Lisocabtagen maraleucel (4) – Breyanzi®

• Clinical trials
  • The completed TRANSCEND-NHL-001 trial is a single-arm, open-label, multicentre Phase I trial investigating the efficacy and tolerability of lisocabtagen maraleucel.

Adults with relapsed or refractory mantle cell lymphoma (MCL) following at least two lines of systemic therapy, including a Bruton’s tyrosine kinase (BTK) inhibitor

• An additional benefit is not proven.
• Consequently, additional benefit from lisocabtagen maraleucel for the treatment of adult patients with relapsed or refractory mantle cell lymphoma is not proven following at least two lines of systemic therapy, including a Bruton’s tyrosine kinase (BTK) inhibitor.
• The TRANSCEND-NHL-001 study submitted by the pharmaceutical manufacturer does not allow for a comparison with the appropriate comparator therapy due to its single-arm design 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 assessment
  • For the assessment of the additional benefit of lisocabtagen maraleucel, the pharmaceutical manufacturer submitted the results of the single-arm TRANSCEND-NHL-001 study.
  • The results of the single-arm TRANSCEND-NHL-001 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 over the appropriate comparator therapy.

Courtesy translation only, please refer to the German original.