Categoria: Abstract

Home / Abstract
Articolo

Phase II study SECOMBIT (sequential combo immuno and target therapy study): 4-years OS data and preliminary biomarkers evaluation

Background To investigate the best sequential strategy in BRAFV600-mutated melanoma, the SECOMBIT study was carried out, a three parallel arms phase 2 randomized trial (NCT02631447). We used the combination of encorafenib/binimetinib (E+B) as targeted therapy (T-T) and the combination of ipilimumab/nivolumab (I+N) as immunotherapy (I-O). We explored T-T (Arm A) or I-O (Arm B) as...

Articolo

Tumor biomarker analysis from COLUMBUS part 1: Encorafenib + binimetinib for BRAF V600E/K-mutant advanced or metastatic melanoma

Background In the randomized, 2-part, multicenter, open-label, phase 3 COLUMBUS study, encorafenib (enco) + binimetinib (bini)—approved in the US, EU, and other countries—and enco alone improved 5-year PFS and OS vs vemurafenib (vemu) in patients (pts) with BRAF V600E/K–mutant metastatic melanoma. We retrospectively investigated genetic and transcriptional correlates of response and intrinsic resistance to enco...

Articolo

Encorafenib and binimetinib followed by radiotherapy for patients with symptomatic BRAF mutated melanoma brain metastases: GEM1802/E-BRAIN clinical trial

Background Patients (pts) with symptomatic melanoma brain metastases (MBM) have very poor prognosis. For BRAF mutated (mut) targeted therapy achieves high intracranial response rate (iRR) but intracranial progression free survival (iPFS) is usually short. With immunotherapy iRR can be long lasting in asymptomatic pts but are less frequent in symptomatic ones, especially if they need...

Articolo

Real-world evidence of encorafenib (E) plus binimetinib (B) in unresectable advanced or metastatic BRAFV600-mut melanoma in Spain (GEM 2002 – BECARE)

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...

Articolo

Treatment with tumor-infiltrating lymphocytes (TIL) versus ipilimumab for advanced melanoma: Results from a multicenter, randomized phase III trial

Background Immune checkpoint inhibitors and targeted therapies have greatly improved the outcome of patients (pts) with advanced melanoma. However, as approximately half will not derive durable benefit, a large unmet need for additional treatment options remains. Adoptive cell therapy with TIL is a treatment modality with promising response rates (RR) of 36-70% in pts with...

Articolo

Neoadjvuant versus adjuvant pembrolizumab for resected stage III-IV melanoma (SWOG S1801)

Background Adjuvant therapy (AT) is currently considered for resected stage IIB-III melanoma and selected patients with resected stage IV melanoma. AT for melanoma is anti-PD-1 or targeted therapy in the presence of a BRAF mutation. Neoadjuvant therapy (NAT) with anti-PD-1 therapy is hypothesized to generate a stronger immune response from the activation of resident tumor-infiltrating...

Articolo

Intradermal IMO-2125 versus placebo as adjuvant treatment in patients with stage II pT3-4/cN0 melanoma: Interim efficacy and safety results of the randomized phase II INTRIM study

Background Adjuvant immunotherapy is currently moving into earlier stages of melanoma. CPG7909, a Toll-like receptor-9 (TLR9) agonist, injected at the primary tumour excision site in patients with clinical stage I/II melanoma, was found to boost loco-regional and systemic anti-melanoma immunity. In an exploratory analysis this was accompanied by a significant decrease in tumour-positive sentinel lymph...

Articolo

Nivolumab (NIVO) + relatlimab (RELA) vs NIVO in previously untreated metastatic or unresectable melanoma: Additional response outcomes from RELATIVITY-047

Background In the phase 2/3 RELATIVITY-047 trial, NIVO + RELA as a fixed-dose combination (FDC) significantly improved the primary endpoint of progression-free survival (PFS) and showed a clinically meaningful improvement in overall survival (OS), although not statistically significant, with a numerically higher confirmed objective response rate (ORR) vs NIVO in patients (pts) with previously untreated...

Articolo

Pembrolizumab versus placebo after complete resection of high-risk stage III melanoma: 5-year results of the EORTC 1325-MG/Keynote-054 double-blinded phase III trial

Background We conducted the randomized phase 3 double-blind EORTC 1325/KEYNOTE-054 trial to evaluate pembrolizumab vs placebo in patients (pts) with resected high-risk stage III melanoma. At 3.5-year (yr) median follow-up, pembrolizumab improved recurrence-free survival (RFS) (hazard ratio [HR] 0.59; 95% CI 0.49-0.70, P<0.0001) and distant metastasis-free survival (DMFS) (HR 0.60, 95% CI 0.49-0.73, P<0.0001) as...

Articolo

Pembrolizumab versus placebo after complete resection of high-risk stage III melanoma: Long-term quality of life analysis results of the EORTC 1325-MG/Keynote-054 double-blinded phase III trial

Background Adjuvant pembrolizumab significantly reduces the risk of metastasis after complete resection in high-risk stage III melanoma (Eggermont et al, TLO, 2021), which may reduce exposure to new treatments, deterioration of physical functioning and global quality of life (QOL). Yet, pembrolizumab may cause long-term toxicities, negatively affecting QOL. The main aim of this analysis is...