LAUSR

Background: In phase 2 studies (NCT02296684 and NCT02641093), neoadjuvant and adjuvant pembrolizumab demonstrated a pathological response (PR) and acceptable safety in patients with high-risk, resectable, LA HNSCC. KEYNOTE-689 (NCT03765918) is a randomized, open-label, phase 3 trial that will evaluate efficacy and safety of neoadjuvant pembrolizumab and adjuvant pembrolizumab in combination with SOC in patients with previously untreated LA HNSCC. Methods: Key eligibility criteria include histologically confirmed, newly diagnosed, resectable, nonmetastatic SCC (stage III oropharyngeal p16-positive disease [T4 (N0-N2), M0]; stage III/IVA oropharyngeal p16 negative; or stage III/IVA larynx or hypopharynx or oral cavity, independent of p16 status), evaluable tumor burden (measurable and/or nonmeasurable tumor lesions), newly obtained core or excisional biopsy, and ECOG performance status 0 or 1. Patients will be randomly assigned 1:1 to arms A and B. Randomization will be stratified by primary tumor site (oropharynx/oral cavity vs larynx vs hypopharynx), tumor stage (III vs IVA), and PD-L1 status defined by tumor proportion score 50% (TPS ≥50% vs TPS Citation Format: Nancy Y. Lee, Ravindra Uppaluri, William Westra, Ezra E. Cohen, Robert I. Haddad, Stephane Temam, Christophe Le Tourneau, Rebecca Chernock, Sufia Safina, Arkadiy Klochikhin, Amichay Meirovitz, Irene Brana, Joy Yang Ge, Ramona F. Swaby, Cecilia Pinheiro, Douglas Adkins. KEYNOTE-689: A phase 3 study of neoadjuvant and adjuvant pembrolizumab plus standard of care (SOC) in locally advanced (LA) head and neck squamous cell carcinoma (HNSCC) [abstract]. In: Proceedings of the Annual Meeting of the American Association for Cancer Research 2020; 2020 Apr 27-28 and Jun 22-24. Philadelphia (PA): AACR; Cancer Res 2020;80(16 Suppl):Abstract nr CT285.