Liso-cel Shines in TRANSCEND FL: Impressive Complete Responses, Durable Overall Responses, and Manageable Safety as a Second-Line Treatment for Relapsed Follicular Lymphoma

In the TRANSCEND FL study, 130 individuals grappling with relapsed or refractory follicular lymphoma (FL) were actively involved and subjected to BREYANZI treatment within the second-line and third-line settings. These patients were administered BREYANZI at a targeted dosage of 100 x 10⁶ CAR-positive viable T cells. Remarkably, TRANSCEND FL stands as the largest clinical trial assessing the efficacy of CAR T cell therapy in individuals with relapsed or refractory FL. Moreover, it marks the pioneering trial to divulge outcomes for a CAR T therapy in the high-risk, second-line FL category, highlighting results that align with the overall efficacy and safety patterns witnessed in third-line FL. 

As per the findings presented at the ASH 2023, in the second-line treatment of high-risk relapsed or refractory follicular lymphoma using BREYANZI, 23 patients evaluated for efficacy exhibited substantial and widespread positive responses at a median on-study follow-up of 18.1 months. Notably, all responders achieved a complete response, resulting in an overall response rate (ORR) and complete response (CR) rate of 95.7%. With a median follow-up of 16.8 months, the duration of response (DOR) was not reached, and the probability of patients maintaining response at 12 months stood at an impressive 89.8%. Furthermore, the median progression-free survival (PFS) was not reached, demonstrating a PFS rate of 91.3% at 12 months. In terms of safety analysis, BREYANZI maintained a consistent and well-tolerated safety profile, characterized by the absence of new safety signals, low incidence of severe cytokine release syndrome (CRS), and minimal neurologic events (NE). Of the patients, 52.2% experienced any grade CRS, with no instances of grade >3 CRS reported.

KOL Insights

“Despite high initial response rates to front-line treatment, the majority of patients with follicular lymphoma relapse with prognosis worsening, leaving them in need of a treatment option that will provide significant and lasting responses. Based on results from TRANSCEND FL for liso-cel as a second-line treatment option, the vast majority of patients achieved a complete response, with probability of overall responses lasting at least 12 months. Additionally, the safety profile for liso-cel continued to be manageable, showing the clinically meaningful value of using this differentiated treatment option for patients with relapsed or refractory follicular lymphoma after failure of front-line therapy.”–Expert Opinion.

Conclusion

The outcomes from the TRANSCEND FL trial highlight liso-cel’s effectiveness as a second-line treatment for patients with relapsed or refractory follicular lymphoma. The majority of patients achieved a complete response, demonstrating the durable nature of overall responses lasting at least 12 months. Furthermore, the safety profile of liso-cel remained manageable, emphasizing the clinical significance of this distinct treatment option for individuals following the failure of front-line therapy.

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