The Society for Immunotherapy of Cancer consensus statement on immunotherapy for the treatment of squamous cell carcinoma of the head and neck (HNSCC)

Abstract

Head and neck cancers, including those of the lip and oral cavity, nasal cavity, paranasal sinuses, oropharynx, larynx and nasopharynx represent nearly 700,000 new cases and 380,000 deaths worldwide per annum, and account for over 10,000 annual deaths in the United States alone. Improvement in outcomes are needed for patients with recurrent and or metastatic squamous cell carcinoma of the head and neck (HNSCC). In 2016, the US Food and Drug Administration (FDA) granted the first immunotherapeutic approvals – the anti-PD-1 immune checkpoint inhibitors nivolumab and pembrolizumab – for the treatment of patients with recurrent squamous cell carcinoma of the head and neck (HNSCC) that is refractory to platinum-based regimens. The European Commission followed in 2017 with approval of nivolumab for treatment of the same patient population, and shortly thereafter with approval of pembrolizumab monotherapy for the treatment of recurrent or metastatic HNSCC in adults whose tumors express PD-L1 with a ≥ 50% tumor proportion score and have progressed on or after platinum-containing chemotherapy. Then in 2019, the FDA granted approval for PD-1 inhibition as first-line treatment for patients with metastatic or unresectable, recurrent HNSCC, approving pembrolizumab in combination with platinum and fluorouracil for all patients with HNSCC and pembrolizumab as a single agent for patients with HNSCC whose tumors express a PD-L1 combined positive score ≥ 1. These approvals marked the first new therapies for these patients since 2006, as well as the first immunotherapeutic approvals in this disease. In light of the introduction of these novel therapies for the treatment of patients with head and neck cancer, The Society for Immunotherapy of Cancer (SITC) formed an expert committee tasked with generating consensus recommendations for emerging immunotherapies, including appropriate patient selection, therapy sequence, response monitoring, adverse event management, and biomarker testing. These consensus guidelines serve as a foundation to assist clinicians’ understanding of the role of immunotherapies in this disease setting, and to standardize utilization across the field for patient benefit. Due to country-specific variances in approvals, availability and regulations regarding the discussed agents, this panel focused solely on FDA-approved drugs for the treatment of patients in the U.S. Electronic supplementary material The online version of this article (10.1186/s40425-019-0662-5) contains supplementary material, which is available to authorized users.

Characterization of the immune cell infiltration landscape in head and neck squamous cell carcinoma to aid immunotherapy

“…Even the Society for immunotherapy of Cancer who issued the first guidelines on immunotherapy for the treatment of HNSC has appealed the need to identify appropriate patients for immunotherapy [34]. In this study, we established a methodology to quantify the comprehensive tumor immune milieu of HNSC patients.…”

Impact of PD‐L1 expression and human papillomavirus status in anti‐PD1/PDL1 immunotherapy for head and neck squamous cell carcinoma—Systematic review and meta‐analysis

“…For HNSCC, the predictive capacity of PD‐L1 is less understood and the immune landscape of HPV+ vs HPV− tumors may further impact the response of these tumors to immunotherapy. In light of the recent FDA approval of pembrolizumab and nivolumab for R/M HNSCC, our meta‐analysis sought to illustrate the potential of either PD‐L1 or HPV status as predictive biomarkers for survival rate and tumor response post PD‐1/L1 inhibition in HNSCC patients.…”

Development and Radiation Response Assessment in A Novel Syngeneic Mouse Model of Tongue Cancer: 2D Culture, 3D Organoids and Orthotopic Allografts

“…Our in vivo orthotopic model could also serve as a valuable tool to examine the activity of novel immunotherapeutic strategies against this disease. While immune checkpoint inhibitors have recently received approval for clinical use in head and neck cancer patients [41], the optimal dose, schedule and sequence of combining checkpoint inhibitors with standard of care chemoradiation regimens is still unclear [42,43]. As such, several ongoing trials are investigating the combination of these immune-oncology agents with chemotherapy, radiation and targeted therapies [43].…”