Infinity Pharmaceuticals Inc (INFI) 2016 Q1 法說會逐字稿

Welcome to the Infinity Pharmaceuticals conference call to discuss the Company's financial results for the first quarter 2016. My name is Kevin, and I will be your operator for today's call. (Operator Instructions) Please be advised that this call is being recorded at Infinity's request. At this time, I would like to introduce your host for today's call, Ms. Jaren Madden, Senior Director of Investor Relations and Corporate Communications at Infinity. You may begin, ma'am.

Thank you, Kevin, and good afternoon, everyone. Welcome to today's call to discuss our recent business progress and review our first quarter 2016 financial results. With me today are Adelene Perkins, President and Chief Executive Officer; Julian Adams, President of R&D; and Larry Bloch, EVP, Chief Financial Officer and Chief Business Officer. Following our remarks, we will open up the call for Q&A.

The press release issued earlier today details our results and is available on our website at infi.com. Please note that during this call we may make forward-looking statements about our future expectations and plans, including clinical development milestones, the therapeutic potential of our product candidates, and financial projections. It is possible that our actual results may differ materially from what we project today due to the considerations described in the Risk Factors section of the annual report on Form 10-Q for the first quarter of 2016. While these forward-looking statements represent our views as of today, they should not be relied upon in the future as representing our then-current views. We may update the statements in the future, but are not taking on an obligation to do so. Now, I'd like to turn the call over to Adelene.

Thanks, Jaren. Good afternoon, everyone, and thank you for joining us on today's call. 2016 is the year of results for Infinity, as we work to advance medicines with the potential to meaningfully impact patients' lives. While there has been considerable progress in the treatment of patients with B-cell malignancies, like indolent non-Hodgkin lymphoma, or iNHL, and chronic lymphocytic leukemia, or CLL, there is still a significant need for new therapies that can provide these patients with deeper and more durable responses and an acceptable safety profile. Our goal is to address this need and we are on track to report top line data from two registration focused of duvelisib, an investigational dual inhibitor of PI-3 kinase delta and gamma with first-in-class potential. We anticipate reporting top line data from DYNAMO, a Phase II monotherapy study of duvelisib in patients with relapsed/refractory iNHL early in the third quarter of this year.

We also expect to report top line data predicated on a PFS interim analysis from DUO, a Phase 3 monotherapy study of duvelisib in patients with relapsed/refractory CLL early in the second half of the year. These data, if positive, could enable regulatory submissions in the US and Europe in the fourth quarter of 2016. In parallel with our preparations for data readouts and regulatory submissions, we are planning for a potential 2017 launch of duvelisib.

In addition to the potential to address patient needs through results from DYNAMO and DUO, we have the opportunity to address additional patient need and further differentiate duvelisib through other clinical studies ongoing across multiple indications and lines of therapy. To that end, initial data from CONTEMPO, a Phase 1b/2 study in first line follicular lymphoma patients evaluate duvelisib plus Rituxan and duvelisib plus Gazyva will be presented in a poster session at the 21st Congress of the European Hematology Association, or EHA, in Copenhagen next month. In addition to duvelisib, we are independently advancing IPI-549, an oral immuno-oncology development candidate that selectively inhibits PI-3 kinase gamma. IPI-549 represents an important extension of our oncology portfolio into solid tumors. Earlier this year we initiated the first Phase 1 study of IPI-549 and are pleased with the progress we are making. Preclinical data supporting the rationale for combining IPI-549 with checkpoint inhibitors was recently presented at AACR, which Julian will review shortly.

In summary, 2016 results are critical to advancing Infinity's goal of bringing new medicines to patients, and we expect to deliver the following seven significant milestones during the year. First, report top line DYNAMO data early in the third quarter. Second, report top line DUO data early in the second half predicated on the results over the planned interim analysis. Third, submit our NDA for duvelisib in the fourth quarter. Fourth, submit the MAA for duvelisib by AbbVie also in the fourth quarter. Fifth, report initial data from CONTEMPO, our Phase 1b/2 study in treatment-naive patients with follicular lymphoma at EHA. Sixth, advance the Phase 1b/2 study of duvelisib in combination with Venclexta, AbbVie's BCL-2 inhibitor. And our seventh big milestone for 2016 is to advance the Phase 1 study of IPI-549 in solid tumors. With that, I'll turn the call over to Julian to review our development programs in more detail.

Thank you, Adelene. I, too, an excited about the progress we are making as we work toward our goal of bringing duvelisib to physicians and patients. Duvelisib has a distinct profile from other B-cell receptor inhibitors because it inhibits both PI-3 kinase delta as well as PI-3 kinase gamma. PI-3 kinase delta inhibition primarily targets the malignant B-cells; the PI-3 kinase gamma inhibition primarily disrupts the tumor microenvironment. It is our hope that targeting both malignant B-cells and the tumor microenvironment could meaningfully improve outcomes for patients living with B-cell malignancies.

Our enthusiasm for duvelisib is based on data from our Phase 1 study where we observed broad activity across a range of hematologic malignancies including profound activity in patients with iNHL and CLL. These data led us to initiate our first two registration focused studies of duvelisib, DYNAMO and DUO. As Adelene mentioned, we are on track to report top line data from DYNAMO early in the third quarter. This is a Phase 2 monotherapy study designed to evaluate the safety and activity of duvelisib in approximately 120 patients with double refractory iNHL. The primary endpoint is overall response rate. If the data are strong, we intend to seek accelerated approval with FDA. In relapsed/refractory iNHL, double refractory patients have limited treatment options. We believe that duvelisib could address an important need for these patients.

Our second potential path to approval is through DUO, our p 3 randomized monotherapy study of duvelisib in approximately 300 patients with relapsed/refractory CLL. This study is designed to evaluate the safety and efficacy of efficacy compared to ofatumumab, an anti-CD20 antibody. The primary endpoint is progression-free survival, or PFS. This study has an event-driven interim analysis for PFS, which we expect will occur early in the second half of 2016. We believe that duvelisib may offer patients with relapsed/refractory CLL the first PI-3 kinase monotherapy treatment option without requiring combination with Rituxan.

Before I review the rest of our clinical study trials with duvelisib, I will briefly comment on patient management in our studies. We have comprehensive risk mitigation measures in all our studies, including routine safety analyses. It is known as a result of the underlying disease, patients with iNHL and CLL are prone to infections. To further protect against the risk of certain infections, we included prophylaxis for all patients in our DYNAMO and DUO studies, and are now including prophylaxis for all patients in our other studies underway.

Turning now to a review of our other ongoing clinical studies of duvelisib. These trials support our strategy of evaluating the safety and activity of duvelisib in broader patient populations. We are conducting BRAVURA, a Phase 3 double blind, placebo-controlled study in approximately 600 patients with relapsed iNHL. This study is designed to evaluate the potential of duvelisib to improve upon chemotherapy by evaluating the safety and efficacy of duvelisib plus Rituxan and bendamustine compared to placebo plus Rituxan/bendamustine. The primary endpoint is PFS.

To evaluate the opportunity to eliminate chemotherapy for some patients, we are conducting the FRESCO study. An analysis from several studies of patients with follicular lymphoma demonstrated that approximately 20% of patients progressed within two years upon initial diagnosis in treatment with R-CHOP, a chemotherapy cocktail commonly used for the treatment of follicular lymphoma, and that early progression is associated with significantly short survival. Given the unique and targeted biological mechanism of action for duvelisib, we are evaluating whether we can address an important medical need for these patients who do not have durable responses to chemotherapy. This Phase 2 study is designed to evaluate the safety and efficacy of duvelisib and Rituxan versus R-CHOP in approximately 230 patients with follicular lymphoma who have relapsed within two years. The primary endpoint is progression-free survival.

Additionally, we are evaluating duvelisib in front line therapy, CONTEMPO is an ongoing Phase 1b/2 study in treatment-naive follicular lymphoma patients. This study is designed to evaluate the safety and activity of duvelisib in combination with Rituxan or Gazyva anti-CD20 antibodies. The primary endpoints include safety measures and complete response rate. We are pleased to announce today that initial data from this study has also been accepted for presentation in a poster session at EHA next month. An abstract describing these data was also accepted by ASCO for online publication.

We are also continuing to enroll patients in our SYNCHRONY study, designed to evaluate duvelisib in combination with Gazyva in patients with CLL who were previously treated with a PTK inhibitor. A post-PTK setting represents a significant medical need and there are limited treatment options for these patients, progress on, or who are intolerant to PTK inhibitor therapy. We believe the best chance for transformational outcomes for patients with hematologic malignancies is through the combination treatment particularly by combining novel targeted therapies. AbbVie has initiated a Phase 1b/2 clinical study of duvelisib in combination with Venclexta, their BCL-2 inhibitor. This is a comprehensive study designed to evaluate the safety and efficacy of the combination in approximately 174 patients with relapsed or refractory iNHL, aggressive NHL, small lymphocytic lymphoma, or CLL. The rationale for this study is based on extensive preclinical research where we observed strong synergy between duvelisib and Venclexta.

Our commitment to innovation and improving patient care led us to broaden our own oncology portfolio into solid tumors with a new and exciting approach in immuno-oncology. At the AACR meeting last month, Infinity researchers in collaboration with the Memorial Sloan Kettering Cancer Center, presented new preclinical data for IPI-549, our potential first-in-class PI-3 kinase gamma selected inhibitor. The data demonstrated that IPI-549 targets immune cells and alters the immune-suppressive microenvironment promoting an anti-tumor response that leads to tumor growth inhibition. Data also demonstrated that IPI-549 enhances the effects for checkpoint inhibitors resulting in an improved survival in multiple murine models.

To evaluate immune memory, mice that achieved complete response as far as IPI-549 plus anti-PD-1 antibody therapy were then reimplanted with the same tumor type. These animals showed low or no tumor engraftment indicating that they were immunized against the recurrent tumor growth, a significant preclinical finding. These preclinical data provided additional rationale for our ongoing Phase 1 study of IPI-549. The first portion of this study includes a dose escalation phase to evaluate a recommended dose for IPI-549 as monotherapy in combination with an anti-PD-1 antibody. Once dose escalation is complete, we are planning an expansion phase with these patients with select solid tumors, including non-small cell lung cancer and melanoma. We will evaluate IPI-549 in combination with an anti-PD-1 antibody. This study is progressing well and we now expect to initiate an expansion phase later this year.

In conclusion, we have a number of important milestones as we head into the second half of this year, and I look forward to reporting key data over the coming months as we work toward regulatory filing in 2016 and prepared to potentially bring duvelisib to patients in 2017. And with that, I will pass the call over to my friend Larry.

Thanks, Julian. I will now provide an overview of the financial results for the first quarter of 2016. As of March 31, 2016, we had total cash, cash equivalents and available for sale securities of $193 million compared to $245.2 million at the end of 2015. We anticipate earning $200 million in regulatory milestones from AbbVie in the fourth quarter of 2016. This includes a $125 million milestone associated with the acceptance of our planned NDA filing, and a $75 million milestone upon acceptance of AbbVie's planned MAA filing. While the acceptance of these submissions are expected to occur in the fourth quarter of 2016, the payments of these milestones will likely not occur until the first quarter of 2017. Excluding the $200 million in anticipated milestones, we expect to end 2016 with a cash and investment balance ranging between $45 million and $65 million.

While our collaboration with AbbVie is designed to fund the development of duvelisib, it is not intended to fund IPI-549 or early discovery programs. Today we filed a $50 million at-the-market, or ATM, offering program to provide us with the option in the future to issuing sell shares of Infinity from time to time, which is consistent with our philosophy of maintaining financial optionality.

Turning to our financial results for the first quarter of 2016, revenue during the quarter was $9.3 million for R&D services associated with the collaboration with AbbVie. Revenue during the first quarter of 2016 was $4.4 million, also for R&D services associated with the collaboration with AbbVie. R&D expense for the quarter was $39.2 million compared to $88.4 million for the same period last year. R&D expense for the first quarter of 2015 included a $52.5 million payment related to the exercise of option to buy out the Company's royalty obligation of the Takeda Pharmaceutical Company Ltd. of duvelisib worldwide oncology sales. Excluding the option to exercise, the increase in R&D expense for the quarter was primarily due to higher clinical development expenses for duvelisib as well as increases in staffing.

G&A expense for the quarter was $10.8 million compared to $8.6 million the same period last year, primarily related to an increase in staffing as well as external commercial expenses in preparation for the potential 2017 duvelisib launch.

Net loss for the quarter was $40.7 million, or a basic and diluted loss per common share of $0.82 compared to a net loss of $93.3 million, or a basic and diluted loss per common share of $1.91 for the same period last year. Our financial guidance for 2016 remains unchanged.

In closing, we expect 2016 to be a foundational year of progress for Infinity. We expect important data this year that, if positive, will enable us to file for approval with regulatory authorities in the US and will allow AbbVie to file for approval in Europe. We are also continuing to make progress with IPI-549, our immuno-oncology candidate for solid tumors. We are confident that we have the elements in place to bring duvelisib to patients and make a meaningful difference in their lives. With that, we will open the call up for Q&A. Operator?

(Operator Instructions) Our first question comes from Michael Yee with RBC Capital Markets.

For Julian I have two key topics I wanted to get some clarification on. The first topic was on the side effect profile of the drug. There is a lot of Wall Street focus on trying to differentiate from Zydelig and the couple of things that people are kind of thinking about are infections, colitis, I guess, and maybe hepatotoxicity. On infections I know you are prophylaxing, but do you expect your drug to be different than Zydelig on colitis and hepatotoxicity? And can you remind us if that is a key thing you're going to be looking at and why do you expect it to be different? And then, secondly, on CLL, you have a pivotal study that could possibly read out later in the second half. When I look at the control arm, I think that's about eight months of PFS, but Zydelig plus (R) was 10.7. Can you explain to me what the one or two data points are that would support why your drug would be significantly better, just remind us on that, what we should be looking at? And then, lastly, would you say in your press releases whether you intend to file and would that be pretty clear to people? Thanks.

Mike, this is Adelene. Let me start on some of your questions and then I'll turn it over to Julian to add additional perspective around safety. We just can't emphasize enough that protecting the safety of our patients in our trials, which are, of course, intended to show the benefit of our drug is our number one priority. So, we've followed closely the information that has been made available regarding the Gilead's termination of certain trials with Zydelig. And although we watch that, I want to remind you of two very important differences. One is that our medicines are different. Not only are they different chemical entities that are administrated at very different doses, but they also have different mechanisms of action. As you know, duvelisib is an inhibitor of both PI-3 kinase delta and gamma, whereas, Zydelig is an inhibitor of just PI-3 kinase delta only. And, second, the drugs have been developed very differently. Patients with blood cancers have compromised white blood cell function, compromised impunity and are prone to infection. So, to protect patients who are already vulnerable to infection, we instituted a prophylaxis for all of our patients in DYNAMO and DUO and, as Julian mentioned earlier, are including prophylaxis in all of our trials going forward.

So, the data that was reported with Zydelig in their studies has been just 15% to 30% of patients who are prophylaxed. So, as a result of the fact that these different drugs, different doses, different mechanisms, different patient management strategies, we think the most useful way to address duvelisib is on the data that we are generating with duvelisib itself. And with that I'll turn it over to Julian to talk about our experience with our ongoing safety monitoring from DYNAMO and DUO.

Yes, Michael, so thanks for your question. I also want to add to Adelene's comment that we have regularly planned independent data monitoring committees, external reviews that have been quarterly that monitor the safety for our patients. And we believe that two things are important in the management of safety for our patients. One, as Adelene mentioned, is prophylaxis, which we have instituted for all studies. But also there is a patient management strategy, which for the indolent diseases like iNHL and CLL, if we see a developing grade 3 toxicity, we can pause the drug, allow the adverse event to resolve, and we allow up to six weeks for that to occur, and then we can re-challenge patients with the same dose of duvelisib. And I believe that this patient management has served us well over the conduct of the DYNAMO and DUO studies. And so we are proceeding with this believing that we are at the right dose in the schedule and this is how we are proceeding with future trials as well.

Okay. So, do you think that there will be better protection against that? And I'm not really sure how to quantify that, but we'll wait to see the data. But also on the colitis and hepatotoxicity, I think you're probably doing a good job on the infections, we'll take that, we'll see the data. But colitis is certainly a big issue as well, I think. Just commercially, too, so is there any reason to believe that that's a differentiation as well? Just want to try and understand and tease out some of these things.

Yes, and the premonitory sign of colitis is the developing diarrhea, which if unchecked becomes an immune base -- autoimmune disease resulting in colitis, autoimmune colitis. And so we monitor patients very carefully and we have guided our investigators to immediately stop the drug and to manage those patients, allowing also oral [monotherapy] steroids, and we have found that in general this is a very effective way to mitigate against the GI toxicity.

Got it. Okay. Okay. Second part.

Turning to CLL, I think you have stated that ofatumumab on the expectation is about eight months PFS, and you asked what gives us confidence with monotherapy? I can only refer to our Phase 1 data, where we had not achieved median PFS at 24 months, and so we -- based on the encouraging results from the Phase 1 population, which admittedly is about the same as running a randomized Phase 3 study. We projected that monotherapy was an appropriate way to go up against ofatumumab.

Got it. And then disclosure, last part of the question was just disclosure. Would you say you're filing this stuff pretty clearly if the data is in your expectations? That's something I think the street would want to know.

You're talking about regulatory filing?

Yes. I mean, you expect to file, so if the data is as your expectation, would you be able to Wall Street in your press releases that you intend to file? Because that triggers an important milestone, so that would be an important thing for us to understand.

So, we have to have, of course, a conversation with FDA about filing strategies, and so as long as we've had that appropriate communication, we do intend to file on DYNAMO based on, as we've said, a single arm study based on an accelerated -- with the intention of an accelerated approval. And the filing in CLL is predicated on a successful achievement of the interim analysis hazard ratio.

Okay, thank you.

Our next question comes from Katherine Xu with William Blair.

So, Adelene, when you say one comes out in early Q3, the other one comes out in early second half; are they pretty much the same time frame?

Katherine, we have said in the past that they could be within very close proximity of each other, so I think that's a reasonable expectation.

Okay. With regards to the safety management for duvelisib, it looks like the prophylaxis was implemented kind of halfway in the Phase 1-2. Just curious, from your experience, did you see a difference prior and after the implementation of the prophylaxis in terms of infection rate?

Yes, so we reported on our Phase 1 data and don't want to revisit ancient history, but we did have observed infections without prophylaxis and upon observing these infections, we have instituted prophylaxis. And we believe this is the proper way to manage these patients.

And the only thing we do say about DYNAMO and DUO, for which all patients have been prophylaxed, is that, as Julian mentioned, the independent data monitoring committee has reviewed those patients and encourage us to continue with the trials, but we can't speak to specific infection rates in those trials until we have that data.

Yes, I'm curious, Phase 1-2 after the implementation, did you see a pronounced difference in the infection rate?

So, again, we have published the data and we did not see an enhanced -- we did not see infectious data upon prophylaxing patients. So, we believe that that was the right measure. As well, we amended the protocol to institute those interruptions for any adverse event, and again I mentioned that we allowed up to six weeks to resolve the adverse event so that we can successfully rechallenge these patients at full dose. And we believe that this has been the appropriate way to manage this patient population.

Okay. And then the other, I guess, characteristic of Zydelig is that the safety gets worse when it moves front line, so I'm just curious, of course you're reporting data on CONTEMPO soon. But from what you see so far, for example, DYNAMO, and that's a second line refractory setting kind of study and it's pretty much a single arm. Do you have some observations there versus your CONTEMPO? Do you see any differences on the safety side?

You know, we are under embargo for the EHA presentation, so if you can make the trip to Copenhagen I certainly invite you there to come and see the data. Again, I think we've implemented the appropriate patient management schema in all of our trials.

Larry Bloch: Although Julian would like you all to travel to Copenhagen, there will also be an abstract online for ASCO and ER on May 18, 19, respectively, so just a few weeks we'll have the beginning of that data stream.

But we'd also warn that your expectations that it's early data, so -- but, of course, it will be updated by the time we have a poster, but we'll have a couple thousand patients and with relatively early exposure. So, it's an evolving dataset.

Larry Bloch: But we're very excited to explore duvelisib in frontline setting, as you alluded to.

Right. One last question is more on the science. So, recently, AbbVie's company, StemcenTrx, the lead asset is [against the DL3] which is expressed in cancer stem cells. I'm just wondering any, from a biology perspective, any interactions with PI-3 pathway additives, synergistic or not too much interaction?

This is fresh news to us as well. I followed this antibody drug conjugate. I mean, primarily there is a right expression on these neuroendocrine tumors, small cell lung cancer and the toxin, of course, is the cargo to kill these cells. So, I think the purpose of this antibody is simply to kill cells in small cell lung cancer based on early data. And so we've had no other interaction or knowledge of PI-3 kinase activity.

Thank you.

Our next question comes from Jim Birchenough with Wells Fargo.

Hi. This is actually [Yen] in for Jim today. We have a few questions on the 549 program. First, have you talked about the timing for the data from the PD-1 combo study yet?

We just announced this afternoon that we expect to begin the expansion cohorts in the second half of this year. So, we are pleased with the way the Phase 1 has progressed thus far, but we have not released any data or discussed anything with IPI-549. That would be forthcoming with more data.

Larry Bloch: I'll remind you, we just started the Phase 1 the beginning of this year, so it really has been -- we've been very pleased with the progress we've made to date.

Yes, yes, got it. And in terms of the outcome, the data, obviously, this is a single arm study studying the combo, and PD-1 is expected to have some activity as well. So, how do we think about -- how should we think about potential outcome of the data? Any particular -- I'm interested in if you are examining some biomarkers in terms of the phenotype of the macrophage and whether there is indeed an M2 to M1 transition in the study? Thanks.

That's an excellent question. First of all, I think we will be able to have a read of the Phase 1, because the majority of patients in the Phase 1 trial that was non-small cell lung cancer, melanoma and other solid tumor types will have likely seen a PD-1 antibody and either never responded or responded and progressed. So, they are Phase 1 patients, so the combination will be interpretable. In addition, we have in some of the cohorts mandated biopsies to look at the change in architecture and cellularity of the microenvironment in patients pre- and post-treatment with our combination. And, of course, we are very keen to look at the phenotyping and the reprogramming of the M2 macrophage to the M1 phenotype to initiate a prolonged inflammatory activation of CD8 positive cell.

Got it. If I may, without seeing the Phase 1 data, if we want to have some early insight into the possible mechanism of action of 549 in terms of PI-3K gamma inhibition macrophage or phenotype, would it be possible to look into the available data with the duvelisib study and look at the macrophage phenotype in patient samples to see if -- obviously, gamma is inhibited by duvelisib.

So, unfortunately, we do not collect samples with this understanding at the start of duvelisib trials. In addition, the gamma-selective compound is designed to inhibit greater than the IC980 for PI-3 kinase gamma in a selective mode without influencing PI-3 kinase delta. So, it's a cleaner and purer study to see what IPI-549 will do. And we have a number of ways of assessing its activity, including a PD biomarker looking at phosphor Akt, phosphorylation inhibition of Akt in monocytes and T cells, as well as other flow cytometric measures that are available to us now that we better understand the role of PI-3 kinase gamma.

Got it. Lastly, would you mind comparing the interesting mechanism of two M1s with the alternative approach of depleting macrophages through CSF1R targeting?

To my understanding, CSF1R will deplete all macrophages irrespective of their polarization. In our case, we are hopefully inducing a pro-inflammatory N1 phenotype, which we think will be more effective -- we hope will be more effective, and we have tested that in our murine model and feel that we're getting complete responses in multiple murine models, including inducing immunity or effective vaccination of these mice to the tumor in question leads us to believe that this is operating. And we've done many control experiments that we know that we are operating through the M1 macrophage mechanism as well as inducing CD8 mediated killing, having no effect on the solid tumor whatsoever. We've checked the -- IPI-549 had no effect directly on the tumor. It's all through the immunology of the intended treatment.

Right, got it. Thank you very much.

Our next question comes from Anupam Rama with JPMorgan.

Hey, guys. This is Eric in for Anupam. Thanks for taking the questions. Maybe just sort of a housekeeping question on the top line releases this summer in 3Q. Just wondering what level of detail you might expect to learn sort of beyond the primary endpoint in both DYNAMO and DUO, understanding that you might need to preserve some of the detail for a medical meeting. And then I have a follow-up.

I think you answered your own question. We prefer to represent top line data as the primary endpoint and to the extent that we can, we would like very much to present this trial result in totality at a medical meeting. And we will be submitting abstracts, of course.

Well, I guess specifically, how do you feel -- if you can be sort of around the safety profile?

I think we can report acceptable safety. I don't think -- the risk-benefit will have to be analyzed in the totality of the full presentation at a medical meeting.

Got it. And maybe just a question on CONTEMPO. You noted that we're looking at an early level of exposure here, but just wondering whether, kind of down the line whether there is a certain sort of level of response rate or complete response that might warrant moving forward with a larger study in the front line in particular?

That's exactly the purpose of this study. So, patients, newly diagnosed patients, treatment-naive patients receiving standard chemotherapy, R-CHOP, or bendamustine-Rituxan, the response rates are very high, greater than 90%. And so it's really the complete response rate. Our primary endpoint is here, safety and complete response rate, and we are looking for that to guide us as to future development in the treatment-naive [patients].

Okay, great. Thanks for taking the questions.

(Operator Instructions) Our next question comes from Mike King with JMP Securities.

A couple questions on what I would refer to as trial execution issues with respect to DUO. A couple in things in that regard. As far as taking interim, as far as -- I keep going back to the safety issue, but FDA tends to be monolithic about certain things, so I'm just wondering from sort of an all-clear standpoint from a regulatory perspective, is an interim look on the efficacy side going to be sufficient for filing from an FDA point of view? And have you had a conversation with them about the safety -- I'm sorry, the efficacy bar is something on the order of what was seen with idelalisib going to be adequate in light of what might be a class effect or at least a perception of a class effect?

So, in the design of DUO, this trial was presented to FDA before we even started the study. And, as I said, we've been monitoring this study throughout the course of the study. The trial is fully enrolled. We had completed it last fall and we reported then. And the statistical analysis plan had prespecified this interim analysis for efficacy. So, we have set the bar before we ever enrolled the first patient. And when we get the data, we will, of course, communicate with FDA.

And, Mike, I'll remind you that the trial, we're blinded to the trial, so it's our independent data monitoring safety committee that looks and makes the recommendation, is the benefit-risk profile such that it shows an overwhelming benefit? And then they make the recommendation to us that the trial be stopped. So, that's the first step. And then if they make that recommendation, we then go to the FDA and it's the FDA's decision to look at the data and determine whether we can stop early and file on that. So, there are two steps and they are really out of our hands. It's first the IDMC and them the FDA that makes that assessment.

And then you made another point that I want to address, the comparison to Zydelig. There is no comparison to Zydelig for two reasons. One, it's a different drug, as Adelene has mentioned -- dual inhibition, delta and gamma, but also, perhaps more impactfully is Zydelig was not used as monotherapy. So, Zydelig plus Rituxan versus Rituxan. So, we did not run the same trial. They also ran Zydelig plus ofatumumab versus ofatumumab. So, the points of comparison are not possible.

Larry Bloch: In terms of the safety question you asked, we can't speak to the safety until we actually have the data and the interim analysis, but what we can say is the independent data safety monitoring committee has recommended the trial continue without modification in their last review. So, that's the most recent update that we have to the blinded data.

Okay, great. Those are all very helpful. And then one other question. Have you spoken to the FDA as far as what they'd like to see as far as some proportion of the patients in DUO that will have been ibrutinib failures?

No, ibrutinib is -- prior treatment with ibrutinib is excluded, was an exclusion criteria. When we started this trial, ibrutinib wasn't yet available on the market, so we began this trial and excluded ibrutinib from -- and so these patients are naive to ibrutinib.

We have another trial called SYNCHRONY, which is evaluating patients who are (inaudible) to progress following the B2K inhibitor or who are intolerant to a B2K inhibitor, but that is a different trial.

Okay, thanks for clearing me up on that. Then I had a question about the combination study with venetoclax, and I may have missed this. I've had a tough time with my signal. But just curious what the endpoint is and I assume it's going to be response rate, but just want to get clarity on that. And given that venetoclax can often drive MRD in certain histologies, how you would evaluate combination of venetoclax and duvelisib in those instances. Thank you.

First of all, it's a broad exploration of 174 patients across five different tumor types that I enumerated during the initial remarks. And so the first order of business is to find the dose path, so there is a drug-drug interaction phase, 1b, safety, running, and a clinical pharmacology intent to study to understand what is the right dose path for those two drugs. And then after which there will be cohort expansion obviously looking for continued -- always looking for safety and biological activity. On Phase 2 studies that are not controlled, we hope that the preclinical data translate into synergy that we saw in the lab, and so we are open to looking at all of these various histological subtypes, and we may find ourselves with different dose paths for different disease types. So, it's an area that -- AbbVie is conducting the study, so there is not much more I can add to it, but it's a very thoughtful protocol.

Thank you.

And I'm showing no further questions at this time. I'd like to turn the call back over to Adelene.

Thank you, Kevin. Thank you to everyone joining us today. We appreciate your interest and time with preliminary CONTEMPO data at EHA in June, and anticipated top line data from DYNAMO, and potential top line data from DUO in the coming months. We expect 2016 to be a very important year for Infinity and look forward to updating you on our progress. Operator?

Ladies and gentlemen, this does conclude today's presentation. You may now disconnect and have a wonderful day.