Predictive biomarker of response to anti-PD-1 treatment in non-small cell lung cancer patients.
148 Background: PD-1 inhibitors have shown significant clinical activity in different cancer types. However, responses in pts with NSCLC are variable, and insights are needed to identify a predictive biomarker of response with greater diagnostic accuracy. Here we tested the hypothesis tha tserum TNF-a level is predictive of response to anti-PD-1 treatment. Methods: NSCLC patients treated with nivolumab or pembrolizumab were studied. Pts received nivolumab (3mg/kg, q2w) or pembrolizumab ( 2mg/kg, q3w). Pts on anti-PD1 were classified as either responders (R) deriving clinical benefit (with SD, PR, CR) or non-responders (NR) not deriving clinical benefit (PD) based on RECIST criteria.Serum was collected at baseline; at 2-3 weeks after the first dose (early stage); and at the time of response evaluation. Serum TNF-a levels were determined by Luminex kit. Changes in serum TNF-a levels and their strength of association with response were compared with Non-parametric Analysis. Results: Evaluable plasma samples were collected from twenty-one NSCLC patients treated with nivolumab or pembrolizumab. There was no significant difference in baseline serum TNF-a levels in responders (n = 15) vs non-responders (n = 6). Between baseline and early stage ,serum TNF-a levels significantly increased in responders (P = 0.010), while in non-responders, no significant change was found. High early change rate of serum TNF-a levels ( > 50%) was observed only in responders(n = 7).At early stage, responders had significantly higher serum TNF-a levels than non-responders(P = 0.008). We found no significant difference in serum TNF-a levels at the time of response evaluation. Conclusions: Early changes in serum TNF-a levels and high serum TNF-a levels at early stage in non-small cell lung cancer patients correlate to response to anti-PD-1 treatment.