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Synta Pharmaceuticals (SNTA)
Q4 2012 Earnings Call
March 14, 2013 10:00 am ET
George Farmer - Vice President of Corporate Development
Safi R. Bahcall - Co-Founder, Chief Executive Officer, President and Director
Keith S. Ehrlich - Chief Financial Officer, Principal Accounting Officer and Vice President of Administration & Finance
Daniel Brims - Brean Capital LLC, Research Division
Thomas Wei - Jefferies & Company, Inc., Research Division
Brian Klein - Stifel, Nicolaus & Co., Inc., Research Division
George B. Zavoico - MLV & Co LLC, Research Division
Robin Davison - Edison Investment Research Limited
Jason Zhang - Edison Investment Research Limited
Previous Statements by SNTA
» Synta Pharmaceuticals' Management Presents at Barclays Global Healthcare Conference (Transcript)
» Synta Pharmaceuticals Management Discusses Q3 2012 Results - Earnings Call Transcript
» Synta Pharmaceuticals Management Discusses Q2 2012 Results - Earnings Call Transcript
At this time, for opening remarks, I will turn the call over to George Farmer, Vice President of Corporate Development at Synta. Please go ahead, sir.
Hello. Thank you, all, for taking the time to join us today. With me are Dr. Bahcall, our Chief Executive Officer; Sumant Ramachandra, our new President of Research and Development; Vojo Vukovic, our Chief Medical Officer; and Keith Ehrlich, our Chief Financial Officer. This morning we issued a press release that reported results for the fourth quarter and year-end 2012. 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 related SEC filings, also available through our website. I will now turn the call over to Dr. Bahcall, after which we will open the call to questions. Safi?
Safi R. Bahcall
Thanks, George, and thank you, all, for joining us this morning. I'll keep my introductory comments brief this morning, since we are approaching an important data event, and there isn't too much we can say before that data. After my comments, I'll turn the call over to Keith for a financial update and then questions.
I mentioned an important data event. We specified in our release and recent presentations what to expect from our GALAXY-1 trial over the next few months. Just a reminder, GALAXY-1 is a global, randomized trial evaluating standard of care, docetaxel, with and without ganetespib in the second-line lung cancer setting. We completed enrollment of 252 all-comer adenocarcinoma patients in November of last year. We have a prespecified overall survival analysis for 6 months from the last patient enrolled, which we expect will be conducted in May. At that time, those 252 patients will have a median follow-up of 9 to 10 months, which will be a fairly mature survival data set.
We're hopeful that we'll have the opportunity to present those results at a major medical meeting around that time. But of course, we can't guide to any specific meeting until we hear about whether or not we've been selected to present. Since these results will be very important for our future plans with ganetespib, it doesn't make too much sense to discuss future plans right now. We would expect to have more to say about future plans after the results are presented.
As many of you are aware, based on encouraging results from an interim analysis of the GALAXY-1 trial last year, we moved forward with a confirmatory trial, the GALAXY-2 trial, which will enroll 500 patients in the same second-line lung cancer setting, with the same design, dose, schedule of docetaxel with or without ganetespib. We've opened sites in a number of countries and expect to announce first patient treated within the next few weeks.
As we've described on a number of occasions, the GALAXY-2 trial will be enriched for those patients who show the greatest benefit from ganetespib and GALAXY-1. A prespecified analysis for GALAXY-1 showed that patients who received the normal course of first-line therapy were the ones who benefited the most from ganetespib. In other words, those patients who progressed very rapidly through first-line therapy, what are sometimes called "outright progressors" didn't benefit much. The rest did. This design is fairly common in other second- or third-line trials in other tumor types, with exclusions for primary refractory patients. In our GALAXY-1 lung cancer trial, the outright progressors are about 1/3 of the total second-line population.
We've been asked a few times if, in our major presentation, we would provide the results for how this enriched population performed. The answer is yes, we plan to do that analysis and provide that data. That's where we are with the GALAXY program. We should have a lot more to say a couple months from now.
A quick update on our monotherapy programs. As we've said on a number of occasions, based on our most recent results and understanding of the science of ganetespib, we see that the combination therapy opportunities -- we see the combination therapy opportunities as the most attractive ones for ganetespib right now, and our monotherapy trials have decreased in relative priority. For our CHIARA trial in ALK+ lung cancer, we're in the process of completing an initial enrollment phase and collecting the data. We expect to make a decision about the future of that program in the next few months.
Breast cancer, as many of you know, taxanes are a widely used standard of care. We have seen a very high interest from breast cancer investigators in replicating what was done in the GALAXY trial at lung cancer, a randomized trial of taxanes with and without ganetespib. In lung cancer, single-agent docetaxel is commonly used. In breast cancer, docetaxel was also used but so was paclitaxel. But for ENCHANT trial, which was originally designed to evaluate monotherapy ganetespib in breast cancer, we're in the process of amending the trial to add an arm evaluating the ganetespib/paclitaxel combination in order to enable greater choice in any future breast cancer trials we may do. We should also have more to say about the breast cancer plans a couple of months from now.