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Synta Pharmaceuticals (SNTA)
Q3 2013 Earnings Call
November 04, 2013 10:00 am ET
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
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
Previous Statements by SNTA
» Synta Pharmaceuticals Management Discusses Q2 2013 Results - Earnings Call Transcript
» Synta Pharmaceuticals' CEO Hosts Investor Meeting at the 2013 ASCO Annual Meeting (Transcript)
» Synta Pharmaceuticals Management Discusses Q1 2013 Results - Earnings Call Transcript
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.
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?