Roche's Lunsumio clears late-stage hurdle in follicular lymphoma

Roche (RHHBY) has scored another win for its T-cell engager portfolio, after a phase 3 trial showed its drug Lunsumio improved outcomes for patients with follicular lymphoma who have received earlier treatment.

The company and its subsidiary Genentech said the Celestimo study met its primary endpoint. Lunsumio combined with lenalidomide delivered a statistically and clinically meaningful improvement in progression-free survival over rituximab plus lenalidomide, a regimen known as R2. Roche released no figures.

The trial enrolled patients who had undergone at least one prior line of therapy. It is the confirmatory study needed to convert Lunsumio's accelerated approval as a third-line monotherapy into full approval, and it could also open the door to use in the second-line setting.

Roche said overall survival data were immature and that no new safety signals emerged beyond the known profiles of each drug.

Detailed results will matter for how investors and clinicians judge the Lunsumio doublet against two rivals that won US approval last year for second-line follicular lymphoma, both as three-drug regimens built on R2. Incyte's (INCY) Monjuvi improved progression-free survival by 57 per cent in the phase 3 inMind trial. Epkinly, from AbbVie (ABBV) and Genmab (GMAB), cut the risk of progression or death by 79 per cent in the Epcore FL-1 study. Epkinly is, like Lunsumio, a CD20xCD3 T-cell engager, while Monjuvi targets CD19.

Levi Garraway, Roche's chief medical officer and head of global product development, said the results "indicate that a two-drug outpatient Lunsumio regimen may offer these patients an effective new option earlier in their treatment journey."

The field is set to become more crowded. Gilead Sciences (GILD) is testing its CD19 CAR-T therapy Yescarta in the phase 3 Zuma-22 trial in second-line-plus follicular lymphoma. BeOne Medicines (ONC) is pairing its BTK inhibitor Brukinsa with Roche's CD20 antibody Gazyva in the phase 3 Mahogany trial, which also covers marginal zone lymphoma.

Roche is deploying its CD20xCD3 bispecifics across B-cell cancers. The FDA is due to decide by February 9, 2027 on Lunsumio combined with the antibody-drug conjugate Polivy in second-line diffuse large B-cell lymphoma. Attention is also turning to the forthcoming Skyglo readout for Columvi, Roche's other bispecific, in first-line DLBCL.

Roche has also taken Lunsumio beyond oncology, into an early-stage trial in systemic lupus erythematosus.