ASH 2023 | GLOBRYTE: investigating glofitamab monotherapy in patients with R/R MCL

Sure, so I mean that is a treatment in progress. So that’s just a study where we’re looking at the bispecific antibody glofitamab. It’s a 2:1 binding epitope given in step-up dosing, with obinutuzumab pretreatment. So patients will get obinutuzumab on cycle one day one, then start glofit at 2.5 mg in the following week, 10 mg and then 30 mg, thereafter they get 30 mg for 12 weeks. So we have early data that we presented last year from the Phase I/II study that showed efficacy of in a small patient population of less than 50. And so that has led us to sort of develop this Phase III trial where patients will get randomized to glofitamab versus standard of care.

As we are looking at in a post BTK setting, there isn’t really a true standard of care other than CAR-T, and so CAR-T is not, unfortunately, available in all countries worldwide. This is being a global study, the standard of care arm is R squared or VR, but it does allow patients who progress on either of those treatments to cross over to glofitamab. And our primary endpoint is looking at progression-free survival in this patient population, with the hope that we confirm some of the early findings we found in that early trial with this Phase III study, which will allow glofitamab to be utilized in this patient population.