So my name is Shibli Atrosh. I am a myeloma physician at the Levine Cancer Institute, Charlotte, North Carolina. Today I will update you about one of our clinical trials that we run at the Levine Cancer Institute. The trial name is KRDB. We know that carfilzomib, Revlimid, and dexamethasone, those three drugs are approved backbone for treatment of multiple myeloma. In this trial, we test the addition of belentamab mafetotin. Let's call it Bela. It's a drug that was approved for multiple myeloma previously. That drug shows good efficacy for multiple myeloma patients who are out of treatment options. And the thought here, we can combine this drug with the three approved drugs to see if we can get a better, first of all, acceptable safety signal, phase one trial, and then a better signal for efficacy means making sure the drug, the combination is very effective, especially for high-risk multiple myeloma patients in the phase two portion of the trial. Here I'll just update you about the phase one portion as we still are rolling to that phase. Belentamab mafetotin or Bela has a lot of eye toxicity. This was seen at first when the drug was approved. We were using it with a high dose of 2.5 milligrams per kilogram every three weeks. And in this trial, to medicate or to decrease the eye toxicity, the dry eyes signal that we get with this drug, we sought to give it every eight weeks. And instead of 2.5 milligrams per kilogram, we used 1.9 milligrams per kilogram. We tested two doses and indeed 1.4 milligrams per kilogram, which is clear, and 1.9 milligrams per kilogram, which is the dose that we're working on expanding at this point. So in terms of safety, the combination was very well tolerated, very acceptable side effects profile. Notably, the eye toxicity remained there. However, about a third of the patients had grade three eye toxicity, which means it affected their daily life activity. The toxicity was short-lived for about a week, but then it was reversible for all patients. In terms of infection signals, there wasn't much increase of infections or admissions for infections for patients. About 90, close to 90 percent of the patients were able to get their doses of the treatment as scheduled. There's about 10 percent of the patients where we had to reschedule the dosing and decrease the dose frequency for those patients. But the other doses were given as scheduled. In terms of responses, all patients had a response. So response rate was 100 percent. And actually, importantly to say that 40 percent have complete response. This is an important number as it could predict better or longer survival. Overall, the trial of the patients have been followed for about 10 months. So the trial is still early, in early phase of it. And we currently are rolling to the expansion of 1.9 milligrams per kilogram. Once we finish that portion, we will be more informed about toxicity and efficacy, how effective this regimen is before we decide to move to phase two portion of the trial.
HealthTree • October 6, 2023