ASH 2024 | A Phase II trial of mosunetuzumab for newly diagnosed follicular lymphoma with high tumor burden

We presented the data of our Phase II trial conducted at Memorial Sloan-Kettering by my colleague Lorenzo Falchi. We are assessing the role of mosunetuzumab, the CD3-CD20 antibody, bispecific, in the front-line setting of newly diagnosed follicular lymphoma with a high tumor burden. We enrolled 78 patients in this trial, 76 are evaluable for response and follow-up. What we observed is an overall response rate of 96%, a complete response rate of 80%, and with 14.8 months of follow-up, 91% of the patients are free of progression, 99% of them are alive. These are very encouraging results, demonstrating the efficacy of the single-agent bispecific antibodies in patients with newly diagnosed follicular lymphoma in the first-line setting, better results than those that were published in the relapse setting, not surprisingly. The safety was also very satisfactory. About half of the patients had a CRS, but the vast majority of them were CRS grade 1. There was only 3% of CRS grade 2. The other side effects were common that you can find in this patient treated without any new safety signal and only 20% of the patients received steroids, very few received tocilizumab and three of them had to be hospitalized. So the safe treatment with a subcutaneous formulation of mosunetuzumab which could be delivered easily in this patient. Very encouraging result, obviously Phase II data but which will probably lead the way to more comparative studies in the setting of first-line follicular lymphoma needing therapy.

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