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A new two-drug combo is showing promise for blood cancer patients. The phase 3 CELESTIMO trial found that mosunetuzumab plus lenalidomide significantly improved progression-free survival compared to the standard rituximab plus lenalidomide regimen in patients with relapsed/refractory follicular lymphoma. The results could support an expanded FDA approval for the combination earlier in the treatment journey.
A bispecific antibody combo clears a major trial hurdle in follicular lymphoma
The phase 3 CELESTIMO trial has hit its primary endpoint: mosunetuzumab (Lunsumio) plus lenalidomide (Revlimid) significantly improved progression-free survival (PFS) compared to the standard rituximab plus lenalidomide in patients with relapsed/refractory (R/R) follicular lymphoma who had received at least one prior line of therapy. The safety profile was consistent with what's already known about each drug individually — no new red flags.
Roche plans to submit the data to health authorities, with the goal of converting mosunetuzumab's existing accelerated FDA approval (currently for third-line or later FL) into a full approval — and potentially securing a new second-line indication. Full results will be presented at an upcoming medical meeting.
Key Takeaways:
Why it matters: Follicular lymphoma is the most common indolent B-cell lymphoma, and patients often cycle through multiple therapies. A chemo-free, outpatient combination that improves PFS earlier in the treatment course could meaningfully shift how oncologists approach second-line care.