SUPREME-HN: a retrospective biomarker study assessing the prognostic value of PD-L1 expression in patients with recurrent and/or metastatic squamous cell carcinoma of the head and neck

Abstract

Background: Programmed cell death ligand-1 (PD-L1) expression on tumor cells (TCs) is associated with improved survival in patients with head and neck squamous cell carcinoma (HNSCC) treated with immunotherapy, although its role as a prognostic factor is controversial. This study investigates whether tumoral expression of PD-L1 is a prognostic marker in patients with recurrent and/or metastatic (R/M) HNSCC treated with standard chemotherapy.

Methods: This retrospective, multicenter, noninterventional study assessed PD-L1 expression on archival R/M HNSCC tissue samples using the VENTANA PD-L1 (SP263) Assay. PD-L1 high was defined as PD-L1 staining of ≥ 25% TC, with exploratory scoring at TC ≥ 10% and TC ≥ 50%. The primary objective of this study was to estimate the prognostic value of PD-L1 status in terms of overall survival (OS) in patients with R/M HNSCC.

Results: 412 patients (median age, 62.0 years; 79.9% male; 88.2% Caucasian) were included from 19 sites in seven countries. 132 patients (32.0%) had TC ≥ 25% PD-L1 expression; 199 patients (48.3%) and 85 patients (20.6%) had TC ≥ 10% and ≥ 50%, respectively. OS did not differ significantly across PD-L1 expression (at TC ≥ 25% cutoff median OS: 8.2 months vs TC < 25%, 10.1 months, P = 0.55) or the ≥ 10% and ≥ 50% cutoffs (at TC ≥ 10%, median OS: 9.6 months vs TC < 10%, 9.4 months, P = 0.32, and at TC ≥ 50%, median OS 7.9 vs TC < 50%, 10.0 months, P = 0.39, respectively).

Conclusions: PD-L1 expression, assessed using the VENTANA PD-L1 (SP263) Assay, was not prognostic of OS in patients with R/M HNSCC treated with standard of care chemotherapies. Trial registration ClinicalTrials.gov, NCT02543476. Registered September 4, 2015.

Keywords: Biomarker; Head and neck squamous cell carcinoma; Immuno-oncology; PD-L1; Prognosis; Programmed cell death ligand-1.

Conflict of interest statement

SIP has served as a consultant or in an advisory role for AbbVie, AstraZeneca/MedImmune, Cue, EMD Serono, Merck, Newlink Genetics, Oncolys, Replimune, and Sensei; has received research funding for Abbvie, AstraZeneca/MedImmune, Cue, Merck, Tesaro; and received compensation for travel, accommodations and/or expenses from AbbVie, AstraZeneca/MedImmune, EMD Serono, Newlink Genetics, Oncolys, and Sensei. EEWC has been a consultant or held an advisory role for AstraZeneca, Bristol-Myers Squibb, EMD Serono, Human Longevity, Inc, Merck, Pfizer. GF has received honoraria from AstraZeneca; and served as a consutant or in an advisory role for Boehringer Ingelheim, Celgene, and Lilly. ESK has received honoraria from AstraZeneca, Boehringer Ingelheim, Celgene, and Lilly; has served as a consutant or in an advisory role for AstraZeneca, Boehringer Ingelheim, Celgene, and Lilly; and received compensation for travel, accommodations and or expenses from AstraZeneca, Boehringer Ingelheim, Celgene, and Lilly. NB has received honoraria from Merck Serono, MSD, AstraZeneca, and BMS; has served as a consutant or in an advisory role for BMS, Merck Serono, and Nanobiotix. DC has received research funding from AbbVie. MS is an employee of Evidera and provided epidemiological support to AZ in the development of this manuscript. HW, PT-A, SW, AK, GM, and NS are employees of AstraZeneca and may hold stock or other ownership in AstraZeneca. The other authors declare that they have no competing interests.

Figures

Fig. 1

Overall survival (OS) by PD-L1 expressiona. aPatients with PD-L1 result n = 396: a TC ≥ 25%, b TC ≥ 10%, and c TC ≥ 50%; d oropharynx anatomical sub-site (n = 91) by PD-L1 status

Fig. 2

PFS by PD-L1 expression. a From start of first-line chemotherapy (n = 242) and b second-line chemotherapy (n = 83)

Fig. 3

Multivariable analysis of risk factors for OS. aPatients with OS data n = 370, patients with PD-L1 result n = 355