Abstract 1056P
Background
Targeted therapy (TT) and immune-check-point inhibitors (CPi) have improved the survival of patients (pts) with advanced melanoma (mel). Real-world data of these treatments are needed to confirm the results of clinical trials.
Methods
GEM1801 is a prospective observational study including 400 pts with resected stage III and advanced mel diagnosed since 2018 in Spain. Objectives were to analyze the clinical and pathological presentation, treatment choice and health outcomes. We report results of the advanced mel group (N=357).
Results
Median age was 65 years, ECOG 0-1 85.7% and AJCC 8th Ed stage IV 90.7% (24.9% a, 14.3% b, 34.7% c and 16.9% d). BRAF, reported in 348 pts (97.5%), was BRAF V600-mutated (Mut) in 50.4%. LDH, reported in 302 pts (84.6%), was > upper limit normal (ULN) in 32.8%. First-line (1L) was CPi in 94.9% of BRAF-wild-type (wt) and 30% of BRAF V600-Mut. For TT, BRAF+MEK inhibitors were selected as 1L in 64.1% of BRAF V600-Mut. Median follow up was 18.3 months (m) (95% CI 17.1-19.6). Median overall survival (OS) was (estimated) 28.1 m (95% CI 22.9-NA). With 1L CPi, 12 and 18-m OS was 79.4% and 70.5% respectively for BRAF-wt group and 90.2% and 82% for BRAF V600-Mut (median OS not reached in either group). In pts with BRAF V600-Mut and TT, 12 and 18m OS was 62.4% and 50.9% respectively and median OS 18.5m (95% CI 13.3-28.1). OS according to ECOG, LDH and M1 stage is in the table G3-4 AEs appeared in 7.9% of pts treated with TT and 9.2% with CPi. Table: 1056P
| Factor | % | % 12 - 18 m OS *p (Cox/log-rank) <0.05 | ||
| BRAF V600 Mut TT | ECOG | 0-1 vs >1 | 77/33 | 67.5 - 56.4* vs 44 - 35 |
| LDH | ≤ULN vs >ULN | 53/47 | 78 – 63* vs 46.7 - 39.8 | |
| M1 | a-b vs c-d | 59/41 | 75.6 – 71* vs 53.1 - 37 | |
| BRAF V600 Mut CPi | ECOG | 0-1 vs >1 | 98/2 | 90.2 - 85.2 vs NA |
| LDH | ≤ULN vs >ULN | 72/28 | 88.5 - 88.5 vs 90 - 80 | |
| M1 | a-b vs c-d | 55/45 | 84.2 - 84.2 vs 91.3 - 82.6 | |
| BRAF wt CPi | ECOG | 0-1 vs >1 | 89/11 | 83.9 - 74.9* vs 46.2 - 30.8 |
| LDH | ≤ULN vs >ULN | 66/34 | 89 – 82* vs 61.1 - 43.3 | |
| M1 | a-b vs c-d | 56/44 | 90.1 - 79.5* vs 67.3 - 59 |
Conclusions
Survival of pts with advanced mel is similar to reported in clinical trials. 1L TT was chosen for 2/3 BRAF V600-Mut cases while 1/3 were treated with CPi. OS in pts treated with CPi seems superior to TT in BRAF V600-Mut group although potential bias must be considered since stage, LDH and ECOG impacted OS.
Clinical trial identification
NCT03605771.
Editorial acknowledgement
Legal entity responsible for the study
Spanish Melanoma Group.
Funding
Novartis, Pierre Fabre, Incyte, BMS, MSD and Roche.
Disclosure
I. Marquez-Rodas: Financial Interests, Personal, Advisory Board: BMS; Financial Interests, Personal, Advisory Board: MSD; Financial Interests, Personal, Advisory Board: Novartis; Financial Interests, Personal, Advisory Board: Pierre Fabre; Financial Interests, Personal, Advisory Board: Roche; Financial Interests, Personal, Advisory Board: GSK; Financial Interests, Personal, Advisory Board: AstraZeneca; Financial Interests, Personal, Advisory Board: Celgene; Financial Interests, Personal, Advisory Board: Regeneron; Financial Interests, Personal, Advisory Board: Sanofi; Financial Interests, Personal, Advisory Board: Merck Serono; Financial Interests, Personal, Advisory Board: Highligth Therapeutics; Financial Interests, Personal, Advisory Board: Bioline Rx; Financial Interests, Personal and Institutional, Invited Speaker, GEM1802 clinical trial: Pierre Fabre; Financial Interests, Institutional, Invited Speaker, GEM1801 clinical study: Novartis; Financial Interests, Institutional, Invited Speaker, GEM1801 clinical study: BMS; Financial Interests, Institutional, Invited Speaker, GEM1801 clinical study: Roche; Financial Interests, Institutional, Invited Speaker, GEM1801 clinical study: Pierre Fabre; Financial Interests, Institutional, Invited Speaker, GEM1801 clinical study: Incyte; Financial Interests, Institutional, Invited Speaker, GEM1801 clinical study: 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: BMS; Financial Interests, Personal, Advisory Role: BMS; Financial Interests, Personal, Invited Speaker: Novartis; Financial Interests, Personal, Advisory Role: Novartis; Financial Interests, Personal, Invited Speaker: Pierre Fabre; Financial Interests, Personal, Advisory Role: Pierre Fabre; Financial Interests, Personal, Invited Speaker: Roche; Financial Interests, Personal, Advisory Role: Roche; Financial Interests, Personal, Invited Speaker: Pfizer; Financial Interests, Personal, Advisory Role: Pfizer; Financial Interests, Personal, Invited Speaker: Sanofi; Financial Interests, Personal, Advisory Role: Sanofi; Financial Interests, Personal, Invited Speaker: Eisai; Financial Interests, Personal, Advisory Role: Eisai; Financial Interests, Personal, Invited Speaker: Pharmamar; Financial Interests, Personal, Advisory Role: Pharmamar; Financial Interests, Personal, Invited Speaker: Kyowa Kirin. E. Muñoz Couselo: Financial Interests, Personal, Advisory Role: BMS; Financial Interests, Personal, Speaker’s Bureau: BMS; Financial Interests, Personal, Other, travel and accommodation: BMS; Financial Interests, Personal, Advisory Role: Novartis; Financial Interests, Personal, Speaker’s Bureau: Novartis; Financial Interests, Personal, Advisory Role: Roche; Financial Interests, Personal, Speaker’s Bureau: Roche; Financial Interests, Personal, Advisory Role: Sanofi; Financial Interests, Personal, Speaker’s Bureau: Sanofi; Financial Interests, Personal, Advisory Role: MSD; Financial Interests, Personal, Speaker’s Bureau: MSD; Financial Interests, Personal, Invited Speaker, travel and accommodation: MSD; Financial Interests, Personal, Speaker’s Bureau: Pierre Fabre. G. Crespo Herrero: Financial Interests, Personal, Advisory Role: BMS; Financial Interests, Personal, Advisory Role: Ipsen; Financial Interests, Personal, Advisory Role: Roche; Financial Interests, Personal, Advisory Role: Eisai; Financial Interests, Personal, Advisory Role: Sanofi; Financial Interests, Personal, Advisory Role: Janssen; Financial Interests, Personal, Advisory Role: EUSA pharma; Financial Interests, Personal, Speaker’s Bureau: Merck; Financial Interests, Personal, Speaker’s Bureau: Roche; Financial Interests, Personal, Speaker’s Bureau: EUSA pharma; Financial Interests, Personal, Speaker’s Bureau: Eisai; Financial Interests, Personal, Speaker’s Bureau: MSD; Financial Interests, , Invited Speaker, travel and accommodation: Roche. A. Soria: Financial Interests, Personal, Other, honoraria: Roche; Financial Interests, Personal, Other, honoraria: Merck Serono; Financial Interests, Personal, Other, honoraria: Novartis; Financial Interests, Personal, Other, honoraria: BMS; Financial Interests, Personal, Other, honoraria: Sanofi; Financial Interests, Personal, Other, honoraria: Pierre Fabre; Financial Interests, Personal, Other, honoraria: MSD; Financial Interests, Personal, Advisory Role: Roche; Financial Interests, Personal, Advisory Role: Merck Serono; Financial Interests, Personal, Advisory Role: Novartis; Financial Interests, Personal, Advisory Role: BMS; Financial Interests, Personal, Advisory Role: Sanofi; Financial Interests, Personal, Advisory Role: Pierre Fabre; Financial Interests, Personal, Advisory Role: Merck; Financial Interests, Personal, Speaker’s Bureau: Roche; Financial Interests, Personal, Speaker’s Bureau: Merck; Financial Interests, Personal, Speaker’s Bureau: Novartis; Financial Interests, Personal, Speaker’s Bureau: BMS; Financial Interests, Personal, Speaker’s Bureau: Sanofi; Financial Interests, Personal, Speaker’s Bureau: Pierre Fabre; Financial Interests, Personal, Speaker’s Bureau: MSD; Financial Interests, Personal, Expert Testimony: Roche; Financial Interests, Personal, Expert Testimony: Merck; Financial Interests, Personal, Expert Testimony: Novartis; Financial Interests, Personal, Expert Testimony: BMS; Financial Interests, Personal, Expert Testimony: Sanofi; Financial Interests, Personal, Expert Testimony: Pierre Fabre; Financial Interests, Personal, Expert Testimony: Merck; Financial Interests, Personal, Other, travel accommodation: Novartis; Financial Interests, Personal, Other, travel accommodation: BMS; Financial Interests, Personal, Other, travel accommodation: MSD. P. Cerezuela: Financial Interests, Personal, Advisory Role: Sanofi; Financial Interests, Personal, Advisory Role: Novartis; Financial Interests, Personal, Speaker’s Bureau: Merck; Financial Interests, Personal, Speaker’s Bureau: Novartis; Financial Interests, Personal, Speaker’s Bureau: Sanofi; Financial Interests, Personal, Speaker’s Bureau: BMS; Financial Interests, Personal, Speaker’s Bureau: ROVI; Financial Interests, Personal, Other, travel accommodation: Roche; Financial Interests, Personal, Other, travel accommodation: Novartis; Financial Interests, Personal, Other, travel accommodation: Merck. T. Puertolas Hernandez: Financial Interests, Personal, Advisory Role: BMS; Financial Interests, Personal, Advisory Role: Novartis; Financial Interests, Personal, Advisory Role: Pierre Fabre; Financial Interests, Personal, Advisory Role: Roche; Financial Interests, Personal, Other, travel accommodation: Roche. A. Berrocal: Financial Interests, Personal, Advisory Role: BMS; Financial Interests, Personal, Advisory Role: MSD; Financial Interests, Personal, Advisory Role: Novartis; Financial Interests, Personal, Advisory Role: Roche; Financial Interests, Personal, Advisory Role: Pierre Fabre; Financial Interests, Personal, Advisory Role: Merck; Financial Interests, Personal, Other, travel and accommodation: MSD; Financial Interests, Personal, Other, travel accommodation: BMS; Financial Interests, Personal, Other, honoraria: BMS; Financial Interests, Personal, Other, honoraria: MSD; Financial Interests, Personal, Other, honoraria: Novartis; Financial Interests, Personal, Other, honoraria: Amgen; Financial Interests, Personal, Other, honoraria: Pierre Fabre; Financial Interests, Personal, Other, honoraria: Merck; Financial Interests, Personal, Other, honoraria: Sanofi. M. Majem Tarruella: Financial Interests, Personal, Advisory Role: AstraZeneca; Financial Interests, Personal, Advisory Role: Roche; Financial Interests, Personal, Advisory Role: Lilly; Financial Interests, Personal, Advisory Role: BMS; Financial Interests, Personal, Advisory Role: MSD; Financial Interests, Personal, Advisory Role: Pfizer; Financial Interests, Personal, Advisory Role: Boehringer; Financial Interests, Personal, Advisory Role: Novartis; Financial Interests, Personal, Advisory Role: Tesaro; Financial Interests, Personal, Advisory Role: Helsinn Therapeutics; Financial Interests, Personal, Advisory Role: Takeda; Financial Interests, Personal, Advisory Role: Sanofi; Financial Interests, Personal, Other, travel and accommodation: AstraZeneca; Financial Interests, Personal, Other, travel accommodation: Roche; Financial Interests, Personal, Other, travel and accommodation: Lilly; Financial Interests, Personal, Research Grant: BMS. L. Bellido Hernández: Financial Interests, Personal, Other, honoraria: BMS; Financial Interests, Personal, Other, honoraria: Roche; Financial Interests, Personal, Advisory Role: Novartis; Financial Interests, Personal, Advisory Role: Boehringer. E. Espinosa: Financial Interests, Personal, Advisory Role: MSD; Financial Interests, Personal, Other, travel accommodation: MSD; Financial Interests, Personal, Other, honoraria: BMS; Financial Interests, Personal, Other, honoraria: MSD; Financial Interests, Personal, Other, honoraria: Novartis; Financial Interests, Personal, Other, honoraria: Roche; Financial Interests, Personal, Other, honoraria: Pierre Fabre; Financial Interests, Personal, Research Grant: Roche. J. Medina Martínez: Financial Interests, Personal, Advisory Role: Roche; Financial Interests, Personal, Advisory Role: BMS; Financial Interests, Personal, Advisory Role: Novartis; Financial Interests, Personal, Speaker’s Bureau: Roche; Financial Interests, Personal, Speaker’s Bureau: BMS; Financial Interests, Personal, Speaker’s Bureau: Novartis; Financial Interests, Personal, Speaker’s Bureau: Pierre Fabre; Financial Interests, Personal, Speaker’s Bureau: MSD; Financial Interests, Personal, Other, travel accommodation: Novartis; Financial Interests, Personal, Other, travel accommodation: Roche; Financial Interests, Personal, Other, travel and accommodation: BMS; Financial Interests, Personal, Other, travel accommodation: MSD. L.A. Fernandez Morales: Financial Interests, Personal, Other, honoraria: Novartis; Financial Interests, Personal, Other, honoraria: Roche; Financial Interests, Personal, Other, honoraria: BMS; Financial Interests, Personal, Advisory Role: Novartis; Financial Interests, Personal, Advisory Role: Sanofi; Financial Interests, Personal, Advisory Role: Roche; Financial Interests, Personal, Research Grant: Novartis; Financial Interests, Personal, Research Grant: Roche; Financial Interests, Personal, Other, travel accommodation: Pfizer; Financial Interests, Personal, Other, travel accommodation: Roche; Financial Interests, Personal, Other, travel and accommodation: Novartis. C. Aguado de la Rosa: Financial Interests, Personal, Advisory Role: Roche; Financial Interests, Personal, Advisory Role: Novartis; Financial Interests, Personal, Advisory Role: AstraZeneca; Financial Interests, Personal, Advisory Role: Sanofi; Financial Interests, Personal, Other, travel accommodation: Roche. R. Lopez Castro: Financial Interests, Personal, Advisory Role: Roche; Financial Interests, Personal, Advisory Role: Novartis; Financial Interests, Personal, Advisory Role: Boehringer; Financial Interests, Personal, Advisory Role: AstraZeneca; Financial Interests, Personal, Other, travel accommodation: Roche; Financial Interests, Personal, Other, travel accommodation: Novartis; Financial Interests, Personal, Other, travel and accommodation: Boehringer; Financial Interests, Personal, Other, honoraria: Roche; Financial Interests, Personal, Other, honoraria: Novartis; Financial Interests, Personal, Other, honoraria: Boehringer; Financial Interests, Personal, Other, honoraria: Takeda; Financial Interests, Personal, Other, honoraria: AstraZeneca; Financial Interests, Personal, Research Grant: Roche; Financial Interests, Personal, Research Grant: MSD. S. Martin Algarra: Financial Interests, Personal, Advisory Role: BMS; Financial Interests, Personal, Advisory Role: Regeneron; Financial Interests, Personal, Advisory Role: Sanofi; Financial Interests, Personal, Advisory Role: MSD; Financial Interests, Personal, Speaker’s Bureau: BMS; Financial Interests, Personal, Speaker’s Bureau: Roche; Financial Interests, Personal, Speaker’s Bureau: Pierre Fabre; Financial Interests, Personal, Speaker’s Bureau: Sanofi; Financial Interests, Personal, Speaker’s Bureau: MSD; Financial Interests, Personal, Other, travel accommodation: BMS; Financial Interests, Personal, Other, travel and accommodation: Roche; Financial Interests, Personal, Other, travel accommodation: Pierre Fabre; Financial Interests, Personal, Other, travel and accommodation: MSD. All other authors have declared no conflicts of interest.