Business Wire

Kite Submits Biologics License Application to U.S. Food and Drug Administration for Company’s Second CAR T Cell Therapy

Share

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.

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

Deloitte Launches < "The Next Wave" Emerging Digital Life in South and Southeast Asia > Report At Ant Group’s INCLUSION Fintech Conference25.9.2020 06:45:00 EESTPress release

Deloitte launched <"The Next Wave" Emerging Digital Life in South and Southeast Asia > Report today at the INCLUSION Fintech Conference, organized by Ant Group and Alipay to foster a global dialogue on building a more inclusive, green, and sustainable world through digital technology. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20200924005941/en/ (Graphic: Business Wire) Through an extensive survey conducted across age groups in eight countries in South and Southeast Asia, specifically Singapore, Malaysia, Thailand, Indonesia, the Philippines, India, Bangladesh and Pakistan, the report showed that consumers aged between 21 and 40 years old are the leading force enabling the rapid adoption of a digital life in the region in the post Covid-19 world. Speaking at one of the media forums on Day 2 of INCLUSION, Taylor Lam, Technology, Media & Telecommunications Industry Leader at Deloitte China, said: “Young and vibrant economies

Science, Data, and Facts Should Unite Decision-Making, Says PMI CEO in Speech at Concordia Summit24.9.2020 22:20:00 EESTPress release

André Calantzopoulos, CEO of Philip Morris International (PMI) (NYSE: PM), today delivered high-level remarks at the 2020 Concordia Annual Summit. Calantzopoulos discussed the impact that uncertainty, polarization, hyperpartisanship, and ideology are having on international efforts to overcome pressing global issues. He called for science to be protected from politicization and highlighted the importance of developing open dialogues based on factual scientific objectivity. Calantzopoulos shared PMI’s belief that with the right regulatory encouragement and support from civil society, cigarette sales can end within 10 to 15 years in many countries. The Concordia Annual Summit, which coincides with the United Nations General Assembly (UNGA) meeting, convenes the world’s most prominent business, government, and nonprofit leaders to foster dialogue and enable effective partnerships for positive social impact. Excerpts of the remarks by André Calantzopoulos follow: “Reflecting on the state o

Swiss Medical Group Holding Acquires CoreMedica Europe24.9.2020 18:54:00 EESTPress release

Swiss Medical Group (SMG) Holding Luxembourg S.A., leading the development of STARKS Age-Management in Europe and Asia, announced today the acquisition of CoreMedica Europe, to expand in Europe and the rest of the world. CoreMedica Europe recently made the headlines in Switzerland for combining a COVID-19 Screening Test and Immunity profile with its existing home self-collection kit that allows customers to collect a few drops of blood and send them by mail to CoreMedica Europe’s accredited laboratory in Geneva to screen the anti-SARS-COV-2 IgG antibody and assess any previous infection to SARS-COV-2, the virus responsible for COVID disease, and analyze a set of 5 key biomarkers known to support the immune system (vitamin D, zinc, magnesium, copper, selenium) so as to receive personalized actionable recommendations to help patients build up their natural defenses against the effects of a next potential viral infection. “In this epidemic and containment context the essential objective

Esri and AfroChampions Launch Partnership to Promote GIS in Africa24.9.2020 16:52:00 EESTPress release

Esri, the global leader in location intelligence, today announced a joint initiative with AfroChampions, a Pan-African nonprofit that aims to promote policies that foster private-public collaboration for Africa's economic transformation. The goal of the initiative is to engage leaders in business, governments, the African Union, and other regional economic communities through dialogue and potential partnership building in applying geospatial technology and solutions. This new partnership with AfroChampions seeks to contribute to sustainable economic development in Africa and promote the benefits of a shared geospatial infrastructure throughout the continent. As a majority of Africans still live in rural areas, geographic information system (GIS) technology can create new opportunities for growth, especially in critical fields such as health and telemedicine, land management, agriculture, and mobility. The powerful mapping and data analytics that GIS provides forms a foundation for some

DXC Technology Announces Leadership Appointments to Support the “new DXC"24.9.2020 16:20:00 EESTPress release

DXC Technology (NYSE:DXC) today presented its latest leadership appointments further strengthening the DXC leadership team, the majority being new to DXC within the last year. This team is bringing the “new DXC,” which is focused on its customers and its people, to the market as it executes the company’s transformation journey. DXC Customer Portfolio Leadership Over the past year, CEO Mike Salvino has recruited new IT services industry leaders who bring formidable experience delivering for customers, inspiring people, and running and growing businesses. DXC announces the following appointments and changes to the team that will run DXC’s business and lead execution of the DXC transformation journey: Americas will be led by Jim Brady and David Swift . Jim joined DXC in June 2020 from Accumen, where he was the COO and previously worked at Accenture and Honeywell. David Swift joined DXC in November 2019 from Accolade where he was Chief Service Officer and previously worked at Aon Hewitt an

Statement on One-Year Anniversary of Women’s Entrepreneurship Accelerator24.9.2020 16:07:00 EESTPress release

Please find the statement below from Women’s Entrepreneurship Accelerator leadership regarding the one-year anniversary of the ground-breaking initiative. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20200924005283/en/ Anita Bhatia, Deputy Executive Director, UN Women One year ago, we committed to educating and empowering ten million women entrepreneurs over the next ten years through the Women’s Entrepreneurship Accelerator (WEA). We began to lay the groundwork for a systemic transformation to break down the barriers keeping women from achieving financial independence and contributing to a better future for themselves and their communities. Today, in our unprecedented reality, women find themselves at history’s crossroads. They are disproportionately harmed by the economic devastation wrought by COVID-19 while simultaneously holding the keys to recovery. Women make up 39% of global employment but have accounted for 54% of o

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