ICML 2025 | A Phase II study of glofitamab plus Pola-R-CHP for patients with high-risk DLBCL

So yeah at this conference I’m presenting the results of a phase 2 study of glofitamab in combination with Pola-R-CHP in patients with newly diagnosed diffuse large B-cell lymphoma. We know from the results of the POLARIX trial that Pola-R-CHP improves progression-free survival as compared to R-CHOP in patients with newly diagnosed DLBCL. However, patients with relapsed or refractory disease can still be difficult to manage. So we hypothesize that the addition of glofitamab, which is a CD3, CD20 bispecific antibody that’s already approved in the relapsed setting to Pola-R-CHP would improve outcomes for these patients. So in this study, all patients were treated with two cycles of Pola-R-CHP, and then at that time, they had an interim PET scan, and we collected blood for testing of minimal residual disease. The glofitamab was then added in cycle 3 using step-up dosing and continued in combination with Pola-R-CHP through cycle 6. Patients then received two cycles of glofitamab at the end of therapy. We saw that this regimen was well tolerated with side effects that you would expect for Pola-R-CHP. And then notably, we saw that there were very low rates of cytokine release syndrome or CRS, which is a known toxicity of glofitamab. Of the 40 patients in the study, we saw that only four patients had CRS and it was grade one, meaning that the patients had a fever alone and two of the patients the fever resolved without any intervention so that was lower than we have seen in prior studies of bispecific monotherapy so it may be that the two cycles of chemotherapy reduced that CRS risk. We also saw that the regimen was very active the overall response rate was 95% and the complete response rate was 90% percent and even two of the patients with a partial response at the end of therapy went on to convert to a CR without further therapy. There was one patient with progression of disease and that was at the beginning of cycle three even before the patient had glofitamab. So overall we’re very excited about this regimen. There is a phase three trial that’s ongoing comparing glofitamab Pola-R-CHP to Pola-R-CHP alone and so really eager to see the results of that study and to see if this type of regimen will change our practice.

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