Updates on Teclistamab, Talquetamab, and CARVYKTI | Mark Wildgust, PhD | ASH 2022

My name is Mark Wildgust and I'm the Vice President of Global Medical Affairs here at Janssen. And today here on Saturday at ASH it's an exciting time. We're getting to see new data on Toclistomab and Talcoetomab, two of our new types of antibodies that we're developing for patients with myeloma. I think Toclistomab has really been a new step forward for patients with its recent approval here in the United States. And I think that the data here at ASH is going to help, further help patients and physicians really understand how to use it. I think with Toclistomab, I think we've started to see that it can provide a rapid, a deep and a durable response. And I think importantly, regardless of refractory status as well. And just this morning there was new data presented looking at Toclistomab in terms of how it works and in which patients it works best. And I think what we're learning is in those patients where they have their T cells, which are so important for Toclistomab to work, when those T cells are exhausted, or perhaps we're treating patients in very late lines of therapy, perhaps not so that's the best place to use Toclistomab, but using it earlier potentially is better. And I think for Janssen, I think that makes a lot of sense. And we're really excited to have phase three studies ongoing to be able to look at using Toclistomab in the earlier setting as well. One of the stars, I think, of ASH is Talcuetumab. It's such a mouthful, but here at Janssen we fondly call it Tal. We have two amazing different types of antibodies that we're using for the treatment of patients. And actually, Talcuetumab in itself is somewhat unique. I'm sure you've heard about lots of BCMA bispecifics targeting BCMA, but Talcuetumab targets a novel different type of antigen. So it really is a great step forward to have really a next generation compound targeting something different. And I think that's particularly important. an antigen called GPRC5D, but that is expressed very commonly on myeloma cells in a similar way to BCMA. And from a Janssen perspective, we're very excited because we presented for the first time the phase two data for the Talcuetumab study here called Monumental 1. Dr. Ajay Sharri from Mount Sinai presented that. And those data look very promising. And indeed, those were the data that led us to the submission of Talcuetumab to the US FDA in the last couple of days. I think over the last couple of years, we started talking about 60 is the new 20 as we started to see the new therapies coming forward, changing that response rate in those patients who had had triple refractory disease from 20% to 60%. But I think Talcuetumab starts to set perhaps a new number for us to focus in on, which is 73, 74% in terms of overall response rate. But I think Talcuetumab in itself offers other potential clinical advantages. Certainly in the data that we see today, it appears to have lower rates of infection. And I think that's very important for patients. And I think particularly in the era of COVID, we're also seeing very, very few patients, unfortunately, pass away with COVID from infections too. So I think Talcuetumab is going to be a really great option for patients with the regulatory submission that should pave its way, hopefully, as we work with FDA for an approval in the United States sometime in 2024. There's lots of data going on here at ASH with bispecific antibodies like Daclustumab and Talcuetumab. But one of those mainstays of T-cell redirecting therapy is really Cilta-cell or Carvicti, our autologous CAR-T that we have here at Janssen. And I think people have probably heard about the CARTITUDE1 data that I think set a new standard in terms of response rate. And here at ASH, we're seeing longer term follow-up data. And in particular, we're seeing those patients who have sustained minimal residual disease where we essentially can't find those myeloma cells within the patient's bone marrow. When that has gone away and we're seeing that's gone away for a prolonged period of time, we call that sustained MRD, that we're seeing that those patients who have long sustained MRD have very long durable responses. And if you remember from a data perspective, before things like Carvicti were around, perhaps we would think that a patient in that clinical situation might unfortunately only have a median overall survival of a year. Here now we're seeing in those patients who have sustained levels of not being able to detect those myeloma cells anymore, that their median overall survival hasn't been reached beyond two years. And in fact, more than 80% of those patients are still alive at two years who had sustained responses. So I think that long term follow-up data from Carvicti and the CARTITUDE1 study points to potentially that sustained outcome and hopefully long term durable responses for patients.