WCLC 2025 - Posters & ePosters-P3.18.30 A Phase II Clinical Study of Tafolecimab Combined With Sintilimab in the Treatment of Advanced NSCLC Who Failed the Previous Immunotherapy

P3.18.30 A Phase II Clinical Study of Tafolecimab Combined With Sintilimab in the Treatment of Advanced NSCLC Who Failed the Previous Immunotherapy

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This phase II clinical trial (ChiCTR2400085872) investigates the safety and efficacy of combining Tafolecimab with Sintilimab in patients with advanced non-small cell lung cancer (NSCLC) who have experienced disease progression following prior immunotherapy. Tafolecimab is a recombinant fully human IgG2 anti-PCSK9 antibody currently approved for cardiovascular disease treatment. Emerging preclinical evidence suggests that PCSK9 may be a novel target to enhance immunotherapy outcomes in cancer. The study is sponsored by Innovent Biologics, Inc. and is being conducted at the Comprehensive Oncology Center, Shanghai Pulmonary Hospital.<br /><br />The primary endpoints focus on objective response rate (ORR) based on RECIST 1.1 criteria and safety profiles. Secondary endpoints include progression-free survival (PFS), overall survival (OS), one-year PFS rate, disease control rate (DCR), and duration of response (DOR). Exploratory endpoints involve biomarker analyses of blood and tumor tissue through RNA sequencing, single-cell RNA sequencing (scRNA-Seq), flow cytometry (FACS), and multiplex immunohistochemistry (mIHC) to identify predictors of treatment response.<br /><br />Enrollment started on August 24, 2024, and the study is ongoing. Patients undergo radiographic imaging at baseline, every six weeks for the first 54 weeks following treatment initiation, and every nine weeks thereafter until disease progression, unacceptable toxicity, or withdrawal of consent occurs. Adverse events are monitored and graded according to the CTCAE version 5.0 criteria.<br /><br />The rationale for this study arises from the need for effective therapies after immunotherapy failure in advanced NSCLC, a setting characterized by treatment resistance. By targeting PCSK9 alongside PD-1 blockade with Sintilimab, this trial aims to improve antitumor responses and clinical outcomes in this difficult-to-treat population.

Asset Subtitle

Mengqing Xie

Meta Tag

Speaker Mengqing Xie

Topic Clinical Trials in Progress

Keywords

Phase II clinical trial

Tafolecimab

Sintilimab

Advanced non-small cell lung cancer

Immunotherapy failure

PCSK9 antibody

Objective response rate

Progression-free survival

Biomarker analysis

Innovent Biologics