Novartis (NVS) To Stop Trial On Breast Cancer Drug Early

Novartis AG (NYSE:NVS) announced that an independent Data Monitoring Committee has recommended the early stoppage of the MONALEESA-2 trial on its breast cancer candidate, LEE011.

The trial is evaluating LEE011, a CDK4/6 inhibitor, in combination with letrozole, compared to letrozole alone, in postmenopausal women who have received no prior therapy for hormone receptor positive, human epidermal growth factor receptor-2 negative (HR+/HER2-) advanced breast cancer.

The committee’s recommendation came after the trial met the primary endpoint, significantly extending progression-free survival (PFS) compared to letrozole alone, as observed in a pre-planned interim analysis. Results showed that LEE011, in combination with letrozole, led to clinically meaningful improvement in PFS in postmenopausal women who received no prior therapy.

The trial will continue to assess overall survival data. Novartis expects to present efficacy and safety data efficacy at a major medical congress.

Recently, Novartis announced that it has split its Pharmaceuticals Division into two business units – Novartis Pharmaceuticals and Novartis Oncology. These units will form the Innovative Medicines Division at the company. The change in the divisions is primarily to reflect the integration of the oncology assets acquired from GlaxoSmithKline (NYSE:GSK) .

We remind investors Novartis decided to realign its portfolio and move the ophthalmic pharmaceutical business and some drugs from Sandoz’s portfolio to its pharmaceutical division owing to the challenges faced by the company in 2015.

Approval of new drugs and label expansion of existing ones bode well for Novartis as it has been facing stiff generic competition for some of its key drugs like Diovan. Additionally, its oncology drugs are facing competition from immuno-oncology therapies. Moreover, its Alcon segment is facing a decline in surgical equipment sales in the U.S. and emerging markets.

Novartis currently carries a Zacks Rank #3 (Hold). A couple of better-ranked stocks in the health care sector include Pfizer Inc. (NYSE:PFE) and Abbott Laboratories (NYSE:ABT) . Both the stocks carry a Zacks Rank #2 (Buy).