Hi, my name is Mohamed Bailerci and I'm Associate Professor of Medicine at Vanderbilt University Medical Center. I'm the Director of our Multiple Myeloma Program and Director of our Amyloidosis Multidisciplinary Programs as well. I've had the privilege of being on an abstract which I think is showing some interesting and important data in terms of ABV383 or otherwise recently more known as Entantamic, new name for this bispecific antibody. So ABV383 or Entantamic is a BCMA binding bispecific antibody which has already presented its phase one and published its phase one data in terms of efficacy and safety. What we're going to showcase in this ASH meeting is phase one B data of a step-up dosing study that was done subsequently in order to optimize the delivery of this bispecific antibody in a step-up dosing fashion which is very convenient. There's only one step-up dose followed by monthly delivery. So every four weekly delivery of this bispecific antibody which is fantastic, no other bispecific antibody that is currently labeled has this type of step-up or dosing schedule from the very beginning. So what this study did is it employed several different step-up doses in terms of the Entantamic dose as well as the dexamethasone pre-medication. The dose that was taken forward was a schedule of two milligram of bispecific followed by or pre-medicated by rather 10 milligrams of dexamethasone followed by on day four of cycle one 60 milligram full four weekly dosing that was pre-medicated with 36 milligrams of dexamethasone. And then on day one of each subsequent cycle Entantamic or ABV383 was given every four weeks. So what this led to is a really impressive low CRS overall rate of 30 percent. So all grade CRS only 30 percent of which 26 percent was grade one and four percent was grade two. No grade three or higher CRS events. So this is really impressive because no other bispecific antibody has demonstrated this low rate of overall CRS without the aids of other medications beyond dexamethasone. Furthermore, the overall response rate didn't seem to change that dramatically from the previously published phase one experience. Overall response rate was 69 percent and vast majority of that overall response rate was actually VGPR or better so 65 percent. So in summary I think this data is actually the base for registration of phase three chervena trial which is currently ongoing globally as well as in United States and many centers where ABV383 or Entantamic is going to be pitted against a couple of different standard care treatment options and patients who have received at least two prior lines of therapy so third line and onward. And again this dosing schedule of small dose of two milligrams of drug premedicated with 10 milligrams of dexamethasone on cycle one day one followed by a full 60 milligrams Q4 weekly dose on day four of cycle one premedicated with 36 milligrams of dexamethasone to be taken then you know monthly from cycle two onward every four weekly with a full 60 milligram dose so that's something that's going to be employed in this phase three registration or chervena trial. So we think this is really important because it showcases both you know excellent safety signal as well as maintained efficacy signal. Our patients are frequently frail have different considerations that makes them ineligible to keep coming to hospital for more frequent dosing schedules and developing a strategy that delivers by specific antibodies in a very convenient monthly delivery is surely something that we have seen has already been welcomed by patients and certainly has potential to positively impact availability and use of this particular by specific antibody in community settings in particular.
HealthTree • December 23, 2024