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News|Articles|September 18, 2026
Mosunetuzumab Combo Improves PFS in R/R Follicular Lymphoma
Author(s)Andrea Eleazar, MHS
Fact checked by: Sabrina Serani
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Key Takeaways
- CELESTIMO established superior PFS for mosunetuzumab/lenalidomide over R2 in R/R FL, positioning the bispecific-containing regimen as a potential new standard after ≥1 prior line.
- Interim OS data are not yet definitive, underscoring the need for longer follow-up to characterize survival impact and durability beyond PFS.
CELESTIMO trial shows mosunetuzumab plus lenalidomide boosts PFS in relapsed follicular lymphoma, supporting earlier-line outpatient, chemo-free care.
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The phase 3 CELESTIMO trial (NCT05529524) combining mosunetuzumab (Lunsumio) with lenalidomide (Revlimid) met its primary end point, showing a statistically significant improvement in progression-free survival (PFS) compared with rituximab (Rituxan) plus lenalidomide in patients with relapsed or refractory follicular lymphoma (R/R FL).1
At interim analysis, a statistically significant and clinically meaningful PFS benefit with mosunetuzumab was observed; overall survival (OS) data remained immature at the time of analysis. The safety profile was reported to be consistent with the known safety profiles of the individual study drugs, with no new safety signals identified. According to the sponsor, full data will be submitted to health authorities and presented at an upcoming medical meeting.
“People living with [R/R FL] need treatment options that provide meaningful clinical benefit and minimal disruptions to everyday care,” Levi Garraway, MD, PhD, chief medical officer and head of global product development at Roche, stated in a news release.1 “The CELESTIMO results indicate that a 2-drug outpatient [mosunetuzumab] regimen may offer these patients an effective new option earlier in their treatment journey."
About Mosunetuzumab
Mosunetuzumab is a CD20xCD3 bispecific antibody currently indicated as fixed-duration monotherapy for treatment of adult patients with R/R FL after 2 or more lines of systemic therapy. In R/R FL, the FDA approved the intravenous formulation in December 2022 under an accelerated pathway2; 3 years later, the agency approved the subcutaneous formulation (Lunsumio VELO) in
About CELESTIMO
CELESTIMO is a confirmatory phase 3 trial required to convert the current accelerated approval of mosunetuzumab monotherapy in the third-line setting to a full traditional approval, and to also support an indication in second-line or later.3
The study is evaluating the efficacy and safety of mosunetuzumab in combination with lenalidomide compared with rituximab plus lenalidomide, an established immunomodulatory treatment approach in R/R FL, in patients who have received at least 1 prior line of systemic therapy. The study is intended to evaluate whether the mosunetuzumab-based regimen can provide a treatment option earlier in the course of R/R disease.
The combination is also being investigated as an outpatient treatment regimen, with the potential to provide a fixed-duration, nonchemotherapy approach for patients with R/R FL.
Moving Mosunetuzumab Into Earlier Lines
The potential expansion of mosunetuzumab into earlier lines of therapy could broaden the population treated with a CD20xCD3 bispecific antibody. Detailed data from CELESTIMO, including the magnitude of PFS benefit, safety findings, outcomes across patient subgroups, as well as longer follow-up and subsequent OS analyses, will help further define the role of the mosunetuzumab combination in these settings.
REFERENCES
1. Roche’s Lunsumio-based regimen significantly improves progression-free survival in follicular lymphoma in phase III CELESTIMO study. News release. September 16, 2026. Accessed September 17, 2026. https://tinyurl.com/4jm9rtj8
2. FDA Approves Genentech’s First-in-Class Medicine for Relapsed/Refractory Follicular Lymphoma After at Least Two Prior Therapies. News release. Genentech. December 22, 2022. Accessed September 18, 2026. https://tinyurl.com/55zecpbk
3. Signatures of Response and Resistance to Mosunetuzomab in Follicular Lymphomas (FL). ClinicalTrials.gov. Updated January 24, 2025. Accessed September 18, 2026. https://clinicaltrials.gov/study/NCT05529524
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