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Vertex Pharmaceuticals Incorporated Message Board

  • thirdmeinvestor thirdmeinvestor Jun 10, 2008 10:15 PM Flag

    Chances for PROVE 3 failure

    In an earlier post Dew raised a valid point in observing that SVR12(= undetectable 12 weeks post-treatment =UND @ 36wk) is not the same as SVR (undetectable 24 weeks post-treatment=UND @48wk). Below, I did copy/paste the PROVE 3 data out yesterday to observe the trends in break-through (= HCV detectable on-treatment after UND) and relapse (=HCV undetectable on-treatment, but detectable post-treatment) among different categories of previously SOC-failed patients.

    ____________Week 12__Week 24(EOT)__SVR 12
    SOC NR (n=66)__ 71%_______65%______41%
    SOC Rel.(n=40)__88% ______83%______73%
    SOC Break.(n=9)__44%______44%______44%
    __________________________________
    Total(n=115)____75%______70%______52%

    (1) Observe that patients who had suffered SOC breakthroughs had a 44% chance of UND at week 12, the same at week 24, and also 44% 12 wks post-treatment. No breakthroughs or relapses.(see Data line 3 above). Many in this group most likely have HCV mutants resistant to SOC and TVR.
    (2) Patients who had relapsed after SOC has much higher percentages at week 12 and also at week 24, but had a relapse chance of 10% between the end of treatment(EOT) and at week 12 post-treatment. Notice that a 73% SVR12 is higher than the SVRs recorded in PROVE 1 or 2.
    (3) Now, the SOC NR (=non-responders, Data line 1 above) group has a 24% chance of relapse at Week 12 post-treatment. Most relapses have probably occurred by this time point. But even if we allow another 24% relapse rate after Week 12, the SVR for this group would be 17%.

    Conclusion -- Under the harsh assumption made in (3) above, the weight averaged SVR is about 44%, 8% lower than the SVR12. In this I assume that no relapse occurs for SOC-relapse and SOC-breakthrough groups.
    A 44% SVR for SOC failed group is still an outstanding number.

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    • I made an error in computation. I had to assume 27% not 17% for the SVR for the SOC non-responder group to get the overall SVR of 44%. Sorry about that. The 17% gives the overall SVR of 38%, which is still a good number. In PROVE 1 and PROVE 2, the relapse rate for the TVR arms between the 12th and 24th weeks post-treatment was 0.0%. The patient groups in the TVR arms of PROVE 1 and 2 contained lots of potential SOC nonresponders (if they had received SOC alone) and yet there was no relapse after the 12th week post-treatment. So, the overall averaged SVR for PROVE 3 would be very close to 52%, not 38% or not even 44%.

    • Correct third, but I would like to point out that because of their expierence now in the trial design it would be fair to assume that the results of a Phase III for non responders should also be higher than those numbers they will get out of the Porve 3 data - which likley will be the data they will use the file for NDA

      Than again Ian Smith did say in a Conference Call, I believe the one with the Deutsche Bank, that the quickest way to approval would be to file for NDA with the Prove 3 Data and in the same time run a FDA designed Phase 3 and not wait for the outcome of that data, to help the patiens in need.

      That could be the best case scenario from here on out. I find it very courious that VRTX broke with their policy not to present data to the public anymore, just in medical conferences.

      When Michael Partridge was asked in one of the last Conference Calls about a month ago by an analysts he stated that we will not hear or see Prove 3 data until the AASLD in the fall (?).

      Taking those statements in consideratin it must be more than 4 weeks ago that they shared those data with the FA and than likley after a feedback from the FDA decided to relaese those data in a press release month before they told us we would see them. Or three days before they have a Conference - (Timing)

      "Goldman Sachs Twenty Ninth Annual Global Healthcare Conference June 11 4pm pt."

      Why would they have done that? Hopefully we find out more today....

      Your thougths are as always apreciated,

      emserm,

      • 2 Replies to emserm
      • em, about your thoughts in the first paragraph, you are right about higher SVRs for phase III data. PROVE 3 patients are a hard-to-treat group. Also notice that the dropout rate for PROVE 3 was 11%, not 17% scored for PROVE 1 and 2. They know how to manage the side effects better now. A 6% reduction in the discontinuation rate means a higher SVR for Phase III. A SVR of 70% or higher for Ph III is not out of question. Remember that the SOC-relapse group of PROVE 3 had an SVR12 of 73%.

      • em, you are right about the timing. But the management appears to be more conscious of the stock prices now. Remember the release of Study 107 data? that was premature. They may be thinking about buying one or two polymerase inhibitors. If that was the case, there will be more buying opportunities.

 
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