Safety and Efficacy of Multi-Target TKI Combined with Nivolumab in Check-Point Inhibitor-Refractory Patients with Advanced NSCLC
Study Overview
A study published in BMC Cancer explored the use of anlotinib, a multi-target tyrosine kinase inhibitor, in combination with nivolumab in patients with non-small cell lung cancer (NSCLC) who were resistant to immune checkpoint inhibitors (ICIs).
Study Methods
The study involved two stages: dose-finding and expansion cohorts. Patients received anlotinib orally and nivolumab intravenously on a 21-day treatment cycle. The primary objectives were to determine the recommended phase 2 dose (RP2D), assess safety, and evaluate objective response rate (ORR).
Key Findings
Out of 34 screened patients, 21 were enrolled. The recommended phase 2 dose of anlotinib was determined to be 12 mg/day orally for 14 days, followed by 7 days off, in combination with nivolumab (360 mg every 3 weeks). The treatment showed manageable safety and promising efficacy, with an ORR of 19.0% and disease control rate (DCR) of 76.2%. The median progression-free survival (PFS) was 7.4 months, and the median overall survival (OS) was 15.2 months.
Conclusion and Implications
The study suggests that the combination of anlotinib and nivolumab exhibits manageable safety and promising efficacy signals in ICIs-refractory NSCLC patients. Further research is needed to validate these findings.
Clinical Trial Registration
TRIAL REGISTRATION: NCT04507906 August 11, 2020
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