Hello, my name is Ravi Vij. I'm professor of medicine at Washington University in St. Louis. Here at the ASH annual 2023 meeting on behalf of my co-investigators, I have presented a poster on the novel bispecific from ABVI 383 in patients with relapsed and refractory multiple myeloma. We do have a number of bispecifics in development, but this bispecific is unique in several respects. It has two binding domains for the target BCMA, which is potentially going to make it more effective. It has a lower affinity to bind to the T cells, which is likely to make it less toxic. And then it has a modification that gives it a very long half-life, so one has to take it less frequently. So in the trial that I presented, it was what we call a phase one two study, where initially we escalated the dose and we went up to 60 milligram dose every three weeks. Thereafter, we actually went back and added more patients to lower dosing schedules of 20 milligrams every three weeks and 40 milligrams every three weeks. And one other cohort that we accrued at the end was 60 milligrams every four weeks. And what we see is robust activity in about two thirds of patients. There were responses. And what is unique about this drug is that the toxicity profile we saw very little in the way of grade three, four cytokine release syndrome. And in the dosing regimen, where it was given once every four weeks, we employed a higher dose of dexamethasone for a single day. And that led to literally no grade three, four CRS and very little even grade two CRS. The drug doesn't, like other bispecifics, have to start at a low dose and get to a higher dose. The full dose can be given from the outset. And instead of spending several days and sometimes a week or more in the hospital, patients with that 60 milligram every four week dose just spent one 24-hour period in the hospital for the initial dose. The data suggests that at the 60 milligram dose every three weeks, we see a robust period of disease control stretching out to about a year. And in the 60 milligram every four week dosing schedule, which is actually the dosing schedule that is moving forward to a larger trial to get this on the market, we see that because of the short follow-up that we haven't yet even reached the maximum duration of response. So this is a drug that is expected to be approved by the FDA in the years to come after the larger phase three completed and may offer potentially a best-in-class treatment with less toxicity, equivalent efficacy, and a much favorable dosing regimen with very short period of hospitalization.
HealthTree • December 19, 2023