Clovis Oncology's (CLVS) CEO Patrick Mahaffy on Q2 2014 Results - Earnings Call Transcript

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 |  About: Clovis Oncology (CLVS)
by: SA Transcripts

Operator

Good day, ladies and gentlemen, and welcome to the Second Quarter 2014 Clovis Oncology Earnings Conference Call. My name is Jackie and I will be your operator for today. (Operator Instructions). I would now like to turn the conference over to Ms. Anna Sussman, Senior Director [and] Investor Relations. Please proceed.

Anna Sussman

Thank you, Jackie. Good afternoon, everyone. Welcome to the Clovis Oncology second quarter conference call. You should have received the news release announcing our second quarter financial results. If not, it's available on our website. As a reminder, this conference call is being recorded and webcast. Remarks can be accessed live on our website during the call and will be available in our archive for the next several weeks.

The agenda for today's call is as follows. Patrick Mahaffy, our President and CEO will discuss the highlights of the quarter and provide an update on our clinical development program. And Erle Mast, our Chief Financial Officer will cover the financial results for the quarter and comment on the company's outlook for 2014. Patrick will make a few closing remarks, and then we'll open the call for Q&A.

Before we begin, please note that during today's conference call, we may make forward-looking statements within the means of the federal securities laws, including statements concerning our financial outlook and expected business plans. All of these statements are subject to risks and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements.

Please refer to our recent filings with the SEC for a full review of the risks and uncertainties associated with our business. Forward-looking statements speak only as of the date on which they are made and Clovis undertakes no obligation to update or revise any forward-looking statements.

Now, I will turn the call over to Patrick Mahaffy.

Patrick Mahaffy

Thanks, Anna. Welcome, everybody, thanks for joining us. We made significant progress during the second quarter. I like to improve the receipt of breakthrough designation for CO-1686 in May. Data updates at ASCO in late May or June and continue to advance our clinical development programs with the initiation of multiple clinical studies during the quarter.

Importantly, these include the initiation of the TIGER2 study or 1686, which together with the Phase 2 expansion in cohort performed the basis of our NDA submission plan from mid-2015. Let me start with 1686, which was recently assigned as proposed international non-proprietary name or INM. Lucitanib we try will attempt to you going forward as we plan to assemble several times between the two things during this call. At ASCO we announced the most update of rociletinib clinical data which continues to demonstrate that rociletinib is a very active and well tolerated drug. Highlights of the data presented at ASCO include the following.

58% objective response rate was achieved in evaluable, centrally-confirmed T790M positive patients treated with the therapeutic dose, and a 90% of that patient population achieved disease control defined by the disease stabilization or an objective response. The median duration of response could not yet be determined in the T790M positive patients and similarly, median progression-free survival or PFS had not been reached. However, follow-up for some patients now exceeds one year.

These data continue to mature and we remain extremely encouraged by the impressive durability and benefit we are seeing, potentially longer than the median PFS observed in newly diagnosed patients treated with front-line TKI such as erlotinib and this reinforces our belief that inhibition of EGFR bio metabolite maybe contributing to this.

Equally or perhaps even more encouraging is the response rate in PFS we see in patients that brain met presence at time of enrollment. As you know brain met become more common as the disease progresses and to have clear evidence of meaningful activity in these patients is very good news. We look forward to providing an update of rociletinib data during the 26th EORTC-AACR-NCI Symposium on Molecular Targets and Cancer Therapeutics in Barcelona in mid-November. As we discussed at ASCO, rociletinib is also well tolerated, we have seen no evidence of systemic wild-type EGFR inhibition, side effects of which could include rash, (inaudible).

The most common adverse events were nausea, hyperglycemia, diarrhea, vomiting and decreased appetite, and these were mostly grade 1 and 2 in severity. Given the full file of the drug emerging from our studies, investigators are extremely enthusiastic about moving rociletinib program forward rapidly ensuring it can be approved and made available for the large number of patients for whom it may provide benefit.

As such, we are very pleased with the rate of enrollment underway for the for the Phase 2 expansion cohorts in patients with EGFR mutant non-small cell lung cancer as well as TIGER2 and we remain on track for these studies to service the basis for an NDA submission by mid 2015.

These expansion cohorts are testing the activity of rociletinib in two patient subsets. The first in approximately 150 to 200 patients who are T790M positive, directly after progression on their first and only TKI therapy, similar to our TIGER2 study design; and the second, in approximately 150 to 200 T790M positive later-line patients, after progression on their second or later TKI therapy or subsequent chemotherapy. Both cohorts are exploring doses of 500 mgs, 625 mgs and 750 mgs.

During the second quarter, we initiated the TIGER2, a global registration study for rociletinib in patients with EGFR mutant non-small cell lung cancer. More specifically, this trial examined T790M positive second line patients directly after progression on their first and only TKI.

There are two additional global studies in the TIGER program for rociletinib initiating soon. In the very near term, hopefully this month, we expect to enroll our patient in the Phase 2 portion of TIGER1, a randomized Phase 2/3 registration study versus erlotinib, in newly diagnosed EGFR-mutant patients.

We’ve been very pleased with overwhelming interest and participation in this study and now expect the Phase 2 portion will enroll the plan 200 patients in about six months. Later in 2014, we intend to initiate TIGER3, a randomized comparative study versus chemotherapy in patients with EGFR-mutant non-small cell lung cancer and acquired TKI resistance. Based on data today, we have chosen a dose of 625 mgs BID for each of these studies.

Last for today's discussion of rociletinib but no means least, during the second quarter, we were granted Breakthrough Therapy designation for the drug, for the treatment for mutant non-small cell lung cancer in patients with the T790M mutation after progression on EGFR-directed therapy.

Turning now to rucaparib. We were pleased with the Phase 1 data presented at ASCO and we look forward to providing an update on the Phase 2 treatment data in germline BRCA mutation ovarian cancer. We are actively enrolling patients in both studies and the ARIEL programs, which includes the Phase 2 treatment study and our registration focused phase III maintenance file.

ARIEL2 is our global Phase 2 single arm open label study designed to identify molecular features that predict sensitivity to Rucaparib, as in DNA sequencing to evaluate each patient’s tumor. The study especially correlates with rucaparib efficacy with the genotype and phenotype with each patients tumor. And these data will inform the final definition of homologous recombination deficiency for the ARIEL3 registration study analysis.

To our knowledge we’re the only company seeking to prospectively demonstrate inhibitor activity in a molecularly selected ovarian cancer population beyond germline and BRCA mutations. This is the BRCA-mutant patient and it successfully we believe we will meaningfully differentiate with cap rate from competitors.

We’re very encouraged with enrollment and results to-date with ARIEL2 which is demonstrating consistently strong results in patients for BRCA mutations. In addition we are seeing clear evidence of very good activity in BRCA mut patient whose BRCA genes are normal and little to no activity in bottom or for negative patients supporting our hypothesis. We think data from this trial will change the way the community will think about patients who may benefit from rucaparib the only HERP inhibitor that seek to prospectively demonstrates this and targeted activity in a clinical study.

ARIEL3 is our global randomized double-blind Phase 3 registration study that compares the effective rucaparib versus placebo. This study will evaluate whether maintenance rucaparib there, we can spend the period of time for which diseases control at the successful chemotherapy in platinum-sensitive ovarian cancer patients. The study will utilize pre-specified step-down efficacy analysis, first in BRCA mutant patients, then in the broader HRD populations as defined by the ARIEL2 study, than in Alzheimer's.

Rucaparib is a very active drug and data support our approach to identify patients with BRCA mutations as well as BRCA-ness or other DNA repair defects that maybe address rucaparib therapy. The inclusion of BRCA patients, our target patient population will potentially include more than 50% of women with serious ovarian cancer.

During the quarter we also initiated the Phase 2 RUCAPANC study for pancreatic cancer patients with BRCA mutations. This study is based on the partial responses observed in two germline BRCA mutation pancreatic cancer patients treated with rucaparib (inaudible) additional chemotherapy.

Turning now to lucitanib. Our oral potent inhibitor with tyrosine kinase activity FGFR 1 and 2, VEGFR 1 through 3 and PDGFR alpha and beta. Lucitanib has demonstrated impressive response rates with manageable side effects in previous trials of heavily pre-treated patients with solid tumors. We hold exclusive U.S. and Japanese rights and have a collaboration agreement with Servier, the holder of European and Rest of world rights for the global clinical development of the drug.

Our development program for lucitanib is initially targeting solid tumors with FGFR pathway activation including breast and squamous non-small cell lung cancer.

In addition to the Servier-sponsored study in advanced breast cancer currently underway, we're preparing to initiate two Clovis-sponsored trials in the very near term.

A U.S. Phase 2 study in treatment for FGFR 1 or 11q-amplified patients with advanced breast cancer and a global Phase 2 study in advanced squamous lung cancer patients with FGFR 1 amplification.

Data on the lucitanib was presented at ASCO and largely familiar to many of you but we were pleased to receive an oral presentation for the introduction of lucitanib to U.S. physicians. The next data for lucitanib is at the ASCO 2015.

Now, let me turn the call over to Erle to discuss second quarter 2014 financial results and updated guidance.

Erle Mast

Thanks Pat and good afternoon everyone. We reported a net loss for the second quarter of 2014 of $34.8 million or $1.03 per share and $65.5 million or $1.93 per share for the first half of 2014. Research and development expenses totaled $28.4 million for the second quarter of 2014 and $52.6 million for the first half of 2014. Each of these amounts to up considerably from the comparable periods in 2013 due to the increased enrollment in the ongoing Phase 1/2 non-small cell lung cancer study for rociletinib as well as the initiation of the TIGER2, the Japanese Phase 1 studies for rociletinib and the ARIEL2, ARIEL3 and RUCAPANC study for rucaparib.

And as a reminder, the development expenses for lucitanib are currently being funded by Servier, so its addition to our portfolio had no impact on R&D expenses for 2014. Total operating expenses include non-cash charges totaling $6 million for the second quarter and $15.2 million for the first half of 2014 associated with share based compensation expense and the amortization of an intangible asset and accretion of contingent purchase consideration both of which are associated with our 2013 acquisition of EOS.

Our net cash burn for the second quarter of this year totaled $30.4 million and that was up from $19.6 million for the first quarter of 2014. Now this increase is primarily due to the $13.6 million milestone payment that we received from Servier in the first quarter associated with the lucitanib program. As of June 30th we had $273.2 million in cash and cash equivalents and we had $34 million in outstanding shares of our common stock. We continue to expect cash burn for 2014 will total approximately $120 million and that will end the year with approximately $200 million in cash.

Now with that I will turn the call back to Pat for some closing remarks and then we’ll open it up for Q&A.

Patrick Mahaffy

Thanks Erle. These are our anticipated milestones for the remainder of the year. For rociletinib we intend to initiate additional studies in the TIGER program for non-small cell lung cancer which includes the following, the Phase 2 portion of the TIGER1 registration study in newly diagnosed EGFR mutant patients and the randomized comparative TIGER3 study of rociletinib versus chemo in patients with EGFR mutant disease and acquired TKI resistance. We also planned to present the updated data for [triple] meeting in November.

Rucaparib will continue enrollment of the ARIEL2 treatment study in ARIEL3 maintenance study in platinum sensitive ovarian cancer patients with BRCA mutation and other DNA repair deficiencies as well as the Phase 2 study of rucaparib in pancreatic cancer patients with BRCA mutation. We plan to present updated data at ESMO in September and potentially again at the [triple] meeting in November. And finally for lucitanib we intend to initiate our Phase 2 study to lucitanib in selective patients very soon. We have included the U.S. Phase 2 study in patients with treatment-refractory FGF-aberrant breast cancer and the global Phase 2 study in patients with metastatic squamous non-small cell lung cancer with FGFR-1 amplification.

In summary, we are actively preparing for our first NDA by mid-2015 as well as building out our commercial and medical affairs leadership prepared for a potential product launch for rociletinib at the end of 2015. And we continue to be very encouraged by the data we are generating.

With that, thanks for joining us, I should note Andrew Allan our Chief Medical Officer of course is on the call as well. And with that we will open the call for Q&A.

Question-and-Answer Session

Operator

(Operator Instructions). And your first question comes from the line of Cory Kasimov with JP Morgan. Please proceed.

Unidentified Analyst

Hi, guys, this is actually Whitney on for Cory. Just a question on the rociletinib update expected in November. What should we be looking for there in terms of these numbers average duration et cetera versus?

Patrick Mahaffy

Well, it's a little early to predict exactly what we would be presenting. I think you should expect a presentation that is generally consistent in format with what we have presented at ASCO. One thing I do want us to do is show a mono-therapy that's from the Phase 1 experience and then of to show PFS that's emerging from the abundant population. But we're piling patients on. And so that's the only way you would be able to get a kind of clear view of key PFS with some degree of maturity.

Unidentified Analyst

Great. And then I guess in terms of the expansion cohorts. Are you getting any early feedback just around hyperglycemia and whether it is easily managed as you thought it would be?

Patrick Mahaffy

Yes and yes. I mean we get very little discussion of it now with clinicians. As we've said it is easy to manage with metformin it is well managed with metformin and that's what we are seeing in clinical practice.

Unidentified Analyst

Great. Thanks for taking the questions.

Operator

And your next question comes from the line of Yaron Weber with Citi.

Unidentified Analyst

Hi, this is (inaudible) for Yaron. Thank you for taking my question. So, in the brain mix patients you are seeing few responses. Can you please comment on the levels of 1686, you are seeing in the brain in animal models? And also are you planning to do any high dose studies in these patients with brain mets?

Patrick Mahaffy

Yes. We don’t spend a lot of time looking at animal models with brain mets because we don’t think they’re productive of the human experience, some clinicians don’t either. So what really matters is clinical data. And what we’re seeing in the patients with brain mets is as I noted herem exceptionally encouraging from the data we’ve seen so far. What was your second part of your question?

Unidentified Analyst

Are you planning to do any higher dose studies in those patents. We have interest on the part of clinicians and looking at some sort of higher dose or more likely kind of full dosing. We haven’t formally decided to do that but there is a great degree of interest on the part of the clinicians in doing so. And we manage normally to live upto what they desire. So, I would be surprised if we don’t.

Operator

Okay. Thank you. And your next question comes from the line of [Barney] Klein with Stifel. Please proceed.

Brian Klein - Stifel

Great thanks. It’s Brian Klein. First question on the selection of the 625 milligram dose for TIGER1 and TIGER3, can you walk us through what criteria you used to make that dose selection please?

Patrick Mahaffy

Andrew?

Andrew Allen

Sure. It was mostly clinical data that has influenced that decision. The initial Phase 1 study like most Phase 1 studies is in relatively small numbers of patients. And it’s very hard with well tolerated drugs to really kind of get a strong sense of where the optimum doze exactly sits. And so, treating more patients at the various doses is the only way you can truly choose between doses? And so we’ve been relying mostly on clinical data to inform that selection of the optimum dose. And obviously what we’re trading off is efficacy on a one hand and toxicity on the other hand and trying to find the sweet spot where we retain all efficacy but we minimize toxicity. And that approach led us to 625 milligrams BID.

Brian Klein - Stifel

Great. In terms of those two studies, is there an opportunity to either dose escalate or dose intensify if the patient isn't responding after a certain amount of time.

Andrew Allen

It depends on the phase of study. Obviously the later of the phase, the more flexibility you offer physicians early on when one is more cautious because you have less drug experience, you do not allow such flexibility. But in latest studies we typically do permit escalation if deemed appropriate. Obviously we’ve cleared doses all the way up to a 1,000 milligrams BID is being safe for the Phase 1 study and therefore we have cover for dose escalation from 625 if it's regarded as appropriate.

Brian Klein - Stifel

Great, Thanks.

Andrew Allen

Brian, one thing, Brian I can chip into, one thing to remind you is we have basically equivalent efficacy across all of these efficacious doses including 900 mgs of the freebase, 500 mgs BID, 625 and 750. So, I don’t think at 625 we’re treating of efficacy, it's a very active drug and contributed 90% to diseases control rate that we reported ASCO and before.

Brian Klein - Stifel

Great. Thanks for that additional color. Just one final question. Is the data that you’re generating right now between the expansion studies and TIGER2 sufficient for a European filing as well? Thank you.

Patrick Mahaffy

Yes.

Brian Klein - Stifel

Great.

Operator

And your next question comes from the line of Terence Flynn with Goldman Sachs. Please proceed.

Terence Flynn - Goldman Sachs

Hi. Thanks for taking the question. I was just wondering with respect to TIGER1, if you can remind us if you plan to top-line any of the data from the Phase 2 portion of that trial? And if so, is that going to be a response rate or whether it’d be also some PFS data? Thank you.

Patrick Mahaffy

The data are open to us. And to remind everybody of the way this trial works. The Phase 2 portion is for us to learn about activity including PFS versus erlotinib and apply that to the Phase 3 portion. And as such those Phase 2 patients will not be a part of our NDA submission. So we have access to all that data and we will share those data with you at scientific meetings. So at the appropriate forum as early as, not certain but as early as ASCO next year, we may provide an initial view of data from the Phase 2 portion of that study and clearly we won't have mature data at that time but if the data mature, we will continue to provide update. We know that important to investors.

Terence Flynn - Goldman Sachs

Okay. Thank you.

Operator

And your next question comes from the line of [Howard Liang with Clovis] Please proceed.

Howard Liang - Leerink

Hi, it's Howard Liang with Leerink. Regarding rociletinib, are you looking at between power marker studies, looking at EGFR reception activation to the patients might be appropriate?

Patrick Mahaffy

Andrew?

Andrew Allen

We're not yet at that point. There are two issues, one is that the selection of patients based on EGFR pathway activation has been difficult because the reagents are tricky to develop for a pre-clinical use. That's kind of issue one. Issue two is that, it's not clear that the role of EGFR will be apparent early on in the patient's clinical course. And the data that are in the literature suggest that the role of EGFR may be less in terms of driving to active tumor proliferation and fast growing clone, but more about being responsible for cell sometimes to the sisters cells which is related to stem cells. And so perhaps the reason we're seeing similar response rates to AZD-9291 is that both drugs are acting through T790M inhibition. But then it’s the emergence of acquired resistance to the drug through those persisted populations and sort of complex heterogeneity of the tumor clone that is leading to selection that in the case of 9291 perhaps is allowing EGFR to be a very active pathway driving faster relapse whereas with 1686 standards metabolized that pathway that opportunity is suppressed and that may not be a occurrence in the baseline biopsy obviously in the patients who hasn’t yet been exposed to the drug. So it’s a complex field and obviously we are going work in that area but nothing is yet that is prime time.

Patrick Mahaffy

And Howard if I could add, there is no need for us to do further selection by selecting for T790M we are getting a 90% disease control – it’s pretty hard to do better than that. And so it is evident to us to underscore what Andrew just said that we would ever need to select beyond it.

Unidentified Analyst

Great. Just another question are you doing anything different in managing the hyperglycemia in the Phase 3 studies as compared to the earlier studies?

Patrick Mahaffy

No, the good news is that we have learned with our investigators that we can easily manage it with that format and so in all of these studies we will recommend to use of (inaudible) when symptoms emerge or in glucose level rise and so having learned it in the context of the Phase 1 we can now apply it to our further studies.

Unidentified Analyst

Thanks so much.

Patrick Mahaffy

Good luck.

Operator

And your next question comes from the line of Peter Lawson with Mizuho Securities.

Peter Lawson - Mizuho Securities

Hey Patrick just with the data…

Patrick Mahaffy

Peter, hello?

Operator

Mr. Peter, will you please check your mute feature?

Peter Lawson - Mizuho Securities

Hi, can you hear me?

Patrick Mahaffy

I can now, but I didn't hear anything you said though.

Peter Lawson - Mizuho Securities

Okay, perfect. So with CO 1686 rociletinib, from the ASCO data, did you get any push back from oncologists around side effect profile? And then secondly did the data help accelerate the enrollment rates?

Patrick Mahaffy

Well, I can't quantify whether the data have held enrollment rates. They were very good and they remain very good. So, I don't we have in general at the clinics where we were enrolling where we already have approval leading us for participation in our studies. And so at some level, I don't know that they could have done more to it there was already a great amount of enthusiasm for the drug within the community based on prior presentation.

So, we clearly are very pleased with our enrollment. And they forgot to push back on side effects, not really. What most believe like Tom Lynch said at the meeting, in fact to everyone we speak to is what we do to manage side effects. If we have great data, we'll manage the side effects. And it's not uncommon to see, it's very common in fact to see side effects emerge with new therapies, obviously Avastin is a $6 billion drug and when it was launched, there was anxiety about the hypertension it caused and physicians became very adaptive to treating hypertension, because they were getting great benefit from the drug. So, we’re completely comfortable with our positioning of this drug and fortunate that we have the only one side effect and that one side effective is very easily managed with Metformin that’s pretty rare. So, we’re in very good shape with this drug and our interactions with our clinicians about the management of the side effects.

Peter Lawson - Mizuho Securities

Thank you. And then just on rucaparib, there is no update. Is that around the HRD biomarker validation study in ovarian or is that some additional Phase 1/2 data?

Patrick Mahaffy

Andrew?

Andrew Allen

There is no post that’s insignificant except that it is around phase 2 data from the single arm study in germline BRCA mutant platinum sensitive ovarian cancer. So that’s a very homogeneous patient population that we have been treating essentially to credential the drug to show it’s kind of merit against the target population of germline BRCA mutants, where obviously one of the whole class of drugs has activity. So that’s the focus at ASMO, obviously the more exciting data will be related to the ARIEL2 study where we step outside of that narrow arena and begin to show activity in patients who have normal BRCA genes but have this alternate mechanism that leads to the same biology and hopefully that will lead to good efficacy of the drug in that population.

Peter Lawson - Mizuho Securities

And just a follow-up and then additional data what would be is presented the around rucaparib?

Patrick Mahaffy

Our intention for obviously we have to be a little bit cautious because not all of the data has been accepted yet, but our intention is to show our preliminary clinical data from the ARIEL2 study in patience so far enrolled, it’s a decent number of patients the study has been enrolling extremely well.

Peter Lawson - Mizuho Securities

Got you. Thank you so much.

Operator

And your next question comes from the line of Charles Duncan with Piper Jaffray. Please proceed.

Unidentified Analyst

Hi guys. This is [Corey]. Andrew has kind of answered this question but regarding to ARIEL2 data, does it seem clear evidence in the back of patient have guys lock down the HRD profile pretty well it's still moving around what's the data look like in terms of that?

Patrick Mahaffy

We have a preliminary definition which we have put in today’s statistical analysis down on ARIEL2, so this is a pre-specified analysis. And that is performing very well in the date we have so far. Now, we reserve the right to modify that based upon the complete ARIEL2 data that obviously in large partners why we are doing the ARIEL2 study so we should not and do not need to lock it down yet. We have time because the primary goal of the classify is to you use -- is to analyze patients in the ARIEL3 study which is underway as you know. And we are blinded to ARIEL3 data and therefore we have the opportunity to continue to work on the classifier and no need to lock it down in principle relatively near to the end of the ARIEL3 study.

Now, for various reasons ones likes to try and lock it down before very end of the blinded study. The number that we have time is on our side to get this right. And so, as I recall, the kind preliminary classifier provisional classifier that we're using today is working well but we may tweak it a little bit based on complete ARIEL2 data.

Unidentified Analyst

Okay. And can you just remind me briefly how you determine that pre-specified criteria?

Patrick Mahaffy

How we got?

Unidentified Analyst

Yes. How you got the pre-defined criteria?

Patrick Mahaffy

It was nicely done using a public domain data from the Cancer Genome Atlas.

Unidentified Analyst

Okay.

Patrick Mahaffy

And in 2011, they published the genotypic analysis of over 200 patients and actually that data has grown since then together with clinical outcome data. Now, none of those patients had received PARP inhibitors but they all received platinum. And as you know there is biologic commonality between the response to platinum and the response to PARP, it's not perfect but there is some commonality there. And so we used outcome on platinum as the proxy for outcome on PARP inhibitor to define the first PARP definition of the (inaudible) and that's what we have prospectively coded to ARIEL2 but obviously we reserve the right as I say to tweak it for the definitive ARIEL3 study.

Unidentified Analyst

Okay, great. Thank you.

Operator

And your next question comes from the line of Ravi Mehrotra with Credit Suisse. Please proceed.

Koon Ching - Credit Suisse

Hi, thanks for taking my quarter, this is actually Koon, asking a question on behalf of Ravi. So regarding the NDA filing in mid-15, is there a specific patient number that the FDA is going to be looking for that's going to be part of that submission? And then my other question is, in terms of combination studies, what types of other mechanisms or molecules are you contemplating in paring up with 1686? Thanks.

Patrick Mahaffy

Yes. So quickly, we have a clear understanding with FDA of what will be in our package. And that helps inform our timeline of the 2015. We have not, choose not to disclose what that agreement in detail is as all smart companies do. Secondly, we are planning to -- we have an active effort with collaborators now, very interesting collaborators in defining our combination program. And our intent at the triple meeting will be to announced the details of our combination trial plans. And some of them may initiate by the end of this year but we’ll detail all of them at the time of the triple meeting in November.

Koon Ching - Credit Suisse

Okay, thank you very much.

Patrick Mahaffy

You bet.

Operator

Ladies and gentlemen that concludes today’s Q&A session. And with that I would like to hand the call back to Ms. Sussman for closing remarks.

Anna Sussman

Thank you. We thank everyone for your interest in Clovis Oncology today. If you have any follow-up questions, please call me at 303-625-5022. This call can be accessed via replay over webcast at clovisoncology.com, beginning in about an hour. Again we appreciate your interest and time. And thank you, have a good evening.

Operator

And ladies and gentlemen, this concludes today's conference. Thank you for your participation. You may now disconnect. And have a great day.

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