Pharmacyclics' CEO Hosts ASH 2012 Recap Conference (Transcript)

Dec.12.12 | About: Pharmacyclics, Inc. (PCYC)

Pharmacyclics Inc. (NASDAQ:PCYC)

ASH 2012 Recap Conference Transcript

December 12, 2012 8:30 AM ET

Executives

Ramses Erdtmann - Vice President, IR, Education and Training

Bob Duggan - Chairman and CEO

Dr. Maky Zanganeh - Chief Operating Officer

Dr. Lori Kunkel - Chief Medical Officer

Paula Boultbee - Executive Vice President, Sales and Marketing

Josh Brumm - Executive Vice President, Finance

Dr. Maria Fardis - Executive Vice President, Operations and Alliances

Dr. Jesse McGreivy - Vice President, Clinical Science

Dr. Joe Buggy - Vice President, Research

Rich Love - Vice President, Legal

Analysts

Geoffrey Porges - Sanford Bernstein

Alan Carr - Needham & Company

Ian Somaiya - Piper Jaffray

Brian Lian – SunTrust

James Cole - Lazard Capital Markets

Howard Liang - Leerink Swann

Joel Sendek - Stifel Nicolaus

Brian Skorney - R.W. Baird

Charmaine Chan - RBC Capital Markets

Operator

Greetings. And welcome to the Pharmacyclics ASH 2012 Recap Call. At this time, all participants are in listen-only mode. A brief question-and-answer session will follow the formal presentation. (Operator Instructions)

As a reminder, this conference is being recorded. It is now my pleasure to introduce your host, Ramses Erdtmann. Thank you, sir. You may begin.

Ramses Erdtmann

Thank you, Dan. Good morning. And thank you for joining us for our conference call today. With me on the call today and available to answer questions are our CEO and Chairman of the Board, Bob Duggan; our Chief Operating Officer, Dr. Maky Zanganeh; our Chief Medical Officer, Dr. Lori Kunkel; our Executive Vice President, Sales and Marketing, Paula Boultbee; our Executive Vice President, Finance, Josh Brumm; Dr. Maria Fardis, our Executive Vice President of Operations and Alliances; and I hope they have made it to dial in from California is Dr. Jesse McGreivy, our Vice President of Clinical Science; and our Vice President of Research, Dr. Joe Buggy; and Rich Love, our Vice President of Legal.

Our agenda for today's call will focus on the ASH presentation we just highlighted in our press release. We will not go through each program individually in our official remarks, but rather have Bob provide a high level summary of ASH and then open the floor for questions. We will limit the call today to one hour. All our ASH presentations are uploaded to our website under www.pcyc.com in the IR section. We invite you to explore these presentations.

Before we start, let me remind you that this non-confidential presentation contains forward-looking statements about the business prospects of Pharmacyclics, including expectations regarding Pharmacyclics' financial performance, commercial product and potential future products in different areas of therapeutic research and development.

Results may differ materially depending on the progress of Pharmacyclics' product program, action, actions of regulatory authorities, availability of capital, future actions in pharmaceutical market and developments by competitors and those factors detailed in Pharmacyclics' filings with the SEC, such as 10-Q, 10-K and 8-K reports.

I would now like to turn the call over to Bob Duggan, our CEO and Chairman of the Board. Bob?

Bob Duggan

Thank you, Ramses. We are dialing in today from Atlanta, where we attended ASH, the Annual Meeting of the American Society of Hematology. Over the past year we have made tremendous clinical progress, which we have shared here in Atlanta with our peers. ASH is one of the two events in a year where we typically provide clinical and preclinical updates from our investigators and scientific collaborators.

At this Annua Meeting over 5000 abstracts were initially submitted showing clinical and preclinical advances in Hemotology. About 3000 of these abstracts were expected and presented as posters and about 1000 were accepted and presented in oral sessions.

Pharmacyclics and our investigators published nine posters and gave nine oral presentations. Since 2008 this is the highest ever for Pharmacyclics as they reviewed preclinical and clinical presentations at this meeting and real accomplishment for our team.

This presentation represents hard smart work and scientific rigor from our investigators, our clinical and scientific staff, our researchers and our collaborators. They demonstrated advances which increase our understanding of the mechanisms of action of our drug, the effectiveness in certain cancer type and they demonstrate opportunities to explore ways to help our patients in need increasingly friendly, body-harmonious therapy, welcome to summer now calling this coming new era.

This year there were 16 presentations showing clinical and preclinical results with our lead compound ibrutinib, two of the oral presentations achieved unusual recognition. One was led by investigator John Byrd of the Ohio State University and showed ibrutinib results in treatment-naive and relapsed/refractory chronic lymphocytic leukemia CLL patients.

The other one was led by investigator Dr. Jan Burger of MD Anderson, who presented data showing ibrutinib use in combination in high risk patients with relapsed/refractory CLL.

Both of these presentations were highlighted in the ASH Press Program on Saturday. ASH brings together over 20,000 attendees and over 250 American and international journalist to cover latest developments in the field.

The Press Program guide report -- report this to the studies that program committee has found to be of great interest to the public. Both of these presentations were also included in “The Best of ASH” category, which was announced yesterday.

This year there were only 25 presentations in total that were recognized as “Best of ASH” and we are very pleased that ibrutinib with the help of our collaborators has achieved this recognition in two of our studies.

Together with our extraordinary partner Janssen we have now successfully entered three pivotal Phase III trial programs now broadly developing ibrutinib at multitude of hematologic cancer study.

The results we have shown over the past couple of days and highlighted in our press release today have been very encouraging and demonstrate our commitment to a comprehensive and broad development program, there is wide acclaim that substantive progress has been generated.

All of these developments would not have been possible without the continue support of many. I would like to thank all those scientist, doctors, collaborators, investigators, our staff and that of Janssen, and also our patients for their devotion to the program, their courage and their willingness to explore the potentials of ibrutinib. It is our mission to provide patients with body-harmonious solutions and ibrutinib is leading the way.

Thank you for your participation in this call. This concludes our special remarks. We will now open the floor for questions. Operator?

Question-and-Answer Session

Operator

Thank you. (Operator Instructions) Our first question comes from Geoffrey Porges of Sanford Bernstein. Caller, please proceed with your question.

Geoffrey Porges - Sanford Bernstein

Thanks very much and congratulation, Bob and whole team on a very successful ASH, really remarkable data.

Bob Duggan

Thank you.

Geoffrey Porges - Sanford Bernstein

My question is for Lori, there is some also like carryon in the ibrutinib development program and could you just clarify two things. First, what if any of the plan ongoing Phase II trial could potentially be registration enabling? And then secondly, what would be the likely first Phase III to read out given your tough finding and timelines? Thanks.

Dr. Lori Kunkel

Okay. Thank you for the question. So, with respect to the first question that, which of our ongoing trials could be use for accelerated approval. When we look at achieving accelerated approval that is especial designation by the FDA in the high unmet need population where there is no available treatment and activity is reasonably likely to predict a clinical benefit.

So we have two trials that are open-label currently in unmet need patients. One in mantle cell which is open and enrolling, the second one is -- will be opening in 17p deleted CLL patients. Until we see the magnitude and duration of those responses, we would not comment on whether that is an accelerated approval path. We need to actually see the results there.

We do have for both of those indications, randomized control trials that which report both indications in CLL and in Mantle cell lymphoma. So the first full approval trial that we would expect to read out or the first randomized trial we would expect to read out would be ofatumumab versus ibrutinib, which is RESONATE. That study has been open since summer.

It is enrolling as we have expected. It has a primary end point of PFS and it is so far on track to be the first randomized controlled study to read out.

Geoffrey Porges - Sanford Bernstein

Thank you very much. It’s truly helpful. Again, congratulations.

Dr. Lori Kunkel

Thank you.

Operator

Our next question comes from Alan Carr of Needham & Company. Caller, please proceed with your question.

Alan Carr - Needham & Company

Hi. Thanks for taking my questions. You reported some work on mechanism of action of ibrutinib at ASH, inhibition of Il2-inducible kinase. Can you comment on that work, any implications for clinical development whether or not there might be some other targets for ibrutinib too?

Dr. Lori Kunkel

So I would like to turn that question over to Joe Buggy, who is instrumental in helping – He is not on?

Bob Duggan

He is on.

Dr. Maky Zanganeh

He is on.

Dr. Joe Buggy

Hi Ma’am.

Dr. Lori Kunkel

Yeah. Joe Buggy instrumental in helping set up that work.

Dr. Joe Buggy

I would just comment that it’s too early to know whether or not this mechanism points us in any particular new direction in clinical development. I mean, the speaker did have some -- did present some pre-clinical models and anti-effective models. But those were mostly just demonstrated ITK as important. To me the point of this -- of exploring ITK was to gain more insight into the mechanism of action of ibrutinib in CLL. And so we think that it’s possible that ITK inhibitions is important in certain aspects of the mechanism of action in patients of CLL.

So it could be a combination of BTK inhibition and ITK inhibition. But I’ll just point out that ITK inhibition is still very much a research programs. This was our first indication that ibrutinib can irreversibly inhibit in enzyme other than BTK and as such, it’s interesting -- it becomes an interesting point of research and we hope to have more research on the impact of ITK in future meetings.

Alan Carr - Needham & Company

Okay. Thanks. And is there, do you suspect there might be other targets as well or is that particular enzyme, I’m wondering how much work is going on in terms of…

Joe Buggy

That’s an active area of research. I would never conclude we know everything, curious to know about ibrutinib and its target. You know a lot of time. Although ibrutinib is pretty selective for a hand -- we think for a small handful of potential targets and as you know further study of lot of kinase inhibitors, (inaudible) is a classic example. It reveals some overtime -- other interesting targets and we are just trying to accelerate that line of research so that we understand as much as we can about mechanism of actions as quickly as we can.

Alan Carr - Needham & Company

Okay. Great. Thanks very much and congratulations on your progress.

Joe Buggy

Thank you.

Operator

Our next question comes from Ian Somaiya of Piper Jaffray. Caller, please proceed with your questions.

Ian Somaiya - Piper Jaffray

Thanks, guys. I just want to congratulate you guys. Again great ASH, maybe want to follow-up on Jeff’s question on this. Given the data we’re seeing, can you just give us a sense of whether there is any reprioritization of the clinical efforts in terms of scheduled programs you want to proceed with, whether it be in lymphoma or within leukemia. Now, it’s the question number one and then I just have follow-up question.

Dr. Lori Kunkel

So our program has always been focused on putting ibrutinib in areas of highest unmet medical need. So our two lead indications remain our two lead indications which would be mantle cell relapsed and refractory and CLL. I think what we have identified is that even within relapsed and refractory CLL, there is a particularly high unmet medical need which is those patients with deletion 17p who at this point have very limited options.

The patients have acquired a resistant to standard DNA damaging agents and other chemotherapies. And we see that ibrutinib has produced remarkable responses in these patients and that the majority of them respond and that the responses appear to be quite durable.

So shift in the program with opening of Phase II to really study these patients more thoroughly. The RESONATE trial ofatumumab versus ibrutinib does include 17p patients and we will have a randomized study to compare your current standard.

Ian Somaiya - Piper Jaffray

I was maybe more thinking about longer term. As we think about the potential of all of the drug frontline, is there a potential to move, maybe more aggressively forward in frontline setting. And again I think you’d appreciate the long-time duration of that since you get approval of those indications. Just as you can maybe speak to that, what trials, what trial we should expect to kick off in 2013 out of that earlier usage?

Dr. Lori Kunkel

Sure. Certainly. So we did announce that we will be opening an upfront randomized controlled Phase III with ibrutinib as single agent compared to chlorambucil that is called RESONATE-2. So we -- any RESONATE trials, you will know contain ibrutinib in them. The 17p is RESONATE-17. Both of those trials will be initiated in Q1. Also it was announced that there will be an upfront trial that will be conducted by Janssen in mantle cell lymphoma and that trial is also expected to open by mid year of 2013.

So we do see ibrutinib becoming an important part of the treatment of both of these stuff that the patients and I think it already has demonstrated anti-tumor activities that warranted from moving in the primary setting.

Ian Somaiya - Piper Jaffray

Okay. And if I may, just ask question on the Phase II diffuse large B-cell data, one that I have gotten quite often is look, appreciate your view on this. You saw an improvement in response, the quality of your response, higher CRs. Can you speak to the PFS benefits, I know we saw there was information provided in the abstract but not in the official presentation. If you could speak to the PFS as to the duration of the response given that trial.

Dr. Lori Kunkel

So in open label -- in open label studies, the most reliable measurement of activity is overall response rate and duration of response. So in that study, if we look at the overall response rate and then tend to treat population with 70 patients, we saw 16 out of 70 or an overall response rate of 23%. And when we look at the hypothesis that the ABC would have been the driver of -- or the major contributors of those response.

We saw within the 29 ABC gene expression profile patient that our overall response rate was up to 41% with 17 complete responses. So when we go and we look at the duration of response for those, the duration of response is around five months. It was reported a difference in overall survival in the ABC and the GCP where the overall survival is 9.6 months versus 3.35 months.

Ian Somaiya - Piper Jaffray

Okay. Thank you very much. You’re awesome

Dr. Lori Kunkel

You’re welcome.

Operator

The next question comes from Brian Lian with SunTrust. Caller, please proceed with your question.

Brian Lian - SunTrust

Hi. Good morning. Thanks for taking the questions and congratulations on the data and all the recognition in the oncology community. I have a question on the diffuse large B-cell lymphoma settings. A lot of the presentations that I thought didn’t necessarily break out the ABC subtype when talking about high-risk groups. I guess, my question is why isn’t this as bigger focus and how do you think this impacts if at all your regulatory approach that you might be planning?

Dr. Lori Kunkel

So, just to put this into context, the ABC subtype is recognized as a high-risk group for total response to chemotherapy within the diffuse large B-cell population. So when we refer to high risk generally, we’re referring to those patients who historically have a worst outcomes with chemotherapy. And this has been shown to be true with [CHOP-R] in this particularly population.

[CHOP-R] cures 50% of the patients, then when you look at the patients who have early relapse or higher incident of relapse, this is the ABC subtype. So this subtype does predict outcomes with R-CHOP both in progression free survival as well as overall survival. They are inferior to the GCP diffuse large B-cell.

Does that…

Brian Lian - SunTrust

Yeah. That’s great. Thanks. I thought you’re going to say something else. And then one of the things that has come up in talking to people is that in mantle cells and maybe some of the other settings, many of the relapse patients would continue to benefit from further courses of Rituxan. So I guess, how do we think about that and related questions? How does the data hold up in fully refractory versus simply relapse. I’m sure you broke this up before. I just don’t remember what they are?

Dr. Lori Kunkel

So when we look at the mantle cell population which was studied with relapse and refractory population. So after [CHOP-R], there is no evidence that have been there. There is no evidence that single-agent rate testing would, that I’m aware, there could be some small studies would be active in mantle cell that’s single agent. So maintenance has not -- is currently used but is not in any vertical label.

The drug that is approved in the U.S. is bortezomib that provides a 30% response rate and about six months progression free survival. So in our studies, we looked at the primary division with whether or not they had received bortezomib or not. We did not see any difference between those groups.

With respect to being primary refractory, the analysis of that was not presented -- was not presented in this particular meeting because the numbers are relatively -- I mean, these numbers are relatively small within the bortezomib. You are looking at numbers that have population of 21 patients. So it would be really hard to interpret that data.

However, as we showed in the presentation as Mike Wang showed that the normal high-risk factors such as bulky disease and the prior treatment did not matter for that population.

Brian Lian - SunTrust

Okay. Thanks very much and congratulations on the results.

Bob Duggan

You’re welcome, Brian.

Operator

Our next question is from James Cole of Lazard Capital Markets. Caller, please proceed with your questions.

James Cole - Lazard Capital Markets

Thanks for taking the question. Could you tell us what the next step for your HDAC inhibitor -- based on the strong data in lymphoma?

Bob Duggan

That program is really led by the survey group. We have -- we retained all rights in the United States. We’re very pleased with the results that were our only drug. It would be incredibly more active. It’s not -- so as a relative priority, it’s not at the highest part in our listings. And if that would have changed then we would have substantive money behind it. We would have announced that at that time.

James Cole - Lazard Capital Markets

Thank you.

Bob Duggan

You’re welcome.

Operator

Our next question is from Howard Liang of Leerink Swann. Caller, please proceed with your question. Howard Liang, your line is lost.

Howard Liang - Leerink Swann

Yeah. I’m sorry. Can you hear me?

Operator

Yeah, sir.

Howard Liang - Leerink Swann

What would you conclude from the NIH work, a bit on the mutation analysis in DLBCL, biomarkers selection based on either CD13, CD79b or MYD88 indications in either DLBCL or other indication such work, this maybe helpful such as multiple myeloma?

Dr. Lori Kunkel

So the -- with respect to the patient analysis that was done and we didn’t have presented at this meeting. We’re looking at particularly mutations that would be drivers of BCR signaling pathway or activated -- activating NF-kappaB. So the mutations when you narrow this down as was pointed out, these mutations are infrequent but appear to be important with an ABC subtype and that in particular when we look at the mutations around CARD11, MYD88, we were able to define subsets of patients that appear to respond even better to ibrutinib or had an improved response.

So we did what looked as the CD79 mutant, five out of seven responded, that was 71%. Then if you did additional look at those who had both this at CD79 and MYD88, both were mutated. There was an 80% response rate.

So, the, I think, there is a couple of take home points for this, is that we are now -- we are able to enrich the patient that are depended on this BCR signaling pathway. They are a proportionate patient at the ABC that certainly important portion and if these patients will help us understand the biology of this disease.

Moving forward, the team is working on enriching and maybe see subtype or future trials and we’ll continue to explore these mutations where -- if these mutations may project a very high activity of ibrutinib.

Howard Liang - Leerink Swann

Could I just follow up on the -- are these patients were maybe 79 mutation or double mutation also with MYD88. Are those also the ones with the longest duration of therapy, because some have very long duration therapy?

Dr. Lori Kunkel

Yeah. They tend to correlate with, although, these are small numbers, they just tend to correlate with those response and duration. But, at this time, I just need to be cautious that these are very small numbers and preliminary data.

We will, obviously, be looking at this in the future. But it’s amazing. I will say that as a single agent you could achieve CRs in this highly refractory patient population and that those CRs were durable. So we are very excited about that data and obviously, these large B-cell programs will certainly be moving forward.

Howard Liang - Leerink Swann

But…

Bob Duggan

Howard, I might also add we are very thankful to the NIH, [Blue Scout] and Wyndham Wilson for their work in these area. They have been indefatigable in generating forward progress and then lighting us to our path forward.

Howard Liang - Leerink Swann

Great. Can I also, I have another question, can give more color on how you plan to move forward in follicular lymphoma and what were the Phase II look like?

Dr. Lori Kunkel

We have just met with our advisors and advisory board and the JBI and PCYC team are discussing their pathway. What I can tell you, this play, it looks like we would be enriching for the ABC, but the final plan had not been put forward or follicular of, that was still on B-cell lymphoma.

But with respect to the follicular and again, we actually just met with advisors that that plan moving forward is little bit more clear and that we will be moving forward in a define follicular population who have failed chemo-immunotherapy.

So that program is still also quite immature. We presented data on 16 patients. So we will be doing a larger Phase II in follicular and looking to report those results out, as well as getting more insight into the biology of these patients who response ibrutinib. We expect that to start within the first half of 2013.

Howard Liang - Leerink Swann

Great. Thanks for taking my question.

Ramses Erdtmann

Okay. Welcome.

Bob Duggan

Can I just make a comment, Howard, and also Brian’s earlier question? These presentations and the numbers that Lori is quoting, they are all on our website. You can find the DLBCL presentation by Wyndham Wilson. You can find the mantle cell presentation by Dr. Wang. And also the follow presentation, they are all on the website, they are ordered, there are 18 of them, go ahead, all the numbers are there.

Operator

(Operator Instructions) Our next question is from Joel Sendek of Stifel Nicolaus. Caller, please proceed with your question.

Joel Sendek - Stifel Nicolaus

Hi. Thanks a lot. I have two questions. The first a follow up from last one on diffuse large cell, so when I listen to the presentation, at the end there was a question about moving it up into front-line and the answer, I guess, that Dr. Wilson gave is the potential accommodation with chemotherapy?

And that seems that odds with your approach to bring the drug to the largest unmet medical need. I’m wondering how you rationalize those two very different approaches? And then my second question has, if you can just give us an update on the next step for ibrutinib in multiple myeloma effects?

Dr. Lori Kunkel

Okay. So, Howard, I do think, stays in line with their approach to high-end unmet medical. As we discussed earlier, you look at the ABC subtype in diffuse large B-cell. Those patients are the ones who are relapsing for [CHOP-R]. The majority of them do not obtain a sustain progression free survival.

So there is still to be unmet need in the patient group. The average time to relapse looks to be somewhere between two to three years versus the AB -- GCB subtype, which is more in the five to six year range.

So since these patients are curable the addition of and agent such as ibrutinib to that enrich subtype would be reasonable and fit in with our plan. Also take in mind that the safety profile ibrutinib does make this agent a favorable agent to combine with the other chemo-immunotherapy.

Joel Sendek - Stifel Nicolaus

And on multiple myeloma?

Dr. Lori Kunkel

In multiple myeloma, we are moving forward on several fronts. We are initiating a combination with dexamethasone. We are also exploring the higher dose to get a look at -- to be able to really get a look at what ibrutinib does in the microenvironment of these myeloma patients.

At the same time, we have initiated discussions with several groups on what the best path forward would be using a prednisone inhibitor or and even the preclinical model show that either of the classes of agents would combine well with ibrutinib.

And as there is -- as you know, there has been some rapid progress in the area that we still see myeloma as an opportunity. We are still not sharing the majority of the patients. And again, given ibrutinib at least the preliminary activity on the bone and some reductions in paraprotein, this makes it an attractive agent, the safety profile makes it an attractive agent for combination with either in it or prednisone inhibitor.

Joel Sendek - Stifel Nicolaus

Okay. Thank you.

Bob Duggan

You are welcome Joel.

Dr. Lori Kunkel

You are welcome Joel.

Operator

Since we have time for, okay. Our next question comes from Brian Skorney of R.W. Baird. Caller, please proceed with your question.

Brian Skorney - R.W. Baird

Hey. Good morning, guys, and congratulation all the data over the weekend. And I guess, turning to myeloma, can you give us some color on the two myeloma patients that you saw powerful responses, both one as a single agent, one combo effect, dexamethasone. How deep were these responses and how durable are these patients, still in powerful condition?

Dr. Lori Kunkel

So, thanks for the question, Brian. The patients that responded were -- as with all patients that were enrolled in the trial were heavily pre-treated. I think that’s what everybody probably need to first know these patients have failed in it, failed bortezomib and lenalidomide, 12 of them had failed out of stem cell transplant, the majority of them moving refractory to their last treatment.

So we did see decreases in the paraprotein of the patients that decreases occurred. We began to see decreases within the first cycle that overtime the decrease is improved. And then we did add dexamethasone to improve the magnitude of the responses. We still do have six patients on treatment, out of these 13. And the longest follow up is seven months and one of the PRs is at least still on treatment, one has come off.

Brian Skorney - R.W. Baird

Great. And then if I just kind of switch gears little to follicular lymphoma, I know that you have announced the design of Phase II single-arm study in relapse/refractory follicular. I guess, just kind of with the landscape as it is with, some other agents maybe a little ahead of you, some of them just a little behind than follicular as same type pretty clearly in CLL and MCL.

Just wonder kind of what your thoughts on how you kind of maybe move ahead of some of the other agents or ketchup, I’m thinking with the (inaudible) Gilead drug in particular? Should we think about their clinical trial move on, which at least their first study seems similar to the Phase II that you guys are planning right now and then they are about to start enrolling a couple of large combo studies in the relapsed/refractory. I think, do you that’s the, if you similar results in the single-arm Phase II, you will pursue a similar pathway that to what Gilead has done or do you think there is another kind of opportunity for ibrutinib.

Dr. Lori Kunkel

So I think our single agent data was quite compelling in that we demonstrated over a 50% response rate in higher doses that was 55%. And again, the remarkable being was the PFS 19.6%. Now this small number and our next stage is to go into a single-arm trial of 110 patients and this will be coming up shortly and has been really by essence.

Those patients will have -- had to have had at least two cycles of chemo -- two courses of chemo-immunotherapy and what we look at is that they would have relapse within 12 months of their last treatment.

So we now really look at the unmet need, most of the patients are not getting single agent Rituxan, they are getting combination immunotherapy, both first and second line. So we see that as the unmet need of patients who relapse from chemo-immunotherapy, not who relapse from Rituxan.

So we see potential as a single agent given our early results and certainly, again, the combination with something like bendamustine Rituxan in those patients who are relapsing after the first line would be rational forward and we should have more color on that in the upcoming months.

Brian Skorney - R.W. Baird

And then just real quick, any update on a four series BTK inhibitor or plans for ibrutinib and autoimmune inflammatory conditions?

Bob Duggan

Hi, Brian. This is Bob. The four series autoimmune remains work in process. I would say we are making progress. We should be able to give you more substance of read out in late second quarter, probably around the ASCO and give you more color on exact -- on the exact status and how that program could shape up. I would say at this time it looks good. We are strong -- certainly strong enough to continue with caution but interest.

Brian Skorney - R.W. Baird

Okay. Thanks so much guys.

Bob Duggan

Yeah.

Operator

Our next question comes from Michael Yee of RBC Capital Markets. Caller, please proceed with your question.

Charmaine Chan - RBC Capital Markets

Good morning. This is Charmaine on behalf of Michael. We have two questions. First, can you comment on RESONATETM-17p, what do you think the hurdle rate for response rate to go forward and can you speak to the timing of enrollment and whether it’s reasonable to expect data in 2014? And the second question that we have is can you remind us on the powering for ibrutinib versus ofa in RESONATE and what it does in the interim analysis? Thank you.

Dr. Lori Kunkel

Certainly, so with respect to RESONATE-17 or 17p deleted open label trial. When we look at the unmet need population in the relapse and refractory myeloma that particularly population, there is really no agent that gives you a response rate that’s over 50%. So the response rates are in 30% range. With respect to durability, the PFS’ durability is measured in four to six months.

So it would be reasonable for new agents to come in and at least achieve 30% response rate and duration of six months. Now our data from 1/1/02 and then from other ongoing studies conducted by our investigators show that in the deletion 17p, patients’ overall response rate is not really different than those patients who don’t have it and is greater than 60%.

When we look at our PFS, it is estimated to be 57% at 26 months. So this is a remarkable result for those patients and what our investigators tells us is now our PFS in those patients are exceeding the expected overall survival that they would achieve historically.

So we see that that’s a very unmet need in area that ibrutinib looks like, it will be a paradigm change for those patients. This study will open in Q1. We fully expect based on the enrollment of their other trials to enroll that under a year. We would need six months follow-up on our patients and then take a look at the magnitude and duration of response. That answers the first question.

Charmaine Chan - RBC Capital Markets

Yeah. That’s great.

Dr. Lori Kunkel

Okay. So with respect to open trial, that trial was designed to show superiority over ofatumumab, ibrutinib’s superiority with PFS as the primary endpoint. In that trial we expect to conduct the study to completion. There is an interim that will occur at the anticipated 50% of progression event and what we have said and have agreed to with the regulatory agencies that if there is overwhelming effect at that interim, we would certainly go and discuss them. However, we would not stop the trial until we’ve had discussions with the regulatory agencies in the U.S. and in Europe. There is a DMC on that trial as well as the independent review committee.

Charmaine Chan - RBC Capital Markets

So just numerically, what we qualify as overwhelming data at that point of the 50% PFS as the endpoints.

Dr. Joe Buggy

Charmaine we expect to complete that trial before it read out and we ask for registration approval. So that’s really all the more, we should really comment on that.

Charmaine Chan - RBC Capital Markets

Okay. Understood. Thank you.

Operator

(Operator Instructions) It appears we have no further questions at this time. I would now like to turn the floor back to management for closing comments.

Bob Duggan

Thank you, Operator. Over the next 12 months, our development plan will further enfold, allowing us to explore the potential of ibrutinib what it has in B-cell malignancies. Results, we published here at ASH and provided today in our press release and on our website, are exciting and will help us promulgate our clinical trials and define our registration strategy. These are exciting times and substantive progress has been generated.

We look forward to updating you on our clinical progress in June of ASCO. Thank you very much for your participation in this call and have a great day.

Operator

This concludes today’s teleconference. You may now disconnect your lines at this time and thank you for your participation.

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