Pirtobrutinib (1) – Jaypirca®

• Clinical trials
  • For the benefit assessment of pirtobrutinib, the pharmaceutical manufacturer presented the single-arm, ongoing Phase-1/2 trial, BRUIN, to investigate the efficacy, safety and pharmacokinetic properties of pirtobrutinib in adult patients with B-cell neoplasms.

Adults with relapsed or refractory mantle cell lymphoma who have received at least one prior course of treatment with a Bruton’s tyrosine kinase (BTK) inhibitor

• Additional benefit is not proven for pirtobrutinib in the treatment of adults with relapsed or refractory MCL who have previously been treated with a BTK inhibitor.
• As the BRUIN study is a single-arm trial, it does not allow for an assessment of the additional benefit of pirtobrutinib compared with the appropriate comparator therapy and is therefore not suitable for the benefit assessment of pirtobrutinib.
• MAIC analyses compared with aggregated study arms are generally not considered appropriate in the context of benefit assessment.
• Summary of the assessment
  • There are therefore no data available that are suitable for a benefit assessment.
  • An additional benefit of pirtobrutinib for the treatment of adults with relapsed or refractory MCL who have previously been treated with a BTK inhibitor is not proven.

Courtesy translation only, please refer to the German original.