Nivolumab versus chemotherapy in patients with advanced melanoma who progressed after anti-CTLA-4 treatment (CheckMate 037): a randomised, controlled, open-label, phase 3 trial
Tóm tắt
Từ khóa
Tài liệu tham khảo
Ishida, 1992, Induced expression of PD-1, a novel member of the immunoglobulin gene superfamily, upon programmed cell death, EMBO J, 11, 3887, 10.1002/j.1460-2075.1992.tb05481.x
Freeman, 2000, Engagement of the PD-1 immunoinhibitory receptor by a novel B7 family member leads to negative regulation of lymphocyte activation, J Exp Med, 192, 1027, 10.1084/jem.192.7.1027
Keir, 2006, Tissue expression of PD-L1 mediates peripheral T cell tolerance, J Exp Med, 203, 883, 10.1084/jem.20051776
Nishimura, 1999, Development of lupus-like autoimmune diseases by disruption of the PD-1 gene encoding an ITIM motif-carrying immunoreceptor, Immunity, 11, 141, 10.1016/S1074-7613(00)80089-8
Nishimura, 2001, Autoimmune dilated cardiomyopathy in PD-1 receptor-deficient mice, Science, 291, 319, 10.1126/science.291.5502.319
Dong, 2002, Tumor-associated B7-H1 promotes T-cell apoptosis: a potential mechanism of immune evasion, Nat Med, 8, 793, 10.1038/nm730
Brahmer, 2010, Phase I study of single-agent anti-programmed death-1 (MDX-1106) in refractory solid tumors: safety, clinical activity, pharmacodynamics, and immunologic correlates, J Clin Oncol, 28, 3167, 10.1200/JCO.2009.26.7609
Topalian, 2012, Safety, activity, and immune correlates of anti-PD-1 antibody in cancer, N Engl J Med, 366, 2443, 10.1056/NEJMoa1200690
Lipson, 2013, Durable cancer regression off-treatment and effective reinduction therapy with an anti-PD-1 antibody, Clin Cancer Res, 19, 462, 10.1158/1078-0432.CCR-12-2625
Topalian, 2014, Survival, durable tumor remission, and long-term safety in patients with advanced melanoma receiving nivolumab, J Clin Oncol, 32, 1020, 10.1200/JCO.2013.53.0105
Weber, 2013, Safety, efficacy, and biomarkers of nivolumab with vaccine in ipilimumab-refractory or -naive melanoma, J Clin Oncol, 31, 4311, 10.1200/JCO.2013.51.4802
Hamid, 2013, Safety and tumor responses with lambrolizumab (anti-PD-1) in melanoma, N Engl J Med, 369, 134, 10.1056/NEJMoa1305133
Robert, 2014, Anti-programmed-death-receptor-1 treatment with pembrolizumab in ipilimumab-refractory advanced melanoma: a randomised dose-comparison cohort of a phase 1 trial, Lancet, 384, 1109, 10.1016/S0140-6736(14)60958-2
Robert, 2015, Nivolumab in previously untreated melanoma without BRAF mutation, N Engl J Med, 372, 320, 10.1056/NEJMoa1412082
Ansell, 2015, PD-1 blockade with nivolumab in relapsed or refractory Hodgkin's lymphoma, N Engl J Med, 372, 311, 10.1056/NEJMoa1411087
Powles, 2014, Inhibition of PD-L1 by MPDL3280A and clinical activity in pts with metastatic urothelial bladder cancer (UBC), J Clin Oncol, 32, 5S
Seiwert, 2014, A phase Ib study of MK-3475 in patients with human papillomavirus (HPV)-associated and non-HPV–associated head and neck (H/N) cancer, J Clin Oncol, 32, 5S
Hamanishi, 2014, Efficacy and safety of anti-PD-1 antibody (nivolumab: BMS-936558, ONO-4538) in patients with platinum-resistant ovarian cancer, J Clin Oncol, 32, 5S
Wolchok, 2013, Nivolumab plus ipilimumab in advanced melanoma, N Engl J Med, 369, 122, 10.1056/NEJMoa1302369
Eisenhauer, 2009, New response evaluation criteria in solid tumours: revised RECIST guideline (version 1.1), Eur J Cancer, 45, 228, 10.1016/j.ejca.2008.10.026
Wolchok, 2009, Guidelines for the evaluation of immune therapy activity in solid tumors: immune-related response criteria, Clin Cancer Res, 15, 7412, 10.1158/1078-0432.CCR-09-1624
Nishino, 2013, Developing a common language for tumor response to immunotherapy: immune-related response criteria using unidimensional measurements, Clin Cancer Res, 19, 3936, 10.1158/1078-0432.CCR-13-0895
Hodi, 2014, Evaluation of immune-related response criteria (irRC) in patients (pts) with advanced melanoma (MEL) treated with the anti-PD-1 monoclonal antibody MK-3475, J Clin Oncol, 32, 5S
Armand, 2013, Disabling immune tolerance by programmed death-1 blockade with pidilizumab after autologous hematopoietic stem-cell transplantation for diffuse large B-cell lymphoma: results of an international phase II trial, J Clin Oncol, 31, 4199, 10.1200/JCO.2012.48.3685
Brahmer, 2012, Safety and activity of anti-PD-L1 antibody in patients with advanced cancer, N Engl J Med, 366, 2455, 10.1056/NEJMoa1200694
Segal, 2014, Preliminary data from a multi-arm expansion study of MEDI4736, an anti-PD-L1 antibody, J Clin Oncol, 32, 5S
Herbst, 2013, A study of MPDL3280A, an engineered PD-L1 antibody in patients with locally advanced or metastatic tumors, J Clin Oncol, 31
Ribas A, Puzanov I, Dummer R, et al. A randomized controlled comparison of pembrolizumab and chemotherapy in patients with ipilimumab-refractory melanoma. 2015 Society for Melanoma Research Annual Meeting; Zurich, Switzerland; Nov 13–16, 2014.
Robert, 2013, Efficacy and safety of retreatment with ipilimumab in patients with pretreated advanced melanoma who progressed after initially achieving disease control, Clin Cancer Res, 19, 2232, 10.1158/1078-0432.CCR-12-3080