Kite Presents Positive Results From Pivotal ZUMA-2 Trial in Relapsed or Refractory Mantle Cell Lymphoma
Kite, a Gilead Company (Nasdaq: GILD), today announced primary results from ZUMA-2, a global, multicenter, single-arm, open-label Phase 2 study of KTE-X19, an investigational CD19 chimeric antigen receptor (CAR) T cell therapy, in adult patients with relapsed or refractory mantle cell lymphoma (MCL). After a single infusion of KTE-X19, the best objective response via independent radiologic central review (n=60 evaluable for efficacy analysis) was 93 percent, with 67 percent of patients having achieved a complete response. These findings were presented today at the 61st American Society of Hematology (ASH) Annual Meeting & Exposition, in Orlando from December 7–10, 2019.
“There is a significant need for novel treatment options for patients with MCL, especially those whose disease has progressed following several lines of previous therapy,” said Michael Wang, MD, ZUMA-2 Lead Investigator and Professor, Department of Lymphoma and Myeloma, Division of Cancer Medicine at The University of Texas MD Anderson Cancer Center. “The impressive response rates observed with KTE-X19 support its potential as the first cell therapy for people living with MCL.”
With a median follow-up of 12.3 months (range: 7.0 to 32.3 months) at the time of data cutoff, 57 percent of patients remained in an ongoing response. Of the first 28 patients treated (minimum follow-up of 24 months), 43 percent were alive and remained in continued remission without additional therapy. The 12-month estimates of progression-free survival (PFS) and overall survival (OS) were 61 percent and 83 percent, respectively. Median duration of response, PFS and OS were not yet reached.
Among the 68 patients evaluable for safety, cytokine release syndrome (CRS) and neurologic events were observed in 91 percent and 63 percent of patients, respectively. Grade 3 or higher CRS and neurologic events were seen in 15 percent and 31 percent of patients, respectively. No Grade 5 CRS or neurologic events occurred.
“Today’s results represent a significant milestone for Kite and for the MCL community,” said Christi Shaw, Chief Executive Officer of Kite. “With KTE-X19, we have the opportunity to deliver on the promise of our industry-leading cell therapy development program with a second CAR T therapy, and the first ever for patients with relapsed or refractory MCL. We look forward to progressing KTE-X19 with the FDA and other regulatory authorities to bring it to patients as quickly as possible.”
Based on the results of the trial, Kite plans to submit a Biologics License Application (BLA) for KTE-X19 to the U.S. Food and Drug Administration (FDA) by the end of this year and a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) in the first quarter of 2020. KTE-X19 has been granted Breakthrough Therapy Designation (BTD) by the FDA and Priority Medicines (PRIME) by the EMA for relapsed or refractory MCL based on interim data from ZUMA-2.
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.
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.
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 Independent Radiology Review Committee.
Secondary endpoints include duration of response, best objective 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.
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).
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.
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 possibility of unfavorable results from other ongoing and additional clinical trials involving KTE-X19. There is also the possibility that Kite may be unable to file a Biologics License Application to the FDA or a marketing authorization application to the EMA for KTE-X19 in the anticipated timelines, or at all. Further, it is possible that Kite may make a strategic decision to discontinue development of KTE-X19, and as a result, KTE-X19 may never be successfully commercialized. 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.
Greg Mann, Investors
Nathan Kaiser, Media
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
BCG Collaborates with Tencent Marketing Insight to Release 2020 BCG x Tencent Digital Luxury Report25.9.2020 13:21:00 EEST | Press release
Since early 2020 when the COVID-19 pandemic broke out worldwide, the luxury market has been hit hard and is expected to decline 25% to 45% compared to the previous year. The Chinese luxury market, however, which has benefitted from successful domestic control of the pandemic and has taken the lead in recovery against a depressed global market environment, is forecast to grow from 20% to 30% in the whole year of 2020. Thanks to its stunning market performance, China has become the main battleground of each major luxury brand. In was in this environment that Boston Consulting Group (BCG) joined hands with Tencent Marketing Insight (TMI) to release the 2020 BCG x Tencent Digital Luxury Report, drawing on deep insights into post COVID-19 trends in the luxury market and consumers based on BCG and TMI’s quantitative consumer research and industry experience, as well as TMI’s marketing and big data capabilities. Crystal Hao, Managing Director & Partner of BCG said, “The luxury market in China
U.S. MRTP Authorization Pathway Explored in PMI’s Latest Scientific Update25.9.2020 13:15:00 EEST | Press release
Philip Morris International (PMI) (NYSE: PM) has released the 11th edition of its Scientific Update, a regularly issued publication on its research efforts to develop and scientifically assess a range of smoke-free alternatives to cigarettes. The latest edition features an overview of the historic decision made by the U.S. Food and Drug Administration (FDA) to authorize the marketing of the IQOS Tobacco Heating System with reduced exposure information. The Scientific Update explains the various MRTP decisions under U.S. law; the steps, processes, and timeline PMI undertook; and the ongoing post-market surveillance and studies that will monitor the impact of the orders on consumer perceptions, behavior, and health. “The FDA undertook a scientific and regulatory evaluation of IQOS and determined that it is ‘appropriate for the promotion of public health’” said Dr. Gizelle Baker, director of Global Scientific Engagement at PMI. “In this edition of our Scientific Update, we describe how th
Palladio Completes $20 Million Series B Financing25.9.2020 13:09:00 EEST | Press release
Palladio Biosciences, Inc. (Palladio), a privately-held, clinical stage biopharmaceutical company developing medicines for orphan diseases of the kidney, announced today the completion of a $20 million Series B investment. The financing was led by new investor, Samsara BioCapital, with participation from new investor, the Roche Venture Fund and existing investors, Medicxi and Osage University Partners. Proceeds from the financing will fund Palladio’s Phase 3 ALERT Study and advance operations. Srinivas Akkaraju M.D, Ph.D, Managing General Partner of Samsara BioCapital, stated, "We are very excited about our investment in Palladio to support the development of lixivaptan, a drug that has the potential to deliver a meaningful therapeutic advancement in the treatment of Autosomal Dominant Polycystic Kidney Disease (ADPKD). The ALERT Study is an important step in assessing the safety differential of lixivaptan.” “We are very pleased that Samsara and the Roche Venture Fund recognize the opp
Ant Group Launches “Trusple,” an AntChain-Powered Global Trade and Financial Services Platform for SMEs and Financial Institutions25.9.2020 10:54:00 EEST | Press release
Ant Group, a leading provider in the development of open platforms for technology-driven inclusive financial services, and the parent company of China’s largest digital payment platform Alipay, today unveiled Trusple, an international trade and financial service platform powered by AntChain, the company’s blockchain-based technology solutions. Trusple aims to make it easier and less costly for all participants – especially Small-to-Medium Enterprises (SMEs) – to sell their products and services to customers around the world. It also reduces costs for financial institutions so they can better serve SMEs in need. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20200925005110/en/ (Photo: Business Wire) Based on the concept of “Trust Made Simple,” Trusple works by generating a smart contract once a buyer and a seller upload a trading order on the platform. As the order is executed, the smart contract is automatically updated with k
Ipsen Appoints Philippe Lopes-Fernandes as Executive Vice President, Chief Business Officer25.9.2020 08:00:00 EEST | Press release
Regulatory News: This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20200924005822/en/ Philippe Lopes-Fernandes, Executive Vice President, Chief Business Officer, Ipsen (Photo: Business Wire) Ipsen (Euronext: IPN; ADR: IPSEY) today announced the appointment of Philippe Lopes-Fernandes as Executive Vice President, Chief Business Officer, effective 1 October 2020. Based in Cambridge, Massachusetts, USA, he will be responsible for business development and alliance management, reporting directly to David Loew, CEO, Ipsen. Philippe will serve on the Executive Leadership Team. “As Chief Business Officer, Philippe will play a crucial role in our external innovation strategy. The ELT and I are delighted to welcome Philippe to Ipsen and look forward to working closely with him. His extensive and impressive track record in international business development, his outstanding reputation and his ability to work closely with the scientific comm
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 EEST | Press 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
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