Phase 3 trial for locally advanced head and neck cancer terminated
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A randomized phase 3 study designed to evaluate the addition of avelumab to chemoradiotherapy for patients with untreated locally advanced head and neck squamous cell carcinoma has been terminated based on the recommendation of the independent data monitoring committee.
A preplanned interim analysis of the JAVELIN Head and Neck 100 study showed the combination is unlikely to confer significant improvement in PFS — the study’s primary endpoint — compared with standard chemoradiotherapy alone.
Standard treatment for locally advanced HNSCC consists of high-dose chemotherapy combined with radiotherapy. However, more effective treatments are needed to prevent recurrence or metastatic disease.
The double-blind JAVELIN Head and Neck 100 study included 697 patients who received no prior therapy for locally advanced HNSCC.
Researchers assigned patients to chemoradiotherapy alone, or chemoradiotherapy plus the PD-L1 inhibitor avelumab (Bavencio; EMD Serono, Pfizer) followed by avelumab maintenance.
PFS served as the primary endpoint. Secondary endpoints included OS, time to locoregional failure, time to distant metastatic failure, overall response, duration of response and pathologic complete response.
A detailed analysis of the results is underway and will be shared with the scientific community, according to an EMD Serono-issued press release.
The FDA previously approved avelumab for treatment of certain patients with Merkel cell carcinoma and urothelial carcinoma.