GlaxoSmithKline (GSK) recently announced data from a phase III trial (n = 940) evaluating its oncology drug, Votrient (pazopanib). The randomized, double-blind, placebo-controlled phase III trial evaluated the use of Votrient as maintenance therapy in women suffering from epithelial ovarian, fallopian tube or primary peritoneal cancer, whose disease did not worsen after receiving standard debulking surgery and first-line chemotherapy treatment.
The study met its primary endpoint of progression free survival (PFS/the time a patient lived without worsening of their disease). In the Votrient arm of the study, median PFS of 17.9 months was observed as compared to 12.3 months in the placebo arm, representing an improvement of 5.6 months. It was observed that treatment with Votrient reduced the risk of the disease worsening by 23%.
The company said that there were insufficient events to estimate median overall survival (:OS) at the time of data cut off. However, no difference in survival was found between the two arms of the trial in the interim analysis.
Glaxo plans to submit the marketing applications for the approval of Votrient in the ovarian cancer indication during the course of the year. Votrient is already marketed for the treatment of patients with advanced renal cell carcinoma. Last year, the drug’s label was expanded to include advanced soft tissue sarcoma.
We note that Glaxo’s oncology portfolio received a boost recently when two melanoma drugs, Tafinlar (dabrafenib) and Mekinist (trametinib) gained approval from the US Food and Drug Administration. While Tafinlar was approved for use in BRAF V600E mutation-positive unresectable or metastatic melanoma patients, Mekinist received clearance for the treatment of patients suffering from unresectable or metastatic melanoma with BRAF V600E or V600K mutations.
Glaxo carries a Zacks Rank #3 (Hold). We are pleased with Glaxo’s label expansion efforts. Moreover, Glaxo boasts of a robust pipeline. A number of pipeline-related news is expected in the coming quarters. Given the declining sales from generic competition, we believe Glaxo’s pipeline must deliver. Companies that currently look attractive include Santarus, Inc. (SNTS), Jazz Pharmaceuticals (JAZZ) and Salix Pharmaceuticals (SLXP). All the three carry a Zacks Rank #1 (Strong Buy).
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