Neoadjuvant nivolumab in resectable non-small cell lung cancer: Extended follow-up and molecular markers of response.

• DOI: 10.1200/jco.2019.37.15_suppl.8524
• Publication Date: 2020-02-24T16:47:28Z
• Authors: Joshua E. Reuss; Kellie Nicole Smith; Valsamo Anagnostou; Jiajia Zhang; Marianna Zahurak; Justina Caushi; Hok Yee Chan; Haidan Guo; Matthew David Hel...; Drew M. Pardoll; Julie R. Brahmer; Jamie E. Chaft; Patrick M. Forde
• Keywords: 03 medical and health sciences; 0302 clinical medicine; 3. Good health

8524 Background: Improved therapy is needed for patients (pts) with early-stage non-small cell lung cancer (NSCLC), as the majority relapse after curative resection. Our group reported first trial of neoadjuvant PD-1 blockade in resectable NSCLC, finding to be safe and feasible. Here we report extended clinical follow-up long-term molecular response data from this trial. Methods: IV nivolumab 3 mg/kg was given every 2 weeks doses prior surgery 20 pts NSCLC at Johns Hopkins MSKCC. Blood correlative studies taken each dose nivolumab, surgery, 2-4 post-surgery, during follow up. In a subgroup pts, longitudinal assessed peripheral blood circulating tumor DNA (ctDNA) dynamics tumor-infiltrating T-cell clonotypes. Results: At median up 30 months (m), 15 are disease-free alive. Two have died (one relapsed disease). Median recurrence free survival (RFS) has not been reached. The 24m RFS rate 69% (95% CI: 51-93). Thus far, presence ctDNA diagnosis major pathologic (MPR - ≤10% viable resected specimen) do associate RFS. One immune-related adverse event occurred (skin, G3). All who on review had ≥30% reduction demonstrated clearance detectable surgery. Pts MPR experienced expansion neoantigen-specific T-cells blood. one patient ongoing disease status, tumor-associated persisted beyond 15m By contrast, peri-operative 75% residual minimal observed blood, decreasing frequency expanded clones over time that correlated eventual relapse. Conclusions: Long-term reinforces safety NSCLC. Analysis responders compared non-responders suggests potential biomarkers surveillance. While encouraging, phase trials evaluate efficacy PD-(L)1 Clinical information: NCT02259621.