Nipocalimab (1) – Imaavy®

• Clinical trials
  • The VIVACITY-MG3 trial is an ongoing, double-blind, randomised controlled trial comparing treatment with nipocalimab against placebo over 24 weeks, in each case in addition to an existing stable standard therapy.
  • The VIBRANCE-MG trial is an ongoing, single-arm trial of nipocalimab in addition to current, stable standard therapy.

a) Adults with acetylcholine receptor antibody-positive generalised myasthenia gravis who are eligible for add-on treatment to standard therapy

• Consequently, the additional benefit of nipocalimab over the appropriate comparator therapy is not proven for this patient group.
• Overall assessment
  • For adults with generalised myasthenia gravis who have antibodies against AChR and who are eligible for add-on treatment to standard therapy, no data are available for comparison with the appropriate comparator therapy.
  • In the double-blind, randomised, controlled, pivotal Phase III VIVACITY-MG3 trial, the efficacy and safety of nipocalimab were compared with placebo. The trial therefore does not allow for a comparison with the specific appropriate comparator therapy.

b) Adults with muscle-specific tyrosine kinase antibody-positive generalised myasthenia gravis who are eligible for treatment as an adjunct to standard therapy

• Consequently, the additional benefit of nipocalimab over the appropriate comparator therapy is not proven for this patient group.
• Overall assessment
  • For adults with generalised myasthenia gravis who are MuSK-antibody-positive and who are eligible for add-on treatment to standard therapy, no data are available for comparison with the appropriate comparator therapy.
  • In the double-blind, randomised, controlled, pivotal Phase III VIVACITY-MG3 trial, the efficacy and safety of nipocalimab were compared with placebo. The trial therefore does not allow for a comparison with the specific appropriate comparator therapy.

c) Adolescents with acetylcholine receptor antibody-positive refractory generalised myasthenia gravis who are eligible for adjunctive treatment alongside standard therapy

• An additional benefit of nipocalimab over the appropriate comparator therapy is not proven for this patient group.
• Overall assessment
  • For adolescents with anti-AChR-antibody-positive, refractory generalised myasthenia gravis who are eligible for add-on therapy to standard treatment, no data are available for comparison with the appropriate comparator therapy.
  • The single-arm VIBRANCE-MG study, which included adolescents with generalised myasthenia gravis, is not suitable for a benefit assessment due to the lack of a comparator.

d) Adolescents with acetylcholine receptor antibody-positive non--refractory generalised myasthenia gravis, or with muscle-specific tyrosine kinase antibody-positive generalised myasthenia gravis, who are eligible for add-on treatment to standard therapy

• There is no additional benefit of nipocalimab over the appropriate comparator therapy for adolescents with AChR-antibody-positive non--refractory generalised myasthenia gravis, or with MuSK-antibody-positive generalised myasthenia gravis, who are eligible for adjunctive treatment alongside standard therapy, has therefore not been proven.
• Overall assessment
  • No directly comparable studies are available for adolescents with AChR-antibody-positive non-refractory generalised myasthenia gravis, or with MuSK-antibody-positive generalised myasthenia gravis, who are eligible for adjunctive treatment alongside standard therapy.
  • However, the VIVACITY-MG3 study in adults is not suitable for establishing any additional benefit. This is due in particular to the fact that the adults in the control arm of the VIVACITY-MG3 study were inadequately treated.
  • Based on the available information, it can be assumed that, at the start of the study, there were still options for optimising treatment for the patients in the comparator arm of the study. Adjustments to standard therapy were not permitted during the course of the study, with the exception of symptomatic treatment with acetylcholinesterase inhibitors, and were not carried out in the relevant patient population either.
  • Overall, the data presented for a patient population from the VIVACITY-MG3 study comparing nipocalimab with placebo in adults with generalised myasthenia gravis are not suitable for a benefit assessment. Consequently, these data cannot be used to extrapolate the evidence to the adolescent population. Furthermore, insufficient information was provided to support the evidence transfer.

Courtesy translation only, please refer to the German original.