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GSK/Genmab Report Positive Arzerra Data
GlaxoSmithKline ( GSK - Analyst Report) and partner Genmab recently announced encouraging top-line data from a phase III study (n = 447) which is evaluating oncology drug, Arzerra (ofatumumab). The study compared the efficacy of Arzerra as an adjunct to another oncology drug at Glaxo, Leukeran (chlorambucil) in treatment-naive chronic lymphocytic leukaemia (CLL) patients versus Leukeran alone.
The study met its primary endpoint of progression free survival (PFS/the time a patient lived without worsening of their disease). Data from the study was assessed by an independent review committee. In the Arzerra + Leukeran arm of the study, median PFS of 22.4 months was observed as compared to 13.1 months in the Leukeran arm, representing an improvement of 9.3 months.
We note Arzerra is already approved, since Oct 2009, for the treatment of patients with CLL refractory to Sanofi’s ( SNY - Analyst Report) Campath (alemtuzumab) and Fludara (fludarabine).
We note that Glaxo’s oncology portfolio received a boost recently when two new melanoma drugs, Tafinlar (dabrafenib) and Mekinist (trametinib) received the US Food and Drug Administration (FDA) approval. 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. and Salix Pharmaceuticals . Both carry a Zacks Rank #1 (Strong Buy).