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Synta Pharmaceuticals Corp. Message Board

  • ivanprokov ivanprokov Oct 30, 2013 6:57 PM Flag

    I missed this in the presentation on Monday

    This is new results we got earlier this month from a patient who as you can see on the left had positive non-small cell lung cancer tumor and within the first scan most of the tumor had been eliminated and that's a year later and the patients still on monotherapy with little evidence of tumor. On page eight, this really takes us two the observation when we started this program, that we had few choices we could develop this drug as monotherapy, which has the advantage that we do have evidence of these rapid durable impressive responses. However this is our relatively rare tumors and it's now fairly crowded or saturated market with over a dozen ALK inhibitors in development well over 50 EGFR,HER2 inhibitors another 50 PI3K, mTOR inhibitors and so on.

    Whereas with combination therapy Ganetespib does have the unique advantage in the safety profile as well as the synergistic activity that's been observed with a number of both chemotherapies and targeted drugs and of course this is a much broader opportunity with a potential to address much larger number of patients and they are still for example in lung cancer has not been any drug approved adding to Docetaxel or any of the other single agent therapies in second line lung cancer.

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    • I'll be very brief it's quite normal that results and values in the course of the study can vary they can fluctuate. The trials are designed to be balanced and approach the true outcome at the end not necessarily in the middle. So, what truly matters is the final, only a final results that we have today and that result looks very favorable and it was obtained in a large international very robust Phase 3 like study, so we have high confidence that result that we have today is a solid result, a robust result and it looks very favorable relative to other historical results.

    • It looks like about 95, something it's relevant and I know our group has looked at it. Almost all of these patients from these two Eastern European countries 95% of them were enrolled in the last six months of this study. So in earlier portions of the study you had kind of a more clean study without those outliers and later those outliers contributed.

      And they contributed in two ways someone like one is these are much longer lived patients so patients are living a year or two years. It's very hard to see a difference after six months because neither arm is dying after six months of 12 months. And two as comments mentioned there was some -- even within there, there was some substantial imbalance against the -- in favor of the control arm against the ganetespib arm that you had in the neighborhood of 40 some percent early stage patients in the control arm versus 5% in the combination arm.

    • Yes, so what the timeline question is going to depend both not only on that but how we think about trial size as well. So maybe I'll address that question and I'll turn it over to Vojo to share any additional thoughts. So when we -- now that we have near final data, we do plan to go back and look into the statistical plan discuss the findings of the lead investigators and our advisers and see if any adjustments are warranted.

      When we started this trial we're all aware that their pivotal trials that have been 200 patients, the docetaxel trial for example, 500 patients or a 1000 patients. We began in the middle and our plan was to be data driven about the final choice once we had in your final data and that's what the protocol specifies.

      Our expectation is that is if we do increase trial size into the 700 or 800 patient range and then with the updated enrollment that would increase enrollment completion time to probably first half of next year and the first interim analysis in to second half of next year. But that's a fairly broad range and we need to spend more time taking this data going back in to the statistical plan and doing other projections before we can make final estimates.

      • 1 Reply to ivanprokov
      • This is an example of where management does suck, you realize? If they had not rushed into phase 3 and had listened to the analyst at Jeffries, they wouldn't be talking about delays and increasing the patient trial size. Don't forget that a lot of haste does make a lot of waste. Doesn't change that this stock is worth more than 10 a share easily. But does indicate that management need to change their approach a bit and grow some humility and listen. Just my two cents.

    • The Hazard ratio right now is just at 0.72. The medians are more than three months apart. And we have 65% date of maturity.

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