Supplementary material Supplementary data to this article can be found online at https://doi.org/10.1016/j.oraloncology.2019.06.017.. were generally comparable across age groups. OS and tumor response benefits with nivolumab versus IC were maintained regardless of age. NGD-4715 The 30-month OS rates of 11.2% ( 65 years) and 13.0% (65 years) with nivolumab were more than tripled versus corresponding IC rates of 1 1.4% and 3.3%, respectively. The nivolumab arm had a lower rate of NGD-4715 treatment-related adverse events versus IC regardless of age, consistent with the overall patient population. Conclusion: In CheckMate 141, nivolumab resulted in a higher survival versus IC in NGD-4715 patients 65 and 65 years, with a manageable safety profile in both age groups. ClinicalTrials.gov: “type”:”clinical-trial”,”attrs”:”text”:”NCT02105636″,”term_id”:”NCT02105636″NCT02105636. strong class=”kwd-title” Keywords: Biomarkers, Nivolumab, Squamous cell carcinoma of the head and neck, Age, Phase 3 clinical trial Introduction Over half of the 500,000 new cases of squamous cell carcinoma of the head and neck (SCCHN) worldwide occur in patients 65 years of age and older [1,2], and this is expected to increase as the population ages [3,4]. A high proportion of cases will go on to develop recurrent/metastatic disease [5,6], for which platinum-based chemotherapy with or without cetuximab or pembrolizumab can be used as first-line therapy for patients able to tolerate treatment [7-9]. Immune checkpoint inhibitors are a recent treatment strategy for patients with SCCHN and offer an opportunity for durable responses with a manageable safety profile . Two programmed death-1 (PD-1) inhibitors, nivolumab and pembrolizumab, are currently approved for the NGD-4715 treatment of patients with recurrent/metastatic SCCHN who experienced disease progression after platinum-based therapy. However, there are concerns that age-related decline in immune function may impact the activity of checkpoint inhibitors [10,11]. Some data have been reported for these brokers in elderly patients with other solid tumors [11,12], and a recent publication of pembrolizumab in recurrent/metastatic SCCHN post-platinum therapy included limited data on efficacy by age . At the primary analysis of the randomized, open-label, phase 3 CheckMate 141 trial (“type”:”clinical-trial”,”attrs”:”text”:”NCT02105636″,”term_id”:”NCT02105636″NCT02105636), nivolumab significantly improved overall survival (OS) versus investigators choice (IC) of therapy in patients with recurrent/metastatic SCCHN who experienced tumor progression or recurrence within 6 months of platinum-based therapy administered in the adjuvant, primary (i.e. with radiation), recurrent, or metastatic setting; survival benefit was maintained at 1 and 2 years of follow-up irrespective of tumor programmed death ligand 1 (PD-L1) expression and human papillomavirus (HPV) status [14-16]. The safety profile of nivolumab was manageable, with fewer grade 3C4 treatment-related adverse events (TRAEs) compared with IC . Here, we report a post hoc analysis of the efficacy and safety of nivolumab by age ( 65 and 65 years old) Rabbit polyclonal to PSMC3 in patients with recurrent/metastatic SCCHN from CheckMate 141. Patients and methods Study design and patients CheckMate 141 is usually a randomized, open-label, phase 3 trial; the detailed study design has been described previously . Briefly, eligible patients were 18 years of age or older, had histologically confirmed, recurrent/metastatic SCCHN of the oral cavity, oropharynx, hypo-pharynx, or larynx, and had tumor progression on or within 6 months after the last dose of platinum-based chemotherapy administered in the locally advanced, recurrent, or metastatic disease setting. Patients were randomized 2:1 to receive nivolumab (3 mg/kg every 2 weeks) or standard single agent of IC (methotrexate 40C60 mg/m2 weekly, docetaxel 30C10 mg/m2 weekly, or cetuximab 400 mg/m2 once, then 250 mg/m2 weekly) and stratified by prior cetuximab treatment. Treatment continued until tumor progression or unacceptable toxicity. Patients in the nivolumab arm were allowed to continue nivolumab treatment beyond tumor progression if they met predefined, protocol-specified criteria . CheckMate 141 was conducted in accordance with the ethical principles in the Declaration.