Third-line anlotinib boosts advanced NSCLC survival
medwireNews: The multikinase inhibitor anlotinib is effective and well tolerated in advanced non-small-cell lung cancer (NSCLC) patients who have used at least two prior lines of systemic therapy, phase III trial results suggest.
The ALTER 0303 trial included 439 Chinese patients without brain metastases who were randomly assigned to receive oral anlotinib 12 mg/day or placebo in cycles of 2 weeks on-treatment, 1 week off-treatment until disease progression or unacceptable toxicity.
Overall survival (OS) was significantly longer in the 296 anlotinib-treated patients than the 143 controls, at a median of 9.6 versus 6.3 months (hazard ratio [HR]=0.68), report Baohui Han, from Shanghai Chest Hospital in China, and co-workers.
Anlotinib was also associated with a significant improvement in median progression-free survival (PFS), at a median of 5.4 months versus 1.4 months in the placebo-treated patients (HR=0.25), they write in JAMA Oncology.
Both OS and PFS favoured anlotinib in most of the predefined subgroups, including those with and without an epidermal growth factor receptor mutation, unlike earlier multitargeted agents that have proven more effective in patients with such mutations, the researchers remark.
The survival benefits of anlotinib therapy were accompanied by significant increases compared with placebo in both objective response rate (9.2 vs 0.7%) and the disease control rate (81.0 vs 37.1%).
Han et al say that anlotinib was “well tolerated”, with the most common grade 3 or more severe side effects being hypertension (13.6%), hyponatraemia (8.2%) and elevated gamma-glutamyltransfersase (5.4%).
In all, 8.2% of patients using anlotinib required a dose reduction to 10 mg/day and 0.7% had a further decrease to 8 mg/day, mainly attributed to hand–foot syndrome and hypertension.
The ALTER 0303 investigators explain that placebo was chosen as the comparator in the absence of third-line options in China at the time of trial design but that a “dramatic change” has since occurred with the development of docetaxel and checkpoint inhibitors for use in this setting.
Nevertheless, they suggest that the “PFS of third-line or further anlotinib in the present study seems to be not inferior to the results achieved by docetaxel or nivolumab in previous reports.”
The authors therefore conclude: “Future studies will look into the therapeutic strategies for anlotinib combined or compared with other therapies in NSCLC and other solid tumors.”
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