Andrew Schorr:
Well, it’s a hopeful time, and we’ll get into that. One doctor we didn’t get a chance to catch up with on video but he’s with us now, he’s been with us on Patient Power before, is Dr. Robert Orlowski. He’s associate professor in the departments of lymphoma and myeloma and experimental therapeutics at the MD Anderson Cancer Center in Houston.
Dr. Orlowski, let’s begin with you, a headline. How do you feel about this year’s ASH when it comes to what’s significant for people living with the illness?
Dr. Orlowski:
Well, Andrew, thanks for inviting me to participate on this call. I think that there were a lot of exciting areas in myeloma that were presented at ASH. I thought just briefly I’d talk about a couple of things from studies that focused on patients with relapsed or refractory myeloma because this is where the new drugs are being developed which will eventually be moved up front.
And a couple of developments I thought that were interesting, one was a randomized study for patients with relapsed myeloma comparing two different ways of giving bortezomib. One was the standard intravenous approach, and the other one was using the same dose and the same schedule but instead of using IV patients were given a subcutaneous injection. And it turned out that very interestingly the approach was quite similar in terms of the response rate, the survival at one year and also the time to progression, but very importantly patients who got the subcutaneous injection had fewer episodes of neuropathy and also a trend toward fewer problems with blood count drops. And overall this suggests that it’s safe to give bortezomib with injections under the skin. It may get people in and out of the clinic or the office more quickly, and any time you can reduce side effects like neuropathy that’s always a positive development.
Another I think important study looked at using carfilzomib, and this is one of the second generation proteasome inhibitors which is irreversible, unlike bortezomib, and the data that were presented showed a nice overall response rate with 24 percent of patients having at least a partial response or better, and if you counted patients with stable disease or better the response rate was almost 70 percent. The duration of response was about 8.3 months. Progression-free survival was quite nice as well. Overall survival was one year. And hopefully these data will be used to support a filing early next year in order to try to get carfilzomib approved by the Food and Drug Administration, which hopefully would get it out there pretty quickly to patients in the community.
There also was one poster presented about carfilzomib that showed if you gave it over a longer IV period of about 30 minutes patients could tolerate higher doses and maybe even have a much better response rate.
Andrew Schorr:
All right. I just want to make sure I get all that right. So first of all, related to Velcade, which of course was a breakthrough drug in myeloma, you could get a little shot rather than infusion and that seems to be as effective but fewer side effects. Did I get that one right?
Dr. Orlowski:
Yep, that’s right.
Andrew Schorr:
Okay.
Dr. Orlowski:
And you don’t need to put in an IV into patients in order for them to get the bortezomib.
Andrew Schorr:
Okay. So that’s great news. And then bortezomib or Velcade being a proteasome inhibitor, now we have a second generation and that is going to be up for FDA approval, and that has encouraging data as well, maybe with reduced side effects.
Dr. Orlowski:
Yes.
Andrew Schorr:
Did I get that one right?
Dr. Orlowski:
Yes.
Andrew Schorr:
Okay. All right. Let’s go to our other expert guest with us--besides Jack and I being experts, too, from our perspective--but Dr. Sagar Lonial is associate professor at the Winship Cancer Institute of Emory Institute in Atlanta. He’s also director of translational research for the B-cell malignancy program. Dr. Lonial, we have you on video as well, but just now you’ve had a couple of week to think about it, for patients what do you feel is significant from ASH?
Dr. Lonial:
Well, thank you again for having me on. It’s always a pleasure to be able to interact with my friend Dr. Orlowski and try and provide new updates for patients on what was exciting at the meeting. I think that in addition to the relapsed refractory data that Dr. Orlowski touched on I think that the other big question that is starting to emerge now in myeloma is about the role of maintenance therapy. And I think we did see a number of abstracts looking at post-transplant maintenance therapy. We saw a number of abstracts also that talked about patients who had not had a transplant being on randomized to either maintenance versus no maintenance or different kinds of maintenance dosing, using thalidomide, using lenalidomide or using bortezomib or combinations of those drugs in the maintenance setting.
I think that there are a number of themes that are emerging around which patients perhaps should receive some form of maintenance therapy versus those who perhaps can wait until their disease comes back and be retreated at that time point. So I think it’s not a one-size-fits-all kind of an approach. I think that what is making this more difficult and more challenging is that if you had 10 different patients with myeloma you have at least 10 different kinds of myeloma in those 10 patients, and so trying to say that every patient should get maintenance or that no patient should get maintenance is probably a little too black and white, and there are subtleties to clinical practice that I think make a decision an individual one, one that a patient certainly participates in but one where the physician who is treating and working with that patient probably needs to take lots of different factors into account when they make a recommendation regarding maintenance therapy.