Advaxis, Inc., a clinical-stage biotechcompany developing the next generation of immunotherapies for cancer and infectious diseases, Sunday reported conclusive 12-month overall survival and additional data from Lm-LLO-E7-15, a randomized phase 2 study evaluating the safety and efficacy of ADXS-HPV +/- cisplatin in patients with recurrent cervical cancer.
As of May 17, 2013, the trial had completed enrollment and 110 patients have received 264 doses of ADXS-HPV (ADXS11-001). The company reported that final 12-month overall survival is 36 percent with a current 18-month survival of 22 percent. Thesedata compare to data from the last update at 33 percent and 17 percent, respectively, and are the best results yet reported for this study.
Among other data, median overall survival was approximately 8.5 months – patients who have completed the study will continue to be followed for survival. In addition, subset analyses showed that the addition of cisplatin to ADXS-HPV did not significantly improve survival or tumor response in this study.
“These data suggest that ADXS-HPV has the potential to become a non-chemotherapy treatment option capable of improving survival for women with cervical cancer. Clinical benefit was evident in this trial even in women with cancer that recurred aggressively, who had bulky metastatic tumors, and who had been previously treated with both chemotherapy and radiotherapy. The side effects reported by less than half of the patients were mild, and associated primarily with the infusion. Furthermore, the ability of ADXS-HPV in this study to cause durable complete and partial remission of solid tumors as a monotherapy, is very promising,” stated Dr. Petit.
Thomas A. Moore, chairman and CEO of Advaxis, said that in light of the favorable data, the company’s focus will be to advance ADXS-HPV to registrational status.
“These results have stood up very well, both over time and in our new, detailed analysis. We believe the promising clinical benefits and attractive side effect profile shown in the data collected about ADXS-HPV thus far make this potentially a whole new class of therapy in this disease. Advaxis will progress ADXS-HPV to registrational trials as quickly as possible, exploring additional dosing that may further extend any clinical benefits.”
The data were presented by Dr. Robert Petit, chief scientific officer at Advaxis, at the 2013 American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago, IL, on Sunday.
For more information visit www.advaxis.com
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