Liso-cel (lisocabtagene maraleucel) Shines in Second-Line, Yielding Long-Lasting Complete Responses for Non-Transplant Eligible LBCL Patients

For those patients with large B-cell lymphoma (LBCL) who remain uncured following initial treatment, the conventional approach for second-line therapy has been the utilization of high-dose chemotherapy (HDCT) and hematopoietic stem cell transplantation (HSCT). The PILOT study included 61 patients with relapsed or refractory LBCL who met at least one criterion that made them not eligible for transplant. According to the findings presented at the ASH 2023, the overall response rate (ORR) was 80%, with 54% of patients achieving a complete response (CR) and 26% having a partial response (PR). Additionally, around 5% of patients had stable disease, 13% had disease progression, and 2% were not evaluable for response. At a median follow-up of 23.1 months, the median duration of response stood at 23.3 months, with the duration of CR not being reached, and the median duration of PR recorded at 2.1 months. Assessing data at a median follow-up of 24.0 months, the overall median progression-free survival reached 9.0 months. For patients achieving a CR, progression-free survival was not reached, while those with a PR showed a median of 2.9 months. Furthermore, patients with stable disease, progressive disease, or those not evaluable for response had a progression-free survival of 1.0 months. At a median follow-up of 24.25 months, the median overall survival was not reached, and out of 24 reported deaths, 20 deaths were attributed to disease progression, with 18 deaths occurring more than 90 days post liso-cel infusion.

In the treatment-emergent phase (within 90 days following liso-cel infusion), adverse events (AEs) were experienced by 97% of patients, with 79% encountering AEs classified as grade 3 or higher. Noteworthy AEs included cytokine release syndrome (38%) and neurologic events (31%). Beyond the treatment-emergent period, AEs persisted in 51% of patients, with 18% experiencing grade 3 or higher AEs. Apart from that, a single patient reported a grade 3 or higher infection.

KOL Insights

“This analysis of the PILOT study reflects the longest follow-up to date in a broad population of patients with relapsed/refractory large B-cell lymphoma who were not intended for stem cell transplant and were treated with CAR T-cell therapy as second-line therapy. These results continue to support liso-cel as second-line therapy for this underserved population of patients with relapsed/refractory large B-cell lymphoma for whom stem cell transplant was not intended.”–Expert Opinion.

Conclusion

The analysis of the PILOT study presents the lengthiest follow-up to date for a diverse cohort of relapsed/refractory large B-cell lymphoma patients, excluded from stem cell transplant, undergoing CAR T-cell therapy as second-line treatment. These findings consistently endorse liso-cel as a preferred second-line therapy for this overlooked subset of patients with relapsed/refractory large B-cell lymphoma, particularly those not slated for stem cell transplant.

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