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Head and neck cancer, excluding thyroid

5137 - RetroSpective cohort stUdy of PD-L1 expression in REcurrent and/or MEtastatic squamous cell carcinoma of the Head and Neck (SUPREME-HN)


09 Sep 2017


Head and neck cancer, excluding thyroid


Cancers in Adolescents and Young Adults (AYA);  Head and Neck Cancers


Sara Pai


Annals of Oncology (2017) 28 (suppl_5): v372-v394. 10.1093/annonc/mdx374


S. Pai1, E.E. Cohen2, D. Lin3, G. Fountzilas4, E.S. Kim5, H. Mehlhorn6, N. Baste7, D. Clayburgh8, L. Lipworth9, C. Resteghini10, N. Shara11, T. Fujii12, J. Zhang13, M. Stokes14, D. Lawrence15, A. Khaliq16, G. Melillo17, N. Shire18

Author affiliations

  • 1 Department Of Surgery, Massachusetts General Hospital, Cancer Center, 2114 - Boston/US
  • 2 Department Of Medicine, UC San Diego Health System, Moores Cancer Center, San Diego/US
  • 3 Department Of Otolaryngology, Massachusetts General Hospital, Cancer Center, 2114 - Boston/US
  • 4 Medical Oncology, Aristotle University of Thessaloniki, 564 29 - Thessaloniki/GR
  • 5 Department Of Solid Tumor Oncology, Levine Cancer Institute, Carolinas Health Care System, Charlotte/US
  • 6 Head And Neck Surgery And Department Of Head Medicine And Oral Health, Universitaetsklinikum Leipzig, Klinik und Poliklinik fur HNO-Heilkunde, Leipzig/DE
  • 7 Oncology, Hospital Universitari Vall d'Hebron, Barcelona/ES
  • 8 Department Of Otolaryngology/head And Neck Surgery, Oregon Health & Science University, Portland/US
  • 9 Department Of Medicine, Vanderbilt University Medical Center, Nashville/US
  • 10 Head And Neck Medical Oncology, Fondazione IRCCS - Istituto Nazionale dei Tumori, 20133 - Milan/IT
  • 11 Biostatistics And Biomedical Informatics, MedStar Health Research Institute, Hyattsville/US
  • 12 Otolaryngology, Osaka Medical Center for Cancer and Cardiovascular Diseases, Osaka/JP
  • 13 Oncology, Baylor College of Medicine, Houston/US
  • 14 Real-world Evidence, Evidera, MA 02451 - Lexington/US
  • 15 Biostatistics & Information Sciences, AstraZeneca, Cambridge/GB
  • 16 Global Medical Affairs (oncology), AstraZeneca, Gaithersburg/US
  • 17 Immuno-oncology Gmd, AstraZeneca, Gaithersburg/US
  • 18 Global Medicines Development, AstraZeneca, MD20878 - Gaithersburg/US


Abstract 5137


Clinically meaningful antitumour activity and improved overall survival (OS) in recurrent and/or metastatic (R/M) head and neck squamous cell carcinoma (HNSCC) have been achieved by targeting the PD-1/PD-L1 axis. Tumoral PD-L1 expression correlates with response to blocking PD-1/PD-L1 antibodies. In a retrospective study, we investigated tumoral PD-L1 expression as a prognostic biomarker in R/M HNSCC patients (pts) treated with standard of care (SOC) therapy.


Archival tumor samples from R/M HNSCC pts diagnosed between March 2011 and June 2015 at 19 institutions in 7 countries were evaluated for PD-L1 expression using the validated Ventana SP263 assay and scored as PD-L1 high (≥25% of tumor cells [TC]) or low/negative (


The final dataset included 412 pts. Median age was 62.0 years (range 28.0–93.0); 79.9% were male and 88.2% white. PD-L1 expression was high in 132 (32.0%), low/negative in 264 (64.1%), unknown in 16 (3.9%). Median OS (8.2 vs 10.1 months; P = 0.55) and PFS from the start of 1L chemotherapy (4.2 vs 4.8 months; P = 0.37) did not significantly differ between PD-L1 high and low/negative pts, respectively. Median PFS following 2L chemotherapy was statistically significantly longer in PD-L1 high versus low/negative pts (4.1 vs 2.2 months; P = 0.04). PD-L1 status was not statistically significant in multivariate analyses of OS (P = 0.74) or PFS following 1L chemotherapy (P = 0.63); however, there was a trend for improved PFS following 2L chemotherapy (P = 0.09).


Tumoral PD-L1 expression was not significantly associated with OS or PFS following 1L SOC chemotherapy; however, it was associated with prolonged PFS following 2L SOC chemotherapy.

Clinical trial identification

NCT02543476 (August 25, 2015)

Legal entity responsible for the study

AstraZeneca PLC


AstraZeneca PLC


S. Pai: Corporate sponsored research (Abbvie, AstraZeneca, Oncosec, Tesaro), Consultant (Abbvie, AstraZeneca, Merck, Oncosec) Investigator-initiated studies (AstraZeneca, Merck) Speaker at IO drug launches for HN cancer in an international country (Merck). E.E. Cohen: Consultant (Eisai; Pfizer; Merck; AstraZeneca; Bristol-Myers Squibb; Human Longevity(HLI)). D. Lin: Corporate sponsored research (Abbvie, Tesaro, AstraZaneca). G. Fountzilas: Consultant (Pfizer, Sanofi, Roche) Stock shareholder (ARIAD (an immediate family member)) Honoraria (AstraZeneca). E.S. Kim: Consultant (Celgene, Boehringer Ingelheim, Eli Lilly, AstraZeneca). N. Baste: Corporate sponsored research (AstraZeneca) Consultant (Bristol-Myers Squibb, MSD, Merck Serono) D. Clayburgh: Corporate sponsored research (Abbvie & AstraZeneca. N. Shara: Honoraria (NIH-reviewer) Full-time/part-time employee (MedStar Health Research Institute) J. Zhang: Consultant (AztraZeneca & Boehringer Ingelheim). M. Stokes: Employment (Evidera) and research funding (Evidera). D. Lawrence: Full time employee of AstraZeneca UK. A. Khaliq, G. Melillo, N. Shire: Employee and Shareholder (AstraZeneca). All other authors have declared no conflicts of interest.

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