Novartis (NVS) 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 (sorafenib).
Novartis will continue to evaluate Afinitor for gastrointestinal and lung neuroendocrine tumors (:NET), HER2+ breast cancer, lymphoma and tuberous sclerosis complex (TSC).
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 Roche’s (RHHBY) 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.
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