Anlotinib plus docetaxel in advanced NSCLC progressing on immunotherapy: A pooled analysis of two randomized trials.

Authors

null

Lin Wu

Hunan Cancer Hospital, Changsha, China

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

Organizations

Hunan Cancer Hospital, Changsha, China, Medical Oncology Department, Sir Run Run Shaw Hospital, affiliated with the Zhejiang University School of Medicine, Hangzhou, China, The First People's Hospital of Changde, Changde, China, The Affiliated People’s Hospital of Ningbo University, Ningbo, China, The First Affiliated Hospital of Hunan College of Traditional Chinese Medicine, Zhuzhou, China, Taizhou Hospital of Zhejiang Province, Taizhou, China, First People’s Hospital of Chenzhou, Chenzhou, China, Department of Thoracic Medical Oncology, Zhejiang Cancer Hospital, Hangzhou, China, Hunan Cancer Hospital, The Affiliated Cancer Hospital of Xiangya Medical School, Central South University, Changsha, China, Lishui Central Hospital, Lishui, China, Ningbo No. 2 Hospital, Ningbo, Ningbo, China, Yueyang Central Hospital, Yueyang, China, Zhejiang Province People’s Hospital, Zhejiang, China, Sir Run Run Shaw Hospital, College of Medicine, Zh, Hangzhou, China

Research Funding

No funding sources reported

Background: This analysis aimed to evaluate outcomes of anlotinib plus docetaxel versus docetaxel alone in patients with advanced non-small cell lung cancer (NSCLC) after progression on immune-checkpoint inhibitors (ICIs) using the pooled data from two randomized trials (ALTER-L016; ALTER-L018). Methods: Eligible patients for this pooled analysis were aged 18-75 years and had EGFR/ALK/ROS1 wild-type advanced NSCLC progressing after first-line ICIs therapy. Patients were randomly assigned to receive anlotinib (10 mg [L016] or 12 mg [L018] once daily on days 1-14) plus docetaxel (60 mg/m2 [L016] or 75 mg/m2 [L018], on day 1 every 3 weeks) or docetaxel alone. The primary endpoint was progression-free survival (PFS). Second endpoints included overall survival (OS), objective response rate (ORR), disease control rate (DCR), and safety. Results: Total of 71 patients (L016, n = 39; L018, n = 32) who progressed after ICIs were included in this pooled analysis, 40 of whom had received anlotinib plus docetaxel and 31 received docetaxel. Median follow-up for all patients was 27.0 months (IQR, 17.6-31.2). A significant PFS benefit was observed with anlotinib plus docetaxel (5.4 months; 95% CI, 5.0-9.3) over docetaxel alone (2.3 months; 95% CI, 1.4-2.9), with a hazard ratio (HR) of 0.34 (95% CI, 0.18-0.63; P < 0.001). Improvement in PFS was seen across most evaluated subgroups. Anlotinib plus docetaxel induced a higher ORR (25.0% vs. 12.9%) and DCR (82.5% vs. 45.2%) over docetaxel alone. Median OS was similar between two arms (16.2 vs. 13.7 months; HR = 0.82 [0.47-1.44]; P = 0.488). Subsequent therapy with ICIs was associated with a longer OS. The incidence of grade 3 or higher treatment-related adverse events was 32.5% with anlotinib plus docetaxel and 6.5% with docetaxel. Conclusions: Anlotinib plus docetaxel demonstrated survival and response improvements compared with docetaxel alone in patients with advanced NSCLC progressing after ICIs, with a manageable safety profile. This finding suggested anlotinib plus docetaxel might be effective and safe option in this setting. Clinical trial information: NCT03726736; NCT03624309.

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Abstract Details

Meeting

2024 ASCO Annual Meeting

Session Type

Poster Session

Session Title

Lung Cancer—Non-Small Cell Local-Regional/Small Cell/Other Thoracic Cancers

Track

Lung Cancer

Sub Track

Local-Regional Non–Small Cell Lung Cancer

Clinical Trial Registration Number

NCT03726736;NCT03624309

Citation

J Clin Oncol 42, 2024 (suppl 16; abstr 8062)

DOI

10.1200/JCO.2024.42.16_suppl.8062

Abstract #

8062

Poster Bd #

324

Abstract Disclosures

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