The Phase 2 study enrolled 87 out of a planned 110 patients to assess the safety and efficacy of ADXS-HPV with and without cisplatin (40 mg/m2) and to determine if ADXS-HPV can be safely administered in combination with platinum chemotherapy.
The primary efficacy endpoint of the ADXS-HPV trial is overall survival.
The Phase 2 trial demonstrated that percentage of patients alive at 6 months is 62%, at 9 months is 41% and at one year is 40%.
The trial showed that 34% of patients experienced a ADXS-HPV drug-related adverse event, consisting of Grade 1 or 2 events and one Grade 3 event.
ADXS-HPV drug is now being evaluated in four Phase 2 clinical trials for HPV-associated diseases.