For HPV-Associated Anal Cancer, ADXS-HPV Immunotherapy May Be Effective

the Cancer Therapy Advisor take:

Advaxis, Inc. has announced preliminary data from its phase 1/2 study of ADXS-HPV, an investigational immunotherapy, in combination with standard chemotherapy and radiotherapy for the treatment of patients with human papillomavirus (HPV)-associated anal cancer who have a high risk of recurrence.

The researchers of the study observed a clinical complete response in all seven patients who completed the treatment regimen. For the phase 1/2 non-randomized, open-label, multicenter study, researchers enrolled 25 patients in order to determine the safety and efficacy of ADXS-HPV in this patient population. The primary endpoint of the study was to determine the number of patients maintaining a clinical complete response at 6 months after initial treatment.

Currently, seven patients have completed the entire treatment regimen and all are without evidence of disease. The most common adverse effect observed thus far has been flu-like symptoms which typically last for approximately 24 hours. Due to the positive preliminary results, the study will be expanded to other centers.

ADXS-HPV has been designated orphan drug status for the treatment of HPV-associated anal, cervical, and head and neck cancer by the U.S. Food and Drug Administration (FDA) and is currently being studied in multiple clinical trials.