TOPLINE

Lisocabtagene maraleucel (liso-cel) demonstrated durable efficacy in heavily pretreated patients with relapsed or refractory large B-cell lymphoma (R/R LBCL), according to a long-term single-arm analysis. In the study, an estimated 38% of efficacy-evaluable patients were alive at 5 years after treatment, with higher survival rates observed among patients who achieved a complete response. 

METHODOLOGY

• Liso-cel is a standard treatment option for eligible patients with R/R LBCL after multiple prior lines of therapy, but long-term durability data have been limited.
• The TRANSCEND study was designed to evaluate the efficacy and safety of liso-cel in this setting. Investigators now report 5-year outcomes from TRANSCEND, incorporating data from a separate long-term follow-up study that assessed overall survival and late safety events for up to 15 years after liso-cel infusion.
• Overall, 345 patients underwent leukapheresis, 270 received liso-cel, and 257 were included in the efficacy-evaluable population, defined as having confirmed PET-positive disease before receiving at least one dose of liso-cel.
• Among the 138 patients eligible for long-term follow-up, 88 enrolled after completing the initial 2-year follow-up period or withdrawing from TRANSCEND after receiving at least one dose of liso-cel.
• Median follow-up was 20.3 months in the overall liso-cel-treated population and 61.0 months among patients enrolled in the long-term follow-up study.

TAKEAWAY

• Among efficacy-evaluable patients (n = 257), median overall survival was 27.5 months, and the estimated 5-year overall survival rate was 38%. The median disease-specific survival was 67.8 months, with a 5-year rate of 52%.
• Among patients who achieved a complete response, the 5-year overall and disease-specific survival rates were higher — 56% and 74%, respectively.
• Among the 84 efficacy-evaluable patients enrolled in the separate long-term follow-up study, median overall and disease-specific survival were not reached; estimated 5-year overall and disease-specific survival rates were 78% and 92%, respectively. Five years after infusion, liso-cel transgene remained detectable in 13 of 38 evaluable patients (34%). 
• Safety remained consistent over time. In the posttreatment period, 6% of patients (14/249) experienced grade ≥ 3 infections, including three fatal infections, and 8% (19/249) developed second primary malignancies, most commonly myelodysplastic syndrome or nonmelanoma skin cancer. No new safety signals emerged during long-term follow-up.

IN PRACTICE

These results confirmed that “patients who were alive 2 years after liso-cel infusion had increased chances of prolonged survival” and that “5 years of follow-up showed limited late-onset [adverse events] and [second primary malignancies], consistent with expectations for patients who received several lines of prior therapy,” the authors wrote, concluding that “this evidence can support informed decision-making when selecting the appropriate therapeutic approach in R/R LBCL.”

SOURCE

The study, led by Jeremy S. Abramson, MD, MMSc, Massachusetts General Hospital Cancer Center, Harvard Medical School, Boston, was published online as a brief report in Blood.

LIMITATIONS

TRANSCEND followed patients for only 2 years. Long-term follow-up was limited by enrollment in a separate extension study, with only 88 of 138 eligible patients participating, potentially introducing selection bias into long-term outcome analyses. Response assessments were not scheduled in the follow-up study, which likely biased duration of response and progression-free survival estimates and limited interpretation beyond 2 years.

DISCLOSURES

The TRANSCEND NHL 001 study received funding from Juno Therapeutics, a Bristol Myers Squibb Company, and the long-term follow-up study received funding from Celgene, a Bristol Myers Squibb Company. Abramson disclosed consultancy relationships with and receiving honoraria and research funding from several sources, including AbbVie, ADC Therapeutics, AstraZeneca, BeiGene, Bluebird Bio, Bristol Myers Squibb, Caribou Biosciences, Celgene, Cellectar, Century Therapeutics, C4 Therapeutics, EMD Serono, Epizyme, and others. Full disclosures are noted in the original article.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication.