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Synta Pharmaceuticals (NASDAQ:SNTA)

Q3 2013 Earnings Call

November 04, 2013 10:00 am ET

Executives

George Farmer - Vice President of Corporate Development

Safi R. Bahcall - Co-Founder, Chief Executive Officer, President and Director

Vojo Vukovic - Chief Medical Officer and Senior Vice President of Clinical Research & Regulatory Affairs

Keith S. Ehrlich - Chief Financial Officer, Principal Accounting Officer and Vice President of Administration & Finance

Ilker Yalcin - Vice President of Biostatistics & Data Management

Iman El-Hariry - Vice President of Clinical Research

Analysts

Thomas Wei - Jefferies LLC, Research Division

Michael G. King - JMP Securities LLC, Research Division

Gene Mack - Brean Capital LLC, Research Division

Joseph Pantginis - Roth Capital Partners, LLC, Research Division

George B. Zavoico - MLV & Co LLC, Research Division

Brian Klein - Stifel, Nicolaus & Co., Inc., Research Division

Robin Davison - Edison Investment Research Limited

Operator

Good day, and welcome to the Synta Pharmaceuticals Third Quarter 2013 Earnings Conference Call. Today's conference call is being recorded and webcast. At this time, for opening remarks, I would turn the call over to George Farmer, Vice President of Corporate Development at Synta. Please go ahead, sir.

George Farmer

Hello, and thank you, all, for taking the time to join us today. With me are Safi Bahcall, our Chief Executive Officer; Vojo Vukovic, our Chief Medical Officer; Keith Ehrlich, our Chief Financial Officer; and Ilker Yalcin, our Vice President Biostatistics. This morning, we issued a press release that reported results for the third quarter 2013. This release can be found on our website at syntapharma.com.

Before we begin, I would like to point out that we will be making forward-looking statements based on our current intent, belief and expectations, which are subject to certain risks and uncertainties. Additional detail can be found in our related SEC filings also available through our website.

I will now turn the call over to Dr. Bahcall. Safi?

Safi R. Bahcall

Thanks, George. Thank you, all, for joining us this morning. Vojo just returned from the World Conference on Lung Cancer in Sydney where 1-year follow-up results from the GALAXY-1 lung cancer trial were presented. Let me start by turning the call over to Vojo for a clinical update.

Vojo Vukovic

Thank you, Safi. We were very pleased by the reception in Sydney with the results presented by Dr. Ramalingam, the principal investigator of the study. Results are the most mature we have to date from GALAXY-1, with 1-year follow-up since enrollment completion and just over 65% of survival events. They show very clear survival separation in the prespecified population selected for Phase III for well over 1 year of follow-up.

It is also very motivating to talk to those of us who have lung cancer for many years because patients in the sound setting, meaning after first-line treatment, generally have very limited options and live typically 7 to 8 months. With drug to increase the viral by 30% to 40%, it's very exciting.

The strong survival signal from ganetespib with this level of mature data is the key takeaway for all of us and our investigators.

We reviewed some of the findings in more detail in a call from Sydney last week and since we have had the opportunity to address additional details in the Q&A session later in this call, I would like to make just 2 additional remarks and then turn it back to Safi.

First, the goal of this very large Phase III trial to close before 100 patients enrolled in total was to divest Phase III by identifying the best patient population and ways to optimize the operational plan. We're not aware of any oncology program that has had this much data in the same setting with the same trial design and the same countries heading into pivotal trial. We feel very fortunate to have such a wealth of data and to be able to use this to optimize Phase III.

I'm referring both to the selection Phase III population, which was very nicely confirmed again at Sydney, and to the identification of outright patient profiles from certain countries, which led to our decision to no longer enroll patients from Russia and Ukraine. We are aware of many trials that have failed the transition from Phase II to Phase III because of the operational risks that have been expanding to many untested sites and countries.

We've already begun to add new centers in North America and Western Europe to GALAXY-2 and are pleased with the very high level of interest we have seen. Survival data is the gold standard in oncology and positive survival data from a large randomized multicenter trial is the most positive multi-data we know. With our new operational plan, we expect over 75% of sites in GALAXY-2 to be from Western countries.

Secondly, the results from GALAXY-1, as well as other trials, have clearly established that ganetespib is clinically active and the safety profile is very encouraging. Our increased confidence in the activity of ganetespib supports additional investments to mitigate Phase III executional risk, including adding patients will increase the risk from imbalances or statistical fluctuations.

Our internal projections estimate the Hazard ratio for the GALAXY-2 population to be in the 0.6 to 0.7 range. With 700 patients, GALAXY-2 has over 85% power to detect any Hazard ratio below 0.75. We should believe as a comfortable margin to show meaningful survival advantage.

We intend to review an updated statistical plan for a 700-patient trial size with our lead investigators and Data Monitoring Committee, and hope to finalize this change very soon. With this change, we would expect interim analysis from GALAXY-2 in the second half next year and final data in the first half of 2015. Safi?

Safi R. Bahcall

Thanks, Vojo. With regards to the ganetespib program, as Vojo mentioned, the trial to date have shown that ganetespib is clinically active with encouraging safety. Our #1 goal is to honor our commitment to patients by bringing this drug to successful clinical outcome and regulatory approval. The objective of GALAXY-1 was to optimize GALAXY-2 in order to deliver on that goal. The 3 points Vojo mentioned are excellent examples of that strategy: Patient selection, operation and trial size.

I would like to add that the extra insurance from increased trial size and from refocusing enrollment on Western countries is important to us, both as people committed to delivering this drug to patients and interest[ph] to shareholders. We all recognize the potential value at stake in opening the envelope on a positive Phase III trial in lung cancer. And we recognize the benefits of extra steps to ensure this positive outcome.

Before turning it over to Keith for financials and then to questions, I would like to briefly mention our HDC program. As a reminder, HDCs are conjugate molecules that, when ganetespib or other Hsp90 inhibitors, with small molecule cancer drugs using the tumor accumulation properties of Hsp90 inhibitors to improve the delivery of those payload drugs to tumors.

We've been receiving a lot of inquiries about this program from both the pharmaceutical community and investment community, due in part to the high interest in ADCs, antibody-drug conjugates.

One of the most common questions has to do with whether we intend to develop HDCs with older, established drugs such as taxanes or Platinums or with newer and investigational agents. We have generated ACCs for both and we can say that feedback from our partnering discussions has been a high interest in taking their newer or investigational agents, for example, Mac inhibitors, proteasome inhibitors, PI3K inhibitors or CDK cell cycle inhibitors, of which there are many in the industry, and using the HDC technology to generate a competitive advantage.

And in the case of certain pharma companies, to use HDCs as a next-generation life cycle management opportunity. We are all edge [ph] and very excited about the broad potential and broad partnering opportunity of this program. And now to Keith.

Keith S. Ehrlich

Thank you, Safi, and good morning everyone. There were no revenues recognized in the third quarters of 2013 or 2012. In the third quarter of 2013, our research and development expenses were $17.6 million as compared to $11.7 million for the same period of 2012. Our third quarter general and administrative expenses were $4.2 million as compared to $2.8 million for the comparable period of 2012.

Our net loss in the third quarter of 2013 was $22.5 million or $0.33 per basic and diluted share, as compared to a net loss of $15 million or $0.25 per basic and diluted share in the same period in 2012. As of September 30, 2013, we had approximately $53.4 million of cash resources on hand.

Based on our current operating levels, we expect our cash resources will be sufficient to fund operations into the second quarter of 2014. Certain new activities contemplated for 2013 and 2014 will be conducted subject to the availability of sufficient financial resources.

I will now turn the call back over to Safi for concluding remarks. Safi?

Safi R. Bahcall

Thanks, Keith. This concludes our prepared remarks. Operator, we will now open the call to questions.

Question-and-Answer Session

Operator

[Operator Instructions] Our first question is coming from the line of Thomas Wei with Jefferies.

Thomas Wei - Jefferies LLC, Research Division

Just a clarification on how many centers were involved previously in GALAXY-2? And what was the geographic mix? And how many new centers are being opened with the potential expansion of enrollment?

Safi R. Bahcall

Let me turn that over to Vojo.

Vojo Vukovic

Sure. So focus on GALAXY-1, we have approximately 60 active centers. And in GALAXY-2, we have -- obviously, planning a very significant expansion. As we've mentioned in the quarterly report and press release, there will be some operational adjustments going on, which will result in a new number of good number of centers. But what we're really targeting is having the very similar geographical distribution in GALAXY-1 and GALAXY-2.

Thomas Wei - Jefferies LLC, Research Division

And by the way, what was the original number of centers in GALAXY-2, was it 60 as well?

Vojo Vukovic

No. In GALAXY-2, we had, obviously, much larger number of centers because the study is much larger compared to GALAXY-1 and the original number of centers was 140.

Thomas Wei - Jefferies LLC, Research Division

Okay. And do you know how many you'll be taking that to?

Vojo Vukovic

These plans are still under discussion and we are still working on that. But we should have a similar comparable number of centers after we complete the operational adjustments.

Thomas Wei - Jefferies LLC, Research Division

Okay. And these new centers that you're bringing on, can you say -- are these just different academic centers that you had not used previously? Or are you now having to -- have you kind of gone through the -- most of the usual players on the academic center side and you're going to be reaching into the community center level to get these new sites?

Vojo Vukovic

Yes. So we're expanding in the West, as we've said, and there, we expect to have a good mix of both established credible academic centers and very productive experienced community centers.

Thomas Wei - Jefferies LLC, Research Division

Okay. And then just lastly, from a funding standpoint, I guess any update on how things are progressing on a partnership for ganetespib now that World Lung is over and you've had a chance to get some feedback from perspective parties there? And what other options do you have besides some equity financing to help fund the GALAXY-2 trials?

Keith S. Ehrlich

The discussions are, we're in advance discussions. They're going well. We were certainly -- a lot of us were waiting for the World Lung data. I think as Vojo mentioned, we're very encouraged by the positive reception in Sydney to the data in the Lung Community. And I think that will have a positive impact, although I think most expectations on the data are consistent before and after that meeting. Beyond that, I couldn't really give any guidance on timing. We've never really guided on-timing discussions. In addition, we continue to look at all -- we always look opportunistically at all options.

Operator

Our next question is from the line of Mike King with JMP Securities.

Michael G. King - JMP Securities LLC, Research Division

A couple of quick ones, if you don't mind. Vojo, thanks for the updated power information on the upsized trial. I appreciate that. I just wanted to ask if you have formally submitted a protocol amendment for the patient numbers? And whether the pivot to the Western centers is going to also require its own change in protocol? Or is that just kind of a routine change?

Vojo Vukovic

Okay. Hey, Mike. As we mentioned, we are discussing and planning to discuss the plans about those operational adjustments, including potential increase in trial size with our Data Monitoring Committee, with our Steering Committee. And we expect to finalize these changes very soon. In terms of -- would that require a formal amendment of the protocol, we don't think that it will require a formal amendment of the protocol because the protocol allows for a dynamic change in trial size, so those changes can be permitted, for example, in the Sadisco [ph] plan.

Michael G. King - JMP Securities LLC, Research Division

Okay. And I was just wondering, I was also going back and reviewing the curves, the GALAXY-1 curves from World Lung and just noticed there's a substantial number of centered events in both arms but a lot more in the ganetespib and docetaxel. Can you give us exact numbers that were still censored at World Lung? And I'm just wondering also, have you projected out when you hit, if the progression events happen at the same rate, what the final Hazard ratio will be when you cross that 70% threshold?

Vojo Vukovic

So Mike, unfortunately, I don't know the exact numbers in terms of how many patients are exactly centered [ph], and that's, obviously, a [indiscernible] variable. But the percentages that you're looking for are in the presentation, in the slide deck. And so we expect for these additional events to occur over the next couple of months and as we said, we expect to conduct the final analysis in the very early part of 2014.

Operator

Our next question is coming from the line of Gene Mack with Brean Capital.

Gene Mack - Brean Capital LLC, Research Division

Vojo, I wonder if -- or maybe Safi, you could just give us a sense of how the -- I'm assuming that the GALAXY-2 trial has got some built-in interim looks for your futility or whatever. And I'm wondering if you could just give us an idea right from the outside, like what those -- when those looks are -- at what point in terms of event those looks might occur? And if there is statistical penalties? Or any sort of material things that we might want to just consider once those events occur? And what may be stopping criteria, if any, that are pretty close looks?

Vojo Vukovic

Gene, we certainly have defined very specifically at what points the interim looks will occur and that was discussed and agreed-upon with the regulatory agencies. We don't disclose those exact points. And in terms of the procedures regarding alpha spend and statistical penalties, that's all discussed, defined and agreed-upon with regulatory authorities. We are following standard procedures and standard methodology.

Safi R. Bahcall

And then I'll turn it over to our head of Biostats, Ilker you have some comments?

Ilker Yalcin

Correct, the fiscal penalties have been incorporated in the sample size calculation. So yes, we will have the penalties but it's accounted for in the sample size.

Unknown Executive

One thing, Gene, that we guided in the past is that when companies elect to do -- this is run in the GALAXY-2 as a typical pretty plain vanilla Phase III trial with interim looks and a final alpha and the original design at 0.042. So what you can gather for that and what we've commented in the past, companies could put interim looks in more aggressive time points, for example, very early in the study like 30% or 40% would be pretty aggressive and pretty early or companies could put them more conservatively. And what we have guided in the past is that our interim analysis are in a more conservative time point and that's reflected in the final alpha being pretty close to 0.05.

Gene Mack - Brean Capital LLC, Research Division

Great, that's certainly helpful. And then I wonder -- I don't know if you reviewed this in the beginning -- I got in a little late, but can you give us an idea of how much ENCHANT data might be at the San Antonio Breast Cancer Conference, I mean, have you guys just got an idea of how much would actually wind up being presented, how many patients?

Vojo Vukovic

So I'll take the first crack at that. We will be presenting initial data from ENCHANT-1 at the San Antonio. And the exact scope and content will be discussed over the next couple of weeks with the investigators when we finalize the presentation.

Operator

And the next question is coming from the line of Joe Pantginis with Roth Capital Partners.

Joseph Pantginis - Roth Capital Partners, LLC, Research Division

Quick question, is first, is the 700 number for patient enrollment for GALAXY-2, is that a firm number at this point?

Vojo Vukovic

So the 700 number is part of our plan, as we mentioned before, that we're discussing over the next month or 2 with our investigators. And that's pretty much it. That's our thinking.

Joseph Pantginis - Roth Capital Partners, LLC, Research Division

Okay. And I guess, the more important question is, I guess, if you look at -- we're talking about the fundamentals here, so I don't want to invoke the stock price so obviously, there's been some volatility in the understanding of the data or the views on subpopulations, however, you want to describe it. So I guess I would ask -- but you've obviously gone through a very methodical approach to get where you are today in answering the questions of the bright population. So I guess, while this volatility remains maybe on the street, Vojo, can you comment on your initial thoughts that you shared with us at the World Lung Conference when you were discussing the data with the Physician Community with regard to what the Physician Communities views are regarding the approaches that you took and the subpopulations that you looked at?

Vojo Vukovic

Yes, that's a really great question. You've certainly, throughout the program, discussed quite intensively with investigators around the world, the approach. Just as a reminder, we've set on from the beginning to identify the right patient population with a drug like ganetespib, which is an Hsp90 inhibitor with the broad spectrum of activity. Our task of finding the right patient population is little bit more difficult compared to very targeted, very narrowly targeted drugs such as TKIs, for example. And so we've consulted quite frequently with investigators and we've taken this throughout the [indiscernible] broad methodical approach to identifying the right patient population. The concept of our drug showing the best ability in chemo-sensitive patients is a very logical and I think very strongly supported point. I think we -- once we explain the approach, the investigators are on board with that and some recent scientific information. And I think some preliminary part of that has been presented at the World Lung Conference has provided also some of the aspects of the underlying biology about why, for example, ganetespib works better in the chemo-sensitive patient population. So I think it's really coming together and the approach that we're taking I think has really gathered a lot of support in the Lung Cancer Oncology Community.

Operator

The next question is coming from the line of George Zavoico with MLV & Co.

George B. Zavoico - MLV & Co LLC, Research Division

I have a couple of quick ones, I think. First of all, with regard to increasing the number of patients and your costs and your burn, you're saying you have funds into the second quarter of 2014? Does that include the extra couple of hundred patients?

Unknown Executive

Well, as we disclosed, what we said that based on our current operating burn, that cash would last into the second quarter. Obviously, as Vojo said, we're continuing to work on figuring out exactly the sizing of that so it would be difficult to forecast beyond that.

George B. Zavoico - MLV & Co LLC, Research Division

Okay. And can you provide an update at all right now as to how many patients are already enrolled in GALAXY-2?

Safi R. Bahcall

No, we haven't provided enrollment guidance. We're not providing -- just to clarify because I don't think it's good. We are intent to go forward with this 700-patient trial. Cost of patient, in the incremental costs of a new patient added in cancer trials is typically in the $30,000 to $40,000 in external patient costs.

George B. Zavoico - MLV & Co LLC, Research Division

Per patient, yes, okay.

Safi R. Bahcall

Per patient.

George B. Zavoico - MLV & Co LLC, Research Division

With regards to the HDC program, do you have -- can you provide any guidance whatsoever as to regard to when you might be able to get into a pre IND and identify a lead compound or is it still too early to tell?

Safi R. Bahcall

We're in preclinical development now. We hope to have an IND filed within the next -- could be 12 to 14 months.

George B. Zavoico - MLV & Co LLC, Research Division

Okay, good luck for that. I hope, I'm waiting to see which one you pick and for what indication. It would be really interesting. And the final question in regards the GALAXY-1 data you presented at the World Lung Congress. In the median overall survival, from your numbers on May 2013, you had a ganetespib benefit of 4.3 months. It was reduced to 3.3 months just now to World Congress mainly due to the docetaxel alone arm, the median overall survival apparently, going from 6.4 to 7.4 months. The G+D arm stayed about the same at about 10.7 months. Is that largely due to the Russian and Ukrainian patients? Or do you have any other explanation for that increase in the overall survival?

Vojo Vukovic

Hey, George, it is now over [ph] that in large clinical trials to see some fluctuations as it gets along. Our confidence in the numbers that you currently have is just quite substantial. It is a very robust data stat 55% of survival events. We should also remind ourselves that point estimates are not as precise as overall Hazard ratio accident. But then also, specifically framed to your point about Russia and Ukraine, it's quite feasible that patients from 2 countries have contributed to this effect because those patients came on late in the trial and therefore, the results from these patients are seen later in the trial.

George B. Zavoico - MLV & Co LLC, Research Division

And this explains, obviously, I guess, your decision to increase the number of patients to account for these sorts of unpredictable events that might occur in GALAXY-2. So I appreciate that and the added assurance that you're adding to the outcome for GALAXY-2.

Operator

The next question is coming from the line of Brian Klein with Stifel.

Brian Klein - Stifel, Nicolaus & Co., Inc., Research Division

So first, we saw in GALAXY-1 that there was a large regional difference in terms of the survival between patients treated with the docetaxel alone versus docetaxel plus ganetespib. Can you provide us with your assumptions now for the Phase III program in terms of what you expect median survival would be for the docetaxel alone arm? And what you anticipate the combination will demonstrate?

Safi R. Bahcall

Sure, I'll turn it over to Ilker Yalcin -- do you want to address the point to the regional differences as seen in our trials is also seen in quite a few other trials. And it's really behind the strategy that was developed a couple of years ago in the GALAXY-1, GALAXY-2 program to be able to tease this out and get exactly this kind of information. I mean, there are many examples, unfortunately, of trials that see these kind of regional differences at the end of Phase III. And we wanted to go part of GALAXY-1, and part of the point exactly, was to go into all of those countries early, identify that early. And we did start to see some of those patterns as much 6 or 9 months ago and have been following it closely, which led to the decision recently to terminate enrollment in those 2 countries. And you're right, one of the features is that in those countries, we did see a lot of enthusiasm for the drug, especially towards the end of the study. And we did get a lot of long-lived, earlier-stage disease patients and that did lead to patients who have much larger, longer median survivals. Being enrolled from those countries. And -- which means that it just -- you need a lot more follow-up to see a difference. If a patient's going to live 1.5 years or 2 years, you need at least 1.5 years or 2 years to begin to see a difference between 2 treatment times. I think the powering, Ilker can talk to the powering as you know, doesn't depend on the median. So -- but in terms of the timelines, anywhere from a 7-to-9 month median in the control arm would be consistent with the timelines that we've provided. Ilker, do you want to add some points?

Ilker Yalcin

No, I agree with that, physical program is primarily based on the Hazard ratio of 0.75 regardless of the median. So Medians could be 7.5 to 10 or 8.5 to 11.3, should provide the same power.

Brian Klein - Stifel, Nicolaus & Co., Inc., Research Division

Right. I guess, the question really involves -- now that you are pivoting towards more Western enrollment, when we look at the GALAXY-1 data, you showed Western Europe and U.S. survivals of 3.5 to 5 months for the control arm. And then about a 2-month benefit, 2 to 3-month benefit. And then when you looked at Eastern Europe, you showed 7 months median versus 10 months with the combinations. So I'm just trying to understand now that you're pivoting more towards the Western World, are you expecting that medians will be closer to the 3.5 to 5 months or will they still be at around 7?

Safi R. Bahcall

I think those numbers are off. I'm not -- are you thinking of progression-free survival? There's no survival time that's around 3 months to 4 months. Progression-free survival is around 3 months. We've been talking about overall survival.

Brian Klein - Stifel, Nicolaus & Co., Inc., Research Division

Okay, all right. Just wanted to double check on your expectations for your...

Safi R. Bahcall

Yes. We're talking about overall survival. So you're right, patients in the West were more standard, advanced, disease patients. The median survival in the West was in the neighborhood of 6 months and the Hazard ratio that was seen in the West was about 0.5. Median survival in the East was closer to 9 months or 10 months and the Hazard ratio is much less mature there because they live so long, there's relatively less follow-ups. There was median survival of 6 months and a Hazard ratio of about 0.5 in the West and it was a median survival of about 9 to 10 months and a Hazard ratio in, what was it, occur [ph] in the points, 0.8 or 0.9 range in the East. Does that answer your question, Brian?

Brian Klein - Stifel, Nicolaus & Co., Inc., Research Division

Yes, that does answer it. Thank you. My second question is now that you've upsized the trial, can you give us a sense of the number of events that need to occur before you unwind?

Safi R. Bahcall

Yes. Our head of Corporate Communications is saying, no, no, no. We have consistently had a policy where we don't, I guess, provide the exact number of events. I think what we have said in the past on this question is, they're pretty typical plain vanilla assumptions for powering Phase III studies. And we're well in line with what you see in a typical Phase III trial in terms of follow-up and number of events. Is that all right?

Operator

The next question is from the line of Robin Davison with Edison Investment Research.

Robin Davison - Edison Investment Research Limited

Just a quick one, please. I just -- it occurred to me that given you are -- I'm taking this critical amendment and expanding the study -- had you given consideration to excluding any basically mutation types, for example, KRAS where, certainly, the data wasn't good differ [ph] OS in the last data set. So is it possible or had you considered it?

Safi R. Bahcall

I'll turn it over to Vojo and Ilker, if they have any -- I think -- but one should be careful about the KRAS -- we just under powered -- what you're seeing in KRAS is there isn't an enormous effect but it's underpowered to see if you had the same effect. It's only 63 patients, and so with 63 patients, you're powered to detect a very big effect, which is closer to what you're seeing with a high LDH group. But you're not powered -- so there's no evidence one way or the other that it would do better or worse than the overall. Ilker do you want to add anything?

Ilker Yalcin

No.

Safi R. Bahcall

Vojo?

Vojo Vukovic

No.

Safi R. Bahcall

Other than that, they're really -- the GALAXY-1 program, the strategy that was developed a couple of years ago was to gather information on patient population, operational plan of using GALAXY-1. And we've got -- I think it's fair to say we've got all the information that we were looking for and that we need to optimize the Phase III trial. And that's what we've done.

Robin Davison - Edison Investment Research Limited

Right. So there's no other change -- there would be no other changes to the selected patients of the recruited apart from the basically discussed already, obviously, the increase in size and the change in the center profile, if you like.

Safi R. Bahcall

That's right. The GALAXY-1 data, that's correct, Robin. The GALAXY-1 data are near final and they've given us the information we were looking for to optimize the Phase III.

Robin Davison - Edison Investment Research Limited

Right. And just one other one quickly. Actually, did you collect PD-L1 biomarker phase or can you, could you even see whether that has any effect?

Vojo Vukovic

No, we're not collecting that information. Obviously, PDL became interesting for the lung cancer community way after we finished the design of the original GALAXY-1 study. And also, technically, it would be quite challenging to accurately get this information.

Operator

Our next question is a follow-up from the line of Mike King with JMP Securities.

Michael G. King - JMP Securities LLC, Research Division

A couple of questions. You guys had stated that you believe that ganetespib is clinically active. And I feel like there's a constituency of investors out there that don't buy into that. So maybe just give you an opportunity to kind of defend that statement with concrete examples?

Vojo Vukovic

Hey, Mike, I'll take a crack at that. I mean, I think we've shown consistently for the last couple of years -- it's discussed in our presentation, of tumors that shrink on ganetespib monotherapy and that these remains under control for a long period of time. There were a couple of patients, I think, in our early trials who've been on treatment with the drug for more than 3 years now. So I think once you demonstrate that the drug has monotherapy activity, and I think we've provided that evidence in abundance, I think that question about conco activity, I think, is answered. What you also see in the GALAXY program is in a randomized settings we see increase in response rate, an the increase in progression-free survival and we see a very strong survival feel mode, as well. In the subset of patients that's defined prospectively. So, I think we have a pretty substantial evidence about the drug's activity in the clinic.

Safi R. Bahcall

Ilker, do you want to add any comments?

Ilker Yalcin

I'm working in large pharma over 15 years and Synta, about now, close to 3 years. In order to understand what is not clinically active, you have to see a lot of compounds. I put 2 drugs in the market now, it's over $6.5 billion, and I also killed so many drugs. I mean, you know when you look at the data from the body of evidence. If something is clinically active or not active. I have no doubt that ganetespib is chronic [ph] -- I mean looking at the data from many different perspective, we know we have the right perspective.

Safi R. Bahcall

Actually, we actually have Iman El-Hariry here who is working on our breast cancer program. Iman, you frequently get these comments from breast investigators. Do you have anything you want to add?

Iman El-Hariry

Yes. Thank you. Thanks, Mike. I think I also look at my plus 20 years or 15 years of industry experience and working in large pharma. Seeing a single agent activity -- and it's not an end of 1 or end of 2 that we have actually a very good number of single agent activity in different tumor size, including lung cancer, breast and others. It's been very encouraging. And it really is in line with the science that we started to become very conversant with on the HSD science and the incubation of client proteins, so when we took to our investigators specifically in breast cancer, there is huge interest in taking this drug in all subtests for instances in breast cancer. And given the level of evidence that, and the level of activity that we are seeing. So this is really very encouraging. I mean, like Ilker, I also worked on drugs that were approved and came to the market and comparing these with my past experience, I think the level of activity that I am seeing far exceeds that what I have seen in my past experience in any of the drugs that I also have taken to the market.

Michael G. King - JMP Securities LLC, Research Division

The other contention and Safi, I think we've discussed this before in private meetings, but the other contention is that through all of your activities done in the ALK population, I wonder if you could speak to that in whatever level of detail that you are able?

Safi R. Bahcall

I think it's true Hsp90 inhibition has very clearly been demonstrated, now several Hsp90 inhibitors in ALK-positive lung cancer. But we have CRs or near CRs in triple negative. We have remarkable responses in mutant BRAF lung, pretty remarkable results in renal, in melanoma, in colorectal. So as Iman and Vojo said, it is a little bit difficult to grasp because people are very familiar now with ALK inhibitors for ALK-positive lung, or EGFR inhibitors for mutant EGFR lung, or BRAF inhibitors for BRAF melanoma. So this is a compound that's kind of different because it does do that. It does see the kind of activity that you're seeing there with durable objective responses that last a year or in some cases, 3 years now. But it's broad. It's not just ALK lung. I mean, you have CR and triple negative breast or durable responses in gastric, HER2+ gastric or HER2+. It's more broad. So it's like a collection of those drugs acting together because you're targeting a network of proteins, not just 1 protein. It just ties back to exactly what Vojo was saying a few minutes ago. It really underlies the strategy that we developed a couple of years ago. If you're developing an ALK inhibitor for ALK-positive lung, you got to know your patient population. You don't need such a large exploratory trial to identify.

Michael G. King - JMP Securities LLC, Research Division

No, I guess my -- maybe I didn't make my question clear. If the responses, the argument is that the responses in GALAXY-1 are largely in the ALK-positive patient population.

Safi R. Bahcall

I see, yes. It's the other way around, actually. The patients without positive lung or mutant EGFR lung tend to live very long. Median survival is -- can be a couple of years. So it's very hard even with EGFR inhibitors to see a survival difference in mutant EGFR lung. So when you have patient that live 2 years or longer, you won't see any separation very early on because they do well in both. So what a lot of people think is that we may eventually see a tail in the curve of that favors the ganetespib -- I think that was mentioned at the last ASCO meeting. People expect to see a tail in the far and when you wait 2 years or 3 years, you'll see a tail in the far right of the curve and that will be your 5% that's ALK-positive lung. But as Vojo mentioned, there's a very strong separation right away in the first 2 months, 3 months, 4 months, 5 months and 6 months. And that can't be due to ALK lung. The ALK type of patients are all in the far right, the 5% that lived very, very long and there's generally no separation in the early part. Does that answer your question, Mike?

Michael G. King - JMP Securities LLC, Research Division

Yes, but we're taking up a lot of time. So we can continue the rest offline.

Operator

That does conclude the question-and-answer session. I would now turn the conference back over to Dr. Bahcall for concluding remarks.

Safi R. Bahcall

Thank you, all, for your time and attention today. That ends our call.

Operator

Thank you, ladies and gentlemen. This thus conclude today's call. You may now disconnect.

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