This study represents the real word experience with nivolumab and the results are consistent with previously reported in clinical trials. PS 2 and the presence of CNS metastases are associated with poor prognosis.

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e20636 Background: First or second line crizotinib has shown greater efficacy in clinical trials than chemotherapy in patients with NSCLC ALK positive and it was the first approved ALK inhibitor. However, there are limited data describing the use of crizotinib and its outcomes in real-world settings. Methods: This is a retrospective, observational study of patients crizotinib treated ALK positive metastatic NSCLC, who received treatment between 1 January 2013 and 30 november 2018. The primary objective was progression free survival (PFS); secondary objetives were overall survival (OS), response rates and toxicity. Results: Fifty-eight patients with NSCLC ALK+ were recollected, 33 women and 25 men. The median age was 61 years (25-88); 46.6% were never smokers, 31% were former smokers. The majority (96.6%) had confirmed adenocarcinoma histology and 25.9% had brain metastases at inicial treatment. Crizotinib was used as first line 55.2% and second line in 37.9%. Progression disease was the most frequent reason of discontinuation of crizotinib (74%) and in 5 patients was discontinued because of toxicity. The most frequent toxicities were edemas (37.9%), increased transaminases (27.5), diarrhea (24%) and nauseas (20%). Grade 3-4 toxicities were present in 4 cases with increase transaminases, 1 case of neumonitis and 2 patients with diarrhea. The response rate was 63.8%. The median PFS was 12.66 months (95% CI :7.95- 17.38) and median OS was 23.36 months (95%CI: 16.29-30.44).In patients with brain metastases (15) the response rate was 46.6% and median OS decrease to 15.36 months (95%CI: 0.1-30.8). Conclusions: Our findings indicate that the results of crizotinib in the real world are consistent or sightly improved with prior clinical trial in PFS and OS, despite our sample includes patients for first line and second/later line crizotinib and ¼ of patients had brain metastasic at crizotinib initiation.

e20645 Background: The lung immune prognostic index (LIPI) has been proposed as a new biomarker to select advanced non-small cell lung cancer (NSCLC) patients for anti-programmed cell death-1 or programmed death ligand 1 therapy. In this study, we investigate the prognostic and predictive utility of the LIPI in a multicentric nivolumab monotherapy-based cohort. Methods: 153 patients with available baseline LIPI were included. Survival estimates were calculated by the Kaplan-Meier method, and groups were compared with the log-rank test. The impact of the baseline LIPI on survival (PFS and OS), and DCR and ORR was assessed by Cox and logistic regression models respectively, adjusted for age, sex, ECOG-PS, smoking status, histology, TNM stage at diagnosis, presence of brain metastases and number of prior regimens. All p values were 2-sided, and those less than 0.05 were considered statistically significant. Results: 50.3% (n = 77) of the patients had a good (0 factors) LIPI, while 41.2% (n = 63) and 8.5% (n = 13) had intermediate (1 factor) and poor (2 factors) LIPI respectively. No significant differences were observed between the LIPI groups according to clinicopathologic characteristics. A high LIPI was significantly associated with poor OS in univariate (HR = 3.12, 95% CI 2.12 – 4.60; p < 0.0001) and multivariate (HR = 3.10, 95% CI 2.09 – 4.58; p < 0.0001) analyses. A high LIPI was associated with poor PFS (HR = 1.49, 95% CI 1.07 – 2.07; p = 0.02), but this correlation did not reach a statistical significance in multivariate analysis (HR = 1.37, 95% CI 0.98 – 1.92; p = 0.07). A higher LIPI was associated with a lower disease control rate in univariate (OR = 0.50, 95% CI 0.29 – 0.85; p = 0.01) and multivariate (OR = 0.55, 95% CI 0.31 – 0.98; p = 0.04) analyses. Conclusions: This study confirms the utility of the LIPI in prognostication and disease control prediction in advanced NSCLC patients treated with nivolumab in the second line of therapy or beyond.

This combined regimen shows efficacy and a manageable safety profile. PFS and OS outcomes are encouraging and warrant further research.