The results from the ZUMA-12 trial led by researchers at The University of Texas MD Anderson Cancer Center have shown that first-line treatment with Axicabtagene ciloleucel ( Axi-cel; Yescarta ), a chimeric antigen receptor ( CAR ) T cell therapy, achieved a high rate of complete response in patients with high-risk large B-cell lymphoma ( LBCL ).
Of the 40 patients treated with Axi-cel, 89% had an objective response and 78% experienced complete response.
The estimated overall survival rate at 12 months was 91%.
At data cutoff, after median follow up of 15.9 months, 73% of patients had an ongoing response. While the median for duration of response, event-free survival ( EFS ) and progression-free survival ( PFS ) were not-reached, 12-month estimates were 81%, 73% and 75%, respectively.
Axi-cel is an autologous anti-CD19 CAR T cell therapy manufactured from the patient’s own T cells, which have been extracted and then reprogrammed with CAR molecules to help the T cells recognize cancer cells.
The reengineered T cells are infused back into the patient to attack the cancer.
Based on the pivotal ZUMA 1 study, Axi-cel was approved by the FDA in 2017 for the treatment of adults with relapsed or refractory ( R/R ) LBCL who already have received two or more lines of systemic therapies.
The phase II ZUMA-12 trial has expanded on the ZUMA-1 findings by evaluating the use of Axi-cel as first-line therapy for patients with high-risk LBCL.
High-risk LBCL is a subgroup of the disease in which patients have double- or triple-hit lymphoma or additional clinical risk factors identified by the International Prognostic Index ( IPI ) or interim positron emission tomography ( PET ) scan.
Historically, less than half of these patients achieve long-term disease remission with typical treatment approaches like chemoimmunotherapy.
Forty patients with high-risk LBCL were enrolled and treated with Axi-cel. Ninety-five percent had stage III/IV disease, 25% had double or triple-hit status per central assessment and 78% had an IPI score 3 or more.
The treatment was well tolerated with no new safety signals.
A randomized trial is necessary to confirm these results. ( Xagena )
Source: The University of Texas MD Anderson Cancer Center, 2022