It's the dosing period for bispecific antibodies ongoing until progression or is it for a set period of time?

Well, that is a great question. In the studies that have been done, like many studies, they're usually done until progression because you want to allow a person on a trial to continue to keep the drug going if it's working. In in practice, what a lot of people are reporting is that they've had to stop the drugs for various reasons and in many cases the effect, if they've had a good one, is just persisting even while they're off the drug.

So this is bringing up the idea that maybe when we start having more use right now, there's no FDA approved one of these drugs yet in myeloma. But once we start having more experience, we might actually be able to start and stop them, which would be pretty neat.

On October 25th, 2022, the Food and Drug Administration granted accelerated approval to teclistamab CQ YV the first Bispecific B-cell maturation antigen BCMA directed CD3 T-cell engager for adult patients with relapsed or refractory multiple myeloma who have received at least four prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent, and an anti cd38 monoclonal antibody.

Most of the drugs that have used bispecific therapies to date have used it ongoing, meaning that it's used continuously until either there's disease progression or death, or you stop it because of toxicity. That may not be the optimal way to use by specifics. We do have some preclinical data that shows that perhaps giving bispecific for a short period of time and then taking a break and then reinitiating might help in the recovery of those normal plasma cells and might actually be safer from an infection standpoint.

That's not how most of the trials have been designed, but that is something that definitely should be looked at in the future.

So the dosing currently for the FDA approved product that is to teclistamab, it is given continuously to disease progression. So we have a step up dose whereby we can give it either we can do the one three phase schedule. That means we split the first dose into day one and day five, and then we give the first full dose on day five and then followed, followed by that it's going to be weekly dose through disease progression.

So it's a lot of interest in understanding can we modify the dose to every other week, especially in patients who have had a response. So they we see that some of the newer studies are kind of already adopting that that kind of approach.

So this is a really hot topic now in the treatment of myeloma. Currently, the trials were looking at dosing until progression, which is kind of the way we go with the with the patients both in the upfront setting and in the relapsing setting. But I think with the very deep responses we are getting a there are thoughts already of a fixed duration treatment and there hopefully we'll be seeing some of those studies coming up ahead so if we have very, very deep responses, perhaps we are able to get sustained MRD negativity and then stop treatment. And patients might have a longer treatment holiday without any disease. So that will be really great if we are able to achieve that.