Overview
- Eligible patients are adults with relapsed or refractory follicular lymphoma after two or more prior systemic therapies, reflecting the population studied in GO29781.
- Primary data from the phase 1/2 trial show a 75% overall response rate with a 59% complete response rate and a median duration of response of about 22.4 months.
- Additional outcomes reported for the subcutaneous cohort include a median progression-free survival of 23.7 months and overall survival not reached, with efficacy measures similar to intravenous dosing.
- Safety findings include high overall adverse event rates, with cytokine release syndrome in roughly 30% of patients that was mostly low grade and resolved after a median of two days.
- The subcutaneous regimen is a fixed-duration therapy administered in about one minute versus two to four hours intravenously, and the European Commission granted a related conditional authorization in November.