SANTA MONICA, Calif.--(BUSINESS WIRE)--Kite Pharma, Inc. (Nasdaq:KITE) today announced that 82 percent of patients (9 out of 11) achieved complete remission or complete remission with incomplete or partial hematological recovery in a preliminary analysis of the Phase 1 ZUMA-3 and ZUMA-4 trials of KTE-C19 in adult and pediatric relapsed/refractory acute lymphoblastic leukemia (r/r ALL). In these patients, 100 percent of responders tested negative for minimal residual disease (MRD), which has been shown to correlate with risk of disease relapse in ALL. The data were presented today at the American Society of Hematology (ASH) Annual Meeting in San Diego, CA.
In the Phase 1 trials, 13 patients were treated with KTE-C19. Eleven patients were evaluable for response and two patients have not reached the evaluation time point at the data cutoff. Patients received a low-dose conditioning chemotherapy regimen based on extensive clinical experience at the National Cancer Institute (NCI).
“We are encouraged by the KTE-C19 safety and efficacy profile in ALL that is suggested by these data,” said David Chang M.D., Ph.D., Executive Vice President, Research and Development, and Chief Medical Officer of Kite. “In the Phase 1 portion of these studies, we are enrolling patients with high disease burden to rigorously evaluate safety and efficacy of KTE-C19. We look forward to initiating the Phase 2 portions of these studies in 2017.”
Five of 13 (38 percent) patients had ≥ grade 3 cytokine release syndrome (CRS) and five of 13 (38 percent) had ≥ grade 3 neurological events. One patient in ZUMA-3 died from KTE-C19 related CRS and one patient in ZUMA-4 died from a disseminated fungal infection unrelated to KTE-C19. No cerebral edema has been observed.
KTE-C19 was successfully manufactured in these 13 patients across a range of absolute lymphocyte and blast counts in a centralized and streamlined process of six to eight days. The KTE-C19 manufacturing process used in the multicenter ZUMA-3 and ZUMA-4 studies will be discussed in an oral presentation on Monday, December 5, 2016, at 6:45 p.m. PST.
Production of Anti-CD19 CAR T Cells for ZUMA-3 and -4: Phase 1/2 Multicenter Studies Evaluating KTE-C19 in Patients with Relapsed/Refractory B-Precursor Acute Lymphoblastic Leukemia (R/R ALL)
Abstract #1227 https://ash.confex.com/ash/2016/webprogram/Paper93708.html
Presenter: Marianna Sabatino, M.D., Kite Pharma, Director of Product Sciences
Kite Pharma's lead product candidate, KTE-C19, is an investigational therapy in which a patient's T cells are engineered to express a chimeric antigen receptor (CAR) to target the antigen CD19, a protein expressed on the cell surface of B-cell lymphomas and leukemias, and redirect the T cells to kill cancer cells. KTE-C19 has been granted Breakthrough Therapy Designation status for diffuse large B-cell lymphoma (DLBCL), transformed follicular lymphoma (TFL), and primary mediastinal B-cell lymphoma (PMBCL) by the U.S. Food and Drug Administration (FDA) and Priority Medicines (PRIME) regulatory support for DLBCL in the EU.
About Kite Pharma
Kite 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 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 timing and ability to complete Phase 1 of each trial and progress to Phase 2. 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-Q for the quarter ended September 30, 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.