Cited by 1,745Cancer Immunotherapy and BiomarkersHead and Neck Cancer StudiesNonmelanoma Skin Cancer Studies

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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

Seiwert, Tanguy Y, Burtness, Barbara, Mehra, Ranee, Weiss, Jared, Berger, Raanan, Eder, Joseph Paul, Heath, Karl, McClanahan, Terrill, Lunceford, Jared, Gause, Christine, Cheng, Jonathan D, Chow, Laura Q·2016·The Lancet Oncology

DOI 10.1016/s1470-2045(16)30066-3

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Abstract

Background Patients with recurrent or metastatic squamous cell carcinoma of the head and neck have few treatment options. We aimed to assess the safety, tolerability, and antitumour activity of pembrolizumab, a humanised anti-programmed death receptor 1 (PD-1) antibody, in patients with PD-L1-positive recurrent or metastatic squamous cell carcinoma of the head and neck. Methods This study was an open-label, multicentre, phase 1b trial of patients with recurrent or metastatic squamous cell carcinoma of the head and neck. Patients were eligible for enrolment if they were aged 18 years or older, had a confirmed diagnosis of recurrent or metastatic squamous cell carcinoma of the head and neck, and had any level of PD-L1 expression (ie, at least 1% of tumour cells or stroma that were PD-L1-positive by immunohistochemistry). Patients received pembrolizumab 10 mg/kg intravenously every 2 weeks. Primary outcomes were safety in the per-protocol population and the proportion of patients with centrally reviewed overall response per Response Evaluation Criteria In Solid Tumors (RECIST, version 1.1). Overall response was analysed in the full analysis set, which was defined as all patients who had received at least one dose of pembrolizumab, had measurable disease at baseline, and one post-baseline scan or patients without a post-baseline scan who discontinued therapy because of disease progression or a drug-related adverse event. The study is registered with ClinicalTrials.gov, number NCT…

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PD-1 blockade reverses adaptive immune resistance induced by high-dose hypofractionated but not low-dose daily fractionated radiation
Morisada, M. V., Clavijo, P. E., Moore, E. C., Sun, L., Chamberlin, M. M., Waes, C. V., Hodge, J. W., Mitchell, J. B., Friedman, J., & Allen, C. T. (2017) · OncoImmunology · doi:10.1080/2162402x.2017.1395996 · Cited by 150
Therapeutic approaches for the treatment of head and neck squamous cell carcinoma–An update on clinical trials
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BMI1 Inhibition Eliminates Residual Cancer Stem Cells after PD1 Blockade and Activates Antitumor Immunity to Prevent Metastasis and Relapse
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“Unfortunately, the objective responsive rates are not very high and the median response duration is relatively short, indicating that HNSCC might be intrinsically resistant to PD1 blockade and eventually relapse after treatment (Burtness et al., 2019; Ferris et al., 2016; Seiwert et al., 2016).”
The Evolution of Master Protocol Clinical Trial Designs: A Systematic Literature Review
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Self-citation
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“2) 0 Low positive 110 (17) 72 (19) 38 (15) 105 (18) 5 (12) Negative 521 (82) 305 (81) 216 (85) 485 (82) 36 (88)”
Neoadjuvant chemo-immunotherapy with camrelizumab plus nab-paclitaxel and cisplatin in resectable locally advanced squamous cell carcinoma of the head and neck: a pilot phase II trial
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“In the Keynote 012 study of pembrolizumab in patients with recurrent or metastaticHNSCC, the ORR was 24% in HPV -positive patients and 16% in HPV -negative patients 17 .”
Harnessing Tumor Necrosis Factor Alpha to Achieve Effective Cancer Immunotherapy
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“, 2016 [17] NSCLC PD-L1 > 1%, first line, combination with chemotherapy.”
Targeting the signaling in Epstein–Barr virus-associated diseases: mechanism, regulation, and clinical study
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Phase Ib Trial of the Toll-like Receptor 8 Agonist, Motolimod (VTX-2337), Combined with Cetuximab in Patients with Recurrent or Metastatic SCCHN
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Self-citation
The PD-1/PD-L1 axis and human papilloma virus in patients with head and neck cancer after adjuvant chemoradiotherapy: A multicentre study of the German Cancer Consortium Radiation Oncology Group (DKTK-ROG)
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“PD-L11 tumor (and myeloid cells) were evaluated for each sample in different representative fields and due to lack of a standardized scoring system all cases with expression in 5% of the cells were considered positive.(13,18) We did not score PD-L1 separately in the intra-epithelial and stromal compartment.”
Background
PD-Loma: a cancer entity with a shared sensitivity to the PD-1/PD-L1 pathway blockade
Hirsch, L., Zitvogel, L., Eggermont, A. M. M., & Marabelle, A. (2018) · British Journal of Cancer · doi:10.1038/s41416-018-0294-4 · Cited by 131
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Cetuximab-Containing Combinations in Locally Advanced and Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma
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“ICI will shortly become a backbone in the treatment of R/M HNSCC, and are already being investigated in the LA setting in combination with CRT or RT alone (NCT02952586, NCT03040999) (123, 124).”
Method
Pembrolizumab KEYNOTE-001: an adaptive study leading to accelerated approval for two indications and a companion diagnostic
Kang, S., Gergich, K., Lubiniecki, G. M., de Alwis, D. P., Chen, C., Tice, M. A. B., & Rubin, E. H. (2017) · Annals of Oncology · doi:10.1093/annonc/mdx076 · Cited by 113
“In August 2016 pembrolizumab received accelerated approval from the FDA for the treatment of HNSCC with progression on or after platinum-containing therapy [61], based on data from the KEYNOTE-012 trial (NCT01848834) [62, 63].”
A phase I, single-center, open-label study of RM-1929 photoimmunotherapy in Japanese patients with recurrent head and neck squamous cell carcinoma
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Impact of Neoadjuvant Durvalumab with or without Tremelimumab on CD8+ Tumor Lymphocyte Density, Safety, and Efficacy in Patients with Oropharynx Cancer: CIAO Trial Results
Ferrarotto, R., Bell, D., Rubin, M. L., Hutcheson, K. A., Johnson, J. M., Goepfert, R. P., Phan, J., Elamin, Y. Y., Torman, D., Warneke, C. L., et al. (2020) · Clinical Cancer Research · doi:10.1158/1078-0432.ccr-19-3977 · Cited by 127
“and combined proportion score were calculated as previously described.(19)”
Method
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“4) [37-39]: no atypical patterns of response were noted in the expansion cohort of the phase”
Background
Current Understanding of the Mechanisms Underlying Immune Evasion From PD-1/PD-L1 Immune Checkpoint Blockade in Head and Neck Cancer
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Expression of Programmed Cell Death Ligand in Cutaneous Squamous Cell Carcinoma and Treatment of Locally Advanced Disease With Pembrolizumab
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The immune microenvironment of HPV-positive and HPV-negative oropharyngeal squamous cell carcinoma: a multiparametric quantitative and spatial analysis unveils a rationale to target treatment-naïve tumors with immune checkpoint inhibitors
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“Unfortunately, only 15–20% of patients with HNSCC benefit from ICI, with this poor outcome being increasingly ascribed to peculiar characteristics of the TIME [33].”
Background
Neoadjuvant presurgical PD-1 inhibition in oral cavity squamous cell carcinoma
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BackgroundInfluential
Oral cancers: Current status.
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“A growing body of clinical evidence indicates that the level of PD-L1 expression is predictive of best overall response and improved PFS with PD-1 inhibitors (4, 5, 21).”
BackgroundMethodSelf-citation
The Evolving Landscape of PD-1/PD-L1 Pathway in Head and Neck Cancer
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Newly Emerging Immune Checkpoints: Promises for Future Cancer Therapy
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Delivery of an ectonucleotidase inhibitor with ROS-responsive nanoparticles overcomes adenosine-mediated cancer immunosuppression
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“This indicates that additional immunosuppressive mechanisms could be targeted to maximize therapeutic benefit (4, 9, 10).”
Background
Biological mechanisms of immune escape and implications for immunotherapy in head and neck squamous cell carcinoma
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Pembrolizumab: first experience with recurrent primary central nervous system (CNS) tumors
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Background
The Key Differences between Human Papillomavirus-Positive and -Negative Head and Neck Cancers: Biological and Clinical Implications
Powell, S., Vu, L., Spanos, W., & Pyeon, D. (2021) · Cancers · doi:10.3390/cancers13205206 · Cited by 98
“In the phase IB KEYNOTE-012 study evaluating the pembrolizumab monotherapy in an R/M HNSCC cohort, 23% of participants were HPV+ based on p16 status [103].”
Background
Microenvironment-driven intratumoral heterogeneity in head and neck cancers: clinical challenges and opportunities for precision medicine
den Bossche, V. V., Zaryouh, H., Vara-Messler, M., Vignau, J., Machiels, J., Wouters, A., Schmitz, S., & Corbet, C. (2022) · Drug Resistance Updates · doi:10.1016/j.drup.2022.100806 · Cited by 105
Tumor microenvironment in head and neck squamous cell carcinoma: Functions and regulatory mechanisms
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The promise of Immuno-oncology: implications for defining the value of cancer treatment
Kaufman, H. L., Atkins, M. B., Subedi, P., Wu, J. J., Chambers, J. D., Mattingly, T. J., Campbell, J. D., Allen, J., Ferris, A. E., Schilsky, R. L., et al. (2019) · Journal for ImmunoTherapy of Cancer · doi:10.1186/s40425-019-0594-0 · Cited by 112
“Similarly, significant results with checkpoint inhibition approaches have yielded regulatory approvals of novel drugs and combination regimens, leading to new standards of care for patients with RCC, non-small cell lung cancer (NSCLC) [12], small cell lung cancer (SCLC) [13], bladder cancer [14], Merkel cell cancer [1…”
Result
Knockdown of PD-L1 in Human Gastric Cancer Cells Inhibits Tumor Progression and Improves the Cytotoxic Sensitivity to CIK Therapy
Li, J., Chen, L., Xiong, Y., Zheng, X. W., Xie, Q., Zhou, Q., Shi, L., Wu, C., Jiang, J., & Wang, H. (2017) · Cellular Physiology and Biochemistry · doi:10.1159/000460504 · Cited by 96
Genetic risk analysis of a patient with fulminant autoimmune type 1 diabetes mellitus secondary to combination ipilimumab and nivolumab immunotherapy
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“…in phase III clinical trials [3, 4] and, in the case of the anti-PD-1 antibodies, are now being utilized in the treatment of other solid tumors reflected by the recent FDA approvals for their use in non-small cell lung cancer, renal cell carcinoma, and head and neck squamous cell carcinoma [5 – 7].”
Method
Patient-Derived Xenografts for Prognostication and Personalized Treatment for Head and Neck Squamous Cell Carcinoma
Karamboulas, C., Bruce, J. P., Hope, A. J., Meens, J., Huang, S. H., Erdmann, N., Hyatt, E., Pereira, K., Goldstein, D. P., Weinreb, I., et al. (2018) · Cell Reports · doi:10.1016/j.celrep.2018.10.004 · Cited by 94
Immunotherapy for head and neck cancer: Present and future
Fasano, M., Corte, C. M. D., Liello, R. D., Viscardi, G., Sparano, F., Iacovino, M. L., Paragliola, F., Piccolo, A., Napolitano, S., Martini, G., et al. (2022) · Critical Reviews in Oncology/Hematology · doi:10.1016/j.critrevonc.2022.103679 · Cited by 117
PD-1 Expression in Head and Neck Squamous Cell Carcinomas Derives Primarily from Functionally Anergic CD4+ TILs in the Presence of PD-L1+ TAMs
Mattox, A. K., Lee, J., Westra, W. H., Pierce, R. H., Ghossein, R. A., Faquin, W. C., Diefenbach, T. J., Morris, L. G. T., Lin, D. T., Wirth, L. J., et al. (2017) · Cancer Research · doi:10.1158/0008-5472.can-16-3453 · Cited by 100
“Given the efficacy and relative safety profile of targeting the PD-1:PD-L1 pathway in HNSCC patients, we systematically assessed the expression frequency of PD-L1 in the context of other immune cell populations (T cells and tumor associated macrophages) to capture a more comprehensive landscape of the tumor microenvir…”
BackgroundMethodInfluential
Mechanisms of Tumor Cell–Intrinsic Immune Evasion
Spranger, S., & Gajewski, T. F. (2017) · Annual Review of Cancer Biology · doi:10.1146/annurev-cancerbio-030617-050606 · Cited by 113
“Moreover, in patients treated with anti-PD-1, clinical activity is favored in those having a transcriptional signature indicative of T cell infiltration into the tumor site at baseline (Chen et al. 2016, Seiwert et al. 2016).”
Background
Contrasting cytotoxic and regulatory T cell responses underlying distinct clinical outcomes to anti-PD-1 plus lenvatinib therapy in cancer
Guo, X., Nie, H., Zhang, W., Li, J., Ge, J., Xie, B., Hu, W., Zhu, Y., Zhong, N., Zhang, X., et al. (2025) · Cancer Cell · doi:10.1016/j.ccell.2025.01.001 · Cited by 100
Influence of tumor mutational burden, inflammatory gene expression profile, and PD-L1 expression on response to pembrolizumab in head and neck squamous cell carcinoma
Haddad, R. I., Seiwert, T. Y., Chow, L. Q. M., Gupta, S., Weiss, J., Gluck, I., Eder, J. P., Burtness, B. A., Tahara, M., Keam, B., et al. (2022) · Journal for ImmunoTherapy of Cancer · doi:10.1136/jitc-2021-003026 · Cited by 105
Self-citation
Anti–PD-1 and Anti–PD-L1 in Head and Neck Cancer: A Network Meta-Analysis
Botticelli, A., Cirillo, A., Strigari, L., Valentini, F., Cerbelli, B., Scagnoli, S., Cerbelli, E., Zizzari, I. G., Rocca, C. D., d’Amati, G., et al. (2021) · Frontiers in Immunology · doi:10.3389/fimmu.2021.705096 · Cited by 101
“Despite the anti-PD-1 antibodies providing a benefit in terms of tumor progression control and overall survival (OS) compared with chemotherapy (11, 13, 14, 20), overall response still remains limited.”
Background

Authors: Seiwert, T. Y., Burtness, B., Mehra, R., Weiss, J., Berger, R., Eder, J. P., Heath, K., McClanahan, T., Lunceford, J., Gause, C., Cheng, J. D., & Chow, L. Q.
Affiliations: University of Chicago (US)
Fox Chase Cancer Center (US)
University of North Carolina at Chapel Hill (US)
Sheba Medical Center (IL)
Yale Cancer Center (US)
Merck & Co., Inc., Rahway, NJ, USA (United States) (US)
University of Washington (US)
Corresponding author: Seiwert, Tanguy Y
ORCID: Seiwert, Tanguy Y
Burtness, Barbara
Mehra, Ranee
Berger, Raanan
Eder, Joseph Paul
Lunceford, Jared
Chow, Laura Q
Venue: The Lancet Oncology
Publisher: Elsevier BV
Published: 2016-07
Volume: 17
Issue: 7
Pages: 956-965
ISSN: 1470-2045 (ISSN-L)
DOI: 10.1016/s1470-2045(16)30066-3
OpenAlex: W2401455386
Cited by: 1,745
References: 0
Citations by year: 2026: 73 · 2025: 136 · 2024: 149 · 2023: 159 · 2022: 165 · 2021: 213 · 2020: 195 · 2019: 190 · 2018: 216 · 2017: 204 · 2016: 44
FWCI: 117.58
Type: journal article
Language: en
Open access: closed
Licence: www.elsevier.com/tdm/userlicense/1.0/ (tdm)
www.elsevier.com/legal/tdmrep-license (tdm)
Locations: The Lancet Oncology (publishedVersion)
PubMed (publishedVersion)
Topics: Health Sciences › Medicine › Oncology › Cancer Immunotherapy and Biomarkers
Health Sciences › Medicine › Otorhinolaryngology › Head and Neck Cancer Studies
Health Sciences › Medicine › Dermatology › Nonmelanoma Skin Cancer Studies
Keywords: pembrolizumab, PD-1 inhibitors, PD-L1 expression, immune checkpoint inhibitors, antitumour activity, drug safety and tolerability, immune-related adverse events, hyponatremia, elevated liver enzymes, overall response rate
MeSH terms: Adult, Aged, Aged, 80 and over, Antineoplastic Agents, Carcinoma, Squamous Cell, Female, Follow-Up Studies, Head and Neck Neoplasms, Humans, Lymphatic Metastasis, Male, Middle Aged, Neoplasm Recurrence, Local, Neoplasm Staging, Prognosis, Safety, Survival Rate, Young Adult, Antibodies, Monoclonal, Humanized

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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

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