KEY TAKEAWAYS
- ALEX is a phase III trial that aimed to externally validate a framework intended to simulate OS in patients with treatment-naive advanced ALK-positive NSCLC using data from the alectinib ALEX study.
- TGI metrics were estimated from a model using tumor size data from a clinical trial. Baseline factors and TGI metrics were used to predict OS.
- Result showed that the observed survival for alectinib and crizotinib aligned with model predictions, showing a consistent HR agreement.
- Study concluded that the model was validated in a different population, suggesting it may be treatment-independent.
A model was created to predict overall survival (OS) in non-small-cell lung cancer (NSCLC) patients using tumor growth inhibition (TGI) data from atezolizumab studies.
ALEX is a phase III trial and the purpose of this study was to externally validate this existing model intended to simulate OS in patients with treatment-naive advanced anaplastic lymphoma kinase (ALK)-positive NSCLC using data from the alectinib ALEX study.
TGI metrics, obtained from a biexponential model using longitudinal tumor size data were utilized along with baseline prognostic factors to predict OS in ALK-positive advanced NSCLC patients receiving alectinib versus crizotinib as first-line treatment.
Result showed that 286 out of 303 patients (94%) with ALK-positive advanced NSCLC were evaluated using tumor size data up to 5 years (cut-off: 29 November 2019). They used tumor growth rate estimates and baseline prognostic factors to simulate OS. Observed survival for alectinib and crizotinib fell within the model’s 95% prediction intervals for about 2 years. The predicted hazard ratio (HR) of alectinib versus crizotinib aligned with the observed HR (predicted HR 0.612, 95% PI 0.480-0.770 vs. 0.625 observed HR).
Study concluded that the TGI-OS model, originally developed for NSCLC patients in atezolizumab trials, was externally validated in ALK-positive patients from the alectinib ALEX trial. This suggests that the TGI-OS model’s predictive ability may be applicable regardless of the treatment used.
Source: https://pubmed.ncbi.nlm.nih.gov/37410154/
Clinical Trial: https://clinicaltrials.gov/study/NCT02075840
Kassir N, Chan P, Dang S, Bruno R. External validation of a tumor growth inhibition-overall survival model in non-small-cell lung cancer based on atezolizumab studies using alectinib data. Cancer Chemother Pharmacol. 2023 Sep;92(3):205-210. doi: 10.1007/s00280-023-04558-z. Epub 2023 Jul 6. PMID: 37410154; PMCID: PMC10363035.
