9010 Background: Atezolizumab plus chemotherapy was safe and yielded promising clinical outcome as frontline therapy for patients (pts) with advanced NSCLC with untreated brain metastases (BM) in the ATEZO-BRAIN study (NCT03526900). Methods: A multicenter single-arm phase II trial with a Bayesian design for evaluating the safety and efficacy of atezolizumab plus carboplatin with pemetrexed every 3 weeks for 4-6 cycles, followed by maintenance with pemetrexed plus atezolizumab in pts with stage IV non-squamous NSCLC without EGFR or ALK genetic alterations and untreated BM. Pts not presented neurologic symptoms at baseline; but anticonvulsants and dexamethasone (DXM) ≤ 4mg qd were allowed. Co-primary endpoints were safety and investigator-assessed progression-free survival (PFS) at 12 weeks according to RANO-BM and RECIST v1.1 for brain and systemic disease, respectively. Here we present the final data and an exploratory analysis based on PD-L1 expression and corticosteroid treatment at baseline. Results: Out of 40 pts included in the study, 22 (55%) were receiving DXM at baseline and 20 (50%) had positive expression of PD-L1. Sixteen (40%) pts had confirmed intracranial response based on RANO-BM (12 PR, 4 CR) and 19 (47.5%) pts achieved systemic response (all PR). Only 4 pts had discordant responses between the body and the brain. No differences were observed in the overall systemic and intracranial response rate according to the PD-L1 expression or the use of corticosteroids at baseline. As of December 31, 2021 (median follow-up, 20 months), the updated median (95% CI) systemic PFS was 8.9 (6.7 to 13.8) and intracranial PFS was 6.9 (4.7 to 11.9). Median (95% CI) OS was 13.6 (9.72 to not reached) and estimated 2-year OS rate (95% CI) was 30.5% (18.4 to 50.4). Median (95%CI) OS was longer for PD-L1 positive pts (16.2; 10.3 to not reached) compared to PD-L1 negative pts (10.7; 7.6 to not reached) but differences were not statistically significant due to the limited statistical power (HR = 0.99; 95% CI 0.35 to 2.12). No significant differences in OS were observed between pts receiving or not baseline DXM treatment. Treatment was well tolerated and no grade 5 toxicities were observed. Conclusions: In this updated analysis, treatment with atezolizumab plus carboplatin and pemetrexed yields a promising 2-year OS rate and intracranial response rate in patients with untreated BM from NSCLC, regardless of treatment with corticosteroids at baseline and PD-L1 expression. Clinical trial information: NCT03526900.

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e14247 Background: The neutrophil-lymphocyte (N / L) ratio is a marker of general immune response in different stress situations, having shown a relationship between the quotient and the evolution of patients treated with immunotherapy (IT), emphasizing the importance of inflammation in these patients. Methods: In order to evaluate this relationship in a context of usual clinical practice, we performed a retrospective review of patients with pulmonary neoplasia who received IT treatment in the first line or successive, between November 2015 and December 2018, excluding those who received treatment within of clinical trial. Data were collected from the clinical history of each patient, with special attention to baseline neutrophil and lymphocyte numbers, objective response to therapy by criteria iRECIST 1.1 after 3 months of treatment and overall survival (OS) defined from the beginning of treatment until death by progression of the disease. Results: 92 patients (29 women and 63 men) with a median age of 64 years (44-79) were analyzed. 15 (16,3%) patients (p) received immunotherapy as first line treatment, 65.2% (60 p) received it as 2nd line and 18,5% (17 p) as 3rd or succesive lines. The average number of cycles received was 14 (1-52). Regarding the type of IT, 54 p (58,7%) received treatment with Nivolumab, 33 patients (36%) with Pembrolizumab and 5 patients (5.3%) were treated with Atezolizumab. Two stretches of baseline N / L ratios ≤5 (low) and > 5 (high) were defined. Low ratio N / L (≤5) was identified in 62p (67.4%) of the patients treated with IT and high ratio N/L ( > 5) in 30p (32,6%). Of the 62 patients with a low ratio: 41p (66.1%) had some type of response or stabilization of their disease, 13 patients (21%) had progression and 8 patients (12.9%) received less than three months of treatment, 6 patients for PS deterioration and the other 2 patients continue with the treatment and are pending reevaluation. Among the 30 patients with high N / L quotient: 7p (23.3%) presented response or stabilization of the disease, 23 patients (76,7%) presented progression or treatment was interrupted due to deterioration of the ECOG. The average survival in the group with a low N / L ratio (≤5) was 213 weeks compared to the group with a high N / L ratio ( > 5) 144 weeks (p < 0.05). Conclusions: The N / L ratio has been identified in some studies as an adverse prognostic factor in patients treated with IT. Our data from the usual clinical practice support this theory. If these findings are confirmed in future studies, it could be used as a response biomarker for better patient selection.

e18002 Background: Nivolumab has demonstrated efficacy in clinical trials of recurrent or metastatic squamous cell carcinoma of the head and neck (R/M SCCHN). These results have been corroborated in real world studies in different populations. We describe the outcomes of 116 patients with R/M SCCHN in our clinical practice treated with Nivolumab in the main hospitals of the Galician health network (Spain). Methods: This multicenter study was carried out in nine hospitals that belong to the Galician Group of Head and Neck Cancer (GGCC). A total of 116 patients with R/M SCCHN who received nivolumab were recruited between January 2017 and June 2019. These patients were retrospectively reviewed. Overall survival (OS), progression-free survival (PFS) and the disease control rate (DCR) of the overall patient and specifically in the first, second and third lines, as well as toxicity, were evaluated. Results: Data from 116 patients were available. Most of them were males (91.37%) with a median age of 60 years (41-84 years). The primary tumor sites were oral cavity, oropharynx, hypopharynx and larynx. At first diagnosis, the majority of the patients had advanced disease (stage IV a/b/c 74.12%) and a performance status (PS ECOG) rate of 1 (64.65%). Owing to the real-world nature of the study, patients with poor performance status were also included (ECOG 2: 13.79% and ECOG 3: 0.86%). HPV and PDL1 status were not available for the majority of patients. The use of nivolumab in the first, second and third line was carried out in 20 (17.24%), 76 (65.52%) and 20 (17.24%) patients respectively. With a median follow-up of 14 months (1-69), in all patients (n = 116) the median progression-free survival (mPFS) was 2.30 months (95% CI 1.45 – 3.14) and the median overall survival (mOS) was 8.08 months (95% CI 5.93 – 10.23). DCR was 43% with 5% complete response (CR), 25% partial response (PR) and 15% stable disease (EE). The mPFS of the patients who received nivolumab in the first, second and third line was 3.9 (IC 95%1.01- 6.93), 3.6 (IC 95% 0.82-6.47) and 2.3 months (IC 95% 0.72-3.87) and the mOS was 6.8 (IC 95% 2.36-11.43), 8.5 (IC 95% 5,9 - 11.62) and 7.2 months (IC 95% 4.51-10.07) respectively. Drug-related adverse effects (grade 3/4) were observed in 21.27% and were controlled with steroid treatment. Conclusions: in this real-life study, the population is broader than the represented in the phase III CheckMate 141 trial, including patients with higher ECOG PS (0-3). These concordant results in the real-world setting in both efficacy and safety, support the use of nivolumab in this group of patients with R/M SCCHN.

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