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EP.18.05 Tislelizumab Combined With Low-Dose Chemo ...
EP.18.05 Tislelizumab Combined With Low-Dose Chemotherapy in Previously Treated Advanced Squamous NSCLC
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This phase II prospective, single-arm study investigated the safety and efficacy of low-dose chemotherapy combined with the anti-PD-1 antibody tislelizumab as a second-line treatment in patients with previously treated advanced squamous non-small cell lung cancer (SQ-NSCLC). Thirteen patients with histologically confirmed locally advanced or metastatic SQ-NSCLC who had progressed after first-line systemic therapy were enrolled between August 2022 and June 2024. Treatment included low-dose nedaplatin or gemcitabine plus tislelizumab every three weeks for six cycles, followed by maintenance tislelizumab for up to two years or until disease progression.<br /><br />Among 11 evaluable patients, the primary endpoint of 6-month progression-free survival (PFS) rate was 63.6%, exceeding expectations compared with historical median PFS of approximately 3 months for standard second-line single-agent chemotherapy or immunotherapy. The objective response rate (ORR) was 36.4% (4 partial responses), disease control rate (DCR) was 72.7%, median PFS was 9.0 months, and 1-year overall survival (OS) rate was 72.7%. Median OS was not reached at a median follow-up of 27 months. Treatment was generally well tolerated, though two patients experienced grade 3-4 hematologic toxicities including thrombocytopenia and leukopenia.<br /><br />The study highlights that combining low-dose chemotherapy with immunotherapy may enhance anti-tumor immune responses while minimizing immunosuppression seen with conventional maximum tolerated dose chemotherapy. Preclinical evidence suggests low-dose chemotherapy can upregulate PD-L1 expression and stimulate immune memory, synergizing with checkpoint blockade. These findings support further exploration of this chemoimmunotherapy strategy as an effective and safe second-line option for advanced SQ-NSCLC, potentially improving outcomes beyond current standards. Larger, controlled trials are warranted to confirm these promising results.
Asset Subtitle
Binxun Ling
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Speaker
Binxun Ling
Topic
Clinical Trials in Progress
Keywords
Phase II study
low-dose chemotherapy
tislelizumab
anti-PD-1 antibody
second-line treatment
squamous non-small cell lung cancer
progression-free survival
objective response rate
disease control rate
immunotherapy
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