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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...

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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...

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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...

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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...

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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...

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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...

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Distant metastasis-free survival with pembrolizumab versus placebo as adjuvant therapy in stage IIB or IIC melanoma: The phase 3 KEYNOTE-716 study

Background: In previous analyses of the phase 3, double-blind KEYNOTE-716 study, adjuvant pembrolizumab (pembro) significantly improved recurrence-free survival compared with placebo in patients (pts) with resected AJCC-8 stage IIB or IIC melanoma. We present new data from the analysis of distant metastasis-free survival (DMFS), and recurrence-free survival (RFS) with longer follow up. Methods: A total...

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Phase II study SECOMBIT (sequential combo immuno and target therapy study): A subgroup analysis with a longer follow-up

Background: To investigate the best sequential strategy, we started the SECOMBIT study, a randomized three parallel arms phase 2 study (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 the two different sequences and the “sandwich” strategy with a short course...

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Atezolizumab (A), cobimetinib (C), and vemurafenib (V) in patients (pts) with BRAFV600 mutation–positive melanoma with central nervous system (CNS) metastases (mets): Primary results from phase 2 Tricotel study

Background: Despite recent advances in the treatment of melanoma, there remains an urgent need to improve outcomes in pts with CNS mets. To date, studies evaluating intracranial activity of immunotherapies and targeted therapies have included limited numbers of pts with symptomatic CNS mets. Cohort 2 of the phase 2 Tricotel study evaluated the safety and...

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Nivolumab (NIVO) + relatlimab (RELA) versus NIVO in previously untreated metastatic or unresectable melanoma: OS and ORR by key subgroups 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) versus NIVO in patients (pts) with previously untreated metastatic or unresectable melanoma. Secondary endpoints showed a clinically meaningful improvement in overall survival (OS), although not statistically significant, and a higher objective...