Lunsumio plus lenalidomide improves progression free survival in Phase III follicular lymphoma trial

Genentech has reported positive interim results from the Phase III CELESTIMO study evaluating Lunsumio, also known as mosunetuzumab axgb, in combination with lenalidomide in people with relapsed or refractory follicular lymphoma.

The study met its primary endpoint, with the Lunsumio based regimen producing a statistically significant and clinically meaningful improvement in progression free survival compared with Rituxan, or rituximab, plus lenalidomide.

Participants in CELESTIMO had received at least one previous line of treatment for follicular lymphoma.

Overall survival data were not yet mature at the time of the interim analysis.

Genentech said the safety profile of Lunsumio combined with lenalidomide was consistent with the established profiles of the individual treatments, and no new safety signals were identified.

The company plans to submit the findings to regulatory authorities and present the full results at an upcoming medical meeting.

Levi Garraway, MD, PhD, Chief Medical Officer and Head of Global Product Development at Genentech, said patients with relapsed or refractory follicular lymphoma need treatments that can provide meaningful clinical benefits without creating major disruption to everyday care.

He said the CELESTIMO findings suggest that a two drug Lunsumio regimen administered in an outpatient setting could provide another treatment option earlier in the course of the disease.

CELESTIMO is also serving as a confirmatory study for Lunsumio.

The trial is intended to support conversion of the medicine’s accelerated approval and conditional marketing authorisation in third line or later follicular lymphoma to full approval.

The results could also support use of Lunsumio in combination with lenalidomide for patients treated in the second line setting or later.

Lunsumio is a CD20 and CD3 targeting bispecific antibody developed as part of Genentech’s broader programme investigating this treatment approach across B cell malignancies.

The medicine is designed to engage T cells and direct them towards malignant B cells expressing CD20.

Genentech said Lunsumio offers the possibility of outpatient treatment as well as flexibility between intravenous and subcutaneous administration.

Lunsumio is already approved for third line or later follicular lymphoma in 60 countries and has been used to treat more than 3,800 patients.

The medicine is also being studied across additional lymphoma settings, including diffuse large B cell lymphoma.

The U.S. Food and Drug Administration recently accepted a supplemental Biologics License Application for Lunsumio in combination with Polivy, also known as polatuzumab vedotin piiq, for second line or later diffuse large B cell lymphoma based on findings from the SUNMO study.

Genentech is also investigating Lunsumio plus lenalidomide in previously untreated follicular lymphoma through the ongoing Phase III MorningLyte study.

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