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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BackgroundInfluential
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Pseudoprogression in microsatellite instability-high colorectal cancer during treatment with combination T cell mediated immunotherapy: a case report and literature review
Chae, Y., Wang, S.-Y., Nimeiri, H., Kalyan, A., & Giles, F. (2017) · OncoTarget · doi:10.18632/oncotarget.18361 · Cited by 35
“Multiple studies using antibodies against CTLA-4, PD-1 and PD-L1 provide the basis of evaluating the incidence and scale of pseudoprogression across a variety of solid tumors [4-6, 9, 13, 16-26] (Table 2).”
Background
Methylation of RAD51B, XRCC3 and other homologous recombination genes is associated with expression of immune checkpoints and an inflammatory signature in squamous cell carcinoma of the head and neck, lung and cervix
Rieke, D. T., Ochsenreither, S., Klinghammer, K. F., Seiwert, T. Y., Klauschen, F., Tinhofer, I., & Keilholz, U. (2016) · Oncotarget · doi:10.18632/oncotarget.12211 · Cited by 41
“The interferon-inflammatory immune gene signature has been reported as predictive of response to pembrolizumab in HNSCC, gastric cancer and melanoma and as correlated to an immune-evasive phenotype in mesothelioma [3], [35], [22], [36].”
BackgroundMethodInfluentialSelf-citation
Neoadjuvant Nivolumab Plus Chemotherapy Followed by Response-Stratified Chemoradiation Therapy in HPV-Negative Head and Neck Cancer
Rosenberg, A. J., Juloori, A., Jelinek, M. J., Agrawal, N., Cursio, J., Cipriani, N. A., Lingen, M. W., Izumchenko, E., Katipally, R. R., Chin, J., et al. (2025) · JAMA Oncology · doi:10.1001/jamaoncol.2025.0081 · Cited by 36
The Use of Immune Regulation in Treating Head and Neck Squamous Cell Carcinoma (HNSCC)
Wang, C.-W., Biswas, P. K., Islam, A., Chen, M., & Chueh, P. J. (2024) · Cells · doi:10.3390/cells13050413 · Cited by 35
Tertiary Lymphoid Structures Gene Signature Predicts Prognosis and Immune Infiltration Analysis in Head and Neck Squamous Cell Carcinoma
Xing, A., Lv, D., Wu, C., Zhou, K., Zhao, T., Zhao, L., Wang, H., & Feng, H. (2024) · Current Genomics · doi:10.2174/0113892029278082240118053857 · Cited by 33
Human Papillomavirus-Associated Head and Neck Cancers. Where are We Now? A Systematic Review
Pinkiewicz, M., Dorobisz, K., & Zatoński, T. (2022) · Cancer Management and Research · doi:10.2147/cmar.s379173 · Cited by 34
“The median duration of overall survival was 49.0 months in patients treated with combined therapy and 29.3 months in the radiotherapy alone group.57 Cancerous cells express programmed death-ligand 1 or 2 (PD-L1/2), which binds to the PD receptor on the T-cell, resulting in an inactivation of the cytotoxic response of…”
BackgroundInfluential
Is There an Interplay between Oral Microbiome, Head and Neck Carcinoma and Radiation-Induced Oral Mucositis?
Gugnacki, P., & Sierko, E. (2021) · Cancers · doi:10.3390/cancers13235902 · Cited by 39
Pembrolizumab in the first-line treatment of advanced head and neck cancer
de Sousa, L. G., & Ferrarotto, R. (2021) · Expert Review of Anticancer Therapy · doi:10.1080/14737140.2021.1996228 · Cited by 34
“A combination of several predictive biomarkers, such as tumor mutational burden [16,40], tumor-infiltrating lymphocytes [41], and inflamed gene signatures [42,43], may enhance identification of patients who most likely benefit from therapy with PD1 inhibitors, and new candidate biomarkers are under investigation.”
BackgroundInfluential
Causes and Consequences of HPV Integration in Head and Neck Squamous Cell Carcinomas: State of the Art
Balaji, H., Demers, I., Wuerdemann, N., Schrijnder, J., Kremer, B., Klussmann, J., Huebbers, C., & Speel, E. (2021) · Cancers · doi:10.3390/cancers13164089 · Cited by 34
Differences in TCR repertoire and T cell activation underlie the divergent outcomes of antitumor immune responses in tumor-eradicating versus tumor-progressing hosts
Woolaver, R. A., Wang, X., Krinsky, A. L., Waschke, B. C., Chen, S. M. Y., Popolizio, V., Nicklawsky, A., Gao, D., Chen, Z., Jimeno, A., et al. (2021) · Journal for ImmunoTherapy of Cancer · doi:10.1136/jitc-2020-001615 · Cited by 41
Evolving Role of Immunotherapy in Recurrent Metastatic Head and Neck Cancer
Le, X., Ferrarotto, R., Wise-Draper, T. M., & Gillison, M. L. (2020) · Journal of the National Comprehensive Cancer Network · doi:10.6004/jnccn.2020.7590 · Cited by 47
The role of protein methyltransferases as potential novel therapeutic targets in squamous cell carcinoma of the head and neck
Saloura, V., Vougiouklakis, T., Sievers, C. M., Burkitt, K., Nakamura, Y., Hager, G. L., & Waes, C. V. (2018) · Oral Oncology · doi:10.1016/j.oraloncology.2018.04.014 · Cited by 40
Approach to Oligometastatic Disease in Head and Neck Cancer, on Behalf of the GORTEC
Sun, X., Michel, C., Babin, E., Raucourt, D. D., Péchery, A., Gherga, E., Géry, B., Florescu, C., Bourhis, J., & Thariat, J. (2018) · Future Oncology · doi:10.2217/fon-2017-0468 · Cited by 40
Toxicities of systemic agents in squamous cell carcinoma of the head and neck (SCCHN); A new perspective in the era of immunotherapy.
Saba, N., Mody, M., Tan, E., Gill, H., Rinaldo, A., Takes, R., Strojan, P., Hartl, D., Vermorken, J., Haigentz, M., et al. (2017) · Critical reviews in oncology/hematology · doi:10.1016/j.critrevonc.2017.04.011 · Cited by 34
Systemic therapy for head and neck squamous cell carcinoma: Historical perspectives and recent breakthroughs
Blasco, M., Svider, P. F., Raza, S. N., Jacobs, J. R., Folbe, A., Saraf, P., Eloy, J. A., Baredes, S., & Fribley, A. (2017) · The Laryngoscope · doi:10.1002/lary.26629 · Cited by 34
“The KEYNOTE-012 (Study of Pembrolizumab [MK-3475] in Participants With Advanced Solid Tumors) phase I trial investigated the effects of PD-1 inhibitor pembrolizumab in 60 patients with recurrent/metastatic HNSCC, noting an 18% overall response rate.(29) Interestingly, 82% of responders experienced a durable response l…”
Background
Cotargeting mTORC and EGFR Signaling as a Therapeutic Strategy in HNSCC
Swick, A. D., Prabakaran, P. J., Miller, M. C., Javaid, A. M., Fisher, M. M., Sampene, E., Ong, I. M., Hu, R., Iida, M., Nickel, K. P., et al. (2017) · Molecular Cancer Therapeutics · doi:10.1158/1535-7163.mct-17-0115 · Cited by 39
Cancer Immunotherapy: Whence and Whither
Stambrook, P. J., Maher, J. F., & Farzaneh, F. (2017) · Molecular Cancer Research · doi:10.1158/1541-7786.mcr-16-0427 · Cited by 43
“PD-L1 expression occurs in several solid tumor types including melanoma (29–31), bladder cancer (32), non–small cell lung cancer (33, 34), head and neck cancer (35, 36), and metastatic but not primary osteosarcoma (37), amongothers, and like PD-1 presents a therapeutic target.”
Background
Biological predictors of radiosensitivity in head and neck squamous cell carcinoma
Fiedler, M., Weber, F., Hautmann, M., Haubner, F., Reichert, T. E., Klingelhöffer, C., Schreml, S., Meier, J. K.-H., Hartmann, A., & Ettl, T. (2017) · Clinical Oral Investigations · doi:10.1007/s00784-017-2099-x · Cited by 33
Amidst the excitement: A cautionary tale of immunotherapy, pseudoprogression and head and neck squamous cell carcinoma.
Baxi, S., Dunn, L., & Burtness, B. (2016) · Oral Oncology · doi:10.1016/j.oraloncology.2016.10.007 · Cited by 34
Self-citation
Spatial dynamics of tertiary lymphoid aggregates in head and neck cancer: insights into immunotherapy response
Sadeghirad, H., Monkman, J. H., Tan, C. W., Liu, N., Yunis, J., Donovan, M. L., Moradi, A., Jhaveri, N., Perry, C., Adams, M. N., et al. (2024) · Journal of Translational Medicine · doi:10.1186/s12967-024-05409-y · Cited by 35
Efficacy of cetuximab plus PD-1 inhibitor differs by HPV status in head and neck squamous cell carcinoma: a systematic review and meta-analysis
Zhang, S., Zheng, M., Nie, D., Xu, L., Tian, H., Wang, M., Liu, W., Feng, Z., & Han, F. (2022) · Journal for ImmunoTherapy of Cancer · doi:10.1136/jitc-2022-005158 · Cited by 39
Mast cell marker gene signature in head and neck squamous cell carcinoma
Cai, Z., Tang, B., Chen, L., & Lei, W. (2022) · BMC Cancer · doi:10.1186/s12885-022-09673-3 · Cited by 38
“Thus, immunotherapy efficacy is compromised in cold HNSCC tumours with an objective response rate of single-agent anti-PD-1/PD-L1 immunotherapy as low as 13–14% in patients with HNSCC who are not screened for immune checkpoint expression prior to treatment [12, 68, 69].”
Background
Immunotherapy to Avoid Orbital Exenteration in Patients With Cutaneous Squamous Cell Carcinoma
McLean, L. S., Lim, A. M. L., Webb, A., Cavanagh, K., Thai, A. A., Magarey, M. J. R., Fox, C., Kleid, S. M., & Rischin, D. (2022) · Frontiers in Oncology · doi:10.3389/fonc.2021.796197 · Cited by 35
Recent Research on Combination of Radiotherapy with Targeted Therapy or Immunotherapy in Head and Neck Squamous Cell Carcinoma: A Review for Radiation Oncologists
Xing, D. T., Khor, R., Gan, H. K., Wada, M., Ermongkonchai, T., & Ng, S. P. (2021) · Cancers · doi:10.3390/cancers13225716 · Cited by 33
“In 2016, both nivolumab and pembrolizumab received FDA approval for use in platinum-refractory patients with recurrent/metastatic HNSCC based on the CheckMate 141 [11] and Keynote-012 study findings [44].”
Method
Hyperprogression: A novel response pattern under immunotherapy
Han, X., Alu, A., Xiao, Y., Wei, Y., & Wei, X. (2020) · Clinical and Translational Medicine · doi:10.1002/ctm2.167 · Cited by 41
Low ARID1A Expression is Associated with Poor Prognosis in Hepatocellular Carcinoma
Yim, S. Y., Kang, S.-H., Shin, J.-H., Jeong, Y., Sohn, B., Um, S., & Lee, J.-S. (2020) · Cells · doi:10.3390/cells9092002 · Cited by 33
“The six-gene interferon-gamma (IFNG6) composite score, which is associated with clinical response to pembrolizumab therapy [24] is derived from the average expression of the six genes (CXCL9, CXCL10, IDO1, IFNG, HLA-DRA, and STAT1).”
Background
The effects and safety of PD‐1/PD‐L1 inhibitors on head and neck cancer: A systematic review and meta‐analysis
Wang, B.-C., Cao, R.-B., Li, P.-D., & Fu, C. (2019) · Cancer Medicine · doi:10.1002/cam4.2510 · Cited by 33
Immunotherapy Mythbusters in Head and Neck Cancer: The Abscopal Effect and Pseudoprogression
Lauber, K., & Dunn, L. A. (2019) · American Society of Clinical Oncology Educational Book · doi:10.1200/edbk_238339 · Cited by 41
Immunotherapy for Head and Neck Cancer
Sim, F. W., Leidner, R. S., & Bell, R. B. (2018) · Oral and Maxillofacial Surgery Clinics of North America · doi:10.1016/j.coms.2018.09.002 · Cited by 48
Anti PD-L1 DUrvalumab combined with Cetuximab and RadiOtherapy in locally advanced squamous cell carcinoma of the head and neck: A phase I/II study (DUCRO)
Bonomo, P., Desideri, I., Loi, M., Mangoni, M., Sottili, M., Marrazzo, L., Talamonti, C., Greto, D., Pallotta, S., & Livi, L. (2018) · Clinical and Translational Radiation Oncology · doi:10.1016/j.ctro.2018.01.005 · Cited by 34
“In analogy with two other anti-PD1 antibodies [23,24], Durvalumab (DUR) was the first humanized monoclonal IgG1 anti PD-L1 agent to yield promising anti-tumor response in heavily pre-treated, PD-L1 positive HNSCC patients with R/M disease [25].”
Background
Management of Muscle‐Invasive Urothelial Cancer and the Emerging Role of Immunotherapy in Advanced Urothelial Cancer
Giridhar, K., & Kohli, M. (2017) · Mayo Clinic proceedings · doi:10.1016/j.mayocp.2017.07.010 · Cited by 33
Navigating therapeutic strategies: HPV classification in head and neck cancer
Tabatabaeian, H., Bai, Y., Huang, R., Chaurasia, A., & Darido, C. (2024) · British Journal of Cancer · doi:10.1038/s41416-024-02655-1 · Cited by 34
“Moreover, HNSCC tumours, particularly in advanced stages, exhibit increased expression of programmed death-ligand 1 (PDL1), which suppresses the cytolytic activity of T cells [42, 43].”
Background
Current and Emerging Diagnostic, Prognostic, and Predictive Biomarkers in Head and Neck Cancer
Eberly, H. W., Sciscent, B. Y., Lorenz, F. J., Rettig, E. M., & Goyal, N. (2024) · Biomedicines · doi:10.3390/biomedicines12020415 · Cited by 36
“This targeted immunotherapy demonstrated improved survival outcomes for patients with HNC [103,104].”
Background
Small cell neuroendocrine carcinoma of the cervix: From molecular basis to therapeutic advances
Chao, A., Wu, R.-C., Lin, C.-Y., Chang, T.-C., & Lai, C. (2023) · Biomedical Journal · doi:10.1016/j.bj.2023.100633 · Cited by 32
“0.79; p < 0.001) [42] (Table 3).”
BackgroundInfluential
Compartmentalized spatial profiling of the tumor microenvironment in head and neck squamous cell carcinoma identifies immune checkpoint molecules and tumor necrosis factor receptor superfamily members as biomarkers of response to immunotherapy
Sadeghirad, H., Liu, N., Monkman, J. H., Ma, N., Cheikh, B. B., Jhaveri, N., Tan, C. W., Warkiani, M. E., Adams, M. N., Nguyen, Q. H., et al. (2023) · Frontiers in Immunology · doi:10.3389/fimmu.2023.1135489 · Cited by 35
Oral Immune-Related Adverse Events Caused by Immune Checkpoint Inhibitors: Salivary Gland Dysfunction and Mucosal Diseases
Yura, Y., & Hamada, M. (2022) · Cancers · doi:10.3390/cancers14030792 · Cited by 33
Relationship between Tumor Mutational Burden, PD-L1, Patient Characteristics, and Response to Immune Checkpoint Inhibitors in Head and Neck Squamous Cell Carcinoma
Burcher, K. M., Lantz, J. W., Gavrila, E., Abreu, A., Burcher, J. T., Faucheux, A. T., Xie, A., Jackson, C. W., Song, A. H., Hughes, R. T., et al. (2021) · Cancers · doi:10.3390/cancers13225733 · Cited by 40
Immunotherapy in Recurrent/Metastatic Squamous Cell Carcinoma of the Head and Neck
Hsieh, R. W., Borson, S., Tsagianni, A., & Zandberg, D. P. (2021) · Frontiers in Oncology · doi:10.3389/fonc.2021.705614 · Cited by 35
“For example, analysis of patients fromKeynote 055, which included both PD-L1-positive and -negativepatients, showedsimilar response rates,while analysisof the HAWK trial and Keynote 012, both of which included only PD-L1positive patients, showed increased response rate and OS for HPVpositive oropharyngeal compared to…”
BackgroundResult
Overcoming Resistance to Immune Checkpoint Inhibitors in Head and Neck Squamous Cell Carcinomas
dos Santos, L. V., Abrahão, C. M., & William, W. N. (2021) · Frontiers in Oncology · doi:10.3389/fonc.2021.596290 · Cited by 36
In Vivo Evaluation and Dosimetry Estimate for a High Affinity Affibody PET Tracer Targeting PD-L1
Rubins, D. J., Meng, X., Mcquade, P. S., Klimas, M. T., Getty, K. L., Lin, S.-A., Connolly, B., O'Malley, S. S., Haley, H., Purcell, M. L., et al. (2020) · Molecular Imaging and Biology · doi:10.1007/s11307-020-01544-2 · Cited by 33
The Mismatch Repair System (MMR) in Head and Neck Carcinogenesis and Its Role in Modulating the Response to Immunotherapy: A Critical Review
Cilona, M. B., Locatello, L. G., Novelli, L., & Gallo, O. (2020) · Cancers · doi:10.3390/cancers12103006 · Cited by 49
“Many trials have been carried out to determine the effective efficacy of anti-PD-1 therapies in advanced HN cancers: the Phase Ib trial KEYNOTE-012, in which pembrolizumab was administered to 60 patients affected by R/M HNSCC, resulted in an overall response rate (ORR) of 18%, 25% in human papillomavirus (HPV)-positiv…”
Background
Prevalence of PD‐L1 expression in head and neck squamous precancerous lesions: a systematic review and meta‐analysis
Girolami, I., Pantanowitz, L., Munari, E., Martini, M., Nocini, R., Bisi, N., Molteni, G., Marchioni, D., Ghimenton, C., Brunelli, M., et al. (2020) · Head & Neck · doi:10.1002/hed.26339 · Cited by 34
“PD-L1/ PD1 inhibitors are approved for advanced HNSCC,(6,12) and have shown meaningful antitumor activity both alone or in combination with chemotherapy.(13,14) Patterns of toxicity of checkpoint inhibitors are different from conventional chemotherapy agents, with mainly immunerelated adverse events such as endocrinop…”
Background
Transfer RNA methyltransferase gene NSUN2 mRNA expression modifies the effect of T cell activation score on patient survival in head and neck squamous carcinoma
Lu, L., Gaffney, S. G., Cannataro, V. L., & Townsend, J. P. (2019) · Oral Oncology · doi:10.1016/j.oraloncology.2019.104554 · Cited by 32
“A phase-1b trial of pembrolizumab with 60 PD-L1positive HNSCC patients provided 18% (8–32%) overall response [6].”
Background
Targeting the EGFR and Immune Pathways in Squamous Cell Carcinoma of the Head and Neck (SCCHN): Forging a New Alliance
Saba, N. F., Chen, Z. G., Haigentz, M., Bossi, P., Rinaldo, A., Rodrigo, J. P., Mäkitie, A. A., Takes, R. P., Strojan, P., Vermorken, J. B., et al. (2019) · Molecular Cancer Therapeutics · doi:10.1158/1535-7163.mct-19-0214 · Cited by 35
“The phase Ib Keynote-012 trial using pembrolizumab showed an unprecedented 1-year survival benefit of 18%, which resulted in FDA approval of the drug for the treatment of platinum-resistant recurrentmetastatic SSCHN inAugust 2016 (67).”
Immune Checkpoint Inhibitor Toxicity in Head and Neck Cancer: From Identification to Management
Wang, H., Mustafa, A., Liu, S., Liu, J., Lv, D., Yang, H. J., & Zou, J. (2019) · Frontiers in Pharmacology · doi:10.3389/fphar.2019.01254 · Cited by 41

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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