Neoadjuvant presurgical PD-1 inhibition in oral cavity squamous cell carcinoma
Hannah M Knochelmann, Joshua D Horton, Sixue Liu, Kent Armeson, John M Kaczmar, Megan M Wyatt, Mary S Richardson, Shirley H Lomeli, Ying Xiong, Evan M Graboyes, Eric J Lentsch, Joshua D Hornig, Judith Skoner, Seth Stalcup, Maria V Spampinato, Elizabeth Garrett-Mayer, Elizabeth C O'Quinn, Cynthia D Timmers, Martin J Romeo, John M Wrangle, M Rita I Young, Mark P Rubinstein, Terry A Day, Roger S Lo, Chrystal M Paulos, David M Neskey, Hannah M Knochelmann, Joshua D Horton, Sixue Liu, Kent Armeson, John M Kaczmar, Megan M Wyatt, Mary S Richardson, Shirley H Lomeli, Ying Xiong, Evan M Graboyes, Eric J Lentsch, Joshua D Hornig, Judith Skoner, Seth Stalcup, Maria V Spampinato, Elizabeth Garrett-Mayer, Elizabeth C O'Quinn, Cynthia D Timmers, Martin J Romeo, John M Wrangle, M Rita I Young, Mark P Rubinstein, Terry A Day, Roger S Lo, Chrystal M Paulos, David M Neskey
Abstract
Oral cavity squamous cell carcinoma (OCSCC) is a prevalent surgically treated subset of head and neck cancer with frequent recurrence and poor survival. Immunotherapy has demonstrated efficacy in recurrent/metastatic head and neck cancer. However, whether antitumor responses could be fostered by neoadjuvant presurgical immunotherapy remains unclear. Using a Simon's two-stage design, we present results of a single-arm phase-II trial where 12 patients with stage II-IVA OCSCC received 3 to 4 biweekly doses of 3 mg/kg nivolumab followed by definitive surgical resection with curative intent. Presurgical nivolumab therapy in this cohort shows an overall response rate of 33% (n = 4 patients; 95% CI: 12%-53%). With a median follow up of 2.23 years, 10 out of 12 treated patients remain alive. Neoadjuvant nivolumab is safe, well-tolerated, and is not associated with delays in definitive surgical treatment in this study. This work demonstrates feasibility and safety for incorporation of nivolumab in the neoadjuvant setting for OCSCC (ClinicalTrials.gov: NCT03021993).
Keywords: PD-1 therapy; head and neck cancer; neoadjuvant; neoadjuvant immunotherapy; nivolumab; oral cavity cancer.
Conflict of interest statement
C.M.P. is the co-founder of Ares Immunotherapy. R.S.L. received research or clinical trial support from Merck, Pfizer, BMS, and OncoSec. D.M.N. received research or clinical trial support from BMS. M.R.I.Y. received research or clinical trial support Merck and BMS.
© 2021 The Author(s).
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Source: PubMed