My name is Hang Quach. I am a myeloma specialist and I work at Saint Vincent's Hospital, Melbourne in Australia. And I'm a professor of hematology at the University of Melbourne in Australia.
So today I'd like to talk about, the data I presented, on the, long term, a follow up, of the monumental two study phase 1b. And this is a study that explored, a combination of drugs, talquetamab together with pomalidomide a for heavily pretreated patients with multiple myeloma.
Now, talquetamab is the first and it's a class of a drug accord a bispecific T-cell engager. And this drug is an immune drugs. Think of it as a drug, with, two arms. One arm binds to the myeloma cells, on a target called GPRC5D and then the other arm binds to a the immune T cells called CD3 and marries the two up.
And so the T cells, having not, recognized the myeloma cells before, is seeing myeloma for the first time. It gets excited. So eats up the myeloma cells. So that's talquetamab.
We combined to talquetamab with pomalidomide. And pomalidomide is very commonly used are drugs. It belongs to a class called immunomodulatory drugs. And pomalidomide has a capacity to enhance T-cell activities in general, as well as making the myeloma cells commit suicide. So direct tumorsidal effect.
So you can see there is a biological rationale of why the combination would be very effective.
So in the monumental two study phase 1b part one b we involved initially 35 patients, and, these 35 patients were quite heavily pretreated. They had on average, three prior lines of therapy, and some patient had as many as 12 prior lines of therapy.
And around three quarters of patients, had exhausted all options. And they were what we call triple class exposed or refractory, which meant that they've had an IMiD, proteasome inhibitor, and anti-CD38 monoclonal antibody. So they were bad prognostic patients.
And in this study talquetamab was a given through the skin. It was given at a dose of, 0.4mg to 0.8mg, a point four milligram every week and 0.8mg every two weeks.
And we combined with pomalidomide, which was introduced at this second, cycle, at two milligrams. And then we escalated up to the tolerable dose of about four milligrams, eventually. And treatment was until disease progression.
And, in this study, with a long term follow of now 20.7 months, we saw that the result that we initially reported remained very strong. That is we saw an overall response rate of over 85%.
And, people who achieved a very good partial response, that is a 90% reduction in the myeloma burden, was 80%, which is remarkably high. And people who achieved a complete response, was around 45% of all of our patients.
And with this longer term follow up, the people who responded, remained responding. So the median duration of response, was not reached. And the median, progression free survival, was reached at around, over 28 months.
So that's quite a remarkable and in terms of, safety, remarkably, we saw no, new, safety signal. And, importantly, there were no people stopping treatment because of side effects.
And so therefore, we know that with longer, follow up, there is no cumulative toxicity. And so overall, this long term, a data, of a talquetamab and pomalidomide demonstrated that this is a very, tolerable combination and very effective combination.
And it reinforces our earlier report. But more importantly, it really supports our ongoing phase three study of a monumental six that randomizes, patients, to either, pomalidomide and talquetamab, adverse is the investigators a choice of, you know, elotuzumab, pomalidomide, dexamethasone or, bortezomib, pomalidomide. and dexamethasone.
And so I think overall, the data is highly encouraging. And I think this inspires much optimism for the future of myeloma.
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