Axicabtagen-Ciloleucel (4) – Yescarta®

• Clinical trials
  • The ZUMA-5 trial is an ongoing, single-arm, multicentre Phase II trial investigating the efficacy and safety of axicabtagen-ciloleucel in adult patients with indolent B-cell lymphoma, with the histological subtype restricted to grade 1, 2 or 3a follicular lymphoma or marginal zone lymphoma (according to the 2016 WHO classification).
  • The SCHOLAR-5 study is a retrospective, multicentre study based on electronic health records, involving patients with relapsed or refractory indolent non-Hodgkin’s lymphoma.

Adults with relapsed or refractory follicular lymphoma following three or more courses of systemic therapy

• An additional benefit is not proven.
• Consequently, there are no suitable data available to enable an assessment of the additional benefit, which is why an additional benefit of axicabtagen-ciloleucel in patients with relapsed or refractory follicular lymphoma following three or more systemic therapies is not proven.
• Overall assessment
  • The comparison presented of individual arms from the ZUMA-5 and SCHOLAR-5 studies is not suitable for benefit assessment of axicabtagen-ciloleucel, particularly due to the questionable structural equivalence between the treatment arms and the lack of systematic identification of potential confounders.

Courtesy translation only, please refer to the German original.