Question-and-Answer Session
Operator
Thank you, sir. Ladies and gentlemen, we will now begin the question-and-answer session. (Operator instructions) Our first question comes from the line of Lucy Lu with Citi group. Please go ahead.
Lucy Lu – Citigroup
Great. Thank you. Actually can you just please talk about the advanced or metastatic relapsed transitional cell carcinoma of the urinary bladder? I wanted to understand better in terms of the patient number that falls in this segment, what options they have today and can you talk about in general what the options they have today? What kind of response rate you typically see in the clinical setting, and what’s their survival (inaudible) basically, and lastly how did you decide on the dosing regimen for this study? Thank you.
Paul Berns
Sure Lucy, it’s Paul. Thank you for joining us and I think what I’ll do is take your take your – take that in reverse order and have Pablo speak about current treatment options that exist today, speak to some of the decision making that went into our enthusiasm for the evaluation of PDX in this setting and then have Jim answer the question on addressable market size and potential there, so Pablo?
Pablo Cagnoni
Yes. As we decided to start rolling out this ultimate program for PDX last year, we decided to start with a large market opportunity, a small market opportunity in a more niche area. So, that’s why we rolled out the lung program last year and the bladder program this year. Admittedly bladder is a smaller commercial opportunity than lung. However, there are number of reasons why we thought it was very attractive. Number one, there is a lot of historical data about the efficacy of metastatic in patients with bladder cancer. For many, many years the standard treatment for this disease was the MVAC regimen the ?M’ being methotrexate in the regimen. So, that’s number one. Number two, there is data published with the predecessor PDX called (inaudible) showing a much less important predecessor PDX such as to say called (inaudible) showing a 25% response for any patient with relapsed bladder cancer. Three, the fact that there is nothing approved for patients that failed first time chemotherapy with bladder cancer. The two main options in first line are the MVAC regimen or gemcitabine and cisplatin combination. There are roughly equivalent in terms of efficacy with the (inaudible) combination of being a little bit better tolerated. There is nothing approved in second line. The more recent data that’s available is probably the data with Alimta was published a couple of years ago in Journal of Clinical Oncology showing a response of about 30%. No registration was pursued with Alimta and that we know of, there is no ongoing registration of trial with Alimta. So, response rate in the range of 25% to 35%, it’s an indication we think is solid. In terms of median survival was about six months in patients with relapsed or refractory bladder cancer. And as I said, I think more than looking at a really large market opportunity, we are looking at another niche where we can effectively develop PDX aggressively and hopefully in a relatively short period of time initiated some type of registration [ph] trial in this disease. I will turn it over to Jim now for some commercial comments.
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