Advaxis, Inc., (OTCBB: ADXS), a leader in developing the next generation of immunotherapies for cancer and infectious diseases, updated preliminary data from an ongoing randomized 110 patient Phase 2 trial of ADXS-HPV being conducted in India in women with recurrent/refractory cervical cancer who have failed previous cytotoxic therapy. Dr. Robert Petit, Advaxis, presented the update in an oral presentation on Saturday, October 27, 2012 at the Society for Immunotherapy of Cancer (SITC) 27th Annual Meeting in North Bethesda, MD.
This Phase 2 trial assesses the safety and efficacy of ADXS-HPV (1x109 cfu) alone, compared to ADXS-HPV plus cisplatin (40 mg/m2, weekly x5). There are 55 patients in each group.
The primary endpoint of the study is overall survival. As of October 22, 2012, landmark survival at 6, 9, 12, and 18 months was 65%, 44%, 33%, and 17% respectively. There appears to be no difference in survival between the two groups.
The National Comprehensive Cancer Network Guidelines cite historical 12 month survival data of 0-22% with single agent therapy in recurrent cervical cancer. This study shows 12 month survival of 33% among a group of 70 patients.
6 complete (100%) responses and 6 partial (30%+) responses have been reported, an increase of one complete response since our July report.
6 complete responses (CR): 4 in the ADXS alone group; 2 in the ADXS+ cisplatin group.
6 partial responses (PR): 3 in the ADXS alone group; 3 in the ADXS+ cisplatin group.
After 110 patients and 264 doses, the safety data is encouraging. ADXS-HPV continues to demonstrate a well-tolerated and manageable safety profile with 32% of patients reporting Grade 1 or 2 transient, flu-like symptoms that self-resolve or respond to symptomatic treatment. Less than 2% of patients reported serious adverse events associated with ADXS-HPV. Published studies on chemotherapy treated patients like these show 100% of patients experiencing severe adverse events, usually multiple times. Serious adverse events result in death, are life-threatening, cause significant disability or require inpatient hospitalization.
"This study is now well advanced, as evidenced by the fact that the majority of patients have been in the study for more than 12 months and we are reporting 18 month landmark survival data for the first time. ADXS-HPV appears to be emerging as an active agent in recurrent/refractory cervical cancer with significantly less toxicity than chemotherapy. Apparent prolonged survival, durable complete and partial tumor reductions, and stable disease have been observed in both treatment groups," commented Dr. Robert Petit, Vice President of Clinical Operations and Medical Affairs at Advaxis.