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Vical Incorporated Message Board

  • tek_jansen500 tek_jansen500 Feb 8, 2012 7:26 PM Flag

    A-7 Phase 3 question

    The trial extension means that patients on the trial are living much longer than expected. If we assume that's because A-7 is working extremely well, you might think that the trial would get stopped early so that all patients could switch to A-7. That does happen in some trials.

    But on the CC one of the analysts asks if the review board couldn't stop the trial based on overwhelming efficacy. Vijay says that the panel only sees safety data, not efficacy, so there is no way it could be stopped based on efficacy.

    What do we take this to mean? That this trial doesn't have anyone taking an unblinded look to check for overwhelming efficacy? Or is there probably another committee that looks at efficacy, that could have stopped the trial early if the efficacy had been fantastic?

    I assume it's the first, but why wouldn't this trial have someone checking for overwhelming efficacy & an early stop when other trials do?

    If it's the second, the control group is living a looong time, which makes me nervous.

    Thoughts? Thanks in advance.

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    • >>"We are looking at immunotherapy and a drug that helps the immune system spot the cancer tumors and gradually either eliminate them or at least slow their growth. That process is not weeks, it is not even months, it is a process that can take years."<<

      IMO investors are now "GETTING THIS" about cancer immunotherapy... and Shorts are getting concerned that VICL could "explode in their hands." Big mutuals and private investors have big stake bets on Vical right now.

      Hundreds of MB posts here have 'run the numbers' on A7's probable & possible outcomes. Today I re-read Alain Rolland's latest PDF/PPT, esp. the details on the A7 Phase 3 trial design and recruitment factors.

      VICL (and AnGes) went globally to find enough qualified patients with healthy immune systems. And recruited patients DID NOT want the chemo arm. Period.

      Oncologists IMO are rooting for Vical's immunotherapy to become THE primary melanoma treatment on the planet.

      Look again at slide 5 (the median survival chart) and when the responder chart went "flat" in Phase 2.

      What if the responder rate jumped over 25%. Possible? Ya betcha given the healthy immune system criteria AND 2+ injection cycles of A7. This is a game changing oncology trial design for immunotherapy IMO!!!

      If median survival for the A7 arm improves by 20% in Phase 3 vs Phase 2, then we could see responders living 7+ months longer for Phase 3 vs Phase 2 A7 responders. If trial arm responder survival improved by 33%, A7 treated melanoma patient survival could improve by a full year -- A monster outcome -- especially since the DTIC/chemo survival curve is well understood.

      GAME CHANGE: If you read the book or saw the movie MoneyBall (same author as Liars Poker) you know that Billy Bean changed the scouting/trading game in baseball. Now statistics underpin baseball scouting "decision science."

      It's looking like Vical may have smartly applied insights from Phase 1 and 2 and now the Phase 3 trial is playing out... BUT we investors can't see the A7 scoreboard or underlying stats.

      The good news (per recent calls) is that A7 vaccine continues shipping to participating centers and the Company is preparing/spending for the post season -- expecting the scoreboard and standings will show A7 qualifies for FDA's next round.

      Time will tell how much Vical's oncology franchise is worth.

    • What does it mean if the control group also live longer? That is why the trial has to be extended.

      • 1 Reply to qwestisthebest
      • The scenario for the continued trial can only have three possibilities:
        both arms have not arrived at the number of events, drug arm hasn't arrived and the control arm hasn't arrived. Base on the past history of using chemo treatment of melanoma, chemo treatment hasn't proven to be successful to prolong patient's lives at median rate of beyond 12 months at best. I think if one wants to speculate for a reason of the prolonged trial, the most likely reason is because of the success for the A-7 arm. Because the double-blinded nature of the trial, nobody knows the overall effectiveness of the trials, only anecdotal info. the individual site in involved, if even that.

    • Key reading for the suject straight from FDA.

    • Opening lower.

    • Vical is locking the database for the primary endpoint this month but will remain blinded to results until the survival database is also locked. An independent team of radiologists and oncologists will spend the next couple of months assessing the data on the durable response rate. There is also a separate safety panel that has had access to adverse events from the trial's inception and has consistently found no safety reasons for stopping the trial.

    • "The independent trial examiners will have knowledge of the global response rate."

      My understanding is that they only have knowledge of matters pertaining to the safety of the trial underway. They can stop it for safety matters only. But they don't have knowledge of the global response rate.

      Anybody care to confirm or deny?

    • The independent trial examiners will have knowledge of the global response rate. I'd like to think there could be some mechanism where they could make a recommendation to immediately file for marketing approval if the results are spectacular...but I doubt they have this authority. The faster approval occurs the faster melanoma victims can benefit.

    • This question was answered previously:

      Since the trial is spread over dozens of sites, with no more than a handful of patients at each site, or under each doctor, there is no ONE person who has the global view of the trial that would provide the knowledge needed to stop the trial early. While one administrator or doctor may know how his patients are doing, he/she isn't privy to how others are doing. So calling for the trial to stop based on their small number of patients would be gross misconduct. In short, since VICL hasn't locked the database and started collecting the primary endpoint data, the trial will continue until it doesn't.

    • The trial examiners are going to know the response rate by June or July at the latest. While the response rate has certain subjective aspects to it, based on the phase 2 results and the new protocol for phase 3, IMO the response rate could show overwhelming efficacy. If that is the case, is there any way the examiners might stop the trial because of this significant meeting of the primary endpoint? Or notify the company so it can make a decision on whether to continue or to unblind the trial early?

    • Great posts here..

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