Data on Novartis' Afinitor - Analyst Blog

Novartis NVS announced additional results from a phase III trial, BOLERO-2 (Breast cancer trials of OraL EveROlimus-2) on cancer drug, Afinitor.

The results from the trial (n=700) were presented at the 9th European Breast Cancer Conference in Scotland.

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.

The trial did not meet the secondary endpoint, which included overall survival, overall response rate, and incidence of adverse events, patient reported outcomes and clinical benefit rate.

The results showed that even though Afinitor plus Herceptin extended overall survival by 4.4 months as compared to Herceptin alone, it was not statistically significant.

We remind investors that the study met its primary endpoint in 2013.  In Jun 2013, Novartis announced that the study showed that Afinitor plus Herceptin and vinorelbine significantly extended progression-free survival PFS among treatment-experienced women vis-à-vis placebo plus Herceptin and vinorelbine, and reduced the risk of disease progression by 22%.

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 various cancers including advanced renal cell carcinoma and advanced pancreatic neuroendocrine tumors (NET).

We note that Afinitor is also in a phase III study for gastrointestinal and lung NET, lymphoma and TSC-related seizures.

Afinitor generated sales of $1.3 billion in 2013, up 66% year over year. We are encouraged by Novartis' efforts to expand Afinitor's label. The positive results from other trials should boost sales of the drug going forward.

We note that Roche has a pretty strong position in the breast cancer market with drugs like Herceptin, Perjeta and Kadcyla.

Novartis currently carries a Zacks Rank #3 (Hold). Right now, Shire SHPG and Salix Pharmaceuticals SLXP look attractive with a Zacks Rank #1 (Strong Buy).