Advaxis Improves 18-Month Survival in Cervical Cancer

Advaxis has posted final 18-month survival data from its randomized Phase II study evaluating the safety and efficacy of ADXS-HPV with and without cisplatin in 110 patients with recurrent cervical cancer. The primary endpoint of the study is overall survival. Data will be presented at the 2013 Society for Immunotherapy of Cancer (SITC) Annual Meeting.

The final 18-month survival data are 28% (31/110), which is updated from the preliminary 18-month survival of 22% (16/73) reported  in June 2013. The final 12-month survival was 36% (39/110). These data are comparable to the results for the 2004 Phase III study conducted by the Gynecologic Oncology Group of cisplatin alone and cisplatin plus paclitaxel in recurrent cervical cancer patients with the same initial performance. In that study, 12-month survival was presented as 35% for cisplatin alone and 32% for the combination and 18-month survival was presented as 20% for combination therapy and 12% for cisplatin, alone.

Median overall survival in the Advaxis study was approximately 8.5 months, indicative of the late stage of disease and baseline performance status of the patients. Patients who completed the study will continue to be followed for survival. Survival results were not significantly different between treatment groups with or without cisplatin chemotherapy or who had previous therapy comprised of a combination of chemotherapy and radiation, radiation alone, or chemotherapy alone.