(NVS) Novartis’ Cancer Drug Afinitor Shows Promise for Breast Cancer

Novartis’ (NVS) cancer drug Afinitor took a significant step forward, as the company once again presented encouraging data from late-stage trials of Afinitor for the treatment of breast cancer, an indication for which management estimates sales potential in excess of $1 billion. Afinitor is not yet approved for the treatment of breast cancer.

The pivotal late-stage study (BOLERO-2) evaluated the use of Afinitor in combination with Pfizer’s (PFE) Aromasin (a hormonal therapy) in postmenopausal women with metastatic breast cancer whose disease has progressed, despite treatment with hormonal therapies like Novartis’ Femara or AstraZeneca’s (AZN) Arimidex. The long-term data showed that Afinitor plus Aromasin expanded progression-free survival (PFS), or time, without causing tumor growth in patients, by more than two times versus Aromasin alone. Treatment with Afinitor improved the PFS to 7.4 months versus 3.2 months for Aromasin alone. Afinitor plus Aromasin also significantly reduced the risk of cancer progression by 31% versus 10% in the Aromasin arm over a period of 12 months.

The above data represents an additional five month follow up data and was in line with earlier data presented in July 2011 and in late September.

Afinitor is currently marketed for the treatment of advanced renal cell carcinoma (kidney cancer) after an anti-VEGF therapy like Roche’s (RHHBY) Avastin, Pfizer’s (PFE) Sutent or Onyx Pharmaceuticals’(ONXX) Nexavar, in the US and European Union (EU). Afinitor is also approved for the treatment of patients with advanced neuroendocrine tumors (NET) of pancreatic origin in the US and EU. Besides, Afinitor is marketed in the US and approved in the EU (trade name: Votubia) for the treatment of subependymal giant cell astrocytomas (SEGA), a benign brain tumor associated with tuberous sclerosis (TS).

Moreover, Afinitor is studied under late-stage trials for many other cancer types, like diffuse large B cell lymphoma, gastric cancer, hepatocellular carcinoma (HCC).

Our Recommendation

Currently, we have a Neutral recommendation on Novartis. The company carries a Zacks #3 Rank (“Hold” rating) in the short run. Though pleased with Novartis’ wide range of products and its efforts to diversify further, as is evident by the acquisition of eye-care company Alcon, we prefer to remain on the sidelines due to the imminent patent cliff faced by the company.

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