2022 World Conference on Lung Cancer (ePosters)-EP08.01-014. Tislelizumab versus Docetaxel in Previously Treated Advanced Non-Small Cell Lung Cancer: Final Analysis of RATIONALE-303

EP08.01-014. Tislelizumab versus Docetaxel in Previously Treated Advanced Non-Small Cell Lung Cancer: Final Analysis of RATIONALE-303

Back to course

Pdf Summary

The document presents the final analysis of the RATIONALE-303 trial, which compared the efficacy and safety of tislelizumab and docetaxel in previously treated advanced non-small cell lung cancer (NSCLC). The study enrolled patients with histologically confirmed, locally advanced or metastatic squamous or nonsquamous NSCLC. The co-primary endpoints of the study were overall survival (OS) in the intent-to-treat (ITT) population and PD-L1 tumor cell (TC) 25% population.<br /><br />The final analysis included 805 patients who were randomized to receive either tislelizumab or docetaxel. At the data cutoff, the median follow-up times were 16.0 months for tislelizumab and 10.7 months for docetaxel in the ITT population. The analysis showed that tislelizumab significantly improved OS compared to docetaxel in both the ITT population and the PD-L1 TC 25% population.<br /><br />In addition, the study included exploratory biomarker analyses, which showed a potential association between NOTCH1-4 mutations and greater efficacy of tislelizumab, as indicated by improved OS and progression-free survival (PFS). Tissue tumor mutational burden (TMB) was also found to be correlated with PFS benefit for tislelizumab.<br /><br />The safety analysis showed that tislelizumab had a favorable safety profile, with fewer grade 3 treatment-emergent adverse events (TEAEs) compared to docetaxel.<br /><br />Overall, the final analysis of the RATIONALE-303 trial confirmed the superior efficacy of tislelizumab over docetaxel in previously treated advanced NSCLC. The results also suggested a potential association between NOTCH1-4 mutations and the efficacy of tislelizumab. Tislelizumab was well-tolerated and had a favorable safety profile.

Asset Subtitle

Caicun Zhou

Meta Tag

Speaker Caicun Zhou

Topic Metastatic Non-small Cell Lung Cancer - Immunotherapy

Keywords

RATIONALE-303 trial

tislelizumab

docetaxel

advanced non-small cell lung cancer

NSCLC

overall survival

PD-L1 tumor cell

NOTCH1-4 mutations

progression-free survival

safety profile