Kite Submits Biologics License Application to U.S. Food and Drug Administration for Company’s Second CAR T Cell Therapy
12.12.2019 00:05:00 EET | Business Wire | Press release
Kite, a Gilead Company (Nasdaq: GILD), today announced that it has submitted a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for the investigational chimeric antigen receptor (CAR) T cell therapy, KTE-X19, for the treatment of adult patients with relapsed or refractory mantle cell lymphoma (MCL).
The BLA submission is based on data from the Phase 2 ZUMA-2 trial, which demonstrated an overall response rate of 93 percent, including 67 percent with complete response, as assessed by an Independent Radiologic Review Committee (IRRC) following a single infusion of KTE-X19. In the safety analysis, Grade 3 or higher cytokine release syndrome (CRS) and neurologic events were seen in 15 percent and 31 percent of patients, respectively. No Grade 5 CRS or neurologic events occurred. Detailed findings from this trial were recently presented at the 61st American Society of Hematology (ASH) Annual Meeting & Exposition in Orlando.
“There remains a significant need for new treatments for patients with relapsed/refractory MCL despite recent advances, so this regulatory filing is an especially important milestone for the MCL community,” said Ken Takeshita, MD, Kite’s Global Head of Clinical Development. “We look forward to working with the FDA to bring KTE-X19 to appropriate patients as quickly as possible and continuing to deliver on the promise of our industry-leading cell therapy development program with a second CAR T therapy.”
Kite plans to submit a Marketing Authorization Application for KTE-X19 in the European Union in early 2020. KTE-X19 has been granted Breakthrough Therapy Designation (BTD) by the FDA and Priority Medicines (PRIME) by the European Medicines Agency (EMA) for relapsed or refractory MCL.
KTE-X19 is investigational and not approved anywhere globally. Its efficacy and safety have not been established. More information about clinical trials with KTE-X19 is available at www.clinicaltrials.gov.
About MCL
MCL is a rare form of non-Hodgkin lymphoma (NHL) that arises from cells originating in the “mantle zone” of the lymph node and typically affects men over the age of 60.
About ZUMA-2
ZUMA-2 is a single-arm, multicenter, open-label Phase 2 study involving 74 enrolled/leukapheresed adult patients (≥18 years old) with MCL whose disease is refractory to or has relapsed following up to five prior lines of therapy, including anthracycline or bendamustine-containing chemotherapy, anti-CD20 monoclonal antibody therapy and the BTK inhibitors ibrutinib or acalabrutinib. The objectives of the study are to evaluate the efficacy (60 patients) and safety (68 patients) after a single infusion of KTE-X19 in this patient population. The primary endpoint for the study is objective response rate (ORR). ORR in this trial is defined as the combined rate of complete responses and partial responses as assessed by an IRRC.
Secondary endpoints include duration of response, progression-free survival, overall survival, incidence of adverse events, incidence of anti-CD19 CAR antibodies, levels of anti-CD19 CAR T cells in blood, levels of cytokines in serum, and changes over time in the EQ-5D scale score and visual analogue scale score. The study is ongoing.
About KTE-X19
KTE-X19 is an investigational, autologous, anti-CD19 CAR T cell therapy. KTE-X19 uses the XLP™ manufacturing process that includes T-cell selection and lymphocyte enrichment. Lymphocyte enrichment is a necessary step in certain B-cell malignancies with evidence of circulating lymphoblasts. KTE-X19 is currently in Phase 1/2 trials in acute lymphoblastic leukemia (ALL), mantle cell lymphoma (MCL) and chronic lymphocytic leukemia (CLL).
About Kite
Kite, a Gilead Company, is a biopharmaceutical company based in Santa Monica, California. Kite is engaged in the development of innovative cancer immunotherapies. The company is focused on chimeric antigen receptor and T cell receptor engineered cell therapies. For more information on Kite, please visit www.kitepharma.com.
About Gilead Sciences
Gilead Sciences, Inc. is a research-based biopharmaceutical company that discovers, develops and commercializes innovative medicines in areas of unmet medical need. The company strives to transform and simplify care for people with life-threatening illnesses around the world. Gilead has operations in more than 35 countries worldwide, with headquarters in Foster City, California. For more information on Gilead Sciences, please visit the company’s website at www.gilead.com.
Forward-Looking Statement
This press release includes forward-looking statements, within the meaning of the Private Securities Litigation Reform Act of 1995 that are subject to risks, uncertainties and other factors, including the risk that FDA and other regulatory agencies may not approve KTE-X19 for the treatment of adult patients with relapsed or refractory MCL, and any marketing approvals, if granted, may have significant limitations on its use. In addition, Kite may not be able to submit the Marketing Authorization Application for KTE-X19 to the European Union in the currently anticipated timeline, or at all. There is also the possibility of unfavorable results from other ongoing and additional clinical trials involving KTE-X19. All statements other than statements of historical fact are statements that could be deemed forward-looking statements. These risks, uncertainties and other factors could cause actual results to differ materially from those referred to in the forward-looking statements. The reader is cautioned not to rely on these forward-looking statements. These and other risks are described in detail in Gilead’s Quarterly Report on Form 10-Q for the quarter ended September 30, 2019, as filed with the U.S. Securities and Exchange Commission. All forward-looking statements are based on information currently available to Gilead and Kite, and Gilead and Kite assume no obligation to update any such forward-looking statements.
XLP is a trademark of Gilead Sciences, Inc., or its related companies.
For more information on Kite, please visit the company’s website at www.kitepharma.com or call Gilead Public Affairs at 1-800-GILEAD-5 or 1-650-574-3000. Follow Kite on social media on Twitter (@KitePharma) and LinkedIn.
To view this piece of content from cts.businesswire.com, please give your consent at the top of this page.
View source version on businesswire.com: https://www.businesswire.com/news/home/20191211005861/en/
Contact information
Greg Mann, Investors
(424) 322-1795
Nathan Kaiser, Media
(650) 522-1853
About Business Wire
For more than 50 years, Business Wire has been the global leader in press release distribution and regulatory disclosure.
Subscribe to releases from Business Wire
Subscribe to all the latest releases from Business Wire by registering your e-mail address below. You can unsubscribe at any time.
Latest releases from Business Wire
ClickHouse Launches ClickHouse Labs With Andy Pavlo as VP of Database Research3.8.2026 16:30:00 EEST | Press release
ClickHouse today announced the launch of ClickHouse Labs, a new research group led by Andy Pavlo, one of the database industry’s most prominent researchers. Dr. Pavlo joins ClickHouse as Vice President of Database Research and will build a team dedicated to advancing the state of the art in database systems. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260803890510/en/ Andy Pavlo, VP of Database Research, ClickHouse Pavlo is an award-winning database researcher and professor at Carnegie Mellon University’s Computer Science Department. He is known throughout the database community for his work on autonomous databases, transaction processing, and large-scale data analytics. At ClickHouse, he will bring that expertise to some of the most ambitious and consequential challenges facing modern data systems, as AI reshapes the demands placed on all data-intensive workloads. “At ClickHouse, we are interested in finding new and inno
Lehman Brothers Treasury Considers Sale and Final Wind-Down3.8.2026 16:30:00 EEST | Press release
Lehman Brothers Treasury Co. B.V. in liquidation (“LBT”) today, through its U.S. counsel Herbert Smith Freehills Kramer (USA) LLP, announced that LBT is considering a final wind-down of its estate. In connection therewith, LBT has retained Seaport Loan Products LLC as its exclusive placement agent in connection with the potential sale of LBT’s principal remaining asset – a $19.6 billion Class 4A allowed claim against Lehman Brothers Holdings Inc. (the “LBHI Claim”). LBT expects the sale to occur, if at all, in August 2026. To the extent the LBHI Claim is sold, LBT expects to make a final distribution to the holders of its existing notes and thereafter facilitate the cancellation of those notes and the final wind down of its estate in September 2026. The foregoing is subject to further consents and authorizations and LBT retains sole discretion to abandon or otherwise discontinue any sale process at any time. Accordingly, there can be no assurances that the sale process will be conducte
EuroTeleSites Strengthens Operations One Year into Sitetracker Partnership3.8.2026 16:00:00 EEST | Press release
EuroTeleSites, one of Central and Eastern Europe's leading independent tower companies, today announced the results of its first year in partnership with Sitetracker, the leading global Asset Lifecycle Management platform. One year into the deployment, EuroTeleSites reports meaningful progress in its digital transformation, with measurable improvements in operational efficiency, cross-market transparency, and project coordination across its six-country footprint. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260727009809/en/ EuroTeleSites Strengthens Operations One Year into Sitetracker Partnership Driving Efficiency in a Complex, High-Investment Environment EuroTeleSites invests approximately 25% of its revenue into capital expenditures in 2026, funding the construction and upgrade of tower infrastructure across Central and Eastern European markets. Managing this level of scale and complexity demands robust digital support
Visa to Acquire BioCatch3.8.2026 15:30:00 EEST | Press release
Visa (NYSE: V) today announced it has signed a definitive agreement to acquire BioCatch, a leading provider of behavioral-first, multi-signal fraud intelligence, from funds advised by Permira and other shareholders for $2.4 billion in cash. The acquisition of BioCatch complements Visa’s existing cyber, fraud, risk and security solutions and is expected to help clients better protect themselves and their customers from the growing threat of account takeovers, scams, money mules and application fraud. Since its inception, BioCatch has developed innovative AI and machine learning-based solutions that analyze thousands of application, behavioral, device, and network signals—such as keystrokes, touch gestures, and device handling—to detect fraud and distinguish legitimate users from fraudsters in real time. BioCatch protects 1.8 billion devices and 760 million users around the world, serving more than 350 banking clients in 21 different countries, including more than 100 of the largest bank
U.S. Bank Investment Services enhances investor and client onboarding experience for alternative investments3.8.2026 15:16:00 EEST | Press release
U.S. Bank Investment Services today announced it has gone live with a new client lifecycle management (CLM) platform, providing a comprehensive onboarding solution for alternative investment clients and the investors in their funds. The implementation is a key milestone in Investment Services’ multi-phased technology transformation strategy, aimed at modernizing processes, workflows and reporting across the private funds space. U.S. Bank leverages CLM provider Fenergo and its Fen-X platform. Fen-X automates many of the manual processes traditionally associated with underlying investors and direct client relationships and accelerates account setup while maintaining regulatory requirements. The enhanced onboarding experience provides investors and clients with more transparency throughout the process and enables integration with other solutions providers involved in the investor journey, such as screening and tax reporting. The investor experience has been further enhanced with an invest
In our pressroom you can read all our latest releases, find our press contacts, images, documents and other relevant information about us.
Visit our pressroom