A real-world study update: Efficacy and safety of anlotinib for advanced non-small cell lung cancer.

e21106 Background: Anlotinib is an oral novel receptor tyrosine kinases (RTKs) inhibitor targeting multiple RTKs including VEGFR, PDGFR, FGFR, and c-kit. Due to its high efficacy and low side effects in ALTER 0303 trial, Anlotinib has been approved as a 3rd line therapy for pts with advanced non-small cell lung cancer (NSCLC) by NMPA in May 2018. The interim results of our real-world study suggested anlotinib substantially prolonged the progression-free survival (PFS) with manageable toxicity in later lines treatment of advanced NSCLC patients. Here, we update our latest results on the treatment experience in a broad NSCLC population. Methods: This is a multi-center, non-interventional, prospective real-world study. All registered data are collected from real-life clinical practice setting. Patients with advanced NSCLC treating with anlotinib were included. The primary endpoint was PFS, and the secondary endpoints included overall survival (OS), objective response rate (ORR), disease control rate (DCR) and safety. Results: As of January 2022, a total of 371 pts were enrolled, of whom 347 were evaluable, with a median age of 63 years, 232 males (66.9%). There were 40 pts (11.5%) with brain metastasis, 52 pts (15.0%) with bone metastasis, and 29 pts (8.4%) with liver metastasis at baseline. 109 pts (31.4%) received anlotinib as first/second line treatment, whereas 238 pts (68.6%) as third/later line treatment. In the overall population, DCR and ORR were 84.7% and 18.7% respectively. The mPFS was 6.3 months (95%CI, 5.7, 6.9) and the mOS was 12.2 months (95%CI, 9.5,14.9). Subgroup analysis showed more details. A trend towards better ORR (33.3%) was observed in the first line setting while a significantly better DCR (89.5%) was observed in the second line setting. The mPFS of first-/second-line treatment (6.9 months) was longer than that of the third-line or above treatment (5.8 months). The mOS of the first-/second- and third-line or above treatment were 10.4 (7.8,13) and 13.5 (8.9,18.1) months respectively. 52 pts (15%) had any grade of adverse events, of which 10 pts (2.9%) had grade 3 or above AEs. The most common AEs were hypoalbuminemia (3.5%), alanine aminotransferase reduction (1.4%), proteinuria (1.2%) and hyponatremia (1.2%). Conclusions: The updated results showed that anlotinib prolonged not only PFS but also OS significantly with a favorable safety profile, especially for OS benefits in third-line or later treatment. These data also indirectly revealed that anlotinib is a promising treatment option for patients with advanced NSCLC despite of treatment line in the real world.