Novartis AG NVS presented data from the ongoing phase II clinical study on pipeline candidate CTL019, an investigational chimeric antigen receptor (CAR) T cell therapy at the 51st Annual Meeting of the American Society of Clinical Oncology held in Chicago this year.
The study was conducted by the University of Pennsylvania's Perelman School of Medicine in adults with relapsed or refractory (r/r) diffuse large B-cell lymphoma and follicular lymphoma.
Data showed that 13 of 19 evaluable patients responded to the therapy. Out of these, 11 achieved a complete response while 2 experienced a partial response to the treatment.
We note that the University has an exclusive global agreement with Novartis to research, develop and commercialize personalized CAR T cell therapies for the treatment of various types of cancer. The university is currently conducting several phase I/II trials on CTL019.
The FDA granted Breakthrough Therapy Designation to CTL019 in Jul 2014. Meanwhile, Novartis initiated a phase II study on CTL019 in pediatric patients with r/r acute lymphoblastic leukemia. The company has also presented preliminary safety and efficacy findings of a phase I study investigating the use of CTL019 in the treatment of multiple myeloma.
Novartis continues to work on strengthening its lung cancer portfolio. Novartis presented encouraging data on from two phase II studies (ASCEND-2 and ASCEND-3) on Zykadia. Study results showed that Zykadia reduced tumors clinically significantly in patients with ALK+ NSCLC.
The company also presented data from phase II study on Tafinlar (dabrafenib) in combination with Mekinist (trametinib) in patients suffering from non-small cell lung cancer (NSCLC). The combination of Tafinlar and Mekinist in a phase II study showed a 63% overall response rate in patients with metastatic BRAF V600E+ NSCLC.
The company is expected to face challenging conditions in 2015. Successful development and commercialization of its pipeline is important for the comapny at this stage as it faces generic competition for several key drugs such as Gleevec, Zometa and Diovan. Moreover, currency headwinds will continue to negatively impact sales. Hence, approval/label expansion of new drugs will help the company to boost the top line to some extent.
Novartis currently carries a Zacks Rank #3 (Hold). Better-ranked stocks in the health care sector include Valeant Pharmaceuticals International, Inc. VRX, Gilead Sciences Inc. GILD and Actelion Ltd. ALIOF. All three carry a Zacks Rank #1 (Strong Buy).
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