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9076 Background: PD-L1 has emerged as a potential biomarker for predicting responses to immunotherapy and as a prognostic factor in non-small cell lung cancer (NSCLC). In this network meta-analysis, we aimed to evaluate the efficacy of first-line PD-(L)1 monotherapy in advanced NSCLC patients with high PD-L1 expression. Methods: We conducted a systematic search in PubMed to identify all eligible trials from inception until 1 November 2020, with no start date limit applied. Only phase III trials evaluating the efficacy of first-line (1L) PD-(L)1 monotherapy in patients with stage IIIB/stage IV NSCLC and high PD-L1 expression were included. Results: Six clinical trials (KEYNOTE-024, KEYNOTE-042, EMPOWER Lung-01, IMpower110, MYSTIC and CheckMate-026) with 2,111 patients were included. In head-to-head comparisons, immunotherapy showed a significant improvement in progression-free survival (PFS: HRpooled = 0.69, 95% CI: 0.52-0.90, p = 0.007), overall survival (OS: HRpooled = 0.69, 95% CI: 0.61-0.78; p < 0.001) and overall response rate (ORR) (Risk ratio [RR]pooled = 1.354, 95% CI: 1.04-1.762, p = 0.024) compared to chemotherapy (CT). In the assessment of relative efficacy for PFS through indirect comparisons, pembrolizumab (results from KEYNOTE-024) ranked highest followed by cemiplimab and atezolizumab, with statistical significance determined across some of the drugs. In terms of OS, cemiplimab ranked highest followed by atezolizumab and pembrolizumab, although non-significant OS was determined across these drugs. Overall, 1L PD-(L)1 monotherapy improved OS in almost all subgroups, reaching statistical significance in men (HRpooled = 0.624, 95% CI: 0.51-0.72, p < 0.001), non-Asian patients (HRpooled = 0.66, 95% CI: 0.55-0.79, p < 0.001), all patients regardless of age ( < 65 years [HRpooled = 0.72, 95% CI: 0.57-0.90, p = 0.005]; ≥65 years [HRpooled = 0.61, 95% CI: 0.48-0.77, p < 0.001]), ECOG PS status (ECOG PS = 0 [HRpooled = 0.68, 95% CI: 0.56-0.82, p < 0.001; ECOG PS = 1 [HRpooled = 0.59, 95% CI: 0.43-0.82, p = 0.001) and histological tumour type (Squamous [HRpooled = 0.49, 95% CI: 0.37-0.67, p < 0.001; Non-squamous [HRpooled = 0.67, 95% CI: 0.52-0.87, p = 0.003). In the case of smokers and NSCLC stage, only current/former smokers (HRpooled = 0.623, 95% CI: 0.47-0.83, p = 0.001) and patients with stage IV disease* (HRpooled = 0.687, 95% CI: 0.59-0.81, p < 0.001) benefited from single PD-(L)1 monotherapy over CT. Conclusions: PD-(L)1 inhibitor monotherapy improves efficacy outcomes in the 1L setting of advanced NSCLC patients with high PD-L1 expression. Current/former smokers ≥65 years, with ECOG PS = 1 and squamous NSCLC benefited most from this therapy. *KEYNOTE-042 was the only study including patients with stage IIIB NSCLC.

e20579 Background: The current treatment of advanced non-small cell lung cancer (NSCLC) is conditioned by the presence of molecular and immunohistochemical biomarkers. In the absence of these, the therapeutic option is the use of chemotherapy with or without antiangiogenic agents. The efficacy of non-target systemic treatments is not proven, beyond a second-line and the experiences in their use are limited to retrospective analyzes. We present the experience of the Grupo Gallego de Cáncer de Pulmón in patients with advanced NSCLC treated exclusively with three or more lines of chemotherapy. Methods: Retrospective analysis of patients with advanced NSCLC, treated with three or more lines of chemotherapy in standard regimen, with or without antiangiogenic agents, in Galicia´s hospitals, Spain. Results: We included 168 patients (134 male and 34 female) treated with three or more chemotherapy lines, with a median age at the time of receiving the first-line, of 60.84 years (41-83). Of these, 51 (30,35%) received a fourth-line and 18 (10,74%) a fifth-line of treatment. None received antitarget therapy or immunotherapy. The median overall survival (OS) was 18.1 months. The median OS after the third line was 6.1 months, with 73% of patients alive at three months and 44% six months after the start of that therapeutic line. We did not appreciate differences in OS between those who received three lines and those who received the largest number of subsequent treatments. Our multivariate analysis (age, gender, histology, performance status at initiation of each teatment-line, response to previous treatments) identified that the individuals who benefited the most were those under the age of 60 years, PS-ECOG 0-1 at diagnosis and those with a more durable response to the first-line. Conclusions: The third-line of chemotherapy can benefit those patients with advanced NSCLC, under 60 years of age at the time of diagnosis, with good performance status and with long-lasting responses to the first line of treatment. We did not see benefit in adding fourth or fifth-line of chemotherapy. All data will be presented in the 2019 ASCO annual meeting.

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.

e20654 Background: Treatment with tyrosine kinasa inhibitors has been a revolution for the patients with non-small cell lung cancer and EGFR positive mutation, especially in patients with exon 19 deletions. Afatinib seems one of the best options of treatment. Methods: Retrospective study on patients from differents hospitals in Galicia (Spain) diagnosed of metastasic lung adenocarcinoma with EGFR positive mutation who have received first line treatment with afatinib between July 2015 and September 2018 were included. The main objective was to compare our clinical experience concerning response rate, progression free survival and toxicity with published data. Results: 45 caucasians patients were included in our analysis (33 women, 12 men). Median age was 71.2 years (range 39-91 years) and 29 patients had never smoked. Exon 19 deletion was the most common mutation (41 patients, 91.1%). The objective overall response was 68.9% (95% CI: 82.4-55.3), complete responses were observed in 6 patients (13.3%) and partial responses were found in 25 patients (55.6%). Stable disease was observed in 8 patients (17.8%) and disease progression in 1 patient (2.2%), 5 patients have not been re-evaluated (11.1%). Median progression free survival (PFS) was 27 months (95% CI: 14.8-39.1) and overall survival was not reached. Common adverse events grade 3/4 were mucositis and skin toxicity in 11 patients (24.4%) and diarrhea in 6 patients (13.3%), respectively. The dose was reduced in 28 patients (62.2%) and treatment was discontinued in 8 patients (17.8%) owing to adverse events. Conclusions: Median PFS in our patients is 15 months longer than the information retrieved from differents studies with similar response rates and toxicity. This might be due to a majority of population with exon 19 deletion which, according to published data, seems to benefit more from afatinib than from other EGFR mutations.

e19017 Background: The standard treatment for elderly patients in advanced NS-NSCLC is not defined. The aim of this study was to evaluate the efficacy and safety profile of the combination of carbo...

e18146 Background: Efficacy of oral erlotinib has been conclusively established in 2nd line setting (BR.21 and TRUST studies) and the outcomes are similar to those provided by other approved chemotherapeutical agents (TITAN study). Higher responses rates have been found in p with Asian ethnicity, adenocarcinoma, women and never smokers, where predictive EGFR mutations occur more frequently; even though erlotinib has a significant effect on survival in all subgroups of patients. This observational study evaluates the efficacy of 2nd line erlotinib in unselected p with nsNSCLC in 4 Galician institutions. Methods: Unselected p with advanced nsNSCLC were treated with 150 mg/day of erlotinib as 2nd line therapy until unacceptable toxicity or progressive disease. EGFR mutational status was retrospectively tested when feasible, and serum carcinoembryonic antigen (CEA) monitored during the treatment period. Results: Baseline characteristics of 45 p included at the time of this analysis: mean age of 61.7 yrs. (range: 38-83); 80% male; 73.3% adenocarcinoma; 71.1% stage IV; 7/69/24% PS ECOG 0/1/2; 29/33/38 % never/current/former smokers. EGFR activating mutation testing was performed in 24 p (53%) and 2 positive cases were found (8%), both with metastatic adenocarcinoma (stage IV). The median PFS was 3.3 (95% CI: 1.6-5.1) and the median OS 10 months (95% CI: 7.5-12.5). Among p without EGFR mutations, erlotinib conferred a median OS of 8.1 months (95% CI: 1.4-14.9). Out of 31 p evaluable, radiologic response was achieved in 7 p (22.6%), for an overall disease control rate of 45.2 %. No unexpected toxicities were reported: 60 % of p experienced cutaneous toxicity (6.6 % grade ¾), 22.2% asthenia (4.4% grade ¾) and 17.8% diarrhea (2.2% grade ¾). Only 3 p discontinued due to adverse events. Conclusions: This study confirms the efficacy and safety of 2nd line erlotinib in a clinical practice scenario and the outcomes in p with non-squamous NSCLC are equivalent to those reported with the chemotherapy for salvage therapy. Moreover, the absence of mutations does not preclude the benefit from the drug. Updated data of the study will be presented.

e18040 Background: NSCLC is primarily a disease of older people with a median age of approximately 70 years (y) at diagnosis. Platinum combination chemotherapy (CT) has shown to be more effective than single agents but it is associated with more toxicity. Erlotinib is an EGFR TK inhibitor with a favourable toxicity profile and its oral administration makes it suitable to treat elderly p. No much is known about its efficacy and toxicities in this subpopulation, often under-represented in clinical trials. This Galician study aims to evaluate the efficacy and safety of erlotinib as 1st-line treatment (Tx) for elderly p with advanced nsNSCLC. Methods: Elderly p (≥70 years old) with stage IIIB/IV nsNSCLC were included in this prospective observational study. Erlotinib was orally administered at a dose of 150 mg daily until disease progression or intolerable toxicity. PFS (primary objective) and OS were measured from time of diagnosis. Results:A total of 31 p were enrolled. Baseline characteristics: Mean age 78 y (range 70-85); female 67.7%; adenocarcinoma (including BAC) 90.3%; never/current/former smokers (%): 54.8/16.1/22.6 (6.5% unknown), stage IV 84%; ECOG PS 0/1/2 (%): 6.4/45.2/48.4. The median PFS was 6.4 and the median OS was 9.9 months. Out of 26 evaluable p, 8 had PR and 8 SD, for an ORR of 30.8% and a DCR of 61.6%. The most common adverse event was skin rash, 38.7% (9.6% grade 3-4), diarrhoea, 25.8% (3.2% gr. 3-4) and asthenia, 19.3% (no gr 3-4 were reported). 5 p (16.1%) needed dose reduction and 3 p withdrew the Tx due to grade 3 diarrhoea, eye perforation and esofaghitis, respectively. EGFR mutational status was available for 10 p (32.2%); 4 p harboured activating mutations: 3 p achieved PR and 1 p SD. SLP of 31 (ongoing), 22.4 (ongoing), 13.6 and 9.8 months. Conclusions: These results in real-life settings confirm that erlotinib is an active and well tolerated agent as frontline Tx in elderly p (≥70) in nsNSCLC. Response rate is similar to that achieved with CT in younger people; benefit in PFS is modest, but median OS is acceptable, taking into account that half of the p had a PS of 2 EGFR mutation testing should be strongly encouraged among elderly p.