Novartis (NVS) recently released encouraging data on its pipeline candidate, LDK378, from a phase I study (n=114).
We note that Novartis is developing LDK378 for the treatment of patients with anaplastic lymphoma kinase positive (ALK+) metastatic non-small cell lung cancer (NSCLC).
An overall response rate of 60% was observed in patients suffering from ALK+ NSCLC, who were treated with LDK378 compared to 59% in patients treated with Pfizer’s (PFE) Xalkori (crizotinib) and 62% in Xalkori-naïve patients.
Novartis continues to enroll more patients in this study for further evaluation. The first regulatory filing is anticipated in early 2014 based on results from this study.
Meanwhile, Novartis is actively recruiting patients on a worldwide basis for two phase II trials examining LDK378 in patients previously treated with chemotherapy and Xalkori, and Xalkori-naïve patients.
Novartis also intends to commence phase III studies on the candidate for the above indication in the coming months.
NSCLC affects 85%–90% of all lung cancer patients as per the American Cancer Society. We remind investors that the US Food and Drug Administration (FDA) granted Breakthrough Therapy designation to LDK378 in Mar 2013.
This designation from the FDA expedites the development and review of the drugs for the treatment of life-threatening diseases, provided the therapy is able to show substantial improvement over an available therapy on at least one clinically significant endpoint.
We note that Roche (RHHBY) is also developing Avastin in combination with MetMAb (onartuzumab) for the treatment of NSCLC.
Novartis carries a Zacks Rank #3 (Hold). Right now, Salix Pharmaceuticals (SLXP) looks attractive with a Zacks Rank #1 (Strong Buy).
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