Kite Pharma, Inc.
Mar 14, 2017

Kite Pharma Highlights Publication from the National Cancer Institute Demonstrating Durable Complete Remissions in Patients with Relapsed/Refractory Non-Hodgkin Lymphoma Following Low Dose Conditioning Chemotherapy and Anti-CD19 CAR T-Cell Therapy

SANTA MONICA, Calif.--(BUSINESS WIRE)-- Kite Pharma, Inc. (Nasdaq:KITE) today highlighted the publication of results in the Journal of Clinical Oncology from a National Cancer Institute (NCI) study of anti-CD19 chimeric antigen receptor (CAR) T-cell therapy in patients with relapsed/refractory non-Hodgkin lymphoma (NHL). The research, led by James N. Kochenderfer, M.D., an investigator in the Experimental Transplantation and Immunology Branch of the NCI Center for Cancer Research, was performed pursuant to a CRADA between NCI and Kite.

In this study, 22 patients with relapsed/refractory NHL received a single dose of anti-CD19 CAR T-cell therapy after a low-dose chemotherapy conditioning regimen consisting of cyclophosphamide and fludarabine. Objective responses (OR) were seen in 73 percent of patients, and complete remissions (CR) were observed in 55 percent of patients. Among patients with aggressive B-cell NHL (diffuse large B cell lymphoma, primary mediastinal B-cell lymphoma, or transformed follicular lymphoma), OR and CR were 68 percent and 47 percent, respectively. Duration of responses ranged from 7+ months to 24+ months, and 11 of the 12 CRs were ongoing. Reversible grade 3 or 4 neurotoxicity including confusion, dysphasia, encephalopathy, and gait disturbances was observed in 55 percent of treated patients.

"We are encouraged by the durable complete remissions and key translational insights observed in this study conducted by Dr. Steven A. Rosenberg and Dr. Kochenderfer and their team at the NCI," said Jeff Wiezorek, M.D., Senior Vice President of Clinical Development of Kite. "This finding from the NCI and our ongoing clinical trials will help to inform and advance our pipeline of engineered T-cell therapies."

The study showed the low-dose conditioning regimen led to the depletion of lymphocytes and increase in serum interleukin-15 (IL-15). Blood levels of IL-15 were shown to associate with the expansion of CAR T-cells and remission of lymphoma. A similar conditioning regimen is used in Kite's ZUMA-1 study of axicabtagene ciloleucel, Kite's lead product candidate and investigational anti-CD19 CAR T-cell therapy.

"The data from the National Cancer Institute, which has a history of pioneering research in anti-CD19 CAR-T therapy, suggests that it is possible to achieve durable, complete remissions in patients with advanced disease who have no treatment options," said David Chang, M.D., Ph.D., Executive Vice President of Research and Development and Chief Medical Officer of Kite. "This research provides important understanding on the association of certain factors with efficacy and adverse events so we can more quickly advance our research to realize the full potential of CAR-T therapy."

DOI: 10.1200/JCO.2016.71.3024 Journal of Clinical Oncology - published online before print March 14, 2017.

About Kite

Kite is a biopharmaceutical company engaged in the development of innovative cancer immunotherapies with a goal of providing rapid, long-term durable response and eliminating the burden of chronic care. The company is focused on chimeric antigen receptor (CAR) and T cell receptor (TCR) engineered cell therapies designed to empower the immune system's ability to recognize and kill tumors. Kite is based in Santa Monica, CA. For more information on Kite, please visit www.kitepharma.com. Sign up to follow @KitePharma on Twitter at www.twitter.com/kitepharma.

Cautionary Note on Forward-Looking Statements

This press release contains forward-looking statements for purposes of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. The press release 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 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 its Form 10-K for the year ended December 31, 2016. Any forward-looking statements that are made in this press release speak only as of the date of this press release. Kite assumes no obligation to update the forward-looking statements whether as a result of new information, future events or otherwise, after the date of this press release.

Kite Pharma
Christine Cassiano
SVP, Corporate Communications & Investor Relations
ccassiano@kitepharma.com
or
Greg Mann
VP, Investor Relations
gmann@kitepharma.com

Source: Kite Pharma, Inc.

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