Anlotinib as a third- or further-line therapy for patients with non-small cell lung cancer.

This trial was carried out to assess the effectiveness of anlotinib (AL3818) on different subtypes of non-small cell lung cancer (NSCLC). The trial demonstrated that anlotinib improved progression-free survival (PFS) and overall survival (OS) in patients with adenocarcinoma (ACC) and tended to improve survival in patients with squamous cell carcinoma (SCC) patients.

NSCLC accounts for 85% of lung cancers found worldwide. The main form of treatment is the surgical removal of tumors plus chemotherapy. Different subtypes of NSCLC have become the basis of treatment for NSCLC. Being able to identify the different subtypes of NSCLC has become critical in deciding what treatment regimen to use in patients with NSCLC. 

Anlotinib is a tyrosine kinase inhibitor (TKI). TKIs block enzymes that are responsible for many cellular functions in the body. TKIs have been shown to have anti-tumor properties. Anlotinib has been used in clinical trials in order to treat advanced NSCLC. However, its effectiveness according to different subtypes of NSCLC remains under investigation. 

This study had 437 patients with NSCLC. 336 patients had the subtype of ACC. 86 patients had SCC subtyping. 15 patients had other subtypes of NSCLC. All patients had been previously received at least 2 prior treatments. They were randomly assigned to receive either anlotinib or a placebo. The ACC subgroup was followed-up for an average of 7.6 months. The SCC subgroup had an average follow-up of 6.9 months.

In the ACC subgroup, the average survival was significantly higher in the anlotinib group (9.6 months) compared to 6.9 months in the placebo group. Survival without cancer worsening was also significantly longer in the anlotinib group (5.5 months) compared to the placebo group (1.4 months). Significantly more patients in the anlotinib group (9.65%) responded to treatment compared to the placebo group (0.93%). Also, significantly more patients had disease control (tumor shrunk or did not grow) in the anlotinib group (82.89%) compared to placebo (33.33%).

In the SCC subgroup, the average survival was higher in the anlotinib group (10.7 months) than in the placebo group (6.5 months). However, this was not found statistically significant. The average survival without cancer worsening was significantly higher in the anlotinib group (4.8 months) compared to the placebo group (2.7 months).  

Side effects occurred in both the treatment group and the placebo groups. The most common side effects were high blood pressure, elevated thyroid hormones, tiredness, and reduced appetite.

This study concluded that anlotinib significantly improved survival in patients with ACC and tended to improve survival in patients with SCC.

This trial was carried out on a Chinese cohort of patients which may not translate to different populations. Also, this trial was funded by Chia-tai Tianqing Pharmaceutical Group Co, the manufacturer of anlotinib.