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August 6, 2012
Advaxis released interim results from a phase II trial of ADXS-HPV for the treatment of with recurrent/refractory cervical cancer. This multi-arm, randomized study has enrolled 63 female patients thus far who have failed previous cytotoxic therapy. Subjects received ADXS-HPV (1x109 cfu) with or without cisplatin 40mg/m2 weekly for five weeks. The primary endpoint, survival, at months six, nine and 12 is 64%, 46% and 29%, respectively, while the National Comprehensive Network Guidelines cite historical 12-month survival data of 0%-22% with single agent therapy in this patient population. Thus far, ADXS-HPV has triggered five complete responses (three in the ADXS alone group; two in the ADXS+ cisplatin group) and six partial responses (three in the ADXS alone group; three in the ADXS+ cisplatin group). A complete response is defined as 100% elimination of tumor burden, whereas a partial response is defined as 30% or more reduction in tumor burden. The drug was well tolerated. Advaxis is continuing the trial in India, and the Gynecologic Oncology Group plans to conduct a phase II study of ADXS-HPV in a similar patient population in the U.S.
January 30, 2012
Advaxis reported interim results from a phase II trial of ADXS-HPV, an immunotherapy for cervical cancer. Data are from 87 women with recurrent/refractory cervical cancer who have failed cytotoxic therapy. The subjects received ADXS-HPV (1x109 cfu) with and without cisplatin (40 mg/m2). The primary endpoint is overall survival. At six months, the percentage of women alive was 62%; at nine months 41% and at one year 40%. Clinical responses were observed in both treatment arms, with three complete responses and four partial responses. ADXS-HPV drug-related adverse events were reported by 34% of subjects. The majority of the events were transient and responded to symptomatic treatment, or resolved on their own. The trial is being conducted at 17 sites in India.