Roche is seeking a label expansion to use Lunsumio (mosunetuzumab) at an earlier stage after it showed benefit in a Phase III relapsed or refractory (R/R) follicular lymphoma (FL) study.
In the CELESTIMO study (NCT04712097), Lunsumio (mosunetuzumab) was evaluated in combination with lenalidomide compared to MabThera (rituximab) plus lenalidomide in R/R FL patients who had received at least one prior line of treatment.
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The trial met its primary endpoint of a statistically significant and clinically meaningful improvement in progression-free survival (PFS).
Overall survival (OS) data were immature at the time of interim analysis.
The safety profile of the Lunsumio and lenalidomide combination was consistent with the known profiles of the individual medicines.
Dr Levi Garraway, Roche’s CMO and head of global product development, said: “People living with R/R FL need treatment options that provide meaningful clinical benefit and minimal disruptions to everyday care. The CELESTIMO results indicate that a two-drug outpatient Lunsumio regimen may offer these patients an effective new option earlier in their treatment journey.”
CELESTIMO is a confirmatory study Roche initiated to convert the US Food and Drug Administration’s (FDAs) accelerated approval and European Medicines Agency’s (EMAs) conditional marketing authorisation of Lunsumio as a third-line or later monotherapy to full approval, as well as to secure approval in second-line or later.
These authorisations were granted based on data from the Phase I/II GO29781 (NCT02500407) trial in which Lunsumio was investigated as a single agent and in combination with Roche’s Tecentriq (atezolizumab).
Objective response rate (ORR) was examined in 90 patients with R/R FL who had been treated with two prior lines of systemic therapy, including an anti-CD20 monoclonal antibody and an alkylating agent. The trial yielded positive results with an ORR of 80% and 57% of patients maintaining responses for at least 18 months. A median duration of response (DOR) of 22.8 months and a complete response of 60% were also observed in these patients.
FL is a haematological cancer in which B lymphocytes (B cells) become cancerous and accumulate in ‘follicles’ in the lymph nodes. It is the most common subtype of indolent non-Hodgkin’s lymphoma (NHL) and constitutes approximately one in five cases of NHL. Most FL patients can achieve a durable complete or partial response after front-line induction chemoimmunotherapy. However, the cure rate for FL with early progression remains low, and most patients who relapse have poor overall survival (OS) rates.
Lunsumio is part of Roche’s cluster of differentiation (CD)20xCD3 bispecific antibody portfolio, alongside Columvi (glofitamab).
In 2025, Lunsumio plus Polivy (polatuzumab vedotin) showed benefit in a Phase III trial in patients with R/R large B-cell lymphoma (LBCL) who are ineligible for transplant.
A GlobalData report predicts that across the seven major markets (7MM: US, France, Germany, Italy, Spain, UK, and Japan), the B-cell NHL market will see slow growth from 2023 to 2033, at a compound annual growth rate (CAGR) of 2.6%, climbing from $7.66bn in 2023 to $10bn by 2033.
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