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Celldex Therapeutics, Inc. Message Board

  • nickdidomenico nickdidomenico Nov 27, 2013 9:19 AM Flag

    if REACT leads to early approval will they stop PIII and save $ ? If REACT does not lead to early approval was it a

    waste of resources and money? What purpose in the context of PIII can the knowledge gained from a failed REACT study be put?

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    • 'will they stop PIII"

      Oh yeah, the FDA (and shareholders) would love that - approve a drug for recurrent and then just let it sell w/o a definitive trial and w/o marketing. Of course, Avastin was used in a similar fashion for awhile until the recent trial found no benefit in primary GBM, so maybe it would be safer to just stop the Ph III in primary in case it fails too.

      " we can speculate that most would opt for Rindopepimut CDX-110 first, and not Avastin. " Also look at the failed Phase III of Avastin in primary GBM, to reduce some of that speculation.

      " there would be no refractory Avastin patients. "
      There would certainly be in 2nd recurrent pts.

      "Not that strongly indicated for newly diagnosed would avail because of the narrowness of the market, say $10M there" The market for primary is must larger than the market for recurrent.

      ""REACT was a waste of $"
      If you can get approval in recurrent then you can market in approval. W/O a trial, you're not getting approval and your off-label use would be minute with no evidence it works in that setting.

      • 1 Reply to ffmoo
      • ffmmoo where have U been my little faggotta?

        Look your are missing the point as usual although you are basically CORRECT in that Avastin did not show benefit in primary GBM relative to SOC! [The results of the phase III RTOG 0825 study were presented at the 49th Annual American Society of Clinical Oncology (ASCO) Meeting, held from May 31-June 4, 2013, in Chicago, Illinois]...this we all know! Avastin is however approved in recurrent/refractory which is what happens to nearly ALL GBM sufferers over time so that Market is HUGE and unmet....period! That being said the ReACT trial was worth lots to all of tells us that Avastin gives PFS/OS benefit to many GBM patients AFTER they have gone through SOC and they BREAKTHROUGH! What would you have them do when the doc says the Cancer has returned..just DIE..or try something new..when they go on Avastin they live LONGER and that lasts for a finite time..may be 6 months maybe 1 year but they LIVE! Than they fail again..this is the Natrural Course in many Cancers and all we are trying to do is EXTEND life and stay one step ahead of PROGRESSION/Failure and so they did ReACT to see what happens when Rindo is added...BINGO we get a new finding...IN FACT the RINDO ARM seems to have very special IMMUNE PUMPING and PRIMING and stability and we see many refractory patients improving again..mind you they are heavilly PRE TREATED and have failed all best attemps! The study continues...patients are showing a strong early trend to PFS benefit and possibly OS..that will take more time to substantiate but imo its worth it!

        This is now REPORTED!

        Strong interim survival trend (12.0 vs 7.9 months) emerging in ongoing bevacizumab naive randomized cohort; 5.6 month median OS (48% 6 months) in bevacizumab refractory single-arm cohort; robust anti-tumor immune responses were generated among heavily pre-treated patients with recurrent tumors and these responses correlate with improved outcome....

    • 'will they stop PIII"

      Oh yeah, the FDA (

    • IMO, By looking at the overall survival of the three P2 clinical trials (ACTIVATE, ACT II, ACT III) we can speculate that most would opt for Rindopepimut CDX-110 first, and not Avastin. In light of this, there would be no refractory Avastin patients. Only if you can beat Rindo on its own, would you need to combine it with Avastin. Your question is valid, even though REACT results will likely prove successful.

      Sentiment: Strong Buy

    • ReACT and ACT-IV have two different treatment populations.

      ReACT targets patients who have had other treatments already and are proceeding to Avastin. Patients receive Rindo and Avastin in combination in one arm; in another arm patients who have already received Avastin yet have progressed in their disease begin receiving Rindo.

      ACT-IV targets front-line patients, which means patients who have not received any other treatment for GBM yet.

      In summary: ACT-IV is for newly-diagnosed GBM patients whereas ReACT is for patients who have already received other treatments for GBM that haven't worked.

      Approval in one patient group does not mean automatic approval for the other. That is why both trials are important.

      If the expanded arm in ReACT is sufficient for approval, that will only matter regarding GBM patients who are Avastin refractory; it will not impact newly diagnosed GBM patients.

      Sentiment: Strong Buy

    • good thing and well put. let's hope they'll do better on the design of 011 phase III, which matters more. let's hope it'll be a deal for 1127. experience is time and money.

    • No, as on going approval will likely be contingent on the P3 results going forward.
      But then how do they keep their control arm in tact?

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