ICML 2023 | Glofitamab as a single agent in heavily pretreated patients with DLBCL

Glofitamab is a bispecific antibody targeting CD3 and CD20 cells. It has been developed through a large Phase I/II trial, the NP30179 which enrolled essentially diffuse large B-cell lymphoma patients. This study included a dose escalation cohort and once the dose escalation cohort reached the information of the recommended Phase II dose for further studies, we started the dose expansion cohort and the message of using glofitamab in the expansion cohort was summarized in the recently published paper on the New England Journal of Medicine, established that glofitamab used as a single agent IV for a fixed treatment duration of maximum 12 cycles is associated with durable responses and with a complete response rate of 39% obtained in patients that were heavily pretreated, in that they had received a median number of previous chemotherapy lines of three and were highly refractory. In fact, patients in the expansion cohort included 60% of patients that were refractory to last line of therapy and included also 33% of patients who had failed CAR-T. So a very high-risk population really, again, an unmet medical need. Based on these results, during the Phase I study, and then also during the Phase II study of the NP30179 trial, a limited number of patients with Richter’s transformation were enrolled to be treated with glofitamab monotherapy for a maximum of 12 cycles.