Ibalizumab (1) – Trogarzo®

• Clinical trials
  • The TMB-301 trial is a single-arm Phase III trial of ibalizumab in combination with a patient-specific, optimised background therapy over 25 weeks.
  • TMB-311 is a two-arm parallel-group trial of ibalizumab, conducted over 110 weeks with patients with multi-resistant HIV – as defined in the TMB-301 trial.
  • In the double-blind, randomised controlled trial TNX-355.03, ibalizumab was compared with placebo, both of which were administered in addition to patient-specific OBT.

Adults with a multi-resistant HIV-1 infection for whom no other suppressive antiviral regimen can be formulated

• For adults with a multi-resistant HIV-1 infection for whom no other suppressive antiviral regimen can be formulated, the additional benefit is not proven.
• There are no direct comparative data available for the use of ibalizumab in accordance with the marketing authorisation compared with the appropriate comparator therapy.
• Furthermore, the indirect historical control presented by the pharmaceutical manufacturer is not suitable for deriving additional benefit, meaning that, overall, there are no data available that are suitable for a benefit assessment.
• Overall assessment
  • On balance, the indirect historical control presented is considered unsuitable for assessing the additional benefit of ibalizumab compared with the appropriate comparator therapy.
  • The key factor in this decision is, above all, that the appropriate comparator therapy was not implemented in the comparator arm and that, in the intervention arm, active ingredients (INNs) not yet authorised under the OBT were used, which may skew the study results.
  • Furthermore, it is unclear whether the study population is representative of the indication.
  • Consequently, there are no data relevant to the benefit assessment of ibalizumab, meaning that an additional benefit is not proven.

Courtesy translation only, please refer to the German original.