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Nivolumab benefit in advanced head and neck cancer maintained regardless of age
NEW YORK — The OS benefit observed with nivolumab compared with investigator’s choice of single-agent chemotherapy for patients with recurrent or metastatic head and neck squamous cell carcinoma who previously received platinum therapy occurred regardless of patient age, according to a post hoc analysis of the CheckMate 141 trial presented at Chemotherapy Foundation Symposium.
In addition, objective response rates were higher with nivolumab (Opdivo, Bristol-Myers Squibb) among patients aged younger than 65 years, as well as those aged 65 years or older.
Results of the phase 3 CheckMate 141 trial showed nivolumab, an anti-PD-1 antibody, significantly prolonged OS compared with investigator’s choice of single-agent chemotherapy among patients with recurrent or metastatic squamous cell carcinoma who underwent prior platinum therapy (median, 7.5 months vs. 5.1 months; HR = 0.7; 97.73% Ci, 0.51-0.96).
Researchers observed the benefit at 1-year and 2-year follow-up, regardless of tumor PD-L1 expression or HPV status.
In addition, after minimum follow-up of 24.2 months, incidence of grade 3 or grade 4 treatment-related adverse events was lower in the nivolumab group (15.3% vs. 36.9%).
A considerable percentage of patients with HNSCC are aged 65 years or older, and they often have comorbidities that may limit their ability to tolerate chemotherapy. However, data on use of immune checkpoint inhibitors among elderly patients with HNSCC are lacking, according to study background.
Nabil F. Saba, MD, FACP, professor in the department of hematology and medical oncology at Winship Cancer Institute at Emory University, and colleagues presented results of a post-hoc analysis of CheckMate 141 that explored outcomes based on patient age.
The randomized, phase 3 trial included 361 patients with recurrent or metastatic HNSCC of the oral cavity, pharynx or larynx who experienced progression at least 6 months after platinum therapy in the adjuvant, primary, recurrent or metastatic setting.
Researchers assigned 240 patients to nivolumab 3 mg/kg every 2 weeks. The other 121 patients received investigator’s choice of chemotherapy, which included methotrexate, docetaxel or cetuximab (Erbitux, Eli Lilly).
OS served as the primary endpoint. Secondary endpoints included PFS, ORR, duration of response, safety, biomarkers and patient-reported quality of life.
The post-hoc analysis included 113 patients aged 65 years or older (nivolumab, n = 68; chemotherapy, n = 45).
Data cutoff was September 2017, and minimum follow-up was 24.2 months. Median duration of therapy did not differ significantly between patients aged younger than 65 years or 65 years and older in either treatment group.
Results showed the OS benefit with nivolumab was maintained among patients aged younger than 65 years (8.2 months vs. 4.9 months; HR = 0.63; 95% CI, 0.47-0.84) and those aged 65 years or older (6.9 months vs. 6 months; HR = 0.75; 95% CI, 0.51-1.12).
Estimated 30-month OS rates were higher with nivolumab than chemotherapy in both the younger group (11.2% vs. 1.4%) and older group (13% vs. 3.3%).
The OS benefit with nivolumab was maintained in both age groups regardless of PD-L1 expression and HPV status.
ORR also was higher with nivolumab in the younger group (12.8% vs. 6.6%) and older group (14.7% vs. 4.4%).
Rates of treatment-related adverse events in the nivolumab group were similar between the two age groups and were consisted with those reported in the overall patient population.
Patients assigned nivolumab were less likely than those assigned chemotherapy to experience any-grade or grade 3/grade 4 treatment-related adverse events.
“These data support the use of nivolumab in younger and older patients with recurrent or metastatic [head and neck squamous cell carcinoma] after platinum therapy,” Saba and colleagues concluded. – by Mark Leiser
For more information:
Saba NF, et al. Nivolumab versus investigator’s choice in patients with recurrent or metastatic squamous cell carcinoma of the head and neck: Analysis of CheckMate 141 by age. Presented at: Chemotherapy Foundation Symposium; Nov. 7-9, 2018; New York.
Disclosures: Bristol-Myers Squibb supported this study.