EHA 2025 | Long-term data on the efficacy and safety of etentamig in R/R multiple myeloma

Yes, as you mentioned, the etentamig is one of the new bispecific BCMA targeting antibodies. We’ve presented some data at EHA and also just recently completed ASCO. So this work focused on some of the long-term follow-up data of this bispecific BCMA targeting antibody, which is somewhat unique. You can almost say that it’s a novel generation bispecific antibody, because the CD3 engaging domain has a low affinity, which helps this antibody produce lower CRS risk and lower incidence of CRS. Also, they have a silenced FC tail, which actually allows them to effectively dose this antibody quite infrequently, as infrequent as every four weeks. So this was the focus of this data that we presented these last two meetings. We looked at 120 or so patients that were treated every four-weekly period. However, we also focused on the early step-up in the cycle one, which was produced in the Phase Ib study, where a etentamig was given at a small dose on cycle one day one with 10 milligrams of dexamethasone as pre-medication. So that was two milligrams of the bispecific, then followed by 60 milligrams full dose on cycle one day four with 36 milligrams of pre-medication with dexamethasone and this is you know really something astounding because it has generated the lowest CRS among any bispecific on the market which was overall 30 percent 26 of which was grade one which is essentially managed with tylenol and only four percent of which was grade two. So again, this is the lowest overall CRS rate if you take away the data that was generated with prophylaxis with tocilizumab with several different bispecific antibodies. This is meaningful because of these two unique features. This bispecific antibody can be given monthly from the beginning, and it can be given with this increased safety profile with a low risk of CRS. It’s important to not forget and mention that overall response rate is still quite comparable to other bispecific antibodies between different subgroups that we showed from mid-60s to mid-70s in terms of overall response rate. We’ve only had the median follow-up of about 13 months or so so far. The median PFS has not been reached yet. It seems like maybe we’re going to end up settling somewhere around 14, 15, 16 months. We’ll see. But this speaks to the fact that this bispecific antibody is not inferior in efficacy to other bispecific yet it is dosed at once a month and it is you know very safe when it comes to a CRS profile. Also worthy mentioning that a myeloid suppression signal and infection rates etc seem to be really manageable overall perhaps even touch lower than some of the other BCMA bispecific antibodies. Last thing I’ll mention is, what’s really relevant is that this experience had actually informed the registrational study of a etentamig called CERVINO, which is a Phase III global randomized trial that’s gonna randomize one-to-one fashion after at least two prior lines of therapy with exposure to prior Imids and CD38 antibodies, patients towards either etentamig Q4 weekly with the step up in cycle one and then cycle two onward just purely once a month every four weeks versus a couple of different standard care options among which kyprolis dex, selinexor velcade dex, and elotuzumab pomalidomide dex. Those will be the three standard care arms that PIs will have available to put their patients on it’s important to mention that study has really been rationally designed in a way that requires patients not to be exposed to prior kyprolis if the PI wants to give kyprolis dex which is given a high dose or if they want to give elo pom dex they can’t have prior exposure to these agents. For the selinexor velcade dex arm patients can’t have a prior selinexor or exposure they can have a prior velcade exposure but they have to have had at least the PR better and washed out for at least six months. Actually the study will be adjusted a little bit to shorten some of that washout to be more friendly in terms of eligibility for patients.

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