Roche Seeks Earlier Use for Lunsumio in Follicular Lymphoma After Positive Phase III CELESTIMO Results

Roche has filed to expand the approved use of Lunsumio (mosunetuzumab) so it can be used earlier in the treatment pathway for follicular lymphoma (FL), after the Phase III CELESTIMO study showed a meaningful benefit on progression-free survival (PFS) when mosunetuzumab was combined with lenalidomide versus rituximab plus lenalidomide.

Key CELESTIMO Findings

The CELESTIMO trial (NCT04712097) compared mosunetuzumab plus lenalidomide against rituximab (MabThera) plus lenalidomide in patients with relapsed or refractory (R/R) FL who had received at least one prior systemic therapy. The study met its primary endpoint with a statistically significant and clinically meaningful improvement in PFS for the Lunsumio combination arm. At the interim analysis, overall survival (OS) data remained immature.

Safety

The safety profile observed with mosunetuzumab plus lenalidomide was consistent with the known safety profiles of each agent when used alone. No new safety signals were reported in the interim readout.

Background: Earlier Clinical Data and Regulatory Context

CELESTIMO was launched as a confirmatory Phase III study to convert Lunsumio's earlier regulatory pathways—the US Food and Drug Administration's (FDA) accelerated approval and the European Medicines Agency's (EMA) conditional marketing authorisation for third-line or later monotherapy—into full approvals and to support potential approval for second-line use.

Those earlier authorisations were based on the Phase I/II GO29781 programme (NCT02500407), which evaluated Lunsumio as a single agent and in combination with atezolizumab (Tecentriq). In 90 patients with R/R FL who had received two prior lines of systemic therapy (including an anti-CD20 antibody and an alkylating agent), GO29781 reported an objective response rate (ORR) of 80%, a median duration of response (DOR) of 22.8 months, and complete response (CR) rates of 60%; 57% of responders maintained responses for at least 18 months.

Broader Development And Market Context

Lunsumio is part of Roche's CD20xCD3 bispecific antibody portfolio alongside Columvi (glofitamab). Separately, in 2025 a combination of Lunsumio plus Polivy (polatuzumab vedotin) showed benefit in a Phase III trial for relapsed or refractory large B-cell lymphoma (LBCL) in patients ineligible for transplant.

A GlobalData analysis forecasts modest growth in the B-cell non-Hodgkin's lymphoma (NHL) market across the seven major markets (7MM: US, France, Germany, Italy, Spain, UK and Japan), with a compound annual growth rate (CAGR) of about 2.6% from $7.66 billion in 2023 to roughly $10 billion by 2033. (GlobalData is the parent company of Clinical Trials Arena.)

What This Means

If regulators accept the CELESTIMO data, Lunsumio could be approved for earlier use in FL, potentially offering an effective outpatient two-drug regimen that may reduce treatment burden for patients with relapsed or refractory disease. Longer follow-up for OS and continued safety monitoring will be important to confirm long-term benefit.

Quote: "People living with R/R FL need treatment options that provide meaningful clinical benefit and minimal disruptions to everyday care," said Dr 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."

This article was originally published by Clinical Trials Arena, a GlobalData-owned brand.