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.
About Business Wire
(c) 2018 Business Wire, Inc., All rights reserved.
Business Wire, a Berkshire Hathaway company, is the global leader in multiplatform press release distribution.
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
Business Figures for the First Half of 2019: Sartorius Continues Double-digit Growth19.7.2019 05:00:00 CEST | Press release
Sartorius, a leading international partner of biopharmaceutical research and the industry, grew strongly in the first half of 2019, recording double-digit increases in sales revenue, order intake and earnings. Given these results and continued positive prospects for the Bioprocess Solutions Division for the second half, management has raised its full-year targets. “We are very pleased on the whole with business progress in the first half, though both divisions showed different growth dynamics,” said Executive Board Chairman and CEO Dr. Joachim Kreuzburg. “While growth in the lab business slowed down due to the currently uncertain and softer economic environment, especially at the end of the second quarter, momentum for Bioprocess Solutions has remained unchanged at a very high level. In view of further development, we are very confident and expect full-year sales growth of 10% to 14% instead of our previously forecasted 7% to 11%.” Consolidated sales revenue in constant currencies rose
Quanergy and Chery Established Partnership to Propel a New Era of Autonomous Vehicles and Smart Cities18.7.2019 19:00:00 CEST | Press release
Quanergy Systems, Inc., a leading provider of LiDAR (Light Detection and Ranging) sensors and smart sensing solutions, announced a partnership with Chery Automobile, one of the largest automotive manufacturers in China. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20190718005616/en/ Quanergy and Chery Established Partnership to Propel a New Era of Autonomous Vehicles and Smart Cities (Graphic: Business Wire) On June 20th, 2019, Chery unveiled the logo of its new brand Chery Lion, and announced its strategic plan of working with selected partners to solve technological challenges across the ecosystem. Quanergy signed on to Chery Lion’s Smart Partner Program as the LiDAR partner, to focus efforts on advancing autonomous driving and smart cities in China. “As the autonomous vehicle industry matures, it is imperative to build an ecosystem that supports a transportation network with reliable solutions.” said Dr. Yong Huang, Vice
LTI USD Revenue Growth up 11.5% YoY; Digital Revenues at 39%18.7.2019 16:08:00 CEST | Press release
Larsen & Toubro Infotech (BSE: 540005, NSE: LTI), a global technology consulting and digital solutions company, announced its Q1 FY20 results today. Q1 FY20 In US Dollars: Revenue at USD 356.5 million; growth of 0.8% QoQ and 11.5% YoY Constant Currency Revenue growth of 1.0% QoQ and 12.9% YoY In Indian Rupees: Revenue at Rs 24,849 million; growth was flat QoQ and 15.3% YoY Net Income at Rs 3,557 million; growth of (6.1%) QoQ and (1.5%) YoY “We delivered 12.9% YoY revenue growth in constant currency driven by Digital Services that now make up 39% of our revenues. We also won a large deal by opening a new client logo in Insurance vertical with net-new TCV of US$44m. We are also pleased to welcome Lymbyc to LTI family. Lymbyc is a specialist AI, machine learning, and advanced analytics company. The acquisition further strengthens LTI’s Mosaic platform and our fast-growing digital and analytics offerings.” - Sanjay Jalona, Chief Executive Officer & Managing Director, LTI Recent Deal Wins A
Moody’s Analytics Wins Wholesale Modelling Software of the Year at Risk Technology Awards18.7.2019 15:30:00 CEST | Press release
Moody’s Analytics, a global provider of financial intelligence, has won Wholesale Modelling Software of the Year in the 2019 Risk Technology Awards. It’s one of six categories won, spanning finance, accounting, regulatory, and credit functions. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20190718005512/en/ A suite of integrated Moody’s Analytics offerings contributed to this win, including the CreditEdge™ solution, which delivers a leading probability of default model and advanced analytics for managing the daily credit risk of more than 60,000 public firms and sovereigns. Our RiskCalc™ credit scoring platform helps clients assess the credit risk of private firms, commercial banks, project finance projects, and insurance companies. The CMM™ solution combines property performance forecasts with commercial mortgage fundamentals to assess default and recovery risk for commercial real estate properties. The new CAP™ platform ex
Fabasoft is a “Strong Performer” for Cloud Content Platforms, Q3 201918.7.2019 14:39:00 CEST | Press release
Fabasoft, a leading European provider of cloud solutions, was invited by Forrester to be part of the independent evaluation “The Forrester New Wave™: Cloud Content Platforms – Multitenant SaaS, Q3 2019.”* Upon conclusion of the evaluation, Fabasoft was positioned in the “Strong Performers” group. The research and consulting firm Forrester Research Inc. has evaluated 13 top cloud content platforms based on 10 transparent criteria relating to current offering, strategy, and market presence. The report is based on an analysis of data from product presentations, a survey, and customer interviews. “We are proud that with Fabasoft Cloud, we have been positioned in the New Wave as a strong performer by a leading international analyst firm,” says Andreas Dangl, Business Unit Executive Cloud Services at Fabasoft. “We are especially pleased that Fabasoft is the only European cloud provider in this field. This makes it clear to us that Fabasoft Cloud is the best digitalization platform for large-
Gilead to Present New Data on HIV Prevention, Treatment and Cure Research at IAS 201918.7.2019 12:30:00 CEST | Press release
Gilead Sciences, Inc. (NASDAQ: GILD) today announced that new data from the company’s HIV research and development programs will be presented at the 10th International AIDS Society Conference on HIV Science (IAS 2019) being held in Mexico City from July 21-24. Fifteen abstracts, along with community-focused symposia and workshops, reflect Gilead’s ongoing commitment to scientific innovation, a key pillar to addressing unmet and evolving medical needs in HIV. “Gilead’s scientific discovery has helped transform both HIV treatment and prevention and we are committed to advancing the next generation of therapies to improve the care of people and communities impacted by this disease,” said John McHutchison, AO, MD, Chief Scientific Officer, Head of Research & Development, Gilead Sciences. “Our data at this year’s meeting include exciting progress in our HIV prevention, treatment and cure programs, which together are helping to advance the field of HIV toward the ultimate goal of ending the