Second-line systemic treatment for patients with advanced melanoma: Results from the prospective real-world study GEM1801

Information regarding charatcteristics and outcomes of second line treatment for patients with advanced melanoma is scarce since no randomized clinical trials are published in the post-targeted and immunotherapy era. Real-world data studies are capital for benchmarking patients´ outcomes in order to design clinical trials in this scenario. GEM1801 is a prospective observational real-world study that currently has included 551 patients with advanced melanoma treated in 37 centers from the Spanish Melanoma Group (GEM). This is a descriptive analysis of basal characteristics, progression free survival (PFS) and overall survival (OS) from patients that received second line treatment in GEM1801. 186 (33.8%) patients received a second line (2L) treatment. For the 186 patients receiving 2L, with a median follow up of 6.4 months (m) (95% CI: 4.9-9.8), median PFS was 4.7 m (95% CI: 3.5-5.8) and median OS 11.3 m (95% CI: 8.6-13.4) from the beginning of 2L. Additionally, 63 (33.9%) patients received treatment beyond 2L. Table summarizes the patients characteristics and their outcomes according to BRAF status and treatments. For the 365 (66.2%) patients that did not receive 2L, the reasons were: 249 (68.2%) no progression with first line; 110 (30.1%) death before 2L; 6 (1.6%) loss of follow up.Table: 848PCHARACTERISTIC AT 2LBRAF Mutated N= 99BRAF wildtype N= 82SEX female N (%)47 (47.5)33 (40.2)age (median, Rank)59 (23-90)69 (29-93)ECOG 0-1 N (%)87 (87.9)78 (95.1)LDH >UNL N (%)34 (34.3)26 (31.7)M1C-D N (%)62 (62.6)40 (48.8)2L targeted therapy (TT): N, (%)44 (44.4)2 (2.4)TT mPFS, m (95% CI)12.4 (6.1-NR)2 (NA-NA)TT mOS, m (95% CI)20 (11.5-NR)2.7 (NA-NA)2L immunotherapy (IT): N (%)46 (46.5)34 (41.5)IT mPFS, m (95% CI)5.3 (2.9-10.8)3.1 (2.3-8.2)IT mOS, m (95% CI)10.9 (3.7-NR)12.5 (8.1-NR)2L Chemotherapy (CT): N, (%)4 (4)29 (35.4)CT mPFS, m (95% CI)0.4 (0-NR)3.2 (2.7-5.5)CT mOS, m (95% CI)0.6 (0.2-NR)5.6 (3.9-15.2)2L non specified: N (%)5 (5.1)13 (15.9)Treatment beyond 2L N (%)27 (27.8)33 (39.3)There are 5 patients with unknown BRAF status. Open table in a new tab There are 5 patients with unknown BRAF status. Second line treatment is still a difficult clinical scenario, especially for patients with BRAF wildtype melanoma and with BRAF mutated that progress after targeted therapy. The results, remarkably for PFS, need to be improved, thereby clinical trials participation is encouraged.