TY - JOUR
T1 - Nivolumab in patients with recurrent or metastatic squamous cell carcinoma of the head and neck
T2 - Efficacy and safety in checkmate 141 by prior cetuximab use
AU - Ferris, Robert L.
AU - Licitra, Lisa
AU - Fayette, Jerome
AU - Even, Caroline
AU - Blumenschein, George
AU - Harrington, Kevin J.
AU - Guigay, Joel
AU - Vokes, Everett E.
AU - Saba, Nabil F.
AU - Haddad, Robert
AU - Ramkumar, Shanmugasundaram
AU - Russell, Jeffery
AU - Brossart, Peter
AU - Tahara, Makoto
AU - Colevas, A. Dimitrios
AU - Concha-Benavente, Fernando
AU - Lynch, Mark
AU - Li, Li
AU - Gillison, Maura L.
N1 - Publisher Copyright:
© 2019 American Association for Cancer Research Inc.. All rights reserved.
PY - 2019/9/1
Y1 - 2019/9/1
N2 - Purpose: Cetuximab, which modulates immune responses, may affect the efficacy of subsequent immunotherapy. Here, we assessed outcomes with nivolumab, by prior cetuximab exposure, in patients with recurrent or metastatic (R/M) squamous cell carcinoma of the head and neck (SCCHN) who had experienced progression within 6 months of platinumcontaining chemotherapy. Patients and Methods: In the randomized, open-label, phase III CheckMate 141 trial, patients were randomized 2:1 to nivolumab 3 mg/kg every 2 weeks or investigator's choice (IC) of single-agent chemotherapy, with stratification by prior cetuximab exposure. The primary endpoint was overall survival (OS); additional endpoints were progression- free survival, objective response rate, and safety. Results: In patients with prior cetuximab exposure, the median OS was 7.1 months with nivolumab versus 5.1 months with IC (HR, 0.84; 95% CI, 0.62-1.15); OS benefit with nivolumab was maintained across most demographic subgroups. In patients without prior cetuximab exposure, the median OS was 8.2 months with nivolumab versus 4.9 months with IC (HR, 0.52; 95% CI, 0.35-0.77); OS benefit with nivolumab was maintained across patient baseline subgroups including tumor programmed death ligand 1 (PD-L1) expression (<1% or ≥1%). Grade 3-4 treatment-related adverse event rates favored nivolumab versus IC in both subgroups. Conclusions: Nivolumab appeared to improve efficacy versus IC regardless of prior cetuximab use, supporting its use in patients with R/M SCCHN with or without prior cetuximab exposure. The reduction in risk of death with nivolumab compared with IC was greater in patients without prior cetuximab exposure versus with prior cetuximab exposure.
AB - Purpose: Cetuximab, which modulates immune responses, may affect the efficacy of subsequent immunotherapy. Here, we assessed outcomes with nivolumab, by prior cetuximab exposure, in patients with recurrent or metastatic (R/M) squamous cell carcinoma of the head and neck (SCCHN) who had experienced progression within 6 months of platinumcontaining chemotherapy. Patients and Methods: In the randomized, open-label, phase III CheckMate 141 trial, patients were randomized 2:1 to nivolumab 3 mg/kg every 2 weeks or investigator's choice (IC) of single-agent chemotherapy, with stratification by prior cetuximab exposure. The primary endpoint was overall survival (OS); additional endpoints were progression- free survival, objective response rate, and safety. Results: In patients with prior cetuximab exposure, the median OS was 7.1 months with nivolumab versus 5.1 months with IC (HR, 0.84; 95% CI, 0.62-1.15); OS benefit with nivolumab was maintained across most demographic subgroups. In patients without prior cetuximab exposure, the median OS was 8.2 months with nivolumab versus 4.9 months with IC (HR, 0.52; 95% CI, 0.35-0.77); OS benefit with nivolumab was maintained across patient baseline subgroups including tumor programmed death ligand 1 (PD-L1) expression (<1% or ≥1%). Grade 3-4 treatment-related adverse event rates favored nivolumab versus IC in both subgroups. Conclusions: Nivolumab appeared to improve efficacy versus IC regardless of prior cetuximab use, supporting its use in patients with R/M SCCHN with or without prior cetuximab exposure. The reduction in risk of death with nivolumab compared with IC was greater in patients without prior cetuximab exposure versus with prior cetuximab exposure.
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U2 - 10.1158/1078-0432.CCR-18-3944
DO - 10.1158/1078-0432.CCR-18-3944
M3 - Article
C2 - 31239321
AN - SCOPUS:85071784860
SN - 1078-0432
VL - 25
SP - 5221
EP - 5230
JO - Clinical Cancer Research
JF - Clinical Cancer Research
IS - 17
ER -