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GSK’s Votrient meets primary objective in Phase III ovarian cancer trial

GlaxoSmithKline's (GSK) Votrient (pazopanib) has met the primary objective of a statistically significant improvement in the time to disease progression or death that is the progression-free survival (PFS) against placebo in Phase III ovarian cancer trial.

Treatment with Votrient following front-line chemotherapy was found to reduce the risk of the disease progression or death by 23% in women with advanced epithelial ovarian cancer.

While the incidence of serious adverse events was comparatively higher in the pazopanib group, the median PFS was found to be 17.9 months in pazopanib group against 12.3 months in the placebo group.

Median overall survival was not estimated, whereas difference in survival was not noticed between the groups as per the interim analysis.

Hypertension, diarrhoea, nausea, headache, fatigue, and neutropenia were the most common adverse events in the pazopanib arm, while the most common serious adverse events included increased ALT, pyrexia, increased AST and hypertension.

GSK oncology R&D head Dr Rafael Amado said as the ovarian cancer is a leading cause of cancer deaths among women, the company is collaborating with AGO and other cooperative groups to discover new treatments.

"This study showed that treatment with Votrient following surgery and chemotherapy extended the time that these women lived without their disease progressing," Amado added.

"We are planning to submit regulatory applications in 2013."