Abstract
Background
Patients with HRLACC experience a 50% chance of disease recurrence/death following cisplatin-based chemoradiation (CCRT) plus brachytherapy, and represent a group with a significant unmet need
for new treatments. Persistent infection with oncogenic strains of human papillomavirus (HPV) is the most common cause of CC, and provides rationale for therapeutic targeting of HPV. Axalimogene
filolisbac (AXAL/ADXS11-001) is an irreversibly attenuated Listeria monocytogenes-listeriolysin O immunotherapy that secretes a HPV E7 fusion protein that induces HPV-specific cytotoxic T cell generation and reduces immune tolerance in the tumor microenvironment. Previous
studies demonstrated AXAL was well tolerated and associated with objective tumor response and survival benefits in patients with recurrent/metastatic CC. AXAL has received FDA Fast Track Designation for the treatment of HRLACC.