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Best of Scientific Oral Presentations

Head and Neck Surgery

Session: Best of Scientific Orals 1

Three-Year Survival Outcomes of Neoadjuvant Nivolumab-IDO Inhibition in Head and Neck Squamous Cell Carcinoma Patients

Sunday, October 12, 2025

1:48 PM - 1:54 PM EDT

Location: 120

Introduction: Head and neck squamous cell carcinoma (HNSCC) has shown limited response to immunotherapy compared to other cancers. The immunosuppressive tumor microenvironment, including pathways involving indoleamine 2,3-dioxygenase (IDO), presents a significant challenge. The combination of nivolumab, a PD-1 inhibitor, with or without an IDO inhibitor (IDOi) was investigated in a neoadjuvant trial to evaluate its therapeutic impact on previously untreated HNSCC. This study presents updated 3-year outcomes, including overall survival (OS), recurrence-free survival (RFS), and disease-free survival (DFS).

Methods: A single-institutional, randomized, two-arm neoadjuvant trial (NCT03854032) enrolled 37 patients with untreated HNSCC, stratified by HPV status, to receive either nivolumab alone (Arm A) or nivolumab plus BMS986205-IDOi (Arm B). Radiographic response at week 5 determined eligibility for a second cycle of treatment prior to surgical resection. Key endpoints included radiographic response, pathologic treatment effect (pTE, defined as >20%), and long-term survival outcomes.

Results: A total of 37 patients were followed, with 11 patients in Arm A and 26 in Arm B and 45.5% (n=17) HPV-positive patients. At 3 years, overall survival (OS) was 85.3%, with no significant difference between Arms A and B (p=0.71). Recurrence-free survival (RFS) was 82.3%, with comparable outcomes between treatment arms (p=0.55) and across pTE response statuses (p=0.63). DFS was 82.2%, with responders achieving higher DFS (89.7%) than non-responders (72.9%; p=0.4). The addition of an IDOi to nivolumab did not significantly improve long-term survival outcomes compared to nivolumab monotherapy.

Conclusions: Neoadjuvant nivolumab, with or without an IDOi, achieved favorable 3-year survival outcomes in HNSCC, with OS at 85.3%, RFS at 82.3%, and DFS at 82.2%. While the addition of IDO inhibitor did not significantly enhance survival outcomes at three years, responders achieved markedly higher DFS (89.7% vs. 72.9% in non-responders), suggesting that response to neoadjuvant ICI may portent a favorable oncologic outcome.

Presenting Author(s)

KL

Kalena H. Liu, BS

Medical Student
Thomas Jefferson University
Philadelphia, PA, United States

Disclosure information not submitted.
Hani Samarah, BS

Medical Student
Florida International University (Wertheim) - Medical College
Little Rock, AR, United States

Disclosure(s):
faculty for this accredited education activity has no relationship(s) with ineligible companies to disclose.

Co-Author(s)

EM

Eric V. Mastrolonardo, MD

Resident
Department of Otolaryngology - Head & Neck Surgery, Thomas Jefferson University Hospital
Philadelphia, PA, United States

Disclosure information not submitted.
David M. Cognetti, MD

Herbert Kean MD Professor and Chair
Thomas Jefferson Univ Hosp
Philadelphia, Pennsylvania, United States

Disclosure information not submitted.
Joseph M. Curry, MD

Professor
Thomas Jefferson University
Wynnewood, PA, United States

Disclosure information not submitted.

Senior Author(s)

AL

Adam J. Luginbuhl, MD

Professor
Department of Otolaryngology - Head & Neck Surgery, Thomas Jefferson University Hospital
Philadelphia, PA, United States

Disclosure(s):
faculty for this accredited education activity has no relationship(s) with ineligible companies to disclose.