Advaxis Reports Final 18-Month Survival Data For ADXS-HPV In Patients With RCC

(RTTNews) - Advaxis Inc. (ADXS) 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.

The company noted that final 18 month survival data has increased to 28% from the 22% previously reported.

The company said that the last patient last visit (Day 545) occurred on October 18, 2013. The final 18-month survival data are 28% (31/110) which is updated from the preliminary18-month survival of 22% (16/73) reported at the 2013 ASCO Annual Meeting on June 2, 2013. The final 12-month survival was 36% (39/110). These data are comparable to the results for the landmark 2004 Phase 3 study conducted by the Gynecologic Oncology Group of cisplatin alone and cisplatin plus paclitaxel in recurrent cervical cancer patients with the same initial performance (health) status (0-2).

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.

"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," said Robert Petit, Chief Scientific Officer of Advaxis.

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.

The company stated that 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.