Encorafenib with binimetinib efficacy in the first, second, and third line of treatment for patients with advanced melanoma harboring a BRAF mutation — real-world study
Year: 2025
Type: article
Study design: Observational Study
Abstract: Introduction. In patients with advanced melanoma with BRAF mutation, the BRAF and MEK inhibitors can be used before or after immunotherapy, and even as third-line systemic treatment. To date, majority of available data on encorafenib plus binimetinib comes from clinical trials. Material and methods. This was a multicenter retrospective study, which aimed to investigate the efficacy of encorafenib plus binimetinib (E+B) treatment in patients with unresectable stage III or IV melanoma in the real-world setting. The study did not include patients treated with adjuvant intent. Progression-free survival (PFS) and overall survival (OS) estimates were obtained using Kaplan-Meier method. Results. There were 130 patients treated in the first-line setting. Their median follow-up was 24.1 (95% CI 20.9–32) months. Median age of the group treated with E+B first line treatment was 63.5 years and LDH level was abnormal in 53.1% of cases, while 25.4% of patients had brain metastases. The median PFS was 10.3 (95% CI 8–12.4) months, 1- and 3-year PFSs were 40.1% (95% CI 31.9–50.3) and 12.3% (95% CI 6.1–24.7), while the objective response rate (ORR) was 58.5%. After the progression of the disease, 32 (24.6%) patients received second-line treatment (including immunotherapy in 28, 87.5% cases) and 5 (3.8%) patients received third-line treatment. The median OS from the start of the first-line treatment was 15.8 (95% CI 12–23.5) months, while the 1-year and 3-year OS rates were 58% (95% CI 49.6–67.9) and 20% (95% CI 11.9–33.6), respectively. In the second-line treatment, after the anti-PD-1-based first-line treatment, the E+B was administered in 82 patients. The median PFS was 8.5 (95% CI 6.5–12) months, and the ORR was 42 (51.2%). The median OS from the start of the second-line treatment was 13.2 (95% CI 10.9–22) months. In the third-line treatment, E+B was used in 23 patients, with 6- and 12-month PFS being 23% (95% CI 10.7–49.6), and 13.8% (95% CI 4.8–39.4), respectively. The median PFS in third-line setting was 3.6 (95% CI 2.8–5.3) months. Conclusions. This real-world evidence supports the clinically meaningful efficacy of the combination of E+B in first-, second- and third-line treatment.
Source: Oncology in Clinical Practice
DOI: 10.5603/ocp.107991
Authors: Anna M. Czarnecka, Piotr Błoński, Bożena Cybulska-Stopa, Wiesław Bal, Robert Dziura, Magdalena Ciążyńska, Krzysztof Ostraszewski, Katarzyna Krawczak, Łukasz Galus, Katarzyna Kozak, Natasza Kempa-Kamińska, Grażyna Kamińska-Winciorek, Marta Pabianek, Paweł Rogala, Tomasz Kubiatowski, Marcin Ziętek, Jacek Mackiewicz, Piotr Rutkowski
Institutions: The Maria Sklodowska-Curie National Research Institute of Oncology, Medical University of Warsaw, Medical University of Lodz, Wrocław University of Science and Technology, Holy Cross University, University of Rzeszów, Poznan University of Medical Sciences, Polish Mother’s Memorial Hospital Research Institute, Wroclaw Medical University, Greater Poland Cancer Center
Language: English
Topic: Melanoma and MAPK Pathways
Subfield: Molecular Biology
Domain: Life Sciences
Open Access status: diamond
OpenAlex ID: W4413958513