Lisocabtagen maraleucel (3) – Breyanzi®

• Clinical trials
  • The ongoing TRANSCEND FL trial is a single-arm, open-label, multicentre Phase II trial investigating the efficacy and safety of lisocabtagen maraleucel.

Adults with relapsed or refractory follicular lymphoma following at least two lines of systemic therapy

• The additional benefit is not proven.
• Consequently, additional benefit from lisocabtagen maraleucel for the treatment of adult patients with relapsed or refractory follicular lymphoma (FL) is not proven.
• In the absence of direct comparative studies of lisocabtagen maraleucel against the appropriate comparator therapy, the pharmaceutical manufacturer cites the Phase II TRANSCEND FL study and the CA082-092 study as evidence of additional benefit.
• Due to its single-arm design, the TRANSCEND FL study submitted by the pharmaceutical manufacturer does not allow for a comparison with the appropriate comparator therapy and is therefore not suitable for assessing additional benefit.
• MAIC analyses against aggregated study arms are generally not considered appropriate in the context of benefit assessment.
• Overall, the indirect comparisons are not suitable for providing proof of additional benefit compared with the appropriate comparator therapy.
• Overall assessment
  • For the assessment of the additional benefit of lisocabtagen maraleucel, the pharmaceutical manufacturer submitted the results of the single-arm TRANSCEND FL study.
  • The results of the single-arm TRANSCEND FL study are not suitable for assessing additional benefit, as they do not allow for a comparison with the appropriate comparator therapy.
  • Overall, the indirect comparisons are not suitable for providing proof of additional benefit compared with the appropriate comparator therapy.

Courtesy translation only, please refer to the German original.