1114P Encorafenib (E) Plus Binimetinib (B) in Unresectable Advanced or Metastatic BRAFV600-mut Melanoma, Real-World Evidence in Spain (GEM 2002 - BECARE)

Combined BRAF/MEK inhibitors have demonstrated efficacy and tolerability in phase III clinical trials, and is standard of care for advanced/metastatic BRAF-mutated melanoma. However there is limited evidence in the real-world. BECARE is a retrospective study of EB in unresectable advanced/metastatic BRAFV600-mut melanoma in 21 sites from Spain. The study includes melanoma patients (pts) treated according to standard clinical practice with EB in the 1st or after progression to a 1st line with immune checkpoint inhibitors (IT) for advanced or metastatic stage. Previous BRAF- and/or MEK- inhibitor (other than adjuvant ended ≥ 6 m before EB) or chemotherapy was not allowed. The primary objective is to characterize the population of pts receiving EB and assess treatment efficacy and tolerability in the real world. From Sep 2021 to Mar 2023, 117 pts were included. Median age was 59 years (range: 23-89), 59.8% were male, 64.1% had ECOG 0, all pts had metastasis at inclusion, and 21.4% brain metastasis. LDH was elevated in 35.9% of pts. The median follow-up was 13.1 m (95% CI: 11.4-15.1). EB was administered as the 2nd line after IT in 28 (23.9%) pts. The median PFS and OS for pts with brain metastasis treated with EB in the 1st line was 6.3 m (95% CI: 6.2-12) and 10 m (95% CI: 7.4-NR), respectively. Treatment-related adverse events of grade 3-4 were reported in 17 (14.5%) pts, being the most common elevated liver enzymes (6%), diarrhea (2.6%) and fatigue (1.7%). Creatinine was increased in 3 (2.6%) pts, and eye disorders present in 6 (5.1%). EB was administered for a median of 10.7 m (95% CI: 8.2-12.6) and required dose reductions or interruptions due to AEs in 29 (24.8%) and 37 (31.6%) pts, respectively. Treatment was ended due to toxicity in 6 (5.1%) pts.Table: 1114PEB treatmentORR; n (%)median PFS (95% CI); monthsmedian OS (95% CI); months1st line63 (75)12 (9.4-21.6)24.6 (14.8-NR)2nd line after IT21 (77.8)12.5 (6.6-NR)13.9 (10.5-NR) Open table in a new tab EB confirmed efficacy in the real-world including pts with worse prognosis than clinical trials. EB is also a feasible option after IT. Toxicity consistent with previous experience.