Category Ranking
98%
Total Visits
921
Avg Visit Duration
2 minutes
Citations
20
Article Abstract
Background: Obecabtagene autoleucel (obe-cel) is an autologous 41BB-ζ anti-CD19 chimeric antigen receptor (CAR) T-cell therapy which uses an intermediate-affinity CAR to reduce toxic effects and improve persistence.
Methods: We conducted a phase 1b-2 multicenter study of obe-cel in adults (≥18 years of age) with relapsed or refractory B-cell acute lymphoblastic leukemia (ALL). The main cohort, cohort 2A, included patients with morphologic disease; patients in cohort 2B had measurable residual disease. The primary end point was overall remission (complete remission or complete remission with incomplete hematologic recovery) in cohort 2A. Secondary end points included event-free survival, overall survival, and safety.
Results: Of the 153 enrolled patients, 127 (83.0%) received at least one infusion of obe-cel and were evaluable. In cohort 2A (94 patients; median follow-up, 20.3 months), overall remission occurred in 77% (95% confidence interval [CI], 67 to 85), with complete remission in 55% (95% CI, 45 to 66) and complete remission with incomplete hematologic recovery in 21% (95% CI, 14 to 31). The prespecified null hypotheses of overall remission (≤40%) and complete remission (≤20%) were rejected (P<0.001). In the 127 patients who received at least one obe-cel infusion (median follow-up, 21.5 months), the median event-free survival was 11.9 months (95% CI, 8.0 to 22.1); estimated 6- and 12-month event-free survival was 65.4% and 49.5%, respectively. The median overall survival was 15.6 months (95% CI, 12.9 to not evaluable); estimated 6- and 12-month overall survival was 80.3% and 61.1%, respectively. Grade 3 or higher cytokine release syndrome developed in 2.4% of the patients, and grade 3 or higher immune effector cell-associated neurotoxicity syndrome developed in 7.1% of the patients.
Conclusions: Obe-cel resulted in a high incidence of durable response among adults with relapsed or refractory B-cell ALL, with a low incidence of grade 3 or higher immune-related toxic effects. (Funded by Autolus Therapeutics; FELIX ClinicalTrials.gov number, NCT04404660.).
Download full-text PDF |
Source |
|---|---|
| http://dx.doi.org/10.1056/NEJMoa2406526 | DOI Listing |
Publication Analysis
Top Keywords
Similar Publications
JAK1 Inhibition with Upadacitinib in a Patient with Refractory Severe Chronic Spontaneous Urticaria and Concomitant Rheumatoid Arthritis: Complete Resolution of Urticaria and Remission of Rheumatoid Arthritis.
Acta Derm Venereol
September 2025
Faculty of Health Sciences, Ben-Gurion University of the Negev, Beer-Sheva, Israel; Department of Medicine A, Assuta Ashdod University Hospital, Ashdod, Israel.
Rapid early remission in a patient with severe aplastic anemia: a case report of hetrombopag, cyclosporine, and danazol combination therapy.
Front Immunol
September 2025
Department of Hematology, Cancer Center, the First Hospital of Jilin University, Changchun, China.
Severe aplastic anemia (SAA) is a life-threatening bone marrow failure syndrome that is caused primarily by immune-mediated destruction of hematopoietic stem cells. Traditional treatment relies on immunosuppressive therapy (IST) with antithymocyte globulin (ATG) and cyclosporine (CSA). However, the toxicity and limited availability of ATG have spurred interest in ATG-free regimens.
View Article and Find Full Text PDFApplication of MRI-guided hysteroscopic one-step resection in preserving the fertility of early endometrial cancer patients.
Front Oncol
August 2025
Hysteroscopy Center, Obstetrics and Gynecology Hospital, Fudan University, Shanghai, China.
Objective: This study aims to evaluate the role of MRI-guided hysteroscopic one-step precise resection in diagnosing suspected myometrial invasion (MI) of endometrial cancer (EC) in patients desiring fertility preservation and to analyze the impact of suspected MI on the outcomes of fertility-preserving treatments.
Methods: A total of 169 patients with early-stage endometrial cancer who required fertility preservation were enrolled. Among them, 103 cases were ruled out for myometrial invasion by MRI (control group), while 66 cases exhibited suspected myometrial invasion.
Successful remission induction therapy with azacitidine and venetoclax for a treatment-naive elderly patient with ETP/myeloid mixed-phenotype acute leukemia: a case report.
Front Oncol
August 2025
Department Hematopathology, Shenzhen Hospital of Southern Medical University, Shenzhen, China.
Background: Mixed-phenotype acute leukemia (MPAL) is a rare acute leukemia for which data are currently not available to guide therapy. It has a poor outcome, particularly in elderly patients.
Case Presentation: We report the successful use of venetoclax/azacitidine as treatment for a treatment-naive elderly patient with early T-cell precursor (ETP)/myeloid MPAL.
Telitacicept versus mycophenolate mofetil in IgA nephropathy: a real-world comparative study of efficacy, renal outcomes and safety.
Clin Kidney J
September 2025
Department of Nephrology and Institute of Nephrology, Sichuan Provincial People's Hospital, School of Medicine, University of Electronic Science and Technology of China, Chengdu, Sichuan, China.
Background: This study aimed to evaluate the efficacy and safety of telitacicept versus mycophenolate mofetil (MMF) in high-risk progressive immunoglobulin A nephropathy (IgAN).
Methods: This retrospective, multicentre cohort study included patients with high-risk progressive IgAN who received telitacicept or MMF therapy, both combined with low-dose steroids. Clinical data were collected from treatment initiation to 12 months.