
Lunsumio Plus Revlimid Delays Follicular Lymphoma Progression
Key Takeaways
- Mosunetuzumab plus lenalidomide reduced progression risk versus rituximab plus lenalidomide, meeting the phase 3 primary endpoint of progression-free survival in relapsed/refractory follicular lymphoma after ≥1 prior therapy.
- Interim analysis limits interpretability of survival impact, as overall survival is not yet mature and the magnitude of PFS benefit has not been reported in top-line communication.
Lunsumio added to Revlimid kept relapsed or refractory follicular lymphoma from worsening longer than Rituxan plus Revlimid in the phase 3 CELESTIMO trial.
Patients with follicular lymphoma that returned or stopped responding after at least one previous treatment went longer without their disease worsening when treated with Lunsumio (mosunetuzumab) plus Revlimid (lenalidomide), according to top-line findings from the phase 3 CELESTIMO trial.
The trial compared Lunsumio plus Revlimid with Rituxan (rituximab) plus Revlimid and met its primary end point of progression-free survival, the length of time patients lived without their cancer growing or spreading.
Roche, the manufacturer of Lunsumio, described the improvement as clinically meaningful and statistically significant. However, the company has not yet released specific progression-free survival numbers, making it unclear how much longer patients went without their disease worsening.
Follicular lymphoma is a type of non-Hodgkin lymphoma that can return after periods of remission. For patients whose disease comes back, additional treatment options may become necessary as they move through different lines of therapy.
"People living with relapsed or refractory follicular lymphoma need treatment options that provide meaningful clinical benefit and minimal disruptions to everyday care," Dr. Levi Garraway said in the release. "The CELESTIMO results indicate that a two-drug outpatient Lunsumio regimen may offer these patients an effective new option earlier in their treatment journey."
What did the phase 3 CELESTIMO trial find in follicular lymphoma?
Patients treated with Lunsumio plus Revlimid had a lower risk of their cancer progressing than those treated with Rituxan plus Revlimid.
The findings came from an interim analysis, a planned evaluation of the trial before all follow-up is complete. Overall survival data, which measure how long patients live regardless of whether their disease worsens, were not yet mature enough to determine whether the Lunsumio combination helped patients live longer overall.
Roche plans to present more detailed CELESTIMO findings at an upcoming medical meeting and submit the results to health authorities.
How does Lunsumio work in follicular lymphoma?
Lunsumio is a bispecific antibody, meaning it attaches to two different targets at the same time. The drug binds to CD20 on B cells and CD3 on T cells, bringing the immune cells close to the cancerous B cells so the T cells can attack them.
Lunsumio is already approved for adults with relapsed or refractory follicular lymphoma who have received at least two previous treatments. In that setting, it is given on its own for a fixed period of time.
CELESTIMO is evaluating whether Lunsumio can benefit patients earlier, after at least one previous treatment, when combined with Revlimid. Roche plans to use the results to seek approval for the combination in this earlier treatment setting.
Who was included in the CELESTIMO trial?
CELESTIMO enrolled adults with relapsed or refractory follicular lymphoma who had received at least one previous systemic treatment.
Patients received either Lunsumio plus Revlimid or Rituxan plus Revlimid. Participants were treated at sites in the United States and 14 other countries.
What side effects were seen with Lunsumio and Revlimid?
No new safety concerns emerged with Lunsumio plus Revlimid, according to Roche. The company reported that the safety findings were consistent with the known side effects of the individual medicines.
Detailed rates of specific side effects have not yet been released with the top-line findings.
The combination is designed as an outpatient treatment, meaning patients can receive it without being admitted to the hospital.
A separate phase 3 trial, MorningLyte, is evaluating Lunsumio plus Revlimid as an initial treatment for people with follicular lymphoma.
References
- News release. "Roche's Lunsumio-based regimen significantly improves progression-free survival in follicular lymphoma in phase III CELESTIMO study." Roche. Posted: Sept. 17, 2026.
- "A Study Evaluating the Efficacy and Safety of Mosunetuzumab in Combination With Lenalidomide in Comparison to Rituximab in Combination With Lenalidomide With a US Extension of Mosunetuzumab in Combination With Lenalidomide in Participants With Follicular Lymphoma." ClinicalTrials.gov. NCT04712097.
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