Roche’s Lunsumio has cleared a key hurdle in the treatment of relapsed or refractory follicular lymphoma, with a Phase III study showing a statistically significant and clinically meaningful improvement in progression-free survival.

 

Overall survival data remained immature at the time of the interim analysis. Roche said the safety profile of the Lunsumio and lenalidomide combination was consistent with the known safety profiles of the individual medicines, with no new safety signals identified.

 

The company said the CELESTIMO data will be submitted to health authorities and presented at an upcoming medical meeting.

 

“People living with relapsed or refractory follicular lymphoma need treatment options that provide meaningful clinical benefit and minimal disruptions to everyday care,” said Levi Garraway, Roche’s Chief Medical Officer and Head of Global Product Development. 

 

“The CELESTIMO results indicate that a two-drug outpatient Lunsumio regimen may offer these patients an effective new option earlier in their treatment journey."

 

The results could support Roche’s push to move Lunsumio into earlier lines of treatment. CELESTIMO is a confirmatory study required to convert the drug’s accelerated approval/conditional marketing authorisation as a monotherapy for third-line or later follicular lymphoma into full approval, while also supporting a potential indication in second-line or later disease.

 

Lunsumio is a CD20xCD3 bispecific antibody designed to activate and redirect a patient’s T cells against malignant B cells. Roche says the treatment is designed to offer outpatient administration, with flexibility between intravenous and subcutaneous formulations.

 

The drug is already approved for third-line or later follicular lymphoma in 60 countries and has been used to treat more than 3,800 patients, according to Roche.

 

The company is also testing Lunsumio across a broader range of blood cancers and treatment settings.