| Abstract: |
Lisocabtagene maraleucel (liso-cel) demonstrated significant efficacy with a manageable safety profile as third-line or later treatment for patients with relapsed or refractory (R/R) large B-cell lymphoma (LBCL) in the TRANSCEND NHL 001 study. Primary end points were adverse events (AEs), dose-limiting toxicities, and objective response rate (ORR) per independent review committee. Key secondary end points were complete response (CR) rate, duration of response (DOR), progression-free survival (PFS), and overall survival (OS). After 2-year follow-up, patients could enroll in a separate study assessing long-term (≤15 years) safety and OS. Liso-cel–treated patients (N = 270) had a median age of 63 years (range, 18-86 years) and a median of 3 prior lines (range, 1-8) of systemic therapy, and 181 of them (67%) had chemotherapy-refractory LBCL. Median follow-up was 19.9 months. In efficacy-evaluable patients (N = 257), the ORR was 73% and CR rate was 53%. The median (95% confidence interval) DOR, PFS, and OS were 23.1 (8.6 to not reached), 6.8 (3.3-12.7), and 27.3 months (16.2-45.6), respectively. Estimated 2-year DOR, PFS, and OS rates were 49.5%, 40.6%, and 50.5%, respectively. In the 90-day treatment-emergent period (N = 270), grade 3 to 4 cytokine release syndrome and neurological events occurred in 2% and 10% of patients, respectively. The most common grade ≥3 AEs in treatment-emergent and posttreatment-emergent periods, respectively, were neutropenia (60% and 7%) and anemia (37% and 6%). Liso-cel demonstrated durable remissions and a manageable safety profile with no new safety signals during the 2-year follow-up in patients with R/R LBCL. These trials were registered at www.ClinicalTrials.gov as #NCT02631044 and #NCT03435796. © 2024 American Society of Hematology |
| Keywords: |
adolescent; adult; cancer chemotherapy; aged; aged, 80 and over; middle aged; young adult; major clinical study; overall survival; fludarabine; constipation; fatigue; neutropenia; cancer recurrence; cancer growth; diarrhea; drug efficacy; drug safety; hypertension; hypophosphatemia; side effect; systemic therapy; cancer patient; follow up; follow-up studies; progression free survival; thrombocyte; neoplasm recurrence, local; anemia; basal cell carcinoma; leukopenia; nausea; thrombocytopenia; vomiting; cohort analysis; cyclophosphamide; hemoglobin; abdominal pain; backache; chill; coughing; dizziness; dyspnea; febrile neutropenia; fever; hypomagnesemia; pneumonia; confusion; drug fatality; hypokalemia; hypotension; insomnia; cancer regression; disease severity; hematologic malignancy; myelodysplastic syndrome; neutrophil; immunoglobulin g; multicenter study; tumor recurrence; peripheral edema; progressive multifocal leukoencephalopathy; anxiety; headache; lymphoma, large b-cell, diffuse; corticosteroid; immunoglobulin blood level; immunoglobulin deficiency; neurologic disease; tremor; candidiasis; cytomegalovirus infection; adoptive immunotherapy; immunotherapy, adoptive; leukoencephalopathy; immunosuppressive agent; upper respiratory tract infection; cardiomyopathy; multiple organ failure; hypertensive factor; sinus tachycardia; immunoglobulin m; lung hemorrhage; immunoglobulin a; immunoglobulin e; decreased appetite; viremia; septic shock; cytokine release syndrome; acute myeloid leukemia; cell kinetics; thrush; oncological parameters; diffuse large b cell lymphoma; diffuse alveolar damage; refractory cancer; immunoglobulin a deficiency; tocilizumab; duration of response; very elderly; humans; human; male; female; article; complete response rate; immunoglobulin d; lisocabtagene maraleucel; immunoglobulin g deficiency; immunoglobulin m deficiency
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