Biotechnology company Genentech, a member of the Roche Group (SIX: RO, ROG) (OTCQX: RHHBY), announced on Thursday that its Phase III CELESTIMO study of Lunsumio (mosunetuzumab-axgb) plus lenalidomide met its primary endpoint in relapsed or refractory follicular lymphoma.
The regimen produced a statistically significant and clinically meaningful improvement in progression-free survival compared with Rituxan (rituximab) plus lenalidomide in patients who had received at least one prior line of treatment.
Overall survival data were immature at the interim analysis, while the safety profile was consistent with the known profiles of the individual medicines and showed no new safety signals.
Genentech plans to submit the data to health authorities and present the findings at an upcoming medical meeting.
CELESTIMO is intended to support conversion of Lunsumio monotherapy's accelerated approval or conditional marketing authorisation in third-line or later follicular lymphoma to full approval and establish an indication in second-line or later disease.
Lunsumio is already approved for third-line or later follicular lymphoma in 60 countries and has been used to treat more than 3,800 patients.
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