Genentech says Phase III PEMPHIX study met primary endpoint
Genentech, a member of the Roche Group, announced data from the Phase III PEMPHIX study evaluating the efficacy and safety of Rituxan compared to mycophenolate mofetil, or MMF, in adults with moderate to severe pemphigus vulgaris, or PV. The study met the primary endpoint at week 52 and demonstrated that Rituxan is superior to MMF, with 40.3% of patients treated with Rituxan achieving sustained complete remission, or CR, without the use of steroids for 16 consecutive weeks or more, compared to 9.5% in the MMF arm. All secondary endpoints were statistically significant in favor of Rituxan: lower cumulative oral corticosteroid dose, fewer flares, a greater likelihood of sustained CR, a lesser likelihood of flare and a greater improvement in the Dermatology Life Quality Index at week 52 compared to the MMF arm. Adverse events were generally consistent with those seen in previous Rituxan clinical studies in PV and other approved autoimmune indications. The study is ongoing, with patients participating in a 48-week safety follow-up period after treatment completion or discontinuation.