Hello, my name is Fredrik Schjesvold. I'm head of the Oslo Myeloma Center in Oslo, Norway, and I'm here at the EHA in Milan 25 to present the poster of what we call the novel novel study. It's a phase one study where we use mezigdomide as the backbone.
Mezigdomide is the most potent of the IMiDs—what we now call the CELMoDs—which started with thalidomide, lenalidomide, pomalidomide, and now mezigdomide in this phase one study. The study is a phase one study. It has three arms. It's oral treatment. Mezigdomide is combined with either tazemetostat, which is an EZH2 inhibitor, a BET inhibitor which doesn't even have a name yet (also oral), and trametinib, which is a drug that's been around for some time and is a MEK inhibitor.
What we do is we combine mezigdomide with one of these three drugs. There are between 16 and 20 patients in each of the arms, in an extremely difficult patient population to treat. In this study, of the 60 patients, more than 80% were triple-class refractory, and more than 50% had actually received CAR-T or a bispecific. So, not many choices left for these patients.
As we see the results maturing in this phase one trial, in all of these arms, the response rates are over 60%. That’s what we see with bispecifics, and this is in patients who, in the majority, already had a bispecific or CAR-T. So I would say it's one of the most impressive phase one results I've seen since immunotherapy—and this is post-immunotherapy.
You also see that the PFS (progression-free survival) for one of the arms is not so good—three or four months. So we're not moving on with that, or BMS is not moving on with that. But in the two other arms, you have PFS in these extremely difficult patients of seven to eight months. That’s for the total of the patients.
This was a dose escalation. So what we're moving on with is the optimal dosing of these drugs. So I anticipate that PFS and also the response rates will be better in the phase two trial. FDA and BMS are now discussing this trial. The phase two will open with the tazemetostat and trametinib combinations this autumn.
I think we really will see that this will be another tool in our armamentarium to treat this disease. We know that the immunotherapies are really good, but we also know that patients relapse after them. We need more tools. And this looks extremely promising, I would say.
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