Phase 3 Asciminib Tolerability Trial , ASC4FIRST, for Patients with CML | David Andorsky |#ASH2024

Hello. My name is Doctor David Andorsky, I'm a, hematologist medical oncologist, with the Sarah Cannon of Research Institute. And I practice at the Rocky Mountain Cancer Center in Boulder, Colorado. I'm very excited to talk to you today about a paper that I'm a coauthor on here at ASH, 2024, it's a trial called ASC4FIRST.

This is a trial looking at asciminib, which is the newest of the medications available for treating chronic myeloid leukemia. Chronic myeloid leukemia or CML, is a serious condition. And 20 years ago, it was not curable. Patients needed an allogeneic stem cell transplant, which is a very big deal to be cured of this disease.

I don't remember exactly when it was maybe 15 years ago, a drug called. Imatinib or Gleevec came out of the market and really revolutionized the field. And now our expectation is for patients with this disease that they can take a medication. The disease will go on to very deep remission, and they'll live a normal life being able to do whatever they want to do, with the time that they have and to, you know, to live their normal life expectancy as opposed to succumbing to this illness.

So asciminib is really the latest in an evolution of newer and better medications that we have for this disease. So the trial is designed as a randomized trial where patients either are assigned to get asciminib, or their doctor's choice of one of the other available medications for this that included imatinib, which is again the first medication to be used in this disease, as well as a few others what we call second generation, medication.

This is the second, presentation we've done this year for this, trial. The first was in May at Asco the other big oncology meeting in the US. And that, at that presentation, the data from one year showed that asciminib was superior to both imatinib and to the second generation drugs, looking at an endpoint called major molecular response, which is sort of the main, measurement of remission that we use.

We think once patients get to that level that the disease is really under very good control and it's not going to come back and threaten them. So what we what we presented this year, or that were this meeting, at ash was 96 week or nearly two year follow up, and it showed that the asciminib seemed to get a little bit better kind of further away from the others in terms of improved, response rates at that later endpoint.

In addition, it showed that the drug was more tolerable, so you had fewer serious adverse events or side effects with asciminib compared to imatinib or the other drugs. And, we also saw that fewer patients had to discontinue treatment or lower the dose or interrupt their treatment to manage side effects. So for me, this is really a win win.

It's a drug that seems more effective and is safer and better tolerated. The FDA approved its use in May, after the presenting the original presentation of that data for first line use. And I think we're going to see it being used more and more. Again, for the reasons that I mentioned better efficacy and better tolerability.

So thank you for your attention.