Safety and clinical activity of pembrolizumab for treatment of recurrent or metastatic squamous cell carcinoma of the head and neck (KEYNOTE-012): an open-label, multicentre, phase 1b trial.

By T. Seiwert, B. Burtness, R. Mehra, J. Weiss, R. Berger, J. Eder, K. Heath, T. Mcclanahan, J. Lunceford, C. Gause and 2 more. The Lancet Oncology, 2016

1,531 citations recorded by the source corpus.

Subfields: Oncology, Otorhinolaryngology, Surgery

View Paper: https://www.semanticscholar.org/paper/71cb0083a3957f27ff65d22fbcc77a5b74ffaf5f

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Citations in the corpus

Nivolumab for Recurrent Squamous-Cell Carcinoma of the Head and Neck (2016, background): “24,25 In conclusion, nivolumab prolonged survival, as compared with standard therapy, among patients with platinum-refractory squamous-cell carcinoma of the head and neck.”
An update on larynx cancer (2017, background): “A response rate of 18% was reported in this heavily pretreated population, with a median PFS of 2 months and a median OS of 13 months.(129) Pembrolizumab has recently been approved by the US Food and Drug Administration for platinum-refractory, metastatic SCCHN.”
A Structured Tumor-Immune Microenvironment in Triple Negative Breast Cancer Revealed by Multiplexed Ion Beam Imaging (2018, positive): “Although preliminary, overall response rates typically range 15–30%, similar to observations in gastric and head and neck cancers (Muro et al., 2016; Seiwert et al., 2016).”
Integrative molecular and clinical modeling of clinical outcomes to PD-1 blockade in metastatic melanoma patients (2019, neutral): “While ICB has resulted in durable clinical response in multiple tumor types 1-7 only a subset of patients respond, and predictors of response are not fully characterized.”
Pan-tumor genomic biomarkers for PD-1 checkpoint blockade–based immunotherapy (2018, neutral): “PD-L1–unselected B2 (n = 73) cohorts (40, 41) and patients with advanced melanoma from the pembrolizumab arms of the KEYNOTE-001 (n = 30 of 668 total enrolled patients) and KEYNOTE006 (n= 59 of 834 total enrolled patients) studies (26, 42).”
Review of Indications of FDA-Approved Immune Checkpoint Inhibitors per NCCN Guidelines with the Level of Evidence (2020, methodology): “This approval via an accelerated process on based on the increased ORR (16%) and durability of response (DOR) regardless of human papilloma virus (HPV) status, demonstrated in Keynote-012 trial [57].”
Development of PD-1 and PD-L1 inhibitors as a form of cancer immunotherapy: a comprehensive review of registration trials and future considerations (2018, background): “On August 5, 2016, pembrolizumab received accelerated approval for recurrent or metastatic HNSCC with disease progression on or after platinum-containing chemotherapy [42].”
Antitumor Activity of Pembrolizumab in Biomarker-Unselected Patients With Recurrent and/or Metastatic Head and Neck Squamous Cell Carcinoma: Results From the Phase Ib KEYNOTE-012 Expansion Cohort (2016, background): “Age, median (range), years 60 (25-84) Male 110 (83) Race White 95 (72) Asian 29 (22) Other 8 (6) ECOG performance status 0 38 (29) 1 94 (71) Smoking status* Smoked 81 (61) Never smoked 51 (39) HPV status HPV associated 28 (21) Non–HPV associated 104 (79) Sum of target lesions at baseline, median (ra”