Abstract 39P
Background
For NSCLC patients, treatment options after immune checkpoint inhibitors (ICIs) resistance are limited. Recent preclinical studies have suggested that anlotinib (a novel anti-angiogenesis agent) can reverse resistance to ICIs by modulating the immunosuppressive tumor microenvironment (TME). We conducted a real-world study to evaluate the efficacy and safety of anlotinib for solid tumors in Chinese patients who have previously accepted ICIs. Here we report the outcomes of patients with NSCLC.
Methods
Data from patients diagnosed with NSCLC and previously accepted ICIs were collected retrospectively from six medical sites in China between Jan 2018 and May 2024. Patients were divided into two groups according to the subsequent treatments: anlotinib alone or combined therapy, and other treatment methods not including antiangiogenic TKIs. Propensity score matching (PSM) based on age, gender, TNM staging, and number of prior treatment lines. Progression-free survival (PFS) was estimated using the Kaplan-Meier method and compared using the log-rank test. Adverse Events were graded by CTCAE v4.03.
Results
A total of 539 patients were enrolled. The median age was 61.0 years (range 55.0–68.0), 77.0% were male, 73.1% were stage IV, and 59.0% had received only first-line treatment. After 3:1 PSM, there were 285 and 95 patients in the anlotinib and other treatments group, respectively. The PFS was significantly longer in the anlotinib group than in other treatments group (median, 8.8 months vs 8.3 months; HR 0.70, 95% CI 0.49–0.99; P=0.041). The objective response rate (ORR) of the two groups was 12.6% (36/285) and 17.9% (17/95) (P=0.200), and the disease control rate (DCR) was 63.5% (181/285) and 61.1% (58/95) (P=0.668). Of the 285 patients treated with anlotinib, the most common adverse events (≥5% of patients) were allergy (10.2%), gastrointestinal events (9.1%), bleeding (9.1%), and hand-foot syndrome (6.7%).
Conclusions
Our study demonstrated the favorable anti-tumor activity and manageable toxicity of Anlotinib treatment in NSCLC previously treated with ICIs. To our knowledge, this study represents the largest real-world clinical data of anlotinib therapy for solid tumors, analysis of other tumor types will be reported in the future.
Legal entity responsible for the study
The First Affiliated Hospital of Naval Medical University/Changhai Hospital of Shanghai.
Funding
Has not received any funding.
Disclosure
All authors have declared no conflicts of interest.