Kite Announces Updated Data From ZUMA-3 Study of KTE-X19 in Adult Patients With Relapsed or Refractory Acute Lymphoblastic Leukemia
Kite, a Gilead Company (Nasdaq: GILD), announced updated results from ZUMA-3, a single-arm Phase 1/2 study evaluating KTE-X19 (formerly KTE-C19), an investigational CD19 chimeric antigen receptor T (CAR T) cell therapy, in adult patients with relapsed or refractory acute lymphoblastic leukemia (ALL). With a median follow-up of 15.1 months (range 3.7 – 28.6 months) following a single infusion of KTE-X19, 69 percent of evaluable patients (n=25/36) achieved complete tumor remission, defined as complete remission (CR) or CR with incomplete hematological recovery (CRi). The rate of undetectable minimal residual disease (MRD) in patients who achieved complete tumor remission was 100 percent. Detailed results from this ongoing study were presented today at the Annual Meeting of the American Society of Hematology (ASH; Abstract #897).
This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20181203005114/en/
“We are encouraged by the high number of patients who achieved complete leukemia remission following a single KTE-X19 infusion on this trial,” said William G. Wierda, MD, PhD, Executive Medical Director and Professor, Department of Leukemia, Division of Cancer Medicine at The University of Texas MD Anderson Cancer Center. “In relapsed and refractory ALL, where the majority of adult patients have poor response to treatment and short remissions and survival, these findings give optimism for improving outcomes and potentially showing clinical benefit for those affected by ALL.”
Adverse events were consistent with the known toxicities of CD19 CAR T treatment, including Grade 3 or higher cytokine release syndrome (CRS) and neurologic events in 23 percent (n=10/44) and 39 percent (n=17/44) of patients, respectively. The majority of these adverse events were resolved, with the exception of two patients who had ongoing neurological events at the time of death from other causes. Two patients died from adverse events deemed by the treating investigator to be related to KTE-X19.
“These updated results from ZUMA-3 provide continued support for the potential of our CD19-directed CAR T therapies in new types of cancers and reinforce our leadership in cell therapy,” said Alessandro Riva, MD, Executive Vice President, Oncology Therapeutics and Head, Cell Therapy, Gilead Sciences. “Based on these findings, we have initiated Phase 2 of the study evaluating KTE-X19 in a larger set of adult patients with ALL who are in need of new treatment options.”
KTE-X19 is an investigational agent that has not been approved for any uses. Efficacy and safety have not been established.
ALL is an aggressive type of blood cancer which can also involve the lymph nodes, spleen, liver, central nervous system and other organs.
ZUMA-3 is an ongoing multicenter, registrational Phase 1/2 study in adult patients (≥18) with ALL whose disease is refractory to or has relapsed following standard chemotherapy or hematopoietic stem cell transplantation. The objectives of the study are to evaluate the safety and efficacy of KTE-X19 in this patient population.
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 Kite’s ability to complete its Phase 2 clinical trial program evaluating KTE-X19 in the currently anticipated timeline or at all. In addition, there is the possibility of unfavorable results from ongoing and additional clinical trials involving KTE-X19. Further, it is possible that Kite may make a strategic decision to discontinue development of KTE-X19, and as a result, this compound 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, 2018, 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.
For more information on Kite, please visit the company’s website at www.kitepharma.com . Learn more about Gilead at www.gilead.com , follow Gilead on Twitter (@GileadSciences) or call Gilead Public Affairs at 1-800-GILEAD-5 or 1-650-574-3000
Sung Lee, Investors
Nathan Kaiser, Media
For more than 50 years, Business Wire has been the global leader in press release distribution and regulatory disclosure.
Tilaa tiedotteet sähköpostiisi
Haluatko tietää asioista ensimmäisten joukossa? Kun tilaat mediatiedotteemme, saat ne sähköpostiisi välittömästi julkaisuhetkellä. Tilauksen voit halutessasi perua milloin tahansa.
Lue lisää julkaisijalta Business Wire
Anywhere365 Introduces Web Agent for Microsoft Dynamics 36517.1.2019 10:00 | Tiedote
Workstreampeople, a global leader in contact center solutions for Skype for Business and Microsoft Teams, today announced the introduction of the Anywhere365 Web Agent for Microsoft Dynamics 365. Based on the Dynamics 365 Channel Integration Framework (CIF) the Web Agent is nested in the Dynamics 365 interface and provides users with Anywhere365’s omni-channel contact center functionality without having to move between applications. The Dynamics 365 client is automatically resized to accommodate the Web Agent ensuring none of the user interface is masked. Agents can receive, send, and automatically log calls, chats, emails and video all from within Dynamics 365, improving the efficiency and accuracy of customer interactions. From the Anywhere365 Web Agent, Dynamics 365 users can control media interactions and monitor real-time queue information. Integration with Microsoft Azure services provides automatic language detection and real-time translation of chat and voice interactions betwe
Ipsen Presents the Results of the First in-Human Study of a Recombinant Fast-Acting Neurotoxin (rBoNT-E) at TOXINS 201917.1.2019 09:30 | Tiedote
Regulatory News: Results of the first in-human study of a recombinant neurotoxin are being presented at the TOXINS International Conference in Copenhagen. Ipsen’s recombinant BoNT serotype E (rBoNT-E) was investigated in a phase I study that demonstrated its safety and tolerability profile in healthy volunteers1. The study also reported that it has a faster onset of action and a shorter duration of effect, as well as a quick time to peak activity, in comparison with established BoNT-A products. Further studies will be initiated to establish potential aesthetic and therapeutic uses of this investigational therapy. “The application of recombinant techniques to create novel botulinum toxin-based medicines with different onsets and durations of action, will potentially offer clinicians the flexibility to choose the most appropriate neurotoxin for each patient, which is not an option today,” said Philippe Picaut, Pharm. D., PhD, Senior Vice President Research & Development for the Neuroscie
NTT Communications to Expand Ecosystem for Interconnection of Major Data Centers in Japan17.1.2019 06:04 | Tiedote
NTT Communications Corporation (NTT Com), the ICT solutions and international communications business within the NTT Group (TOKYO:9432), announced today that it will expand the interconnection of its Nexcenter™ data centers in Tokyo and Osaka, Japan to enable client companies to connect with cloud and content services more flexibly than ever before. On a sequential basis from this month, NTT Com will begin directly connecting its ecosystem with three major internet exchanges (IXs) in Japan to enable clients to access services offered by these IXs and various NTT Com partner companies. Thereafter, NTT Com will continue to expand this ecosystem centered on NTT Com’s Nexcenter™ data centers. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20190116005908/en/ Expanding Interconnection (Graphic: Business Wire) As a DX Enabler™, NTT Com uses ICT to achieve digital transformation (DX) "Transform and create business" together with clien
Piraeus Bank Presents the Principles for Responsible Banking with the Governor of the Bank of Greece16.1.2019 21:21 | Tiedote
The Principles for Responsible Banking were presented today for the first time in Greece at an event organized by Piraeus Bank with Mr. Yannis Stournaras, the Governor of the Bank of Greece, as the keynote speaker. The event was organised as part of Piraeus Bank’s commitment to the United Nations Environment Programme Finance Initiative (UNEP FI). Piraeus is the only Greek bank to be a member of the global initiative, which includes twenty-eight banks from around the world, representing over USD 17 trillion in combined assets. Mr. Yannis Stournaras, the Governor of Bank of Greece, highlighted in his speech that the Bank of Greece fully supports the Principles for Responsible Banking and urges all of the banks to endorse the Principles and set ambitious targets. The Bank of Greece was one of the first central banks to become involved with the climate change issue, establishing the Climate Change Impacts Study Committee in 2009 and investing in one of the most significant Sustainable Dev
Arrowgrass Has Agreed to an Extension of Its Irrevocable Undertaking Regarding Its Holdings in Basware Corporation16.1.2019 20:30 | Tiedote
The investment funds of Arrowgrass Capital Partners LLP (“Arrowgrass”) hold, directly and indirectly, over 24 per cent of all shares and votes in Basware Corporation (“Basware”), a Finnish listed company providing networked source-to-pay solutions and e-invoicing services. Arrowgrass refers to the announcements made by Basware on 16 November 2018, 20 November 2018 and 7 December 2018 with regard to a possible tender offer by Tradeshift Holdings Inc. (“Tradeshift”) for Basware. Arrowgrass announces that it has agreed, under certain conditions, to extend an irrevocable undertaking with Tradeshift to accept a tender offer by Tradeshift for Basware, should Tradeshift publicly announce its tender offer in accordance with applicable laws and regulations no later than 28 February, 2019. Arrowgrass recognizes that Basware has emphasized in its announcements that the launch of the tender offer remains uncertain. About Arrowgrass Arrowgrass Capital Partners LLP is a London headquartered alternat
PCI Security Standards Council Publishes New Software Security Standards16.1.2019 18:25 | Tiedote
Today, the PCI Security Standards Council (PCI SSC) published new requirements for the secure design and development of modern payment software. The PCI Secure Software Standard and the PCI Secure Lifecycle (Secure SLC) Standard are part of a new PCI Software Security Framework, which includes a validation program for software vendors and their software products and a qualification program for assessors. The programs will be launched later in 2019. “Innovation in payments is moving at an incredible pace. Each advancement provides the industry the opportunity to develop applications more quickly and efficiently than before and to design software for new platforms for payment acceptance,” said PCI SSC Chief Technology Officer Troy Leach. “The new PCI Secure Software Standard and PCI Secure SLC Standard support this evolution in payment software practices by providing a dynamic way for developers to demonstrate their software protects payment data for the next generation of applications.”
Uutishuoneessa voit lukea tiedotteitamme ja muuta julkaisemaamme materiaalia. Löydät sieltä niin yhteyshenkilöidemme tiedot kuin vapaasti julkaistavissa olevia kuvia ja videoita. Uutishuoneessa voit nähdä myös sosiaalisen median sisältöjä. Kaikki STT Infossa julkaistu materiaali on vapaasti median käytettävissä.Tutustu uutishuoneeseemme