Why Kite Pharma Inc. Shares Took Off

Although we don't believe in timing the market or panicking over market movements, we do like to keep an eye on big changes -- just in case they're material to our investing thesis.

What: Shares of Kite Pharma (NASDAQ: KITE  ) , a clinical-stage biopharmaceutical company focused on developing immunotherapy products to treat cancer, advanced as much as 26% today after the company announced positive results from an ongoing phase 1/2a clinical study involving KTE-C19 as a treatment for aggressive non-Hodgkin's lymphoma.

So what: According to the company's press release, after the closing bell last night, the study, which was conducted by the National Cancer Institute but funded by Kite, demonstrated that out of 13 evaluable patients with advanced B-cell malignancies, eight resulted in complete remission, four experienced a partial remission, and one exhibited stable disease, for an overall objective response rate of 92%!

Specifically, the data showed that of seven patients with advanced diffuse large B-cell lymphoma (DLBCL), four of them achieved complete remission, three of which are still ongoing and range from as low as nine months to as high as 22 months. Of the additional three patients, two exhibited a partial response and one stable disease. The findings for this ongoing study were published in the August issue of the American Society of Clinical Oncology's Journal of Clinical Oncology.

Given the early success of these results, Arie Belldegrun, CEO of Kite Pharma, noted that the company's plan is to file an investigational new drug application with the Food and Drug Administration in the fourth quarter to run phase 1/2 studies on DLBCL patients that have failed on two or more types of existing therapies.

Now what: It's hard not to be enamored with today's 92% overall response rate, or the prospect of retraining the body's own immune system to target B-cell malignancies and lymphomas. However, as a word of caution, I would also remind investors that very few immunotherapy products have successfully made it to market up to this point in time, and while the concept looks great on paper, we don't have a lot of real-world or sales efficacy to fall back on from an investable standpoint.

To add, Kite Pharma's entire pipeline, with the exception of its anti-CD19 chimeric antigen receptor KTE-C19 and EGFRvIII, a possible treatment for glioblastoma, is preclinical in nature. Even the company's existing clinical studies are focused on very small patient pools and still considered early stage by design. With the company valued at $1 billion following today's pop, it's probably wise for investors to take a step back and wait for more substantial results before considering Kite Pharma as a long-term investment.

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