FDA Halts Combo Trial of Axalimogene Filolisbac Plus Durvalumab

March 13, 2018 – The FDA has put a clinical hold on a phase I/II study of axalimogene filolisbac (AXAL) plus durvalumab for the treatment of patients with advanced, recurrent or refractory HPV-associated cervical cancer and HPV-associated head and neck squamous cell carcinoma (HNSCC). Axalimogene filolisbac is a targeted Listeria monocytogenes (Lm)-based immunotherapy that attacks HPV-associated cancers. The FDA cited a safety report regarding a patient … (leggi tutto)