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Loretta J. Nastoupil, MD, on Phase III Study on Mosunetuzumab, Rituximab, and Lenalidomide for Follicular Lymphoma

Posted: Wednesday, August 24, 2022

Loretta J. Nastoupil, MD, of The University of Texas MD Anderson Cancer Center, discusses the CELESTIMO trial, which will evaluate the efficacy and safety of mosunetuzumab in combination with lenalidomide compared with rituximab in combination with lenalidomide in patients with relapsed or refractory follicular lymphoma who have received at least one line of prior systemic therapy. The trial is still recruiting participants at 150 sites in 16 countries.

Transcript

Disclaimer: This video transcript has not been proofread or edited and may contain errors.

The CELESTIMO study is a randomized Phase III trial, exploring the combination of Mosunetuzumab, a CD20, CD3 bispecific antibody, in combination with lenalidomide versus rituximab and lenalidomide for previously treated follicular lymphoma. Follicular lymphoma is an inlet lymphoma subtype that is coupled with high response rates to initial, most often chemoimmunotherapy, but followed by multiple relapses over the course of a patient's disease history. Unfortunately, most patients will still succumb to follicular lymphoma. So, there is an unmet need for the development of novel, effective strategies. Mosunetuzumab has been studied in a phase one and two trial, and relapsed refractory follicular lymphoma, including those patients who had failed at least two prior lines of therapy that consisted of a CD20 antibody and alkylator, and in this heavily pretreated population, Mosunetuzumab resulted in quite favorable, complete response rates that also resulted in durable remissions. So, it appears to be a very promising agent, and will likely be FDA approved this calendar year. And that will be based off of the single armed, phase two study. Therefore, a randomized confirmatory study would still be necessary, and that sets the stage for the CELESTIMO trial. Lenalidomide is an oral immune modulator. So, there is a rationale for combining Mosunetuzumab with lenalidomide, and a phase 1-B study demonstrated that the combination was safe without any new safety signals, and preliminary data also suggests effective. Again, the CELESTIMO studies are randomized phase three trial, enrolling patients with previously treated follicular lymphoma. This includes adult patients. Their prior lines of therapy are not as important, though they will be stratified according to that response. The primary endpoint will be progression free survival as assessed by an independent review committee, but other secondary endpoints include complete response rate, duration of response, and overall survival as well as time to next treatment. This study is actively enrolling across 150 different sites, including across 16 different countries, and we anticipate that it may meet target enrollment in the spring of 2023. So, we're quite excited about the rationale behind this study. We do hope that we'll provide new options for patients with relapsed follicular of lymphoma, and we look forward to data as it emerges.



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