Abstract 837P
Background
Combined BRAF/MEK inhibitor therapy has demonstrated efficacy and tolerability in phase III clinical trials, and is standard of care for advanced / metastatic melanoma. However there is limited evidence in the real-world.
Methods
BECARE is a retrospective, non-interventional study that investigates real-world effectiveness and tolerability of encorafenib plus binimetinib in unresectable advanced / metastatic BRAFV600-mut melanoma in 21 sites from Spain. The primary objective is to characterize the population of patients (pts) receiving EB and their outcomes. The study includes melanoma pts treated according to standard clinical practice with EB in the first line or after progression to a first line with immune checkpoint inhibitors (ICI) for advanced or metastatic stage. Previous BRAF- and/or MEK- inhibitor treatment (other than adjuvant ended ≥ 6 m before EB) or chemotherapy was not allowed.
Results
From September 2021, 56 pts were included. Median age was 58 years (range: 25-89), 58.9% were male, 67.9% had ECOG 0, 96.4% had metastasis being 51.8% IVM1C, and 73.2% had ≥3 organs involved (Brain: 17.9%). LDH was elevated in 37.5% of pts. EB was administered as the second line after IT in 10 (17.9%) pts. The ORR to EB was 80.4%. With a median follow up of 13 m (range: 1.1-26.7), median PFS was 11.4 m (95% CI: 9.9-21.6) and 6.6 m (95% CI: 4.4-NR) for pts in first-line and after ICI, respectively. The 12-m OS rate was 72.3% (95% CI: 60.1-87) and 30% (95% CI: 11.6-77.3) for pts in first-line and after ICI, respectively. There were no deaths related to study treatment and most common grade 3-4 toxicities were ALT increased (5.4%), fatigue (3.4%) and diarrhea (1.9%).
Conclusions
EB showed similar efficacy in the real-world setting than in clinical trials, despite the population included pts with worse prognosis. Final OS results are awaited. The toxicity profile was consistent with previous experience.
Clinical trial identification
Editorial acknowledgement
We acknowledge 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-Fabré Ibérica.
Disclosure
A. Soria: Financial Interests, Personal, Invited Speaker: Bristol Myers Squibb, Merck Serono, Merck Sharp & Dhome, Novartis Pharma, Pierre Fabre, Sanofi Aventis; Financial Interests, Personal, Advisory Board: Bristol Myers Squibb, Merck Serono, Merck Sharp & Dhome, Novartis Pharma, Pierre Fabre, Sanofi Aventis. S. Sequero: Financial Interests, Personal, Other, Public speaking: MSD; Financial Interests, Personal, Other, Advisory and Public speaking: Novartis, Roche; Financial Interests, Personal, Advisory Role: Pierre-Fabre, AstraZeneca, Yncite; Financial Interests, Personal, Project Lead, Clinical trial: Roche; Financial Interests, Institutional, Other, Clinical trial: Roche. G. Benítez: Financial Interests, Personal, Advisory Board: Pierre Fabre; Financial Interests, Personal, Invited Speaker: MSD, Pierre Fabre, Bristol Myers Squibb; Financial Interests, Personal, Other, Congress: Pierre Fabre; Financial Interests, Personal, Other, Work in clinical trials: Asociacion Canaria para la Investigacion. E. Espinosa: Financial Interests, Personal, Advisory Role: BMS, MSD, Novartis, Pierre Fabre; Financial Interests, Personal, Other, Educational activities: Novartis, Pierre Fabre; Financial Interests, Personal, Project Lead, Funding for translational investigation: Roche; Non-Financial Interests, Personal, Leadership Role, Vicepresident: GEM. C. Aguayo: Financial Interests, Personal, Advisory Board: Pierre Fabre; Financial Interests, Personal, Other, Continous medical education: Pfizer, Novartis, MSD, Pierre Fabre, BMS, Roche. R. García Galindo: Financial Interests, Personal, Advisory Board: Pierre Fabre; Financial Interests, Personal, Speaker’s Bureau: Novartis, Sanofi, Pierre Fabre. T. Puértolas: Financial Interests, Personal, Advisory Role: BMS, Novartis, Pierre-Fabre, Sanofi; Financial Interests, Personal, Invited Speaker: BMS, Roche, MSD, Novartis, Pierre-Fabre, Sun-Pharma; Financial Interests, Institutional, Invited Speaker, Clinical trial: Roche, BMS, Apexigen Inc, Aduro Biotech, Alkermes Inc; Non-Financial Interests, Institutional, Invited Speaker, congresses inscriptions: Lilly, Sun-Pharma, Novartis, Roche, MSD; Non-Financial Interests, Institutional, Leadership Role, Vocal: GEM (Grupo Español Multidisciplinar de Melanoma); Non-Financial Interests, Institutional, Affiliate: SEOM (Sociedad Española de Oncología Médica), GEM (Grupo Español Multidisciplinar de Melanoma). A. Cunquero-Tomás: Financial Interests, Personal, Invited Speaker: BMS, Fundación ECO, Pierre-Fabre; Financial Interests, Personal, Other, Meeting expenses: MSD, Novartis, Sanofi; Financial Interests, Personal, Writing Engagements: Sanofi; Non-Financial Interests, Personal, Other, Member of the QOPI Steering Group: ASCO; Non-Financial Interests, Personal, Other, Member of the Practising Oncologists Working Group: ESMO. R. López Castro: Financial Interests, Personal, Invited Speaker: Takeda, Novartis, Roche, BMS, MSD; Financial Interests, Personal, Advisory Role: Takeda, Novartis, Roche, Boehringer Ingelheim, BMS. G. Crespo: Financial Interests, Personal, Other, speaker, consultancy and advisory role: BMS, Novartis, Ipsen, Janssen, Sanofi, Eusa Pharma, Pierre Fabre, MSD, Eisai, Bayer. B. Campos: Financial Interests, Personal, Invited Speaker: Roche, BMS, AstraZeneca, Sanofi, Novartis, Merck, Pierre Fabre, ROVI, Leo Pharma, Sun Pharma; Financial Interests, Personal, Advisory Role: Roche, BMS, Sanofi, Novartis, Pierre Fabre, SUN Pharma. P. Cerezuela-Fuentes: Financial Interests, Personal, Other, Consulting. Conferences. Attendance/infrastructure for congresses: BMS, MSD, Pierre Fabre, Roche, Sanofi, SunPharma. All other authors have declared no conflicts of interest.