ASH 2022 | Insights into Phase I/II study assessing fixed-duration glofitamab treatment for R/R LBCL

So this is a paper I just presented in an oral session. It’s data from an ongoing Phase I/II study of glofitamab, which is a bispecific T-cell-engaging CD3/CD20 antibody. First patient was dosed almost six years ago. We have a recommended Phase II dose, and we have completed pivotal different Phase II cohorts, including a pivotal Phase II cohort of large B-cell lymphoma patients. The readout of that cohort has been made. Results have been presented in the summer congresses of this year, today in the New England Journal of Medicine, which was released at the same time as the presentation.

The data that I presented was a focus on patients who at the end of a fixed-duration treatment, because this antibody is not given until progression given for a fixed duration of 12 cycles, eight months, and I focused on the patients who are in CR at the end of treatment, which according to the pivotal Phase II study in large B-cell is approximately 39% of patients. What we have been studying in these patients is the durability of the remissions, those patients who stay in remission, how many are they, and those who go off study. Is it due to progressive disease, death? What are the causes? What we find is that the responses, the complete responses are highly durable. So the vast majority of patients stay in response after one and two years of follow-up so progression-free survival is high. If you look at progression-free survival counting from the end of treatment, it’s over 90% in patients with a CR at the end of treatment after one year. And the duration of complete responses in those patients who are still in CR at the end of treatment is around 80%, just under 80% after two years of complete response so highly durable. This is in my view, in support of the concept of fixed-duration treatment, as opposed to the more commonly used treatment until progression when you’re in third-line or later in the treatment of lymphomas.

Also, interestingly, we have seen that patients who relapse after having been in remission at the end of treatment, they can be offered re-treatment. We’ve done that with a couple of handfuls of patients in this cohort, only two patients, but both these patients entered the second CR when we retreated them with glofitamab. So that’s another support for the fixed-duration treatment that it’s actually possible to reinduce a CR again when people relapse after follow-up.