Abstract 848P
Background
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.
Methods
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.
Results
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: 848P
| CHARACTERISTIC AT 2L | BRAF Mutated N= 99 | BRAF wildtype N= 82 |
| SEX 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.
Conclusions
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.
Clinical trial identification
NCT03605771.
Editorial acknowledgement
mFAR assisted in the writing of this abstract.
Legal entity responsible for the study
Spanish Melanoma Group.
Funding
Novartis, Pierre Fabre, Bristol Myers Squibb, Incyte, Roche, MSD.
Disclosure
I. Marquez-Rodas: Financial Interests, Personal, Advisory Board: BMS, MSD, Novartis, Pierre Fabre, Roche, GSK, AstraZeneca, Celgene, Regeneron, Sanofi, Merck Serono, Highligth Therapeutics, Bioline Rx, Sun Pharma; Financial Interests, Personal and Institutional, Invited Speaker, GEM1802 clinical trial: Pierre Fabre; Financial Interests, Institutional, Invited Speaker, GEM1801 clinical study: Novartis, BMS, Roche, Pierre Fabre, Incyte, MSD; Financial Interests, Institutional, Invited Speaker, National coordinator of Spotlight 203 clinical trial: Highlight Therapeutics; Non-Financial Interests, Invited Speaker: Spanish Melanoma Group. M.A. Berciano Guerrero: Financial Interests, Personal, Invited Speaker: MSD, Novartis, Pierre Fabre, Pfizer, Roche, Sanofi, Eisai, PharmaMar, Kyowa Kirin; Financial Interests, Personal, Advisory Board: MSD, Novartis, Pierre Fabre, Pfizer, Roche, Sanofi, Eisai, PharmaMar. E. Muñoz Couselo: Financial Interests, Personal, Other: Novartis, Pierre Fabre, MSD, Sanofi, Amgen, Roche. A. Soria: Financial Interests, Personal, Invited Speaker: MSD, BMS, Novartis, Merck Serono, Sanofi; Financial Interests, Personal, Expert Testimony: MSD, BMS, Novartis, Merck Serono, Sanofi; Financial Interests, Personal, Advisory Board: MSD, BMS, Novartis, Merck Serono, Sanofi; Financial Interests, Personal, Writing Engagements: BMS; Financial Interests, Institutional, Research Grant: Sanofi. P. Cerezuela-Fuentes: Financial Interests, Personal, Invited Speaker: BMS, MSD, Roche, Sanofi, Sun Pharma; Financial Interests, Personal, Advisory Board: BMS, MSD, Roche, Sanofi, Sun Pharma; Financial Interests, Personal, Other: BMS, MSD, Roche, Sanofi, Sun Pharma. G. Crespo: Financial Interests, Personal, Advisory Board: Janssen, Ipsen, Roche, BMS, Sanofi, Eisai; Financial Interests, Personal, Invited Speaker: Roche, MSD, Eisai; Financial Interests, Personal, Other: Roche. T. Puértolas: Financial Interests, Personal, Invited Speaker: BMS, Roche, MSD, Novartis, Pierre Fabre, Sun Pharma; Financial Interests, Personal, Advisory Board: BMS, Novartis, Pierre Fabre, Sanofi. C. Aguado de la Rosa: Financial Interests, Personal, Advisory Board: Roche, Novartis; Financial Interests, Personal, Other: Roche; Financial Interests, Personal, Invited Speaker: Roche, MSD, Novartis, Sanofi, Pierre Fabre, AstraZeneca. E. Espinosa: Financial Interests, Personal, Advisory Board: BMS, MSD, Novartis, Pierre Fabre. M. Majem Tarruella: Financial Interests, Personal, Advisory Board: MSD, BMS, Boehringer, AstraZeneca, Novartis; Financial Interests, Personal, Invited Speaker: MSD, Roche, Boehringer, AstraZeneca; Financial Interests, Institutional, Research Grant: BMS; Financial Interests, Personal, Other: AstraZeneca, Lilly, MSD. R. López Castro: Financial Interests, Personal, Advisory Board: Takeda, Novartis, Boehringer, BMS; Financial Interests, Personal, Invited Speaker: Takeda, Novartis, BMS, MSD. P. Ayala de Miguel: Financial Interests, Personal, Invited Speaker: Novartis, MSD, Sanofi, Pierre Fabre. J. Medina Martinez: Financial Interests, Personal, Other: Novartis, Roche, Pierre Fabre, MSD, Sanofi. L.A. Fernández Morales: Financial Interests, Personal, Invited Speaker: BMS, MSD, Pierre Fabre, Roche, Novartis; Financial Interests, Personal, Other: BMS, MSD, Pierre Fabre, Roche, Novartis; Financial Interests, Personal, Advisory Role: Novartis. L. Bellido Hernández: Financial Interests, Personal, Advisory Board: Roche, BMS, Novartis, Boehringer. A. Berrocal: Financial Interests, Personal, Invited Speaker: BMS, MSD, Roche, Novartis; Financial Interests, Personal, Advisory Board: BMS, MSD, Roche, Novartis. S. Martín Algarra: Financial Interests, Personal, Advisory Board: MSD, Sanofi; Financial Interests, Personal, Invited Speaker: MSD, BMS, Pierre Fabre, Sanofi; Financial Interests, Institutional, Research Grant: Amgen, MSD, Novartis, BMS; Financial Interests, Personal, Expert Testimony: Novartis; Financial Interests, Personal, Other: MSD, Pierre Fabre, Roche. All other authors have declared no conflicts of interest.