ICML 2021 | Subcutaneous epcoritamab in R/R B-cell NHL
Martin Hutchings, MD, PhD, Copenhagen University Hospital, Copenhagen, Denmark, shares an update on a Phase I/II trial (NCT03625037) of subcutaneous epcoritamab, a bispecific antibody targeting CD20 and CD3, for the treatment of relapsed/refractory (R/R) B-cell non-Hodgkin lymphoma (B-NHL). Dr Hutchings reports updated safety and efficacy data from the dose-escalation cohort of the study at a median follow-up of 14 months, highlighting promising response rates and a manageable toxicity profile. For patients with diffuse large B-cell lymphoma (DLBCL) who received a dose of 12 milligrams and above, at a median follow-up of 9.3 months, the median duration of response (DoR) was not reached and progression-free survival (PFS) was 9.1 months. At the recommended Phase II dose, at a median follow-up of 8.8 months, the median DoR and median PFS were not reached. For patients with follicular lymphoma, at a median follow-up of 8.8 months, DoR and PFS were also not reached. This interview took place at the virtual European Hematology Association (EHA) Congress 2021.
Transcript (edited for clarity)
Epcoritamab is another CD3/CD20 bispecific antibody designed for use in B-cell non-Hodgkin lymphoma. This antibody was from the beginning designed for subcutaneous use. At the ICML meeting, I present updated safety and efficacy data from the dose escalation part of the Phase I/II first-in-human study of epcoritamab in B-NHL.
We update safety and efficacy data, which had previously been presented, now at a median follow-up of 14 months...
Epcoritamab is another CD3/CD20 bispecific antibody designed for use in B-cell non-Hodgkin lymphoma. This antibody was from the beginning designed for subcutaneous use. At the ICML meeting, I present updated safety and efficacy data from the dose escalation part of the Phase I/II first-in-human study of epcoritamab in B-NHL.
We update safety and efficacy data, which had previously been presented, now at a median follow-up of 14 months. The deep and durable responses are still quite impressive and many of them maintained. Also, the safety data still demonstrates a manageable toxicity profile. To put it short, no treatment-related deaths or treatment-related discontinuations. Still no cases of cytokine release syndrome worse than grade II So approximately two thirds of the patients had a cytokine release syndrome, but exclusively grades I and II which is manageable. No patients have had need for intensive care, for example, because of cytokine release syndrome.
So, looking at the efficacy, looking at patients with relapsed/refractory DLBCL, which is the vast majority of patients included into this dose escalation study. At doses of 12 milligrams and above, at a median follow-up of 9.3 months, the median duration of response has not been reached and median progression-free survival for these patients, 9.1 months. At the recommended Phase II dose which is 48 milligrams or above patients were followed for a median of 8.8 months and both the median duration of response and also the median progression-free survival has not been reached.
Looking at the smaller subgroup of patients treated for follicular lymphoma, for efficacy they had a median follow-up of 8.8 months. For those patients, just like were in DLBCL, the median duration of response and median progression-free survival has not been reached. We showed data on progression-free survival in this presentation including Kaplan Meier curves where the durability of the responses for the first time are really being displayed in this way. So, that was the update about epcoritamab in B-cell non-Hodgkin lymphoma, updated data on safety and efficacy showing still very favorable safety profile and encouraging clinical activity including novel PFS data.
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