First real-world data from HANNA – a non-interventional study with nivolumab in patients with squamous cell carcinoma of the head and neck (SCCHN) in Germany

Introduction:

The registrational trial for nivolumab in SCCHN (CheckMate 141, NCT02105636) showed significant superior overall survival (OS), higher response rates, and a favorable safety profile with stabilized quality of life (QoL) compared to the standard of care chemotherapy (methotrexate, docetaxel, or cetuximab). Real-world data in local clinical setting are needed to further evaluate the effectiveness and tolerability of nivolumab, as well as quality of life associated with the treatment in a broader patient population.

Methods:

HANNA is an ongoing, prospective, observational, multicenter study in Germany. Primary study objective is OS. Secondary objectives include progression free survival, response rates, baseline characteristics, safety profiles and patient reported outcomes.

Overall, 385 adult patients diagnosed with SCCHN progressing on or after platinum-based therapy, who start a systemic therapy with nivolumab for the first time according to label, will be enrolled. Patients will be followed for 5 years from treatment initiation until death, withdrawal of consent, loss to follow-up/record or end of study.

Results:

In this interim analysis, we report data on baseline characteristics of 139 patients enrolled, comprising 111 male and 28 female patients aged between 30 and 84 years. The data provide information on disease and treatment characteristics, prior treatment and ECOG performance status. Additionally data from a 3-months follow-up regarding safety and quality of life for 73 patients will be shown.

Conclusions:

Our data provide valuable information about patients with SCCHN treated with nivolumab in routine clinical practice in Germany. It will therefore add further evidence to the existing clinical data.

Publikationsverlauf

Publikationsdatum:
23. April 2019 (online)