Pharmacyclics Earnings Call INSIGHTS: Myeloma Clinical Trials, Enrollment Status of Resonate
On Thursday, Pharmacyclics, Inc. (NASDAQ:PCYC) reported its fourth quarter earnings and discussed the following topics in its earnings conference call. Take a look.
Myeloma Clinical Trials
Michael Yee – RBC Capital Markets: Question on frontline CLL. The first question here is, if we look at the data that’s been presented, it’s phenomenal overall response rate, particularly partial responses, but when you look at the CR numbers and then you look at that compared to chemo, is there something there that we are thinking about as to why those numbers are going to be lower versus chemo on CR rather than PR? If you look at the IWC criteria, which is I think what you were looking at there, are there specific parameters that you didn’t meet to hit the CR or is that just a matter fact of the definition of you explain it, maybe you could help me understand that? Then, in addition in frontline, how are you thinking about the first strategy there in terms of what you are going to be going after, is that against (indiscernible)? Are you thinking about going against FCR, how should we think about that?
Jesse McGreivy – Vice President, Clinical Science: Those are very good questions. To address the question in relation to the CRA, overall, we are very encouraged by our monotherapy CR activity. Certainly, if you compare to other regimens, there may be differences comparing across trials, but as a single agent, ibrutinib is showing tremendous single agent activity, both in the CR rates that are been achieved as well as the overall response rate, and as you know, particularly in the upfront setting. In addition, the progression free survival data which is a key clinical endpoint for overall benefit to patients is tremendously robust. So, looking across the activity we are very encouraged by that. So, on the last update at ASCO, we have meeting and follow-up of 14.4 months, 96% of patients are still progress free, which is really phenomenal and it’s just stopping the disease dead in its track. With regard to your other questions in relation to the (indiscernible) upfront therapy, we are very much interested in upfront clinical setting. We are going to initiating single agent upfront trial in elderly versus a competitor. I am not going to comment on the particular competitor today, we will be providing an update on this later this year on the more specifics of that trial.
Michael Yee – RBC Capital Markets: Last question on myeloma, when we get to ASH, I know you said you would have an update there. Obviously, you have submitted and abstract there, so you know some data there. Is there enough follow-up by the time we get to ASH that we will response rate, what’s really in the (indiscernible), protein, cytokines, and things like that?
Robert W. Duggan – CEO and Chairman: That’s a very good question. If you look across all of our clinical trials for myeloma, it’s the most immature data that we will be submitting and we have – what I can say is, we have completed enrollment in the first cohort of 13 patients. We’re moving forward in myeloma and we are extending to look at myeloma in monotherapy and additional cohort as well as in combination with dexamethasone in the 1111 study, but the specifics of the data that we’ll be presenting obviously I can’t get to that today.
Enrollment Status of Resonate
Brian Skorney – Brean Murray: Just a couple of quick ones. On the first one, I was just wondering if you could give us any update on the enrollment status of RESONATE? I know we’re just about a month after you announced the fifth patient in, but I think previously you’ve said that it would take about 18 months to complete enrollment. I’m just wondering what you’re seeing in terms of new sites opening and new patients coming in? A little bit of a follow-up on Mike’s question about what we can expect at ASH. I guess the flipside is, in terms of diffused large B-cell lymphoma, what sort of data kind of makes the decision – obviously, you’ve said middle of next year, you’ll make more –will be more of the certain point for follicular or on DLBCL, but the data for DLBCL, it should be pretty mature at the point we are at ASH, what sort of response rates would give you comfort in terms of potentially moving forward with a larger study in 2013?
Robert W. Duggan – CEO and Chairman: I’ll refer to Jesse on your question as well, but with regard to the RESONATE trial and enrollment we still remain a very comfortable with our 18-month target. As a fact of a matter, we will not be updating unless there is a meaningful change in enrollment in between now and the conclusion of that period of time. Jesse, would handle the DLBCL?
Jesse McGreivy – Vice President, Clinical Science: Sure. Yes, so the Phase II study 1106 trial has completed enrollment and we’re submitting that data to ASH. As far as what would be a meaningful response rate that we trigger? I think that that really would depending on the durability of the responses and you have to look at the overall clinical picture, you can’t just pick a number and then say well that’s meaningful or not. You have to look at the overall risk-benefit profile and access based on that that overall equation. Brian, we will be giving more color on that post-ASH.