I'm Ola Landgren and I'm professor of medicine, and I lead the myeloma program at the University of Miami in Miami, Florida.
I'm here in Orlando at ASH 2025. We have several presentations. During the meeting, I want you to talk a little bit about our Revive study. That is a phase two study that targets patients with high risk smoldering myeloma.
We for a long time have believed in the field that the right way to handle patients with smoldering myeloma was just to do watch and wait and monitor and see what happens.
But the FDA approved for the very first time in November of 2025, a treatment for patients with high risk smoldering myeloma. So this is a big change in the field. That drug is daratumumab. It's approved as a single drug. And I've been involved in this for a very long time. I was in fact, the lead investigator for the Centaurus trial. That was the first study that explored daratumumab in this setting.
And then that led to the Aquila trial. And I was the chairman for the Independent Data Monitoring Committee for all the years, evaluating all the safety for the Aquila trial. So I followed the field for a very long time, and I also worked on many other studies using therapy from patients with high risk smoldering myeloma.
So I wanted to see if we could leverage and maybe use the bispecific antibodies in addition to daratumumab in this space. And my rationale was that daratumumab can prevent progression of the very high rates. And that is why the FDA approved it. It's about 50% reduction in progression free survival, which is amazing compared to no therapy at all.
But if you look at the details, it's only 8 or 9% of patients that achieve a complete response or a remission. So I was wondering if we added bispecific antibody, could we even see MRD negativity? And we have worked on that for a very long time. And I pushed for this for the FDA for many, many years. And it led to the FDA endorsing MRD as an early endpoint for drug approval.
So using the combination with teclistamab with daratumumab in high risk smoldering myeloma is what the Revive studies doing. So we give the two drugs once a week, the first cycle, and thereafter we give once a month dosing of these two drugs, which is very feasible. And we give it up to 24 cycles. Patient, they get a single dose of tocilizumab before the very first dose of cycle one.
So what we see is that in the first, we have treated up to 25 patients in the first double dose cohort. We have hundred percent MRD negativity 10 to -6. There was no detectable disease with any measure we can use. And we tocilizumab given a single dose before we have zero of the patients having CRS or cytokine release syndrome.
Now we know the toxicity from that. We also see no ICANS. What we do see is that virtually every patient will drop in the IgG and they will need intravenous immunoglobulin G. So IVIG will have to be given once a month to the patients. And we also have to keep patients on antibiotic and antiviral prophylaxis per standard.
The study as I mentioned has 24 cycles total. And after that the study stops and the treatment stops. And we will do bone marrow biopsy. We will confirm that the MRD that we see early on is also sustained. The study also calls for MRD testing once a year for up to five years after completion of the study.
So really the hypothesis we want to test is if you give this very effective treatment and you can achieve such high rates of MRD negativity and then stop, the treatment could potentially be a curative treatment and can be documented up to five years after. I mean, of course, a lot of correlative science. We are looking into many, many markers of disease and immune system as part of this investigation.
And lastly, I want to say that the same regimen, which includes teclistamab and daratumumab, is presented here at ASH as a late breaking abstract in the setting, a 1 to 3 trial line of therapy. So in relapsed refractory patients, extremely high rates of patients achieve MRD negativity. And also compared to the standard of care arm in a randomized study, the MajesTEC three study. The hazard ratio is 0.17.
So highly, much, highly supportive of teclistamab, daratumumab in this setting. And also the curves for PFS look extremely promising, with high rates of patients sustaining no detectable disease years old in the relapsed refractory setting.
This is a continuous treatment, so I am very hopeful that our study that will stop therapy after monthly dosing for up to 24 months potentially could be a cure for some patients. I'm very excited about that.
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