Analysts at Zacks Research have recapped data from Advaxis' recent phase II study evaluating the safety and efficacy of ADXS-HPV +/- cisplatin in patients with recurrent cervical cancer, calling the results "very encouraging" and suggested the data may set the company up for potential partnership talks.
At the 2013 American Society of Clinical Oncology (OTC:ASCO) meeting held June 2, Advaxis' presented 12-month survival and overall data from the study being conducted in India involving 110 patients with refractory cervical cancer. Each patient has been previously treated with chemotherapy, radiotherapy or both, though their cancer has progressed since initial treatment, as confirmed by CT or radiologic scan.
Advaxis initiated the phase II study in November 2010; by May 17, 2013, all 110 patients had received 264 doses of ADXS-HPV (ADXS11-001) - and Advaxis' reported final 12-month overall survival at 36 percent with a (current) 18-month survival of 22 percent, as compared to 33 percent and 17 percent, respectively, at the last update - making the most recent results the best to-date.
In response to the data, Zacks says:
"After 110 patients and 264 doses, the safety data is encouraging. ADXS-HPV continues to demonstrate a well-tolerated and manageable safety profile with 32percentof patients reporting Grade 1 or 2 transient, flu-like symptoms that self-resolve or respond to symptomatic treatment. Less than 2percentof patients reported serious adverse events associated with ADXS-HPV. Published studies on chemotherapy treated patients like these show 100percentof patients experiencing severe adverse events, usually multiple times. Serious adverse events result in death, are life-threatening, cause significant disability or require inpatient hospitalization.
"Great efficacy has been observed which are very promising. Compared to GOG historical one year survival of 5percent, ADXS-HPV has achieved 36percent one-year survival rate. This is a huge improvement. Other literature data showed that generally, recurrent cervical cancer has a poor 1-year survival rate of 15percentand a 5-year survival rate of 3-13percentADXS-HPV's 36percent one-year survival rate is also a 100percentimprovement. Further investigation is warranted. 18 month survival also reached 22percent.
"ADXS-HPV appears to be emerging as an active agent in recurrent/refractory cervical cancer with significantly less toxicity than chemotherapy. The positive ADXS-HPV data may trigger partnership talks for Advaxis."
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