Celgene Corporation Announces Initial Phase 1/2 Liso-cel Data in Patients with Relapsed/Refractory CLL, Including Those with High-Risk Disease, Previously Treated with Ibrutinib, at ASH 2018
Celgene Corporation (NASDAQ: CELG) today announced initial data from the dose-escalation part of an ongoing, open-label multicenter phase 1/2 study of investigational lisocabtagene maraleucel (liso-cel; JCAR017) in patients with relapsed/refractory chronic lymphocytic leukemia (CLL) and small lymphocytic lymphoma (SLL), including patients with cytogenetic features of high-risk disease, who were previously treated with ibrutinib. The data were presented by Tanya Siddiqi, M.D. in an oral presentation at the 60th American Society of Hematology (ASH) Annual Meeting and Exposition in San Diego, C.A. (Abstract #300).
Data presented today from TRANSCEND CLL-004 include 16 patients from the ongoing phase 1 monotherapy dose-escalation part of the study. The median number of lines of prior therapy was 4.5, and 75% of patients had high-risk cytogenetic features. All patients had previously received treatment with ibrutinib, 81% had relapse/refractory disease on ibrutinib and 50% received prior treatment with ibrutinib and venetoclax. Following lymphodepletion with fludarabine (30 mg/m2 ) and cyclophosphamide (300 mg/m2 ) for three days, patients received liso-cel at dose level 1 (5×107 CAR+ T cells) or dose level 2 (1×108 CAR+ T cells).
The overall response rate (ORR), which was an exploratory objective, was 81%, with 43% of patients demonstrating a complete response (CR). As of September 2018, five patients have six-month follow-up and all have maintained a response and undetectable minimal residual disease (uMRD) in the blood as measured by flow cytometry (10-4 ). The median time-to-peak expansion was 16 days, and CAR+ T cells remained detectable in patients at three months.
“Ibrutinib is a standard of care for patients with CLL, but outcomes are poor for patients whose disease progresses on or after ibrutinib,” said Alise Reicin, M.D., President, Global Clinical Development for Celgene. “These initial findings support further research with liso-cel in CLL and reinforce Celgene’s commitment to cellular therapy across a broad spectrum of blood cancers.”
The most common treatment-emergent adverse events reported included anemia (88%), thrombocytopenia (81%), cytokine release syndrome (75%), neutropenia (63%), leukopenia (56%), hypokalemia (50%), pyrexia (38%), lymphopenia (31%), nausea (31%), diarrhea (25%), febrile neutropenia (25%), headache (25%), insomnia (25%), and tremor (25%). One patient (6.3%) experienced grade 3 cytokine release syndrome and three patients (18.8%) experienced grade 3 neurologic events. No patients experienced grade 4 cytokine release syndrome or neurologic events.
"In CLL, undetectable MRD correlates with improved outcomes for patients and is particularly difficult to achieve in patients who have progressed on ibrutinib,” said lead study investigator Tanya Siddiqi, M.D., City of Hope National Medical Center. “The high response rates we observed in heavily pretreated patients in this initial data set, along with undetectable MRD status, that appears to be maintained over time, warrants further investigation of liso-cel in this area of high unmet need.”
Liso-cel is not approved in any country.
Liso-cel is an investigational defined composition CD19-directed CAR T cell product candidate using a 4-1BB costimulatory domain. Celgene’s lead CAR T trial, TRANSCEND NHL-001, is studying 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.
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 .
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.
Information om Business Wire
101 California Street, 20th Floor
CA 94111 San Francisco
Følg pressemeddelelser fra Business Wire
Skriv dig op her, og modtag pressemeddelelser på e-mail. Indtast din e-mail, klik på abonner, og følg instruktionerne i den udsendte e-mail.
Flere pressemeddelelser fra Business Wire
VIFOR-PHARMA26.5.2019 09:02:08 CEST | Pressemeddelelse
Pioneering Project for Pharmaceutics – Vifor Pharma and the University of Basel are Jointly Establishing the World’s First Research Professorship for Nanopharmaceutical and Regulatory Science
XINHUANET25.5.2019 20:22:13 CEST | Pressemeddelelse
XINHUANET: Promotion Event of The Most Beautiful Shooting Location in China Held During Cannes Film Festival
PA-KNOPP-BIOSCIENCES24.5.2019 16:02:05 CEST | Pressemeddelelse
Knopp Biosciences Presents Positive Preclinical Data for Lead Neonatal Epilepsy Drug Candidate at 2019 Antiepileptic Drug and Device Trials XV Conference
NIPA24.5.2019 12:22:09 CEST | Pressemeddelelse
Accelerate Your Business in South Korea Through 2019 K-Startup Grand Challenge
IPSEN24.5.2019 07:02:07 CEST | Pressemeddelelse
New Investigational Clinical Data for Ipsen’s Oncology Products in 11 Solid Tumor Types to Be Presented at 2019 ASCO Annual Meeting
POSIFLEX-GROUP24.5.2019 03:02:05 CEST | Pressemeddelelse
The Posiflex Group Showcases an Ecosystem of Connected Solution Endpoints with IoT Remote Monitoring at Computex 2019
I vores nyhedsrum kan du læse alle vores pressemeddelelser, tilgå materiale i form af billeder og dokumenter samt finde vores kontaktoplysninger.Besøg vores nyhedsrum