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Letermovir Phase III Trial

Panelists: Harry Erba, MD, PhD, University of Alabama at Birmingham; Roy Chemaly, MD, MPH, MD Anderson Cancer Center; Mark Levis, MD, PhD, Sidney Kimmel Comprehensive Cancer Center
Published: Monday, Feb 06, 2017


Transcript:

Harry Erba, MD, PhD:
Did you tell us about the phase III, where it is now? I understand there was a press release recently.

Roy Chemaly, MD, MPH: Right, for week 24. And usually, it’s after week 48, where the last patient will be done. It’s done. I would say they’re still looking at the preliminary analysis. You’re going to hear more about the week-24 data. Probably coming in some of the meetings, the national meeting or international meeting, they’re coming, and hopefully, we need to delve into this result and see really what we achieve. But at least it met the primary endpoint, which was great news for all of us.

Harry Erba, MD, PhD: In terms of management and toxicities, every drug has a toxicity. Is there anything our listeners should know about this drug, if it becomes available, in terms of tricks in management?

Roy Chemaly, MD, MPH: Actually, the only thing is that in the trial, we know that it can interact with cyclosporine.

Mark Levis, MD, PhD: That’s another one.

Roy Chemaly, MD, MPH: Yes. For the patient on tacrolimus, or not on cyclosporine, they got 480 mg, which is the higher dose based on some in vitro modeling. And the one on cyclosporine, they get the regular dose, 240 mg once a day. Other than that, to be honest with you, we enrolled lots of patients on this and we’re looking at the safety data. No signal, at least no myelotoxicity when you compare to placebo, and no nephrotoxicity that you worry about when you compare it to placebo. But more to come.

Mark Levis, MD, PhD: I think transplanters become pharmacologists during that 2-month period. I don’t think we’ll be troubled in the slightest. “Okay, it’s another net I’m juggling here. No problem.”

Harry Erba, MD, PhD: This has been extremely informative. I know I’ve learned a lot. I know that I’m still not going to be a transplanter, I’m pretty certain of that. But I’m happy to know that you guys are taking care of these patients. Before we end this discussion, I’d like to get final thoughts from each of our panelists. So, let me start with you, Dr. Chemaly.

Roy Chemaly, MD, MPH: I would say prevention is very important for any kind of infection. We want to keep these patients alive in order to get their transplant, to go through this hard period of their life. It really saddens us when we see patients die from infection. We have to do more to prevent this infection. If they get relapse and they die from their cancer, what can you do? You’re trying your best to keep them in remission.

Harry Erba, MD, PhD: That’s on us.

Roy Chemaly, MD, MPH: But for us, it’s like a really huge responsibility to keep this patient, to prevent this infection. And there are other infection control measures also, from hand hygiene to isolation precaution, that we have to keep in mind. We don’t want to give our patients infection in the hospitals or in the outpatient department or the clinic, so we take it very seriously and our staff takes it seriously. Everyone should take it very seriously.

Harry Erba, MD, PhD: Thank you. And Dr. Levis?

Mark Levis, MD, PhD: I make no secret of the fact that I think transplant is the most effective anti-leukemia therapy that I can get. And I have been heartened to see, first, the introduction of the mold-active azoles, how that dramatically improved things and such that I could transplant, seemingly, anybody still with this CMV hanging over our heads. I remain quite heartened to see we’re going to make a new advance in that and we can truly focus on the relapse issues. I think this is a very exciting potential development.

Harry Erba, MD, PhD: Well, I thank both of you for your contributions not only to this discussion, but to the field in general. On behalf of our panel, we thank you for joining us, and we hope you found this Peer Exchange® discussion to be useful and informative. Thank you.

Transcript Edited for Clarity
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Transcript:

Harry Erba, MD, PhD:
Did you tell us about the phase III, where it is now? I understand there was a press release recently.

Roy Chemaly, MD, MPH: Right, for week 24. And usually, it’s after week 48, where the last patient will be done. It’s done. I would say they’re still looking at the preliminary analysis. You’re going to hear more about the week-24 data. Probably coming in some of the meetings, the national meeting or international meeting, they’re coming, and hopefully, we need to delve into this result and see really what we achieve. But at least it met the primary endpoint, which was great news for all of us.

Harry Erba, MD, PhD: In terms of management and toxicities, every drug has a toxicity. Is there anything our listeners should know about this drug, if it becomes available, in terms of tricks in management?

Roy Chemaly, MD, MPH: Actually, the only thing is that in the trial, we know that it can interact with cyclosporine.

Mark Levis, MD, PhD: That’s another one.

Roy Chemaly, MD, MPH: Yes. For the patient on tacrolimus, or not on cyclosporine, they got 480 mg, which is the higher dose based on some in vitro modeling. And the one on cyclosporine, they get the regular dose, 240 mg once a day. Other than that, to be honest with you, we enrolled lots of patients on this and we’re looking at the safety data. No signal, at least no myelotoxicity when you compare to placebo, and no nephrotoxicity that you worry about when you compare it to placebo. But more to come.

Mark Levis, MD, PhD: I think transplanters become pharmacologists during that 2-month period. I don’t think we’ll be troubled in the slightest. “Okay, it’s another net I’m juggling here. No problem.”

Harry Erba, MD, PhD: This has been extremely informative. I know I’ve learned a lot. I know that I’m still not going to be a transplanter, I’m pretty certain of that. But I’m happy to know that you guys are taking care of these patients. Before we end this discussion, I’d like to get final thoughts from each of our panelists. So, let me start with you, Dr. Chemaly.

Roy Chemaly, MD, MPH: I would say prevention is very important for any kind of infection. We want to keep these patients alive in order to get their transplant, to go through this hard period of their life. It really saddens us when we see patients die from infection. We have to do more to prevent this infection. If they get relapse and they die from their cancer, what can you do? You’re trying your best to keep them in remission.

Harry Erba, MD, PhD: That’s on us.

Roy Chemaly, MD, MPH: But for us, it’s like a really huge responsibility to keep this patient, to prevent this infection. And there are other infection control measures also, from hand hygiene to isolation precaution, that we have to keep in mind. We don’t want to give our patients infection in the hospitals or in the outpatient department or the clinic, so we take it very seriously and our staff takes it seriously. Everyone should take it very seriously.

Harry Erba, MD, PhD: Thank you. And Dr. Levis?

Mark Levis, MD, PhD: I make no secret of the fact that I think transplant is the most effective anti-leukemia therapy that I can get. And I have been heartened to see, first, the introduction of the mold-active azoles, how that dramatically improved things and such that I could transplant, seemingly, anybody still with this CMV hanging over our heads. I remain quite heartened to see we’re going to make a new advance in that and we can truly focus on the relapse issues. I think this is a very exciting potential development.

Harry Erba, MD, PhD: Well, I thank both of you for your contributions not only to this discussion, but to the field in general. On behalf of our panel, we thank you for joining us, and we hope you found this Peer Exchange® discussion to be useful and informative. Thank you.

Transcript Edited for Clarity
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