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Characteristics associated with response in patients with R/R CLL/SLL treated with liso-cel: TRANSCEND-CLL-004 post hoc analysis
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The phase I/II TRANSCEND-CLL-004 trial (NCT03331198) assessed the safety and efficacy of liso-cel in adult patients with R/R CLL/SLL.1 The primary results from this trial were previously reported by the Lymphoma Hub. Briefly, the ORR and CR/CRi rates at DL2 were 47% and 18%, respectively. Based on results from this trial, liso-cel was approved by the FDA for the treatment of adult patients with R/R CLL/SLL who received ≥2 prior lines of therapy, including a BTKi and a BCL-2 inhibitor. A post hoc analysis of this trial assessed the correlations between patient characteristics and efficacy response and safety in patients treated at DL2 (n = 87). Results from this analysis were presented at the SOHO 2024 Annual Meeting by Wierda.1
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ORR and CRR were similar in patients with or without high-risk disease features at baseline, including unmutated IGHV (ORR, 41.5% vs 63.2%; CRR , 22.0% vs 21.1%), del(17p) (ORR, 47.1% vs 45.1%; CRR, 26.5% vs 13.7%), TP53 mutation (ORR, 41.7% vs 50.0%; CRR, 22.2% vs 16.0%), del(17p) and TP53 mutation (ORR, 44.0% vs 46.7%; CRR, 28.0% vs 15.0%), and complex karyotype (ORR, 44.2% vs 52.9%; CRR, 19.2% vs 17.6%). |
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Patients with fewer prior lines of treatment and lower baseline tumor burden showed improved response rates; the ORRs for patients with ≤3 prior lines of therapy vs >3 prior lines of therapy were 54.5% vs 44.6%, and for patients without bulky (≥5 cm) disease vs with bulky disease were 63.2% vs 31.7%. |
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Inflammatory markers, bulky disease, and lower estimated CrCl rates may be associated with a higher risk of neurological events. |
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These findings highlight the benefit of liso-cel in patients with R/R CLL/SLL, regardless of high-risk disease features, and suggest that patients treated in earlier lines of therapy with a lower tumor burden may have improved outcomes. |
Abbreviations: BCL-2, B-cell lymphoma 2; BTKi, Bruton tyrosine kinase inhibitor; DL, dose level; FDA, U.S. Food and Drug Administration; IGHV, immunoglobulin heavy chain gene; CI, confidence interval; CLL, chronic lymphocytic leukemia; CrCl, creatinine clearance; CRi, CR with incomplete blood count recovery; CRR, complete response rate; liso-cel; lisocabtagene maraleucel; OR, odds ratio; ORR, overall response rate; R/R, relapsed/refractory; SLL, small lymphocytic lymphoma; SOHO, Society of Hematologic Oncology.
- Wierda WG. Characteristics associated with response to lisocabtagene maraleucel (liso-cel) in patients with R/R CLL/SLL: Exploratory analyses from the phase 1/2 TRANSCEND CLL 004 study. Oral Abstract #CLL-184. Presented at: Society of Hematologic Oncology 2024 Annual Meeting; Sep 4–7, 2024; Houston, US.
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