AIM2CERV: a randomized phase III study of adjuvant AXAL immunotherapy following chemoradiation in patients who have high-risk locally advanced cervical cancer (HRLACC)
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.
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