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ASH 2025 | Glofitamab and obinutuzumab as first-line therapy for patients with high-tumor burden FL
Reid Merryman, MD, Dana-Farber Cancer Institute, Boston, MA, discusses the first results of a Phase II trial (NCT05783596) evaluating the combination of glofitamab and obinutuzumab as first-line therapy for patients with high-tumor-burden follicular lymphoma (FL), highlighting the combination’s encouraging efficacy. Dr Merryman notes that the regimen was well-tolerated, with the majority of cytokine release syndrome (CRS) cases being grade one. This interview took place at the 67th ASH Annual Meeting and Exposition, held in Orlando, FL.
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Transcript
So this year at ASH, we presented results from a phase two trial testing the combination of obinutuzumab and glofitamab as first-line treatment for patients with high tumor burden follicular lymphoma. Glofitamab is a CD3xCD20 bispecific antibody that’s approved for patients with relapsed or refractory DLBCL, but it also has excellent results from a prior phase 2 study in follicular lymphoma...
So this year at ASH, we presented results from a phase two trial testing the combination of obinutuzumab and glofitamab as first-line treatment for patients with high tumor burden follicular lymphoma. Glofitamab is a CD3xCD20 bispecific antibody that’s approved for patients with relapsed or refractory DLBCL, but it also has excellent results from a prior phase 2 study in follicular lymphoma. One of the potential downsides of this bispecific is that it was associated with relatively high rates of grade 2 or higher cytokine release syndrome. So in this study, we hypothesized that pre-treatment with four weekly doses of obinutuzumab before glofitamab step-up dosing began could lower the risk of cytokine release syndrome and also deepen responses. So in this study, we enrolled 35 patients with follicular lymphoma. They had frequent high-risk features. Over 80% of patients had stage four disease and 63% of patients had a high-risk FLIPI score.
Among 34 response-evaluable patients, we observed very high response rates with an overall response rate of 100% and a best complete metabolic response rate of 88%, both of which are quite high in this setting. The follow-up is still short, but with a median follow-up around eight months, only one patient has relapsed, yielding an eight-month progression-free survival of 95%. This regimen was also quite well-tolerated. CRS was observed in 40% of patients. All but one case was grade one. There was one case of grade three CRS that was observed in a patient who had pulmonary involvement of their lymphoma and had hypoxia as part of a CRS syndrome. We also observed rare infections. Only about 30% of patients had an infection. All infections were grade one to two.
So in summary, this combination seems to be both safe and highly potent, and we look forward to reporting longer follow-up from this combination. In addition, this trial included a separate cohort looking at a obinutuzumab and glofitamab treatment in patients with marginal zone lymphoma, and we look forward to presenting results from that cohort soon.
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