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FDA Halts Combo Trial of Axalimogene Filolisbac Plus Durvalumab

Jason Harris
Published: Tuesday, Mar 13, 2018

Anthony Lombardo

Anthony Lombardo
The FDA has put a clinical hold on a phase I/II study of axalimogene filolisbac (AXAL) plus durvalumab (Imfinzi) for the treatment of patients with advanced, recurrent or refractory HPV-associated cervical cancer and HPV-associated head and neck squamous cell carcinoma (HNSCC).

HPV genotyping for 41 patients showed that 35 tested positive for the virus, including 33 evaluable patients, 16 who tested positive for HPV-16 and 17 who were positive for HPV-18. The HPV-16-positive subgroup had a 12-month survival of 44% and median OS of 17.8 months for those patients alive at 12 months. The HPV-18-positive subgroup had a 12-month OS of 41% and median OS of 15.7 months among those alive at 12 months.


  1. Slomovitz BM. A phase I/II study of durvalumab alone or in combination with AXAL in recurrent/persistent or metastatic cervical or human papillomavirus (HPV)+ squamous cell cancer of the head and neck (SCCHN): preliminary phase I results. Presented at: 2016 SITC Annual Meeting; November 9-13, 2016; National Harbor, MD. Abstract 248.
  2. Huha W, Brady WE, Dizonc DS, et al. A prospective phase II trial of the listeria-based human papillomavirus immunotherapy axalimogene filolisbac in second- and third-line metastatic cervical cancer: A NRG oncology group trial. Presented at: 2017 SGO Annual Meeting; March 12-15, 2017; National Harbor, MD. Abstract LB3.

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Medical Crossfire®: How Can We Optimize Outcomes in Head and Neck Cancers with Immunotherapeutic Strategies?Oct 31, 20191.5
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