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Supplementary Figure S1 from Durvalumab plus Cetuximab in Patients with Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma: An Open-label, Nonrandomized, Phase II Clinical Trial

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posted on 2023-05-15, 08:21 authored by Shuchi Gulati, McKenzie Crist, Muhammed Kashif Riaz, Vinita Takiar, Maria Lehn, Ilaina Monroe, Sarah Palackdharry, Nicky Kurtzweil, Roman Jandarov, Nusrat Harun, Trisha M. Wise-Draper

Study Schema. This is a single-arm, phase II trial combining durvalumab and cetuximab in patients with recurrent/metastatic HNSCC. Patients received the loading dose of cetuximab followed by the addition of durvalumab with weekly cetuximab doses. CT scans were done every eight weeks. Blood draws for correlatives occurred at screening, after the loading dose of cetuximab, and after the first dose of durvalumab and cetuximab combined.Abbreviations: CT, computed tomography; POD, progression of disease

Funding

National Center for Advancing Translational Sciences (NCATS)

United States Department of Health and Human Services

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National Cancer Institute (NCI)

United States Department of Health and Human Services

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American Cancer Society (ACS)

U.S. Department of Veterans Affairs (VA)

Biomedical Laboratory Research and Development Service

Dr. Bernard S. Aron fund

History

ARTICLE ABSTRACT

The efficacy of cetuximab is poor in metastatic head and neck squamous cell carcinoma (HNSCC). Cetuximab initiates natural killer (NK) cell–mediated antibody-dependent cellular cytotoxicity, with resultant recruitment of immune cells and suppression of antitumor immunity. We hypothesized that adding an immune-checkpoint inhibitor (ICI) could overcome this and lead to an enhanced antitumor response. A phase II study of cetuximab and durvalumab in metastatic HNSCC was conducted. Eligible patients had measurable disease. Patients who had received both cetuximab and an ICI were excluded. The primary endpoint was objective response rate (ORR) by RECIST 1.1 at 6 months. As of April 2022, 35 patients enrolled, of whom 33 received at least 1 dose of durvalumab and were included in the response analysis. Eleven patients (33%) had received prior platinum-based chemotherapy, 10 an ICI (30%), and 1 patient (3%) cetuximab. ORR was 39% (13/33) with a median duration of response of 8.6 months [95% confidence interval (CI): 6.5–16.8]. Median progression-free and overall survivals were 5.8 months (95% CI: 3.7–14.1) and 9.6 months (95% CI: 4.8–16.3), respectively. There were 16 grade 3 treatment-related adverse events (TRAE) and one grade 4 TRAE, with no treatment-related deaths. Overall and progression-free survival did not correlate with PD-L1 status. NK cell cytotoxic activity was increased by cetuximab and further increased with the addition of durvalumab in responders. The combination of cetuximab and durvalumab demonstrated durable activity with a tolerable safety profile in metastatic HNSCC and warrants further investigation.

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