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Published on: October 27, 2014
Durvalumab in combination with chemoradiotherapy in patients with head and neck squamous cell carcinoma: Results from
Julie E Bauman1,2, Sana D Karam3, Cathy O'Brien4
1Department of Medicine, University of Arizona Cancer Center, Tucson, Arizona, USA.
Background:
The Phase 1 CLOVER study (NCT03509012) assessed durvalumab in combination with concurrent chemoradiotherapy (cCRT) in patients with advanced solid tumors; we report results from the head and neck squamous cell carcinoma (HNSCC) cohort.
Methods:
Patients with histologically/cytologically confirmed locally advanced HNSCC, eligible for definitive cCRT and not considered for primary surgery, received durvalumab plus cisplatin and concurrent external beam radiation. Objectives were to assess safety/tolerability and preliminary efficacy.
Results:
Eight patients were enrolled. The most frequent any-cause adverse events (AEs) were nausea and radiation skin injury (each n = 5); most frequent grade 3/4 AEs were lymphopenia and stomatitis (each n = 3). No patients had dose-limiting toxicities. Objective response rate was 71.4% (5/7 patients; four complete responses, one partial response); disease control rate was 85.7% at 18 weeks and 83.3% at 48 weeks.
Conclusions:
Durvalumab plus cCRT was tolerable and active in patients with unresected, locally advanced HNSCC.
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