|Date of Abstract presentation
|10th December 2023
|Follicular Lymphoma (FL)
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.
“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.
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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