Zacks_Analysts' Blog : Novartis Presents Afinitor Data - Analyst Blog

Novartis (NVS) announced presentation of data from a pivotal late stage study (BOLERO-2) which evaluated the use of Afinitor in combination with Pfizer’s (PFE) Aromasin. The study evaluated postmenopausal women with metastatic breast cancer whose disease has progressed, despite treatment with hormonal therapies, Novartis’ Femara or AstraZeneca’s (AZN) Arimidex.

The data showed that Afinitor plus Aromasin expanded progression-free survival (PFS), or time without tumor growth, by more than two times versus Aromasin alone. Treatment with Afinitor improved the PFS to 6.9 months versus 2.8 months for Aromasin alone.

Afinitor plus Aromasin also significantly reduced the risk of cancer progression by 57% versus Aromasin. Novartis plans to file for the approval of Afinitor for the indication by year end.

Novartis also presented data from another phase III trial (EXIST-2) testing Afinitor in patients with non-cancerous kidney tumors (also known as angiomyolipomas) associated with tuberous sclerosis complex (TSC). The study met its primary endpoint of kidney tumor response rate. 42% of patients on Afinitor experienced a response versus 0% on placebo.

TSC is a genetic disorder which can lead to formation of tumors in vital organs like the brain (SEGA) and kidney. Up to 80% of patients with TSC have kidney tumors which is the lead cause of morbidity and mortality in adult TSC patients.

In July this year Novartis presented data from another late stage study of Afinitor in patients with TSC which demonstrated that Afinitor led to reduction in SEGA tumors too. The study showed that in more than one-third of the patients taking Afinitor, the size of the SEGA tumors was reduced by 50% or greater versus 0% on placebo.

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  Sutent or Onyx Pharmaceuticals’(ONXX) Nexavar, in the US and EU. Afinitor is also approved for the treatment of patients with advanced neuroendocrine tumors (NET) of pancreatic origin in the US and EU.

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.