Kite/NCI Anti-CD19 CAR T-Cell Therapy Demonstrates Durable Complete Remissions in Advanced Non-Hodgkin Lymphoma

9 of 19 patients (47%) with diffuse large B-cell lymphoma achieved complete responses, which are all ongoing with a duration of 7 to 20 months

CHICAGO--(BUSINESS WIRE)-- Kite Pharma, Inc. (Nasdaq:KITE) ("Kite") today announced results to be presented at the 2016 American Society of Clinical Oncology (ASCO) Annual Meeting from a study of low-dose chemotherapy conditioning followed by anti-CD19 chimeric antigen receptor (CAR) T-cell therapy. The results showed that CAR T-cell therapy was effective in inducing a high response rate in patients with advanced non-Hodgkin lymphoma (NHL). The results will be presented today as a Late Breaking Abstract by James N. Kochenderfer, M.D., an investigator in the Experimental Transplantation and Immunology Branch of the National Cancer Institute (NCI) Center for Cancer Research (Hall D2, Time: 4:42PM CDT, Abstract #3010).

In this study of 22 patients (19 diffuse large B-cell lymphoma, 2 follicular lymphoma, and 1 mantle cell lymphoma), objective responses were seen in 16 patients (73%). Twelve of 22 patients (55%) achieved complete responses following low-dose chemotherapy conditioning regimen. Kite is using a similar conditioning regimen in its ZUMA-1 Study of KTE-C19, an anti-CD19 CAR T cell therapy. Nine of 19 patients (47%) with diffuse large B-cell lymphoma (DLBCL) achieved complete responses, which are all ongoing with a duration of 7+ to 20+ months. Additionally, the three patients with mantle cell lymphoma and follicular lymphoma achieved complete responses. Reversible grade 3 or 4 neurotoxicity including confusion, dysphasia, encephalopathy, and gait disturbances was observed in 55% of treated patients.

"Patients with chemorefractory DLBCL have few effective treatment options," said Jeff Wiezorek, M.D., M.S., Kite's Senior Vice President, Clinical Development. "These early results are encouraging and served as the foundation for Kite's ongoing KTE-C19 ZUMA-1 Study."

According to the American Cancer Society, NHL is one of the most common cancers in the United States and DLBCL is the most common form of the disease accounting for one out of every three cases of NHL.¹ It is estimated that approximately 26,000 people will be diagnosed with DLBCL in the United States in 2016. DLBCL is an aggressive and fast growing lymphoma, but considered curable in patients who respond to initial treatment with a chemotherapy-based regimen. Patients with chemorefractory DLBCL face limited treatment options and historically poor outcomes.

This study was performed pursuant to a Cooperative Research and Development Agreement (CRADA) between the NCI and Kite.

About Kite PharmaKite Pharma, Inc., is a clinical-stage biopharmaceutical company engaged in the development of novel cancer immunotherapy products, with a primary focus on engineered autologous cell therapy (eACT™) designed to restore the immune system's ability to recognize and eradicate tumors. Kite is based in Santa Monica, CA. For more information on Kite Pharma, please visit www.kitepharma.com. Sign up to follow @KitePharma on Twitter at www.twitter.com/kitepharma.

Cautionary Note on Forward-Looking StatementsThis press release contains forward-looking statements for purposes of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. We may, in some cases, use terms such as "predicts," "believes," "potential," "proposed," "continue," "estimates," "anticipates," "expects," "plans," "intends," "may," "could," "might," "will," "should" or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. Forward-looking statements include statements regarding our intentions, beliefs, projections, outlook, analyses or current expectations concerning, among other things: the success of anti-CD19 CAR T cell therapy. Various factors may cause differences between Kite's expectations and actual results as discussed in greater detail in Kite's filings with the Securities and Exchange Commission, including without limitation in Kite's Quarterly Report on Form 10-Q filed with the SEC on May 9, 2016. Any forward-looking statements that we make in this press release speak only as of the date of this press release. We assume no obligation to update our forward-looking statements whether as a result of new information, future events or otherwise, after the date of this press release.

References:

1. American Cancer Society. Non-Hodgkin Lymphoma. http://www.cancer.org/acs/groups/cid/documents/webcontent/003126-pdf.pdf Accessed May 20, 2016

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Kite PharmaGreg MannVP, Investor Relationsgmann@kitepharma.comorFor Media:inVentiv HealthDavid Polk, 310-309-1029david.polk@inventivhealth.comorAnne Cummings, 212-845-5632anne.cummings@inventivhealth.com

Source: Kite Pharma, Inc.

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