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Subcutaneous Daratumumab in R/R Myeloma: The COLUMBA Trial

Panelists: Sagar Lonial, MD, FACP, Winship Cancer Institute of Emory University; Amrita Y. Krishnan, MD, City of Hope Comprehensive Cancer Center; Thomas G. Martin, MD, UCSF Helen Diller Family Comprehensive Cancer Center; Krina K. Patel, MD, MSc, University of Texas MD Anderson Cancer Center; Saad Z. Usmani, MD, FACP, Levine Cancer Institute
Published: Wednesday, Jul 24, 2019



Transcript: 

Sagar Lonial, MD, FACP: What about subq [subcutaneous] DARA [daratumumab]? This is the first time we’ve seen data on the randomized trial. Amrita, do you want to tell us a little bit about that trial?

Amrita Y. Krishnan, MD: Sure. That was a phase III randomized trial using subcutaneous daratumumab compared to IV [intravenous] daratumumab. And a couple of key things with the subcutaneous is it’s a flat dose first of all, so 1800 mg versus the IV, which as you know is weight-based. The second thing was obviously time of infusion, right? Subq 5-minute injection versus we’re all very familiar with the infusion times for IV daratumumab. And they basically showed equivalency in terms of response rates and PFS [progression-free survival] as well. Obviously, there were fewer adverse effects in terms of infusion reactions being much lower with the subcutaneous daratumumab, 12.7% versus 34% with the IV formulation.

The one point I would make is the timing of the infusion reactions and that was where the discussion is, and I’d be interested to see what people thought, especially I think Saad has had that experience.

Saad Z. Usmani, MD, FACP: If it happens, just like with IV daratumumab, it happens inadvertently the first time patients are getting it. I think putting the numbers into perspective will be important. So on this trial with the IV formulation with having montelukast on board, I think about 30% of the patients had an IRR [infusion related reaction] on the IV arm, and 12-1/2% on the subq arm. So roughly 1 out of 10 patients are going to get it. If they get it, it’s usually the first time around. I think the median time was about 210 minutes, or roughly a little over 3 hours. So our practice is to monitor the patients the first time they’re getting the dose. If they’re doing fine, you don’t need to monitor them each time. It can be given under 5 minutes. And that 3-hour monitoring would still be better than the 8 hours that they’re going to spend the first day that they’re getting it.

Thomas G. Martin, MD: That was probably one of the most impressive parts of the slide where you saw for the subcutaneous administration, it was 5 minutes. But for the first infusion IV it was 420 minutes, and that’s a big difference. That’s a big difference in terms of throughput through all of our infusion centers, etcetera. And I would say that everybody can pick up a book and can read a book for 3 hours after they get a subcutaneous injection in a chair in your clinic, and you can monitor them and after that send them home and say, “OK, that’s the only time you have to bring your book to clinic.” I think it’s huge. It’s going to make a big difference for us in our practice.

Krina K. Patel, MD, MSc: I think they showed some quality of life data too where that time makes a huge difference for our patients, right? For our staff and everybody, of course, but mostly for our patients.

Amrita Y. Krishnan, MD: I would be curious, is everyone going to switch their patients entirely to subq daratumumab when it becomes available?

Saad Z. Usmani, MD, FACP: I think that we would love to do that from a work throughput and patient convenience perspective. I think that there are going to be other issues at play, drug pricing and how our pharmacies deal with that.

Thomas G. Martin, MD: And co-pays too.

Saad Z. Usmani, MD, FACP: And co-pays as well, yes, I agree.

Sagar Lonial, MD, FACP: Is everybody using 90-minute infusion?

All: Yes.

Sagar Lonial, MD, FACP: I was struck—I was in Europe recently—by how little 90-minute is used. I think they’re still following the label, and 5 minutes is clearly better than 90 minutes. But 90 minutes is not bad. You can get through maybe a magazine instead of a book.

Transcript Edited for Clarity

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Transcript: 

Sagar Lonial, MD, FACP: What about subq [subcutaneous] DARA [daratumumab]? This is the first time we’ve seen data on the randomized trial. Amrita, do you want to tell us a little bit about that trial?

Amrita Y. Krishnan, MD: Sure. That was a phase III randomized trial using subcutaneous daratumumab compared to IV [intravenous] daratumumab. And a couple of key things with the subcutaneous is it’s a flat dose first of all, so 1800 mg versus the IV, which as you know is weight-based. The second thing was obviously time of infusion, right? Subq 5-minute injection versus we’re all very familiar with the infusion times for IV daratumumab. And they basically showed equivalency in terms of response rates and PFS [progression-free survival] as well. Obviously, there were fewer adverse effects in terms of infusion reactions being much lower with the subcutaneous daratumumab, 12.7% versus 34% with the IV formulation.

The one point I would make is the timing of the infusion reactions and that was where the discussion is, and I’d be interested to see what people thought, especially I think Saad has had that experience.

Saad Z. Usmani, MD, FACP: If it happens, just like with IV daratumumab, it happens inadvertently the first time patients are getting it. I think putting the numbers into perspective will be important. So on this trial with the IV formulation with having montelukast on board, I think about 30% of the patients had an IRR [infusion related reaction] on the IV arm, and 12-1/2% on the subq arm. So roughly 1 out of 10 patients are going to get it. If they get it, it’s usually the first time around. I think the median time was about 210 minutes, or roughly a little over 3 hours. So our practice is to monitor the patients the first time they’re getting the dose. If they’re doing fine, you don’t need to monitor them each time. It can be given under 5 minutes. And that 3-hour monitoring would still be better than the 8 hours that they’re going to spend the first day that they’re getting it.

Thomas G. Martin, MD: That was probably one of the most impressive parts of the slide where you saw for the subcutaneous administration, it was 5 minutes. But for the first infusion IV it was 420 minutes, and that’s a big difference. That’s a big difference in terms of throughput through all of our infusion centers, etcetera. And I would say that everybody can pick up a book and can read a book for 3 hours after they get a subcutaneous injection in a chair in your clinic, and you can monitor them and after that send them home and say, “OK, that’s the only time you have to bring your book to clinic.” I think it’s huge. It’s going to make a big difference for us in our practice.

Krina K. Patel, MD, MSc: I think they showed some quality of life data too where that time makes a huge difference for our patients, right? For our staff and everybody, of course, but mostly for our patients.

Amrita Y. Krishnan, MD: I would be curious, is everyone going to switch their patients entirely to subq daratumumab when it becomes available?

Saad Z. Usmani, MD, FACP: I think that we would love to do that from a work throughput and patient convenience perspective. I think that there are going to be other issues at play, drug pricing and how our pharmacies deal with that.

Thomas G. Martin, MD: And co-pays too.

Saad Z. Usmani, MD, FACP: And co-pays as well, yes, I agree.

Sagar Lonial, MD, FACP: Is everybody using 90-minute infusion?

All: Yes.

Sagar Lonial, MD, FACP: I was struck—I was in Europe recently—by how little 90-minute is used. I think they’re still following the label, and 5 minutes is clearly better than 90 minutes. But 90 minutes is not bad. You can get through maybe a magazine instead of a book.

Transcript Edited for Clarity
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