Roche CELESTIMO study meets phase III endpoint in relapsed follicular lymphoma

  • Roche reported that the phase III CELESTIMO study met its primary endpoint.
  • CELESTIMO showed statistically significant improvement in progression-free survival at interim analysis.
  • Roche plans to submit the data to health authorities and present them at a medical meeting.

Roche said its phase III CELESTIMO study met its primary endpoint, showing a statistically significant and clinically meaningful improvement in progression-free survival for people with relapsed or refractory follicular lymphoma who had received at least one prior line of treatment. The trial compared Lunsumio (mosunetuzumab) plus lenalidomide with MabThera/Rituxan (rituximab) plus lenalidomide. Overall survival data were immature at the interim analysis. The combination's safety profile was consistent with the known profiles of the individual medicines, with no new safety signals. Roche plans to submit the results to health authorities and present them at an upcoming medical meeting. The company said the findings support efforts to expand Lunsumio, a CD20xCD3 bispecific antibody that redirects T cells to attack malignant B cells, into earlier-line follicular lymphoma treatment. Lunsumio is already approved for third-line or later disease in 60 countries and has treated more than 3,800 patients, while the phase III MorningLyte study continues in first-line follicular lymphoma.

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