Roche upbeat on latest rituximab study data
Roche announced data from the phase 3 ‘PEMPHIX’ study evaluating the efficacy and safety of ‘MabThera’/’Rituxan’ (rituximab) compared to mycophenolate mofetil (MMF) in adults with moderate-to-severe pemphigus vulgaris (PV) on Monday.
The Swiss pharmaceuticals giant said the study met the primary endpoint at week 52, and demonstrated that MabThera/Rituxan was superior to MMF, with 40.3% of patients treated with MabThera/Rituxan achieving sustained complete remission (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 favour of MabThera/Rituxan, the firm said, with 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 all reported compared to the MMF arm.
Adverse events were said to be “generally consistent” with those seen in previous MabThera/Rituxan clinical studies in PV, and other approved autoimmune indications.
Roche said results were presented as a late-breaking oral presentation at the 28th Congress of the European Academy of Dermatology and Venereology in Madrid on 12 October.
“The approval of MabThera/Rituxan for the treatment of pemphigus vulgaris was the first major advancement in the treatment of this rare, serious disease in more than 60 years,” said Roche’s chief medical officer and head of global product development Levi Garraway.
“The PEMPHIX study showed that 40% of people in the study could achieve complete remission from painful blistering without the need for corticosteroids for 16 weeks or more and that Mabthera/Rituxan may be a superior treatment option to mycophenolate mofetil.”
The company said the study was ongoing, with patients participating in a 48-week safety follow-up period after treatment completion or discontinuation.
It described PV as a rare, serious and potentially life-threatening condition, characterised by progressive painful blistering of the skin and mucous membranes.
MMF was a commonly used, unapproved treatment for PV that was recommended in published treatment guidelines.
MabThera/Rituxan became the first biologic therapy for PV when it was approved by the FDA in June last year, and the European Commission in March of this year.
Those approvals were based on data from the Roche-supported ‘Ritux 3’ clinical trial.
The PEMPHIX study would provide additional clinical evidence of the effectiveness of MabThera/Rituxan for PV, the firm added.