GlaxoSmithKline’s Votrient improves progression-free survival in Phase III trial of women with ovarian cancer

Data from a Phase III trial presented at the ASCO annual meeting suggest that GlaxoSmithKline’s Votrient (pazopanib) reduced the risk of disease progression or death by 23 percent compared to placebo when used as maintenance therapy in women with advanced epithelial ovarian cancer following front-line chemotherapy. Commenting on the potential to expand approval of the therapy to include ovarian cancer, Rafael Amado, Head of Oncology R&D at GlaxoSmithKline noted that "we are planning to submit regulatory applications in 2013."

The study included 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. After completing at least 5 cycles of platinum-taxane chemotherapy, patients were randomised to receive Votrient orally once daily or placebo for up to 24 months. Data showed that the median progression-free survival (PFS) for women in the pazopanib group was 17.9 months compared to 12.3 months for those in the placebo group. At the time of data cut off, there were insufficient data to estimate median overall survival, but an interim analysis showed no difference in survival between the two groups. GlaxoSmithKline noted that serious adverse events were 26 percent among patients given pazopanib, compared to 11 percent among patients in the placebo arm.

"Our findings show that we finally have a drug that can maintain control over ovarian cancer growth achieved through initial treatments," remarked study author Andreas du Bois, adding that "if pazopanib is approved for ovarian cancer, many patients will experience longer disease-free and chemotherapy-free periods." However, Len Lichtenfeld, deputy chief medical officer for the American Cancer Society, cautioned that "we just don't know if this is going to translate into a meaningful improvement of survival for these women," adding that "we really have to be cautious in determining where that new treatment fits in the overall care for these women. This may be very exciting, but we need more time and analysis to see how this fits in the treatment protocols we would use for women treated in more routine settings than a clinical trial."

Votrient was first approved by the FDA for the treatment of patients with advanced renal cell carcinoma (aRCC) in 2009 and garnered a complete marketing authorisation from European regulators in March 2013. The therapy is now approved in more than 80 countries as a treatment for patients with aRCC and was also approved for the treatment of patients with advanced Soft Tissue Sarcoma (aSTS) in the US and EU last year. Votrient is not approved in any countries in the ovarian cancer indication. Analysts have speculated that the drug may achieve annual sales of $779 million by 2016 from $441 million this year.

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