Question-and-Answer Session
Operator
Thank you. (Operator instructions). One moment please for your first question. Our first question comes from the line of Mark Monane with Needham & Company. Please go ahead.
Mark Monane – Needham & Company
Thank you. Good afternoon from a cold but – and still a little snowy New York City.
Paul Berns
Hey, Mark.
Pablo Cagnoni
Good, and how are you?
Mark Monane – Needham & Company
Good. God afternoon. Still a little snowy, I think, in our understanding of what the duration of response curve looks like. Pablo, you nicely described what the median duration of response was, but I guess what I'm interested in is some sort of landmark analysis about how many people were – still had duration response of one year, one year-and-a-half. I'm asking this because I think it has the potential for importance for the review of the NDA but also from a commercial point of view, Jim, am I right to assuming that you keep treating patients as long as they do not respond? Could you comment on that, please?
Pablo Cagnoni
Yes, Mark. This is Pablo. The Kaplan-Meier estimate for percentage of patients in response at six months is 53%, okay? That's the extent of the data we're going to disclose now. As we've discussed before, a lot more data will be presented at a future scientific meeting and we want to reserve some of that data, but that should give you an idea of what the curve looks like.
Jim Caruso
And you're absolutely correct, Mark. Based on market research, advisory board feedback and if you chatted with oncologists who practice out in the community, as well as academic centers, you're 100% correct. They will continue to treat as the patient continues to respond or remain stable.
Mark Monane – Needham & Company
And in the study, you looked at response basically doing central review of the radiology reports. But in the real world, patients don't necessarily get scans, especially if they are feeling well. Can you talk about how that is addressed in the market research, or how that might influence the use of the drug in the real world if it's approved?
Paul Berns
It's a great question. When you look at the rigor of this study, especially relative to other studies ongoing in T-cell malignancies, PTCL in particular, the multi-center design, the types of patients, the third-party independent review, there is a high degree of review of these patients from a histology as well as a response perspective. What we do know, from an investigator perspective, you have this 40% response rate.
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