Novartis (NVS) has been striving to differentiate its investigational oncology drug, LEE011, from other breast cancer drugs in three areas. The company aims to strengthen the position of LEE011 by building maximum data to support the drug for first-line metastatic breast cancer treatment. Novartis also plans to test the potential of the drug in pre-specified patient subpopulations. Finally, the company is also working on other investigational programs involving selective estrogen receptor degraders and other novel agents that can support the LEE011 label expansion in future years.
If Novartis manages to successfully implement this differentiation strategy for LEE011, it could have a positive impact on the company’s stock as well as the Vanguard FTSE All-World ex-US ETF (VEU). Novartis makes up about 0.74% of VEU’s total portfolio holdings.
On May 18, 2016, Novartis announced that the independent data monitoring committee had recommended the company stop its mammary oncology assessment of LEE011’s efficacy and safety-2 (or MONALEESA-2) phase three trial after the pre-planned interim analysis. The trial was stopped earlier than scheduled, as the investigational combination therapy managed to meet its primary endpoint and demonstrated statistically significant improvement in progression-free survival as compared to letrozole monotherapy.
Based on these results, Novartis has filed an application with the FDA seeking approval for combination therapy LEE011 and letrozole as first-line breast cancer therapy. The FDA has granted priority review status to this new drug application (or NDA). Novartis expects to receive approval for this regimen in 2Q17. The company also anticipates regulatory approval from the European Medicines Agency (or EMA) in 2H17.
In the next article, we’ll explore Novartis’s efforts to expand LEE011’s label across multiple patient subpopulations in greater detail.