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5-year overall survival (OS) in COLUMBUS: A randomized phase 3 trial of encorafenib plus binimetinib versus vemurafenib or encorafenib in patients (pts) with BRAF V600-mutant melanoma

Background: Combined BRAF/MEK inhibitor therapy has demonstrated benefits on progression-free survival (PFS) and OS and is standard of care for the treatment of advanced BRAF V600-mutant melanoma. Here we report a 5-year update from the COLUMBUS trial. Methods: In Part 1 of COLUMBUS, 577 pts with advanced/metastatic BRAF V600-mutant melanoma, untreated or progressed after first-line...

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Comparison between first line immunotherapy and targeted therapy in different prognostic categories of BRAF v600 mutant metastatic melanoma patients

Background: AntiPD1 immunotherapies (IT) and BRAF and MEK inhibitors target therapies (TT) are available first-line treatments for BRAF v600 mutant metastatic melanoma patients (pts). ECOG PS (E), baseline LDH (L), baseline number of metastatic sites (N)are well known clinical prognostic markers that identify different prognostic categories of pts. Direct comparison between first-line TT and IT...

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Effect of concomitant encephalic radiotherapy (RT) with anti-PD1 or targeted therapy in melanoma brain metastases (BM): a retrospective single institutional study

Background: Development of BM in cutaneous melanoma (CM) is considered a poor prognostic factor. Recent evidence underlies the efficacy of combo-immunotherapy (IT) in asymptomatic patients resulting in high rate of intracranial response. Further studies are required to clarify whether RT can be avoided in this subset of patients in order to spare neurocognitive side effects....

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A digital companion for patients with BRAF-mutant advanced melanoma treated with targeted therapies: TAVIE Skin app

Background: Patients with advanced melanoma are facing questions regarding their disease, their treatment, or potential signs and symptoms that are common, though predictable. Strategies to control symptoms include targeting patient education and unhealthy behaviors. In the context of an increasingly digital healthcare system, it is worth considering the role of mobile health applications (mHealth) as...

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5-year update on COLUMBUS: A 1091TiP – STARBOARD: Randomized phase III study of encorafenib (enco) + binimetinib (bini) + pembrolizumab (pembro) for first-line treatment of metastatic or unresectable locally advanced BRAF V600-mutant melanoma

Background Approximately 50% of patients (pts) with metastatic melanoma have BRAF V600 mutations, which promote melanoma progression through constitutive activation of the MAPK pathway. Current treatment recommendations for metastatic or unresectable BRAF V600-mutant melanoma include BRAF inhibitors (BRAFi) + MEK inhibitors (MEKi) (eg, enco + bini) and immune checkpoint inhibitors (CPIs; eg, pembro). BRAFi and...

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SECOMBIT: The best sequential approach with combo immunotherapy [ipilimumab (I) /nivolumab (N)] and combo target therapy [encorafenib (E)/binimetinib (B)] in patients with BRAF mutated metastatic melanoma: A phase II randomized study

Background Treatment with targeted therapy (BRAF and MEK inhibitors) and immune-checkpoint inhibitors (anti-CTLA4, anti-PD-1) have improved the outcome of BRAF-V600 metastatic melanoma patients in first line. Targeted therapy demonstrated higher response rates, which may be limited over time; while the combination I+N is associated with lower but durable response rate. The best sequencing remains an...

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Pembrolizumab versus placebo after complete resection of high-risk stage II melanoma: Efficacy and safety results from the KEYNOTE-716 double-blind phase III trial

Background Current standard of care for patients (pts) after resection of high-risk stage II melanoma is observation. In the phase 3 double-blind KEYNOTE-716 trial we evaluated pembrolizumab (pembro) versus placebo in pts with resected AJCC-8 stage IIB or IIC melanoma. We present results of the first recurrence-free survival (RFS) interim analysis. Methods Eligible pts aged...

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Relatlimab (RELA) + nivolumab (NIVO) vs. NIVO in previously untreated metastatic or unresectable melanoma: Additional efficacy in RELATIVITY-047

Background RELATIVITY-047 (NCT03470922) evaluated RELA (a LAG-3-blocking antibody) + NIVO as a fixed-dose combination (FDC) vs NIVO in pts with advanced melanoma. The FDC demonstrated superior progression-free survival (PFS) by blinded independent central review in the intent-to-treat (ITT) population with a well-tolerated safety profile and no unexpected safety signals. In this exploratory analysis, we describe...

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Phase II trial of ipilimumab, nivolumab and tocilizumab for unresectable metastatic melanoma

Background Immunotherapy with ipilimumab and nivolumab has response rates of 45-55%, but 50% of patients (pts) suffer grade 3-5 immune-related adverse events. High serum IL-6 is associated with a poor outcome with checkpoint inhibition and with short survival in many cancers. Tocilizumab is a humanized IL-6 receptor blocking antibody approved for several arthritides and cytokine...

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Intracranial activity of encorafenib and binimetinib followed by radiotherapy in patients with BRAF mutated melanoma and brain metastasis: Preliminary results of the GEM1802/EBRAIN-MEL phase II clinical trial

Background Systemic treatment for patients (pts) with BRAF- mutated (mut) melanoma (mel) and brain metastasis (BMs) include immunotherapy and targeted therapy. COMBI-MB clinical trial analyzed the role of dabrafenib + trametinib, with an intracranial response rate (icRR) of 58% for asymptomatic and 59% for symptomatic pts. Encorafenib + binimetinib (EB) has not been prospectively evaluated...