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Threshold Pharmaceuticals Inc. Message Board

  • pharmajedi pharmajedi Mar 30, 2012 5:02 PM Flag

    lets' be honest

    The PFS results of 5 months of the higher dose were not as expected (I was personally expecting 6.5-7 months), however the RECIST response of 27% was impressive to me, from a dose response perspective as well as looking at the PFS of the lower dose. So the efficacy data of the high dose is not entirely blow out, but very good from a clinical perspective considering the very good safety profile. All the signals here point to a very clear and straight forward regulatory path and designing a pivotal trial, which Merck is paying 70% of all costs for...gotta luv it!

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    • You are right - they just need a very good phase 3 design to address the obvious issues in teh phase 1/2 and the phase 2 (primarily the cross over)

      It's also very encouraging when ANY therapy shows greater efficacy in higher dosage with TH-302 did - that being said it is good - but not as good as I was expecting (and I think the market was expecting and has currently priced in) and it is far less eeffacacious then Abraxane. Abraxane had a 7.9mo PFS with 12.2mo OS

      Here is the data from the Abraxane trial

      After the first phase of the study, the recommended Phase II dose was 125 mg/m2 of Abraxane followed by 1000 mg/m2 of gemcitabine on days 1, 8 and 15 of every 28-day cycle.

      In Phase II, almost half of the patients responded (overall response rate was 48% (21/44)) and two-thirds experienced disease control (disease control rate was 68% (30/44)). The median progression-free survival was 7.9 months (95% CI: 5.8, 11.0) and the median overall survival (OS) was 12.2 months (95% CI: 8.9, 17.9). The one-year survival rate for patients was 48%.

    • meant to say 6 months

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