Rozanolixizumab is subcutaneous infused monoclonal antibody targeting the neonatal Fc receptor (FcRn) in adult with MG.
As already presented previously, the phase 3 MycarinG study (NCT03971422) testing weekly subcutaneous rozanolixizumab 7-mg/kg (n = 66) and 10-mg/kg (n = 67) for 6 weeks against placebo (n = 67) showed promising results in gMG.
Briefly:
*MG-ADL was improved by at least 2 points in approximately 70% of patients for both dosages, compared to 31.3% for the placebo group.
*qMG scores, improved by at least 3 points in 54.7%, and 72.6%, in the rozanolixizumab 7-mg/kg, 10-mg/kg groups respectively, compared to 39.1% in the placebo group.
*Finally, 25.8% and 28.4% of patients in the 7-mg/kg and 10-mg/kg groups had minimal symptom expression, against only 3.0% on the placebo arm.
Then a subgroup analyse was performed, using MG-ADL as the main endpoint, showing that the treatment was also effective across subgroups of patients after 43-days of treatment, regardless of prior therapy use, disease severity or disease duration.
*For patient with at least one prior therapy, a least square mean (LSM) changes of –3.2, –3.3 and –1.0 was observed in MG-ADL, on rozanolixizumab 7 mg/kg, 10 mg/kg, and placebo groups, respectively.
*For those on at least 2 prior MG therapies, mean observed change from baseline was –2.5, –3.0, and –0.8, in the respective groups.
*For those with QMG scores less than 15, mean observed changes from baseline were −3.7, −2.6, and −0.6, respectively.
*For those with QMG scores greater than 15, the mean observed changes from baseline were −3.0, −4.0, and −0.7, respectively.
*For patients with disease duration inferior than 4 years, LSM changes was of –2.9, –3.1, and –0.6 for MG-ADL.
*For those with longer disease duration, LSM changes were –3.8 and –3.3, respectively, compared with changes of –0.7 for those on placebo.
In terms of safety, TEAEs occurred in 81.3% (n = 52), 82.6% (n = 57), and 67.2% (n = 45) for the respective groups.
Key Points:
- Rozanolixizumab is subcutaneous infused monoclonal antibody targeting the neonatal Fc receptor (FcRn) in adult with MG.
- Rozanolixizumab is also effective across subgroups of patients after 43-days of treatment, regardless of prior therapy use, disease severity or disease duration.
- safety data were also encouraging
References:
- Bril V, Druzdz A, Grosskreutz J, et al. Rozanolixizumab in generalized myasthenia gravis: responder analyses from the randomized phase 3 MycarinG study. Presented at: AANEM Annual Meeting; 2022. Abstract 204
- Vu T, Druzdz A, Habib AA, et al. Efficacy of rozanolixizumab in generalized myasthenia gravis: subgroup analyses from the randomized phase 3 MycarinG study. Presented at: 2023 AAN Annual Meeting; Abstract 002951
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