Mosunetuzumab plus lenalidomide met the CELESTIMO trial's primary end point, improving PFS in relapsed/refractory follicular lymphoma.
Mosunetuzumab (Lunsumio) plus lenalidomide (Revlimid) improved progression-free survival (PFS) vs rituximab (Rituxan) plus lenalidomide in patients with relapsed/refractory follicular lymphoma who had received at least 1 prior line of systemic therapy, meeting the primary end point of the phase 3 CELESTIMO study (NCT04712097).1
At interim analysis of the phase 3 CELESTIMO trial (NCT04712097), investigators reported a statistically significant and clinically meaningful improvement in PFS favoring the mosunetuzumab-based regimen. Moreover, overall survival (OS) data remained immature at the time of the analysis.
The safety profile of the mosunetuzumab/lenalidomide combination was consistent with the known safety profiles of the individual agents, with no new safety signals identified.
In the news release, Roche stated that data from the study will be submitted to health authorities and presented at an upcoming medical meeting.
"The CELESTIMO results indicate that a two-drug outpatient [mosunetuzumab plus lenalidomide] regimen may offer these patients an effective new option earlier in their treatment journey," said Levi Garraway, MD, PhD, chief medical officer and head of Global Product Development for Roche in a news release. “People living with relapsed/refractory follicular lymphoma need treatment options that provide meaningful clinical benefit and minimal disruptions to everyday care.”
CELESTIMO is the confirmatory study required to convert the
The randomized, open-label, multicenter trial enrolled patients with histologically documented CD20-positive follicular lymphoma that was grade 1 to 3a who had received at least 1 prior line of systemic therapy including immunotherapy or chemoimmunotherapy.2 Patients also need to have an ECOG performance status of 2 or less, adequate hematologic function, and require systemic therapy per tumor size/Groupe d'Etude des Lymphomes Folliculaires criteria.
If patients had grade 3b follicular lymphoma, history of disease transformation, diffuse large B-cell lymphoma, central nervous system lymphoma, leptomeningeal infiltration, history of solid organ transplantation, or received systemic immunosuppressive medications within 2 weeks of their first dose they were not included in the trial.
The trial has enrolled 478 patients, and randomly assigned them to mosunetuzumab plus lenalidomide or rituximab plus lenalidomide.
In the mosunetuzumab arm, mosunetuzumab was administered intravenously (IV) on days 1, 8, and 15 of cycle 1 which was 21 days, and then on day 1 of cycles 2 to 12 which were 28-day cycles. Additionally, patients in this arm received oral lenalidomide on days 1 through 21 of cycles 2 through 12.
In the rituximab arm, patients received IV rituximab on days 1, 8, 15, and 22 of cycle 1, then on day 1 of cycles 3, 5, 7, 9, and 11, plus oral lenalidomide on days 1 through 21 of cycles 1 to 12.
Patients in each arm received tocilizumab (Actemra) as needed to help manage instances of cytokine release syndrome.
The primary end point was PFS per 2014 Lugano Response Criteria. Secondary end points of the trial included investigator-assessed PFS, complete response rate, overall response rates, OS, duration of response, and safety.
Investigation of mosunetuzumab-based regimens in follicular lymphoma spans multiple treatment lines, with the ongoing, phase 3 MorningLyte trial (NCT06284122) which is evaluating mosunetuzumab in the frontline setting.1
Other chemotherapy-free combinations are also under investigation in relapsed/refractory follicular lymphoma,
