Phase III trial of Votrient (Glaxo Smith Kline) shows significant PFS benefits in Ovarian Cancer
A Phase III clinical trial of Votrient (pazopanib), from Glaxo Smith Kline, in women with Ovarian Cancer met the primary objective of a statistically significant improvement in progression-free survival (PFS) compared to placebo. This randomised, double-blind, Phase III, placebo-controlled study evaluated the efficacy and safety of pazopanib monotherapy versus placebo in 940 women with epithelial Ovarian, fallopian tube, or primary peritoneal Cancer whose disease had not progressed after completing standard debulking surgery and first-line chemotherapy.
Pazopanib treatment reduced the risk of disease progression or death by 23% (p = 0.0021). The median PFS for women in the pazopanib group was 17.9 months compared to 12.3 months for those on placebo. The incidence of serious adverse events was higher in the pazopanib group compared to the placebo group (26% vs 11%). Results were presented at ASCO. Votrient is currently approved in 80 countries for the treatment of Renal Cell Carcinoma and was approved in the US and EU for Soft Tissue Sarcoma in 2012.