Nivolumab vs investigator's choice in recurrent or metastatic squamous cell carcinoma of the head and neck: 2-year long-term survival update of CheckMate 141 with analyses by tumor PD-L1 expression.
- Ferris RL University of Pittsburgh Medical Center Hillman Cancer Center, Pittsburgh, PA, USA. Electronic address: ferrisrl@upmc.edu.
- Blumenschein G MD Anderson Cancer Center, Houston, TX, USA.
- Fayette J Centre Leon Berard, Lyon, France.
- Guigay J Centre Antoine Lacassagne, FHU OncoAge, Université Côte d'Azur, Nice, France.
- Colevas AD Stanford University, Stanford, CA, USA.
- Licitra L Fondazione IRCCS Istituto Nazionale dei Tumori and University of Milan, Milan, Italy.
- Harrington KJ Royal Marsden NHS Foundation Trust/The Institute of Cancer Research National Institute of Health Research Biomedical Research Centre, London, UK.
- Kasper S West German Cancer Center, University Hospital, Essen, Germany.
- Vokes EE University of Chicago Medical Center, Chicago, IL, USA.
- Even C Gustave Roussy, Villejuif Cedex, France.
- Worden F University of Michigan, Ann Arbor, MI, USA.
- Saba NF Winship Cancer Institute of Emory University, Atlanta, GA, USA.
- Docampo LCI Hospital Universitario 12 de Octubre, Madrid, Spain.
- Haddad R Dana-Farber/Harvard Cancer Center, Boston, MA, USA.
- Rordorf T Universitätsspital Zurich, Zurich, Switzerland.
- Kiyota N Kobe University Hospital, Kobe, Japan.
- Tahara M National Cancer Center Hospital East, Kashiwa, Japan.
- Lynch M Bristol-Myers Squibb, Princeton, NJ, USA.
- Jayaprakash V Bristol-Myers Squibb, Princeton, NJ, USA.
- Li L Bristol-Myers Squibb, Princeton, NJ, USA.
- Gillison ML MD Anderson Cancer Center, Houston, TX, USA.
- 2018-06-10
Published in:
- Oral oncology. - 2018
CD274 protein, human (PD-L1 Protein, Human)
Carcinoma, squamous cell of head and neck
Clinical Trial, Phase III
Head and Neck Neoplasms
Immunotherapy
Nivolumab
Papillomaviridae (HPV, Human Papillomavirus Viruses)
Programmed Cell Death 1 Receptor
Survival Analysis
Survivors (Long-term Survivors)
Antineoplastic Agents, Immunological
B7-H1 Antigen
Humans
Neoplasm Metastasis
Neoplasm Recurrence, Local
Nivolumab
Squamous Cell Carcinoma of Head and Neck
Survival Analysis
English
OBJECTIVES
We report 2-year results from CheckMate 141 to establish the long-term efficacy and safety profile of nivolumab and outcomes by tumor PD-L1 expression in patients with recurrent or metastatic (R/M),platinum-refractory squamous cell carcinoma of the head and neck (SCCHN).
METHODS
Patients with R/M SCCHN with tumor progression/recurrence within 6 months of platinum therapy were randomized 2:1 to nivolumab 3 mg/kg every 2 weeks or investigator's choice (IC). Primary endpoint: overall survival (OS). Data cutoff: September 2017.
RESULTS
With 24.2 months' minimum follow-up, nivolumab (n = 240) continued to improve OS vs IC (n = 121), hazard ratio (HR) = 0.68 (95% CI 0.54-0.86). Nivolumab nearly tripled the estimated 24-month OS rate (16.9%) vs IC (6.0%), and demonstrated OS benefit across patients with tumor PD-L1 expression ≥1% (HR [95% CI] = 0.55 [0.39-0.78]) and < 1% (HR [95% CI] = 0.73 [0.49-1.09]), and regardless of tumor HPV status. Estimated OS rates at 18, 24, and 30 months with nivolumab were consistent irrespective of PD-L1 expression (<1%/≥1%). In the nivolumab arm, there were no observed differences in baseline characteristics or safety profile between long-term survivors and the overall population. Grade 3-4 treatment-related adverse event rates were 15.3% and 36.9% for nivolumab and IC, respectively.
CONCLUSION
Nivolumab significantly improved OS at the primary analysis and demonstrated prolonged OS benefit vs IC and maintenance of a manageable and consistent safety profile with 2-year follow-up. OS benefit was observed with nivolumab irrespective of PD-L1 expression and HPV status. (Clinicaltrials.gov: NCT02105636).
We report 2-year results from CheckMate 141 to establish the long-term efficacy and safety profile of nivolumab and outcomes by tumor PD-L1 expression in patients with recurrent or metastatic (R/M),platinum-refractory squamous cell carcinoma of the head and neck (SCCHN).
METHODS
Patients with R/M SCCHN with tumor progression/recurrence within 6 months of platinum therapy were randomized 2:1 to nivolumab 3 mg/kg every 2 weeks or investigator's choice (IC). Primary endpoint: overall survival (OS). Data cutoff: September 2017.
RESULTS
With 24.2 months' minimum follow-up, nivolumab (n = 240) continued to improve OS vs IC (n = 121), hazard ratio (HR) = 0.68 (95% CI 0.54-0.86). Nivolumab nearly tripled the estimated 24-month OS rate (16.9%) vs IC (6.0%), and demonstrated OS benefit across patients with tumor PD-L1 expression ≥1% (HR [95% CI] = 0.55 [0.39-0.78]) and < 1% (HR [95% CI] = 0.73 [0.49-1.09]), and regardless of tumor HPV status. Estimated OS rates at 18, 24, and 30 months with nivolumab were consistent irrespective of PD-L1 expression (<1%/≥1%). In the nivolumab arm, there were no observed differences in baseline characteristics or safety profile between long-term survivors and the overall population. Grade 3-4 treatment-related adverse event rates were 15.3% and 36.9% for nivolumab and IC, respectively.
CONCLUSION
Nivolumab significantly improved OS at the primary analysis and demonstrated prolonged OS benefit vs IC and maintenance of a manageable and consistent safety profile with 2-year follow-up. OS benefit was observed with nivolumab irrespective of PD-L1 expression and HPV status. (Clinicaltrials.gov: NCT02105636).
- Language
-
- English
- Open access status
- green
- Identifiers
-
- DOI 10.1016/j.oraloncology.2018.04.008
- PMID 29884413
- Persistent URL
- https://sonar.ch/global/documents/94755
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