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Nivolumab in Patients with Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck: Efficacy and Safety in CheckMate 141 by Prior Cetuximab Use.


ABSTRACT: 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 platinum-containing 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.

SUBMITTER: Ferris RL 

PROVIDER: S-EPMC7721346 | biostudies-literature | 2019 Sep

REPOSITORIES: biostudies-literature

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Nivolumab in Patients with Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck: Efficacy and Safety in CheckMate 141 by Prior Cetuximab Use.

Ferris Robert L RL   Licitra Lisa L   Fayette Jerome J   Even Caroline C   Blumenschein George G   Harrington Kevin J KJ   Guigay Joel J   Vokes Everett E EE   Saba Nabil F NF   Haddad Robert R   Ramkumar Shanmugasundaram S   Russell Jeffery J   Brossart Peter P   Tahara Makoto M   Colevas A Dimitrios AD   Concha-Benavente Fernando F   Lynch Mark M   Li Li L   Gillison Maura L ML  

Clinical cancer research : an official journal of the American Association for Cancer Research 20190625 17


<h4>Purpose</h4>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 platinum-containing chemotherapy.<h4>Patients and methods</h4>In the randomized, open-label, phase III CheckMate 141 trial, patients were randomized 2:1 to nivolum  ...[more]

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