Question-and-Answer Session
Operator
(Operator Instructions)
The first question comes from Mr. Mark Monane. Please state your company name followed by your question.
Mark Monane - Needham & Company
Thank you. Good morning. It's Mark Monane from Needham & Company. Good morning from New York City.
Paul Berns
Good morning, Mark.
David Clark
Good morning.
Mark Monane - Needham & Company
Let's start with a PDX question, please. Since there is no approved agents for peripheral T-cell lymphoma, maybe you can comment on what's currently being used out there and if the current agents may have any affect on response to PDX in a second-line setting.
Paul Berns
Sure, Mark. I'll have both Jim and Pablo speak to that, of course. But as you are probably aware, in our prior conversations, it's clear that in this setting, they tend to use the B-cell therapies really in an off-label capacity to try to treat PTCL patients. Typically, you see them using various chemotherapeutic suites such as CHOP, sometimes ESHAP, for example, and using various components and mixing various components of those, that polypharmacy, if you will, to try to manage the patients.
As we are aware, there aren't any approved agents today. From our market research with clinicians, there is certainly a great unmet medical need that exists in the market for improved therapies not just in the second-line setting, but frankly even ultimately in the first-line setting as well. So, with that comment, I'll turn it over to Jim and then Pablo to add some additional color.
Jim Caruso
The only other thing that I would add to that, Mark, is that this clearly is an area of high unmet medical need regardless of the chemotherapeutic regimens that are being used. Oftentimes, as you know, these agents do not work in first-line settings. And unfortunately, when the do have some type of response, either a partial response or complete response, the patients relapse or refract in a relatively short period of time.
I think the only additional color I will add to that is now you're seeing more and more single-agent utilization and kind of the tertiary or fourth and fifth-line settings for the treatment of these patients onto single-agent ONTAK, Gemzar. You're seeing some FLUDORA use there as well.
So, it's interesting to see that as clinicians move into third, fourth, fifth-line settings, they are getting more aggressive with single-agent monotherapies that really have no documented history and a well-controlled study of having effectiveness for this patient population.
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