Positive Phase III Results for Roche's Gazyva/Gazyvaro
Roche announced statistically significant and clinically meaningful results from the phase III INShore study of Gazyva/Gazyvaro in children and young adults with idiopathic nephrotic syndrome.
- The study met its primary endpoint, with more people achieving sustained complete remission at one year with Gazyva/Gazyvaro compared to mycophenolate mofetil.
- Sustained complete remission was defined by the absence of relapses and a low amount of protein in the urine at week 52.
- Certain key secondary endpoints were also met, with no new safety signals identified.
Safety was in line with the well-characterised profile of Gazyva/Gazyvaro in adults.
No new safety signals were identified and safety was in line with the well-characterised profile of Gazyva/Gazyvaro in adults.
Author's summary: Roche's Gazyva/Gazyvaro shows positive results in phase III study.