1114P - Encorafenib (E) plus binimetinib (B) in unresectable advanced or metastatic BRAFV600-mut melanoma, real-world evidence in Spain (GEM 2002 - BECARE)

Background

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.

Methods

BECARE is a retrospective study of EB in unresectable advanced/metastatic BRAF^V600-mut melanoma in 21 sites from Spain. The study includes melanoma patients (pts) treated according to standard clinical practice with EB in the 1^st or after progression to a 1^st 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.

Results

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 1^st 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: 1114P

Conclusions

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.

Clinical trial identification

Editorial acknowledgement

Mfar Clinical Research staff for their assistance in the development of this abstract.

Legal entity responsible for the study

Grupo Español Multidisciplinar en Melanoma (GEM).

Funding

Grupo Español Multidisciplinar en Melanoma (GEM) as Sponsor with Industry partner Pierre Fabre Ibérica.

Disclosure

A. Soria: Financial Interests, Personal, Other, Honoraria: MSD, Merck Serono, Novartis Pharma, Bristol Myers Squibb, Pierre Fabre, Sanofi; Financial Interests, Personal, Speaker, Consultant, Advisor: MSD, Merck Serono, Novartis Pharma, Bristol Myers Squibb, Pierre Fabre, Sanofi. S. Sequero: Financial Interests, Personal, Speaker, Consultant, Advisor: Novartis, Pierre Fabre, Roche, MSD, Takeda, Pfizer, AstraZeneca, Incyte, Gilead. T. Puértolas: Financial Interests, Personal, Advisory Role: Bristol, Immunocore, Novartis, Seagen; Financial Interests, Personal, Other, Travel, Accommodation, Expenses: Novartis, MSD, Pierre Fabre. J. Fra Rodríguez: Financial Interests, Personal, Speaker, Consultant, Advisor: Amgen, Roche, Sanofi, Merck, Novartis, GSK, Pierre Fabre, Servier, BMS, PharmaMar, AAA. C. Aguayo: Financial Interests, Personal, Advisory Board: Pierre Fabre; Financial Interests, Personal, Other, Honoraria for Continuous Medical Education: Pfizer, Novartis, MSD, Pierre Fabre, BMS, Roche. G. Benítez: Financial Interests, Personal, Advisory Board: Sun Pharma; Financial Interests, Personal, Speaker, Consultant, Advisor: Merck, AstraZeneca, MSD, Bristol, Novartis, Pierre Fabre; Financial Interests, Personal, Principal Investigator: Pierre Fabre. P. Ayala de Miguel: Financial Interests, Personal, Speaker, Consultant, Advisor: MSD, Novartis, Sanofi, Pierre Fabre, BMS. E. Muñoz-Couselo: Financial Interests, Personal, Speaker, Consultant, Advisor: BMS, MSD, Novartis, Pierre Fabre, Sanofi, Roche. B. Campos: Financial Interests, Personal, Speaker, Consultant, Advisor: Roche, BMS, AstraZeneca, Sanofi, Novartis, Merck, Pierre Fabre, Rovi, Leo Pharma, Sun Pharma. All other authors have declared no conflicts of interest.