Efficacy and Safety of Anlotinib Combined with Single-Agent Chemotherapy in Advanced Primary Immune-Resistant NSCLC: A Retrospective Cohort

Objectives: Combination therapy has emerged as a crucial approach to enhance immunotherapy efficacy in advanced Non-Small Cell Lung Cancer (NSCLC). However, its value in reversing primary immune resistance remains unknown. Therefore, we investigated the efficacy and safety of anlotinib combined with single-agent chemotherapy in patients with advanced primary immune-resistant lung cancer. Methods: A total of 35 Advanced Primary Immune-Resistant NSCLC patients were enrolled in this retrospective study over 13 months follow up. The primary endpoints included Progression-Free Survival (PFS), Overall Survival (OS), Objective Response Rate (ORR), Disease Control Rate (DCR), and safety profile are assessed through standardized criteria. Results: Our findings demonstrate that the combination of anlotinib and single chemotherapy bring about promising median PFS (4.0 m) and OS (8.0 m) for this refractory population, with an DCR of 65%. Subgroup analysis indicated that the efficacy correlate with the occurrence of some specific Adverse Event such as hypertension, foot-hand syndrome and proteinuria. Mechanistic studies indicate that such regimen may likely exerts its anti-tumor effects by depleting immunue suppression to active immunity function. Beside promising efficacy, such regimen exhibited a manageable safety profile. Conclusion: These results support the combination of anlotinib and single chemotherapy with promising efficacy and tolerated toxicity for advanced primary immune resistance NSCLC, offering meaningful clinical benefits with tolerable side effects. Further research is warranted to optimize treatment strategies and explore its potential in combination therapies.