Genentech announced positive top line results from the Roche-sponsored Phase III Pemphix study evaluating the efficacy and safety of Rituxan (rituximab) compared to mycophenolate mofetil (MMF) in adults with moderate to severe pemphigus vulgaris (PV). The study met the primary endpoint, and demonstrated that Rituxan is superior to MMF in achieving sustained complete remission.
“The Pemphix study provides additional clinical evidence for the use of Rituxan for the treatment of pemphigus vulgaris,” said Sandra Horning, M.D., chief medical officer and head of Global Product Development. “These data also demonstrated that Rituxan may provide complete remission rates and successful tapering of corticosteroid therapy that is superior to MMF in adults with pemphigus vulgaris.”
The primary endpoint was the percentage of participants who achieved sustained complete remission off corticosteroid therapy (no disease activity, as evaluated by Pemphigus Disease Area Index, without the use of steroids for 16 consecutive weeks or more) at Week 52. Rituxan also met the secondary endpoints, including cumulative corticosteroid dose, number of flares, time to sustained remission, and time to disease flare. Adverse events were generally consistent with those seen in previous Rituxan clinical studies for other autoimmune indications.
PV is a rare, serious, and potentially life-threatening condition characterized by progressive painful blistering of the skin and mucous membranes. MMF is an unapproved treatment for PV that is accepted as standard of care. In June 2018, Rituxan became the first biologic therapy approved by the FDA for PV and the first major advancement in the treatment of the disease in more than 60 years. This approval was based on the Ritux 3 clinical trial. This Pemphix trial provided additional clinical evidence on the effectiveness of Rituxan for PV. Complete data from the Pemphix study will be presented at an upcoming medical congress.
Filed Under: Orphan Drugs
