Roche’s Lunsumio succeeds in follicular lymphoma trial, raising hopes for new option

Roche’s bispecific antibody drug Lunsumio met the primary endpoint in a phase 3 trial in the early treatment of follicular lymphoma.

According to Fierce Pharma on the 18th local time, Roche and its subsidiary Genentech said that the combination of Lunsumio and lenalidomide (brand name Revlimid) significantly improved progression-free survival, both statistically and clinically, compared with the combination of rituximab (brand name Rituxan) and lenalidomide (R2).

The Celestimo phase 3 study enrolled patients with follicular lymphoma who had received at least one prior line of treatment. The study is a confirmatory trial intended to convert Lunsumio’s accelerated approval as a third-line monotherapy into full approval, and it also opens the possibility of moving the drug into the second-line treatment setting.

Roche said overall survival data were not yet mature and added that no new safety signals were identified beyond the established safety profiles of the individual drugs.

Lunsumio competes with Incyte’s Monjuvi and AbbVie and Genmab’s Epkinly. Both drugs received U.S. Food and Drug Administration (FDA) approval last year for second-line follicular lymphoma in combination with R2 as three-drug regimens.

When added to R2, Epkinly reduced the risk of disease progression or death by 79% compared with R2 alone. When added to R2, Monjuvi improved progression-free survival by 57%.

Lunsumio and Epkinly are CD20xCD3 T-cell-engaging antibodies, while Monjuvi is an anti-CD19 antibody.

Levi Garraway, Roche’s chief medical officer and global head of product development, said, “These results suggest that a two-drug outpatient Lunsumio regimen could provide an effective new option earlier in treatment.”

Roche is expanding its CD20xCD3 portfolio across B-cell malignancies. The combination of Lunsumio and the antibody-drug conjugate Polivy is awaiting an FDA decision by February 9, 2027, for second-line diffuse large B-cell lymphoma (DLBCL).

Lunsumio recently moved beyond blood cancers and entered a phase 1 trial in systemic lupus erythematosus.