2023 World Conference on Lung Cancer (Posters)-P1.01. A Phase IB Trial Of Nivolumab For Immunoprevention Of Bronchial Dysplasia Progression In High-risk Current And Former Smokers

P1.01. A Phase IB Trial Of Nivolumab For Immunoprevention Of Bronchial Dysplasia Progression In High-risk Current And Former Smokers - PDF(Slides)

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Pdf Summary

A phase IB trial is being conducted to determine the efficacy of the immune checkpoint inhibitor nivolumab in preventing the progression of bronchial dysplasia in high-risk smokers. The study has enrolled 57 subjects, of which 16 have completed treatment with nivolumab. The treatment has been well tolerated, and histologic improvement has been observed in 9 patients at 6 months. Whole exome sequencing (WES) analysis is still ongoing, but no significant correlation has been found between tissue mutation load and response to nivolumab so far. The PD-1 inhibitor nivolumab has shown promise in improving endobronchial dysplasia in high-risk smokers, potentially preventing the progression to lung squamous cell carcinoma. Nivolumab has been well tolerated in the study population, with no dropouts during treatment. The main treatment-related adverse events include colitis, arthralgia, hypothyroidism, and fatigue. VECTRA multiplex immunofluorescence analysis has shown that strong antigen presentation and high levels of PD1 CD4 lymphocytes at baseline correlate with a response to nivolumab. Furthermore, a decrease in PD1/PDL1 expressing T-lymphocytes over time is associated with a response to nivolumab. The study's primary endpoints include an improvement in endobronchial dysplasia and the assessment of safety and tolerability of nivolumab in high-risk smokers. Secondary endpoints include the analysis of immune microenvironment alterations and mutation load. Overall, the trial suggests that nivolumab may have therapeutic potential in preventing the progression of bronchial dysplasia in high-risk smokers.

Asset Subtitle

Hui Yu

Meta Tag

Speaker Hui Yu

Topic Risk Factors, Risk Reduction & Tobacco Control

Keywords

phase IB trial

nivolumab

bronchial dysplasia

high-risk smokers

treatment

histologic improvement

PD-1 inhibitor

endobronchial dysplasia

adverse events

therapeutic potential