2015
DOI: 10.1001/jamaoncol.2015.1184
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Efficacy and Safety of Nivolumab in Patients With BRAF V600 Mutant and BRAF Wild-Type Advanced Melanoma

Abstract: The results of this retrospective analysis suggest that nivolumab has similar efficacy and safety outcomes in patients with wild-type or mutant BRAF, regardless of prior BRAF inhibitor or ipilimumab treatment.

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Cited by 205 publications
(131 citation statements)
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References 24 publications
(14 reference statements)
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“…To date, however, no prospective analysis of the optimal choice of frontline treatment has been completed. The approved anti-PD-1 antibodies nivolumab and pembrolizumab have demonstrated efficacy in patients with BRAFmutant, BRAF-inhibitor-refractory disease 44,45 , but similar data are lacking for ipilimumab 46 , or for BRAF-inhibitorbased therapy in those refractory to anti-PD-1-antibody therapy. To inform decisions on frontline therapy, the outcomes of BRAF-targeted therapy followed by immunotherapy, or vice versa, are being compared directly in an ongoing clinical trial (NCT02224781).…”
Section: Clinical Trial Evidencementioning
confidence: 99%
“…To date, however, no prospective analysis of the optimal choice of frontline treatment has been completed. The approved anti-PD-1 antibodies nivolumab and pembrolizumab have demonstrated efficacy in patients with BRAFmutant, BRAF-inhibitor-refractory disease 44,45 , but similar data are lacking for ipilimumab 46 , or for BRAF-inhibitorbased therapy in those refractory to anti-PD-1-antibody therapy. To inform decisions on frontline therapy, the outcomes of BRAF-targeted therapy followed by immunotherapy, or vice versa, are being compared directly in an ongoing clinical trial (NCT02224781).…”
Section: Clinical Trial Evidencementioning
confidence: 99%
“…[8][9][10][11][12][13] Immune checkpoint inhibitors represent a distinct approach to treating malignancies, with durable antitumor activity and the potential for long-term survival demonstrated in multiple tumor types, including NSCLC. [14][15][16][17][18] Nivolumab, a fully human IgG4 programmed death-1 (PD-1) immune checkpoint inhibitor antibody, binds with high affinity to PD-1 receptors expressed on T cells and disrupts negative signaling induced by PD-ligand 1 (PD-L1) and PD-ligand 2 to restore T-cell effector function. 19,20 In heavily pretreated patients with advanced NSCLC, nivolumab monotherapy demonstrated an ORR of 17%, with 1-, 2-, and 3-year OS rates of 42%, 24%, and 18%, respectively, and a manageable safety profile.…”
Section: Introductionmentioning
confidence: 99%
“…The programmed death-1 (PD-1) regulatory pathway is active in several tumors and a potent immunotherapeutic target, with PD-1 inhibitors eliciting antitumor responses. [2][3][4] Nivolumab, an anti-PD-1 monoclonal antibody (Ab), is approved therapy for melanoma 5 and non-small squamous cell lung cancer; 6 it also exhibits robust clinical activity in refractory/relapsed Hodgkin lymphoma (HL). 7 Although PD-1 inhibition may effectively unleash GVT responses in relapsed HL after allogeneic SCT, the risks of graft-versus-host disease (GvHD) or graft rejection are unknown.…”
mentioning
confidence: 99%