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EHA 2021 | Updated efficacy data on glofitamab step-up dosing in NHL

Martin Hutchings, MD, PhD, Copenhagen University Hospital, Copenhagen, Denmark, talks on updated data from the step-up dosing cohort of the NP30179 trial (NCT03075696), an ongoing multicenter, Phase I dose-escalation and expansion study of glofitamab with obinutuzumab pre-treatment in heavily pre-treated patients with relapsed/refractory (R/R) non-Hodgkin lymphoma (NHL). Glofitamab is a T-cell engaging bispecific antibody targeting CD20 and CD3. Dr Hutchings discusses the rationale for implementing a step-up dosing cohort and gives an overview of results. This interview took place at the virtual European Hematology Association (EHA) Congress 2021.

Transcript (edited for clarity)

Glofitamab is a bispecific CD3/CD20 antibody designed for use against B-cell non-Hodgkin lymphoma with the expression of CD20. Carmelo Carlo-Stella presents at the ICML meeting updated data from the step-up dosing cohorts of the Phase I first-in-human study of glofitamab in relapsed/refractory B-NHL. And the step-up dosing cohorts were introduced because of too high frequencies and severities of cytokine release syndrome when no step-up dosing was used, so the full dose given from day one...

Glofitamab is a bispecific CD3/CD20 antibody designed for use against B-cell non-Hodgkin lymphoma with the expression of CD20. Carmelo Carlo-Stella presents at the ICML meeting updated data from the step-up dosing cohorts of the Phase I first-in-human study of glofitamab in relapsed/refractory B-NHL. And the step-up dosing cohorts were introduced because of too high frequencies and severities of cytokine release syndrome when no step-up dosing was used, so the full dose given from day one.

52 patients were enrolled in the step-up dosing cohorts using 2.5, 10 and 16 milligrams in, for just under half of the patients, and 2.5, 10 and 30 milligrams as priming, intermediate, and full dose in the cohort which ended being the recommended Phase II dose. So, the recommended Phase II dose is 2.5 milligram priming dose, 10 milligram intermediate dose, and 30 milligram as the full dose.

With the step-up dosing, first of all, the rates and severities, particularly of cytokine release syndrome, were reduced to acceptable levels. So, the vast majority of cases of CRS are grades I or II. So, that was the main purpose of introducing step-up dosing.

But also, data on efficacy are being presented at ICML and they are really quite impressive. With looking at the patients with aggressive lymphoma at the recommended Phase II dose response rate of 79%, including 71% with complete responses and among patients with indolent lymphomas, all of which were follicular lymphomas, response rates of 76%, including 71% with complete responses. So, these were the data presented by Carmelo Carlo-Stella at the ICML 2021 meeting on glofitamab step-up dosing in relapsed/refractory B-cell non-Hodgkin lymphoma.

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