Unmet Needs in R/M HNSCC: The Rationale for Study 1100

In an interview with Targeted Oncology, Colette Shen, MD, PhD, assistant professor at the University of North Carolina (UNC) Chapel Hill and radiation oncologist at the UNC Lineberger Comprehensive Cancer Center, details the unmet needs in patients with recurrent or metastatic (R/M) head and neck squamous cell carcinoma (HNSCC), the rationale for the phase 1 Study 1100 (NCT03589339) testing the safety of the novel radioenhancer NBTXR3 (JNJ-1900).

The patient population of interest in this study is patients with locoregionally recurrent or metastatic HNSCC. A major challenge facing patients with recurrent disease is limited treatment options, as they have already undergone extensive treatments such as local therapies, surgeries, and radiation. These treatments often come with adverse effects such as trouble swallowing and dry mouth; a tumor growing back in the previously treated area can worsen these symptoms and further impair swallowing, speech, and taste. Additional treatment following recurrence risks exacerbating these adverse effects, as well as compounding existing toxicities from previous treatments.

Furthermore, while immunotherapies have emerged as a promising treatment option for metastatic disease, most patients do not respond well to these therapies, narrowing their options down to conventional chemotherapies for disease control or palliative treatments for symptom management.

The need for improved control and response is what motivated Study 1100. Specifically, the first objective of Study 1100 was to provide a treatment that can control the tumor locally where it had developed or in a metastatic site; the second objective was to use an enhanced form of radiation to reinvigorate a response to immunotherapies.

Read the full interview here.