients experienced at least one treatment-related adverse event (TRAE), with 21.5% (14/65) having grade 3 or higher TRAEs. Immune-related adverse events (irAEs) occurred in 74% of patients, with 14% experiencing grade ≥3 irAEs.<br /><br />The combination demonstrated clinically meaningful antitumor activity, prolonged survival, and a manageable safety profile in this difficult-to-treat population. These promising findings justify further investigation in randomized controlled trials to validate the efficacy and safety of penpulimab plus anlotinib in platinum-refractory ES-SCLC.

Asset Subtitle

Yongchang Zhang

Meta Tag

Speaker Yongchang Zhang

Topic Clinical Trials in Progress

Keywords

penpulimab

anlotinib

extensive-stage small cell lung cancer

ES-SCLC

PD-1 inhibitor

tyrosine kinase inhibitor

platinum-based chemotherapy

objective response rate

progression-free survival

immune-related adverse events