Neoadjuvant and Adjuvant Nivolumab and Lirilumab in Patients with Recurrent, Resectable Squamous Cell Carcinoma of the Head and Neck

Glenn J. Hanna*, Anne O'Neill, Kee Young Shin, Kristine Wong, Vickie Y. Jo, Charles T. Quinn, Jennifer M. Cutler, Michelle Flynn, Patrick H. Lizotte, Donald J. Annino, Laura A. Goguen, Jason I. Kass, Eleni M. Rettig, Rosh K.V. Sethi, Jochen H. Lorch, Jonathan D. Schoenfeld, Danielle N. Margalit, Roy B. Tishler, Peter C. Everett, Anupam M. DesaiMegan E. Cavanaugh, Cloud P. Paweletz, Ann Marie Egloff, Ravindra Uppaluri, Robert I. Haddad

*Corresponding author for this work

Research output: Contribution to journalArticlepeer-review

29 Scopus citations


Purpose: Surgery often represents the best chance for disease control in locoregionally recurrent squamous cell carcinoma of the head and neck (SCCHN). We investigated dual immune-checkpoint inhibition [anti-PD-1, nivolumab (N), and anti-KIR, lirilumab (L)] before and after salvage surgery to improve disease-free survival (DFS). Patients and Methods: In this phase II study, patients receivedN (240 mg) L (240 mg) 7 to 21 days before surgery, followed by six cycles of adjuvant N L. Primary endpoint was 1-year DFS; secondary endpoints were safety, pre-op radiologic response, and overall survival (OS). Correlatives included tumor sequencing, PDL1 scoring, and immunoprofiling. Results: Among 28 patients, the median age was 66, 86% were smokers; primary site: 9 oral cavity, 9 oropharynx, and 10 larynx/ hypopharynx; 96% had prior radiation. There were no delays to surgery. Grade 3 adverse events: 11%. At the time of surgery, 96% had stable disease radiologically, one had progression. Pathologic response to N L was observed in 43% (12/28): 4/28 (14%) major (tumor viability,TV≤ 10%) and 8/28 (29%) partial (TV ≤ 50%). PDL1 combined positive score (CPS) at surgery was similar regardless of pathologic response (P = 0.71). Thirteen (46%) recurred (locoregional = 10, distant = 3). Five of 28 (18%) had positive margins, 4 later recurred. At median follow-up of 22.8 months, 1-year DFS was 55.2% (95% CI, 34.8-71.7) and 1-year OS was 85.7% (95% CI, 66.3-94.4). Two-year DFS and OS were 64% and 80% among pathologic responders. Conclusions: (Neo)adjuvantN L was well tolerated, with a 43% pathologic response rate. We observed favorable DFS and excellent 2-year OS among high-risk, previously treated patients exhibiting a pathologic response. Further evaluation of this strategy is warranted.

Original languageEnglish (US)
Pages (from-to)468-478
Number of pages11
JournalClinical Cancer Research
Issue number3
StatePublished - Feb 1 2022
Externally publishedYes

ASJC Scopus subject areas

  • Medicine(all)


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