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ICML 2025 | A Phase II trial evaluating rituximab and epcoritamab as first-line therapy for high-tumor burden FL
Reid Merryman, MD, Dana-Farber Cancer Institute, Boston, MA, presents the preliminary results of a Phase II trial (NCT05783609) combining rituximab and epcoritamab as first-line therapy for patients with high-tumor-burden follicular lymphoma (FL), highlighting the encouraging response rates achieved with this therapeutic approach so far. The safety profile of the combination was manageable, with a low incidence of high-grade cytokine release syndrome (CRS). Dr Merryman looks forward to longer follow-up data to assess the durability of responses and notes that the trial has been expanded to 100 patients, with enrollment continuing. This interview took place during the 18th International Conference on Malignant Lymphoma (18-ICML) in Lugano, Switzerland.
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Transcript
At ICML we’re presenting preliminary results for a Phase II trial that combines rituximab and epcoritamab for patients with follicular lymphoma. So epcoritamab is a CD3, CD20 bispecific antibody that’s approved for relapsed or refractory follicular lymphoma where it’s associated with high complete metabolic response rates and durable remissions. And based on those encouraging results there are a number of trials that are moving bispecific antibodies like epcoritamab into the earlier lines of therapy, including in the frontline...
At ICML we’re presenting preliminary results for a Phase II trial that combines rituximab and epcoritamab for patients with follicular lymphoma. So epcoritamab is a CD3, CD20 bispecific antibody that’s approved for relapsed or refractory follicular lymphoma where it’s associated with high complete metabolic response rates and durable remissions. And based on those encouraging results there are a number of trials that are moving bispecific antibodies like epcoritamab into the earlier lines of therapy, including in the frontline. So in our trial, patients receive four weekly doses of rituximab before the first full dose of epcoritamab. And the goal of the rituximab in this study is twofold. One, to improve the depth of response, and second, to debulk patients before they receive the first full dose of epcoritamab with the goal of improving cytokine release syndrome.
So the plan for this trial is to enroll 35 patients. As of the data cut off back in January, 31 patients had been enrolled. They had fairly high risk features. About a quarter of them had bulky disease or grade 3A follicular lymphoma, 97% had advanced stage disease and over half had a high FLIPI score. And among the evaluable patients, the best overall response rate was 100%, and the best complete response rate was 92%. Very high numbers for this disease. And with about six months of follow-up, no patients had relapsed. So obviously we need longer follow-up, but those preliminary results are very encouraging.
And we saw a manageable safety profile. CRS was the most common adverse event in about half of patients, but we saw very few cases of higher grade CRS. There were two cases or 6% of patients with grade 2 CRS and no grade 3 or higher CRS. So I think our hypothesis that pretreatment with rituximab can lower the risk of high grade CRS seems to be true. So we’re excited for a longer follow-up for this trial to see how durable these responses are. And based on the encouraging results so far, the trial has been expanded from 35 patients to 100 patients and enrollment continues.
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Disclosures
Advisory board: Genmab, Adaptive Biotechnologies, Bristol Myers Squibb, Abbvie, Inteillia, Epizyme, Ipsen, KITE; Consulting: Alphasights, DG Medicine; Honararia: Genmab, Abbvie; Institutional research funding: Merck, Bristol Myers Squibb, Genmab, Genente.
