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August 12, 2013
GlaxoSmithKline issued results of a randomized, double-blind, phase III, placebo controlled trial of pazopanib monotherapy in women with epithelial ovarian, fallopian tube or primary peritoneal cancer whose disease had not progressed after completing standard debulking surgery and first-line chemotherapy. After completion of five or more cycles of platinum-taxane chemotherapy, 940 patients were randomized 1:1 to receive 800mg pazopanib once daily or placebo for up to 24 months (median time from diagnosis to randomization was approximately seven months). Pazopanib treatment reduced the risk of disease progression or death by 23% (HR = 0.77; 95% CI: 0.64-0.91; p = 0.0021). The incidence of serious adverse events was higher in the pazopanib group compared to the placebo group (26% v. 11%). Regulatory applications will be submitted before 2014.
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.