Roche’s T-cell engager portfolio has notched another milestone, as a phase 3 trial of the company’s Lunsumio met its primary endpoint in earlier-line follicular lymphoma.
Without sharing any specific data, Roche and its subsidiary Genentech said Lunsumio’s combination with lenalidomide (Revlimid) demonstrated a statistically and clinically meaningful improvement in progression-free survival against rituximab (Rituxan) plus lenalidomide, known as R2, in the phase 3 Celestimo study.
The trial enrolled follicular lymphoma (FL) patients who have received at least one prior line of treatment, and it serves as the confirmatory study required to convert Lunsumio’s existing accelerated approval as a monotherapy in third-line FL into a full approval, while also potentially moving the drug earlier into the second-line setting.
Besides the positive PFS readout, Roche said overall survival data were immature but did not offer any further description. No new safety signals were identified beyond the known profile of each drug, the company added.
Detailed data could help doctors and industry watchers understand the Lunsumio doublet’s position against Incyte’s Monjuvi and AbbVie and Genmab’s Epkinly, both of which won FDA approvals for second-line FL last year in three-drug regimens with R2.
An in-class competitor to Lunsumio, Epkinly, used on top of R2, reduced second-line-plus patients’ risk of disease progression or death by 79% versus R2 alone, the phase 3 Epcore FL-1 trial showed.
For its part, the addition of Monjuvi to R2 improved PFS 57% among second-line-plus patients in the phase 3 inMind trial.
Both Lunsumio and Epkinly are CD20xCD3 T-cell engagers, while Monjuvi is an anti-CD19 antibody.
The new Celestimo results “indicate that a two-drug outpatient Lunsumio regimen may offer these patients an effective new option earlier in their treatment journey,” Levi Garraway, M.D., Ph.D., Roche’s chief medical officer and head of global product development, said in a statement.
In addition to the three antibody drugs, Gilead Sciences’ CD19 CAR-T, Yescarta, is being tested in the phase 3 Zuma-22 trial in second-line-plus FL. At the same time, BeOne Medicines is combining its small-molecule BTK inhibitor Brukinsa with Roche’s CD20 antibody Gazyva in the phase 3 Mahogany trial in previously treated FL and marginal zone lymphoma.
Roche is targeting its CD20xCD3 portfolio across B-cell malignancies. The Swiss pharma’s combination of Lunsumio and its antibody-drug conjugate Polivy is awaiting an FDA decision in second-line diffuse-large B-cell lymphoma (DLBCL) by Feb. 9, 2027. Meanwhile, all eyes are on an upcoming readout from Roche’s Skyglo trial for the company’s other CD20xCD3 bispecific, Columvi, in first-line DLBCL.
Lunsumio was also recently moved outside blood cancers and into a phase 1 systemic lupus erythematosus trial.