HANNA – Real-world data on effectiveness and safety of Nivolumab in patients with recurrent or metastatic (R/M) squamous cell carcinoma of the head and neck (SCCHN) in Germany

Introduction HANNA is a prospective, observational, multicenter study started in Germany in May 2017. Its objective is to evaluate the effectiveness, tolerability, safety and Quality of life (QoL) associated with nivolumab treatment of patients with R/M SCCHN.

Methods Overall, 56 clinics and practices in Germany will enroll 385 adult patients with R/M SCCHN progressing on or after platinum-based therapy according to the label approved in the EU. Patients are followed for 5 years from enrollment until death, withdrawal of consent, loss of follow-up/record or end of study. Primary study objective is overall survival (OS), estimated using the Kaplan-Meier method. Secondary objectives include progression free survival, response rates, baseline characteristics, safety profiles and QoL. Baseline characteristics are reported using descriptive statistics.

Results By Oct 2019, 324 patients with R/M SCCHN were enrolled. In this interim analysis (data cut off Nov 3rd 2019, results not available before abstract submission) we report baseline characteristics and OS for the total population and subgroups (defined by ECOG performance status, line of treatment, elderly, metastases).

Conclusions Real-World data from HANNA reflect routine clinical use of Nivolumab and provide complementary information about special populations, such the elderly and patients with ECOG =2. Earlier HANNA data (Dietz et al. DGHNO 2019, Oral presentation #101) have shown that real-world treatment with nivolumab provides outcomes similar to those observed in pivotal study CheckMate 141, including good tolerability and stable QoL.

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Publication History

Article published online:
10 June 2020