206 - Durable Survival and Updated Safety of TQB2450 plus Anlotinib Maintenance Therapy in Limited-Stage Small Cell Lung Cancer: Extended Follow-Up from a Prospective Phase Ib Trial
Presenter(s)
X. Liu1,2, X. Yin2, L. Zhuang1,2, J. Wen2, Z. Wei1,2, W. Cui2, M. Yu2, K. Zhao2, L. Liu2, L. Kong2, L. Jiang2, X. Jing2, H. Zhu2, X. Wang3, X. Dong3, J. Yu1,2, and X. Meng1,2; 1Cheeloo College of Medicine, Shandong University, Jinan, Shandong, China, 2Shandong Cancer Hospital and Institute, Shandong First Medical University and Shandong Academy of Medical Sciences Department of Radiation Oncology, Jinan, Shandong, China, 3Chia Tai Tianqing Pharmarceutical Group Co., Ltd, China, Nanjing, China
Purpose/Objective(s): Despite standard chemoradiotherapy, most limited-stage small cell lung cancer (LS-SCLC) patients relapse within 1 year. While the anti-PD-L1 antibody Benmelstobart (TQB2450) combined with Anlotinib demonstrated unprecedented survival in extensive-stage SCLC (ETER701 study), its role in LS-SCLC remains unexplored. This phase Ib trial evaluates the long-term efficacy and safety of TQB2450+Anlotinib as maintenance therapy after definitive chemoradiotherapy in LS-SCLC, with updated 12-month survival outcomes and safety analysis.
Materials/Methods: Fifteen patients with LS-SCLC achieving non-progression after platinum-based chemoradiotherapy (concurrent/sequential) were enrolled in the study and received maintenance TQB2450 (1200mg q3w) + Anlotinib (8mg d1-14, escalated to 10mg if tolerated). Primary endpoints were 12-month progression-free survival (PFS) and safety. The adverse events (AE) were collected by electronic data capture (EDC) system and graded per CTCAE v5.0.
Results: With extended follow-up (median 18.7 months), the 12-month PFS rate was 86.7% (95%CI 71.1-100.0%) and OS rate 100%. The disease control rate was 100%. AEs were reported in 13 patients (86.67 %), with fatigue being the most common treatment related AE (40.00%). Grade 3 AEs occurred in four patients (26.67%), and no grade 5 AE were observed. Radiation pneumonitis (RP) occurred in three patients, all classified as grade 2, and one patient developed grade 1 immune-related pneumonitis.
Conclusion: The combination of TQB2450 and Anlotinib demonstrated durable efficacy with manageable toxicity in patients with LS-SCLC who have not experienced disease progression after first-line therapy. To validate these preliminary findings, a randomized, double-blind, placebo-controlled phase III clinical trial is currently underway, aiming to offer robust evidence for its integration into clinical practice. The trial is registered with ClinicalTrials.gov, NCT05942508. (ClinicalTrials.gov Identifier: NCT06469879)