Ayala Pharmaceuticals Inc (ADXS)

[surf1944]

8:31AM Advaxis reports final 18-month survival data for ADXS-HPV in patients with recurrent cervical cancer (ADXS) 3.71 : Co announced final 18-month survival data from Lm-LLO-E7-15, a randomized Phase 2 study evaluating the safety and efficacy of ADXS-HPV (1x109 cfu) (ADXS11-001) with and without cisplatin (40 mg/m2, weekly x5) in 110 patients with recurrent cervical cancer in two treatment arms of 55 patients each. The primary endpoint of the study is overall survival. These data will be presented at the 2013 Society for Immunotherapy of Cancer (SITC) Annual Meeting in National Harbor, MD, on November 9, 2013 (Poster #258).

"The final 18 month survival outcome of 28% suggests that ADXS-HPV is an active treatment in recurrent cervical cancer. Achieving this promising 18 month survival with a single treatment cycle at the lowest effective dose, further suggests that higher doses and repeated cycles of immunotherapy might extend the lives of patients even further beyond the data presented here."
Median overall survival in the Advaxis study was approximately 8.5 months which is indicative of the late stage of disease and baseline performance status of the patients. Those patients that 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.
Subset analyses showed that the combination arm (addition of cisplatin to ADXS-HPV) did not significantly improve survival or tumor response; and survival and tumor response were equally strong in patients with aggressive disease (defined as recurrence =2 years from initial diagnosis) versus non-aggressive disease (defined as recurrence >2 years from initial diagnosis).