Celgene Announces Updated Safety and Efficacy Data from the TRANSCEND Trial of liso-cel (JCAR017) in Patients with Relapsed or Refractory B-cell non-Hodgkin Lymphoma at ASCO
Celgene Corporation (NASDAQ:CELG) today announced updated six-month safety and efficacy data from the TRANSCEND (NHL-001) study of lisocabtagene maraleucel (liso-cel; JCAR017), an investigational CD19-directed CAR T cell therapy, in patients with relapsed/refractory (r/r) aggressive B-cell non-Hodgkin lymphoma (NHL) in a presentation at the American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago, IL.
“As liso-cel data mature, the durable response rates continue to demonstrate the potential of CAR T cell therapy in patients with DLBCL who have relapsed or are refractory to prior treatments,” said principal investigator Jeremy Abramson, M.D., of Massachusetts General Hospital. “Added to the emerging side effect profile with liso-cel, this therapy has encouraging potential in diffuse large B-cell lymphoma.”
The update provided today was based on a cutoff date of May 4, 2018 and included data from 114 liso-cel treated and 102 safety evaluable patients, of which 51 patients were treated at the pivotal dose of 100 million cells. Abramson highlighted 37 patients who meet the criteria for the planned pivotal patient population in TRANSCEND NHL-001 (including r/r DLBCL, transformed from follicular lymphoma (tFL), and poor-risk high-grade double/triple-hit lymphoma), and were treated with the pivotal cell dose. The new long-term follow up data add to those disclosed on May 16, 2018 in ASCO Abstract #7505.
At six months, 49% of patients remained in remission, with 46% maintaining a complete response (CR) in this cohort (n=37). When durability of response beyond six months was evaluated across all dosing levels ranging from 5 x 107 to 1 x 108 CAR T cells, 93% of patients in CR remained in CR at data cut off. Liso-cel therapy was available for 99% (132/134) of patients apheresed.
The most common treatment-emergent adverse events that occurred at ≥25% incidence included neutropenia (63%), anemia (53%), fatigue (46%), thrombocytopenia (34%), decreased appetite (29%), nausea (28%), hypotension (26%), cough (26%), headache (25%), dizziness (25%), constipation (25%), and diarrhea (25%). Cytokine release syndrome and neurotoxicity were observed at a rate of 37% and 23% for all grades, and 1% and 13% for grades 3 and 4, respectively (n=102). Based on this emerging safety profile, outpatient administration is being evaluated in the TRANSCEND trial.
"The updated efficacy and tolerability data for liso-cel continue to support a potential best-in-class CD19 CAR T profile,” said Nadim Ahmed, President, Hematology and Oncology for Celgene. “With the TRANSCEND pivotal cohort now fully enrolled, we look forward to further progressing this critical program for poor-prognosis patients with relapsed or refractory aggressive NHL and investigating the clinical utility of liso-cel in earlier lines of therapy.”
About Liso-cel and TRANSCEND
Liso-cel is an investigational defined composition CD19-directed CAR T cell product candidate using a 4-1BB costimulatory domain. TRANSCEND is an open-label, multicenter phase I study to determine the safety, pharmacokinetics, and antitumor activity of liso-cel in adult patients with relapsed or refractory diffuse large B cell lymphoma, primary mediastinal B-cell lymphoma, follicular lymphoma Grade 3B, and mantle cell lymphoma.
The pivotal cohort includes patients with DLBCL (NOS and transformed from follicular lymphoma) who are ECOG Performance Status 0-1. These patients represent a high-risk patient population, with approximately 90% of treated patients having one or more predictors of poor survival, including double or triple hit lymphoma, being chemorefractory to front-line or subsequent therapies, never reaching a complete remission with prior treatments, or never having undergone an autologous transplant.
Celgene Corporation, headquartered in Summit, New Jersey, is an integrated global biopharmaceutical company engaged primarily in the discovery, development and commercialization of innovative therapies for the treatment of cancer and inflammatory diseases through next-generation solutions in protein homeostasis, immuno-oncology, epigenetics, immunology and neuro-inflammation. For more information, please visit www.celgene.com. Follow Celgene on Social Media: @Celgene, Pinterest, LinkedIn, Facebook and YouTube.
This press release contains forward-looking statements, which are generally statements that are not historical facts. Forward-looking statements can be identified by the words "expects," "anticipates," "believes," "intends," "estimates," "plans," "will," "outlook" and similar expressions. Forward-looking statements are based on management's current plans, estimates, assumptions and projections, and speak only as of the date they are made. Celgene undertakes no obligation to update any forward-looking statement in light of new information or future events, except as otherwise required by law. Forward-looking statements involve inherent risks and uncertainties, most of which are difficult to predict and are generally beyond our control. Actual results or outcomes may differ materially from those implied by the forward-looking statements as a result of the impact of a number of factors, many of which are discussed in more detail in Celgene's Annual Report on Form 10-K and other reports filed with the Securities and Exchange Commission.
Hyperlinks are provided as a convenience and for informational purposes only. Celgene bears no responsibility for the security or content of external websites.
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 jo ennen kuin ne uutisoidaan? Kun tilaat tiedotteemme, saat ne sähköpostiisi yhtä aikaa suomalaisen median kanssa. Tilauksen voit halutessasi perua milloin tahansa.
Lue lisää julkaisijalta Business Wire
Ascend Performance Materials Announces Price Increase for Intermediate Materials22.6.2018 17:00 | Tiedote
Ascend Performance Materials announced today a price increase for its intermediate materials. The price increase will take effect globally on July 1, 2018, and includes the following terms: Material Price Increase Terms Hexamethylene diamine (HMD) $0.17/lb. • As contracts allow. • Non-contract business – price determined on an order-by-order basis. Acrylonitrile (AN) $0.20/lb. • As contracts allow. • Non-contract business – price determined on an order-by-order basis. Customers should contact their local sales representative for additional information. About Ascend Performance Materials Ascend Performance Materials is a global premium provider of high-quality plastics, fibers and chemicals and is the world’s largest integrated producer of PA66 resin. Headquartered in Houston, Texas, Ascend has eight global locations, including five fully-integrated manufacturing facilities located in the southeastern United States, all dedicated to the innovation and safe production of nylon 6,6. With
Different Countries, Different Customs: Get Ready for the Motorbike Holidays with Moto-tyres.co.uk22.6.2018 16:41 | Tiedote
Pack your bags, close the boot and get away on holiday? When you start your holidays on a motorcycle, you usually have to consider a few things more when getting ready for your trip. The right preparation is therefore a must. So that nothing stands in the way of a smooth journey, Moto-tyres.co.uk has put together some tips for your next trip. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20180622005345/en/ Different countries, different customs: get ready for the motorbike holidays with Moto-tyres.co.uk (Photo: Business Wire) Whether a weekend trip or extended adventure, it all depends on the right equipment. Functional clothing, protectors and rain protection are a must on long trips. Wearing a suitable motorcycle helmet is a legal requirement almost everywhere. However, there are also very different rules and regulations for motorbike equipment and accessories depending on the destination, and you should familiarise yoursel
Boehringer Ingelheim bolsters biologics research and development with 230 million euro investment in new development center22.6.2018 15:00 | Tiedote
Today Boehringer Ingelheim announced a 230 million euro investment into a new Biologicals Development Center (BDC) at the company’s Research and Development site in Biberach, Germany during the foundation stone laying for the new center. “The BDC is another key building block supporting the company’s long-term strategy for increasing the pipeline’s share of biologicals. This is particularly driven by two of our core areas, immune oncology and immunology,” says Dr. Fridtjof Traulsen, Corporate Senior Vice President Development at Boehringer Ingelheim. “The share of new biological entities in Boehringer Ingelheim’s research pipeline has been consistently increasing over the past few years and has now reached forty percent.” The BDC will help to maximize synergies by integrating biologicals analytical and process development as well as manufacturing for clinical studies into one seamless unit, while at the same time increasing development capacity. Following a staggered launch beginning i
Announcement by Viking Corp on Tecnotree22.6.2018 14:09 | Tiedote
In the interests of stakeholder transparency, this announcement provides background and context to Viking's file bankruptcy proceedings upon Tecnotree: As many of you will now know, Viking Corp was recently forced to file bankruptcy proceedings upon Tecnotree, which were withdrawn on the 19 June. In the interests of stakeholder transparency, we make this Announcement to provide background and context to this action. Firstly, we would reflect on the recent history of our attempts to partner with Tecnotree and all its stakeholders. Viking launched a Tender Offer (TO), having conducted detailed discussions with the Tecnotree Board and our advisors. On the basis of those discussions, we were very confident that the TO price of 10 cents per share provided truly superior value for shareholders. So did the Tecnotree Board as evidenced by their unanimous recommendation of our Offer and of course, further evidenced by the current prevailing market price. This TO was supported in the most vigoro
HeartSciences Named “Start-Up to Watch”22.6.2018 14:00 | Tiedote
HeartSciences is delighted to have been highlighted as “Start-Up to Watch” in the June 8, 2018 issue of the MedTech Strategist. The article titled “HEARTSCIENCES: ARTIFICIAL INTELLIGENCE IMPROVES FRONTLINE RISK STRATIFICATION FOR HEART DISEASES” discusses HeartSciences’ role in addressing the current challenges and significant unmet need to identify heart disease at an early stage and reduce the high prevalence of expensive diagnostic testing with low yields. The article highlights the enormous opportunity for HeartSciences’ breakthrough MyoVista® Wavelet ECG (wavECG™) technology to benefit patients and to reduce health system costs and references a recently published study titled “Prediction of Abnormal Myocardial Relaxation From Signal Processed Surface ECG” in the Journal of American College of Cardiology (JACC). This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20180622005088/en/ MyoVista Wavelet ECG Cardiac Testing Device (P
High-Performance Solutions and Complete Protection for Critical Installations: the Latest Innovations from CNIM and Its Bertin Subsidiary to Be Unveiled at WNE 201822.6.2018 12:39 | Tiedote
The third edition of the World Nuclear Exhibition – major event for the global nuclear energy community – will be held at Paris-Villepinte, June 26 th to 28 th , 2018. CNIM and Bertin Technologies , leading players in the fields of nuclear equipment, safe handling and instrumentation for the complete protection of nuclear power plants, will be unveiling their joint offerings at this exhibition (booth D125-Hall 7). This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20180622005185/en/ CNIM's high safety fuel handling systems (Photo: Business Wire) Based on its long experience of major nuclear projects and its cutting-edge industrial capabilities, CNIM’s offering reflects its ability to innovate and adapt to the most difficult environments. Highlights on its exhibition booth will include: The design and manufacturing of high-safety fuel handling systems (notably the design of three remotely operated spent fuel handling and transferri
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