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Introduction <p>Therapeutic options for patients with advanced non-small cell lung cancer (NSCLC) after progression on immune checkpoint inhibitors (ICIs) remain a significant challenge. This analysis compared outcomes of anlotinib plus docetaxel versus docetaxel alone in this population using the pooled data from two prospective randomized trials (ALTER-L016; ALTER-L018).</p> Methods <p>Adult patients with EGFR/ALK/ROS1 wild-type advanced NSCLC progressing on first-line ICIs were eligible. Patients were randomly assigned to anlotinib plus docetaxel or docetaxel alone. The primary endpoint was progression-free survival (PFS). The secondary endpoints were overall survival (OS), objective response rate (ORR), disease control rate (DCR), and safety.</p> Results <p>Seventy-one patients were included in this pooled analysis (L016, <i>n</i> = 39; L018, <i>n</i> = 32), of whom, 40 received anlotinib plus docetaxel and 31 received docetaxel. The median follow-up of all patients was 27.0&#xa0;months. The median PFS was longer with anlotinib plus docetaxel than with docetaxel alone (5.4&#xa0;months [95% CI 5.0–9.3] vs. 2.3&#xa0;months [95% CI 1.4–2.9]; hazard ratio [HR], 0.34; 95% CI 0.18–0.63; <i>P</i> &lt; 0.001). Both ORR (25.0% vs. 12.9%) and DCR (82.5% vs. 45.2%) were higher in the anlotinib plus docetaxel group than in the docetaxel group. Median OS was 16.2&#xa0;months (95% CI 8.3–21.3) with anlotinib plus docetaxel versus 13.7&#xa0;months (95% CI 4.6–22.3) with docetaxel (HR = 0.82; 95% CI 0.47–1.44; <i>P</i> = 0.488). Subsequent ICI therapy was associated with a longer OS. Grade 3 treatment-related adverse events occurred in 32.5% of patients receiving anlotinib plus docetaxel and 6.5% of patients receiving docetaxel.</p> Conclusion <p>Anlotinib plus docetaxel improved PFS but not OS versus docetaxel in patients with advanced NSCLC progressing on ICIs. Larger standardized phase 3 trials are needed to verify these findings.</p> Trial Registration <p>ALTER-L016 (ClinicalTrials.gov identifier, NCT03726736). ALTER-L018 (ClinicalTrials.gov identifier, NCT03624309).</p>

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Anlotinib Plus Docetaxel is Promising in Advanced NSCLC Progressing on First-Line Immunotherapy: A Pooled Analysis of Two Randomized Trials

  • 期刊论文

  • 发表日期：

    2025年5月12日

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  • Xingxiang Pu,
  • Jiawei Shou,
  • Zemin Xiao,
  • Jun Chen,
  • Maoliang Xiao,
  • Qunyi Guo,
  • Zhongxia Ma,
  • Wei Hong,
  • Qianzhi Wang,
  • Yonghui Wang,
  • Jia Li,
  • Chuangzhou Rao,
  • Jie Weng,
  • Liqin Lu,
  • Lin Wu,
  • Yong Fang

摘要

Introduction

Therapeutic options for patients with advanced non-small cell lung cancer (NSCLC) after progression on immune checkpoint inhibitors (ICIs) remain a significant challenge. This analysis compared outcomes of anlotinib plus docetaxel versus docetaxel alone in this population using the pooled data from two prospective randomized trials (ALTER-L016; ALTER-L018).

Methods

Adult patients with EGFR/ALK/ROS1 wild-type advanced NSCLC progressing on first-line ICIs were eligible. Patients were randomly assigned to anlotinib plus docetaxel or docetaxel alone. The primary endpoint was progression-free survival (PFS). The secondary endpoints were overall survival (OS), objective response rate (ORR), disease control rate (DCR), and safety.

Results

Seventy-one patients were included in this pooled analysis (L016, n = 39; L018, n = 32), of whom, 40 received anlotinib plus docetaxel and 31 received docetaxel. The median follow-up of all patients was 27.0 months. The median PFS was longer with anlotinib plus docetaxel than with docetaxel alone (5.4 months [95% CI 5.0–9.3] vs. 2.3 months [95% CI 1.4–2.9]; hazard ratio [HR], 0.34; 95% CI 0.18–0.63; P < 0.001). Both ORR (25.0% vs. 12.9%) and DCR (82.5% vs. 45.2%) were higher in the anlotinib plus docetaxel group than in the docetaxel group. Median OS was 16.2 months (95% CI 8.3–21.3) with anlotinib plus docetaxel versus 13.7 months (95% CI 4.6–22.3) with docetaxel (HR = 0.82; 95% CI 0.47–1.44; P = 0.488). Subsequent ICI therapy was associated with a longer OS. Grade 3 treatment-related adverse events occurred in 32.5% of patients receiving anlotinib plus docetaxel and 6.5% of patients receiving docetaxel.

Conclusion

Anlotinib plus docetaxel improved PFS but not OS versus docetaxel in patients with advanced NSCLC progressing on ICIs. Larger standardized phase 3 trials are needed to verify these findings.

Trial Registration

ALTER-L016 (ClinicalTrials.gov identifier, NCT03726736). ALTER-L018 (ClinicalTrials.gov identifier, NCT03624309).