Roche and Genentech announced on September 17, 2026, that the Phase 3 Celestimo trial of Lunsumio combined with lenalidomide met its primary endpoint, showing statistically and clinically meaningful improvement in progression-free survival for follicular lymphoma patients. The trial serves as a confirmatory study to convert Lunsumio's accelerated approval into full approval and potentially expand its use to second-line treatment, where it faces competition from Epkinly and Monjuvi.
Lunsumio Celestimo trial results
- ▪The Phase 3 Celestimo trial evaluated Lunsumio combined with lenalidomide against rituximab plus lenalidomide in follicular lymphoma patients who received at least one prior line of treatment.
- ▪Roche reported on September 17, 2026, that overall survival data from the Phase 3 Celestimo trial were immature, and no new safety signals were identified beyond the known profiles of each drug.
- ▪Roche and Genentech announced on September 17, 2026, that the Phase 3 Celestimo trial of Lunsumio combined with lenalidomide met its primary endpoint of progression-free survival.
Second-line follicular lymphoma competitors
- ▪Incyte's Monjuvi combined with rituximab and lenalidomide improved progression-free survival by 57% in second-line-plus follicular lymphoma patients in the Phase 3 inMind trial.
- ▪AbbVie and Genmab's Epkinly combined with rituximab and lenalidomide reduced the risk of disease progression or death by 79% compared to rituximab and lenalidomide alone in the Phase 3 Epcore FL-1 trial.
- ▪Gilead Sciences' CD19 CAR-T therapy Yescarta is being evaluated in the Phase 3 Zuma-22 trial, and BeOne Medicines is testing Brukinsa with Gazyva in the Phase 3 Mahogany trial for previously treated follicular lymphoma.
Lunsumio regulatory pathway
- ▪The Phase 3 Celestimo trial results could potentially expand Lunsumio's label to move the drug earlier into the second-line treatment setting for follicular lymphoma.
- ▪The Phase 3 Celestimo trial serves as the confirmatory study required to convert Lunsumio's accelerated approval as a monotherapy in third-line follicular lymphoma into full approval.
Roche CD20xCD3 bispecific portfolio
- ▪Roche is evaluating its other CD20xCD3 bispecific antibody, Columvi, in the Skyglo trial for first-line diffuse large B-cell lymphoma, and has moved Lunsumio into a Phase 1 systemic lupus erythematosus trial.
- ▪Roche's combination of Lunsumio and its antibody-drug conjugate Polivy is awaiting an FDA decision for second-line diffuse large B-cell lymphoma by February 9, 2027.
Debatable claims
- ▪The FDA should fully approve Roche's Lunsumio despite immature overall survival data
- ▪Bispecific antibodies should be preferred over CAR-T therapies for second-line follicular lymphoma
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