) recently announced disappointing results from a phase III
study, EVOLVE-I, on oncology drug, Afinitor.
It was observed in the study that Afinitor failed to extend
overall survival compared to placebo in treatment-experienced
patients with locally advanced or metastatic hepatocellular
carcinoma (HCC) or liver cancer.
These patients were earlier treated with Nexavar
Novartis will continue to evaluate Afinitor for
gastrointestinal and lung neuroendocrine tumors (NET), HER2+
breast cancer, lymphoma and tuberous sclerosis complex
Results from these trials should be out in 2014 and 2015.
We remind investors that Novartis had announced positive
results on Afinitor in Jun 2013, from a phase III trial, BOLERO-3
(Breast cancer trials of OraL EveROlimus-3).
The study evaluated Novartis' Afinitor plus
) Herceptin and vinorelbine for the treatment of women suffering
from human epidermal growth factor receptor-2 positive (HER2+)
advanced breast cancer.
We note that Afinitor is already approved in the U.S. and EU
for the treatment of HR+/HER2- advanced breast cancer.
Afinitor is also approved for advanced renal cell carcinoma
following progression on or after vascular endothelial growth
factor (VEGF)-targeted therapy and locally advanced, metastatic
or unresectable progressive NET of pancreatic origin.
Afinitor generated sales of $797 million in 2012, up 85% year
over year. Although we were disappointed with the results of the
EVOLVE-I study, positive results from other trials should boost
sales of the drug going forward.
Novartis currently carries a Zacks Rank #4 (Sell). Right now,
) look attractive with a Zacks Rank #2 (Buy).
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