Home Forums Melanoma Diagnosis: Stage IV Merck Announces Breakthrough Therapy Designation for Lambrol

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    Celeste Morris

    Well said, Jonathan. Right to the point!



    A little while since I posted but I have just returned from my second course of Ippi, As always it was great to read that some people have had more than one course of ippi and also the new drug that may be available but disappointing to see all the ‘clauses’ which will prevent people from gaining access.

    I will post under a separate heading and update you on regarding my own experience, to include the recent brain tumour I have had removed. I will first read my last post which I think might have been rather irractic due to various reasons.

    with thanks

    Diana Payne

    Stansted UK


    Just a little more info, reinforcing these comments. I just talked to a nice Merck person (on the financial side) and he acknowledged that the “Breakthrough Therapy” status has already allowed for a closer collaboration between the FDA and Merck going back some months, and that this should continue going forward.

    The current plans for their phase II trial (which is very large for a phase II, and includes registration and as noted by Catherine has a blinded placebo element with cross-over option – 500 participants) is that it will be complete by March, 2015, or 4 months later than the planned closure of the BMS anti-PD1 trial.

    My guess from this is that their phase II trial, if the results are as positive as one might anticipate from the published phase Ib trial of 85 patients, may well allow them to use the results as a replacement for a phase III trial – again, my guess is that the FDA is allowing this possibility with their earlier involvement in designing the most efficient path of testing/evaluation (and certainly a large phase III trial on top of this big phase II trial doesn’t make any sense unless the results are questionable).

    So all that is fine and hopeful over the long run (2 years from now), but no one is suggesting (as far as I know) that compassionate use applications or expanded use of this drug will be allowed earlier than at the time of the completion of this drug trial. If anyone has different information on this, for heaven’s sake please post it. And of course we’ll be interested in what they report in June at ASCO…

    Celeste Morris

    Don’t forget….that no matter this “break through therapy” designation…the BMS anti-PD1 product is already in TWO Phase III trials…one currently recruiting with BMS anti-PD1 vs Dacarbazine for those with untreated, unresectable, or metatstatic melanoma…..and another with the BMS anti-PD1 vs the MD’s choice of Dacarbazine or carboplatin and paclitaxel for melanoma patients who have failed ipi. Cross over and lack thereof are issues with these of course. Merck has no Phase III trials in process (to my knowledge) for their anti-PD1 product. I fear these designations are nothing but a game between two competing companies to see who can jump over whom first in order to attain the market prize of being the first anti-PD1 product with FDA approval. I have no horse in the race for either….and they can play whatever games they like…as long as patients reap the benefit and soon. Keep in mind as well…that it is possible that an anti-PD1 product may get approved for some cancer other than melanoma first. The upside would be that the product would be on the market. The down side would be that insurance companies could possibly deny covering its use in melanoma, if it isn’t approved for that specifically. I am just hoping that the game of leap frog that the companies seem to want to play speeds FDA approval for both….for melanoma and any others whom it can benefit. c



    The Merck trial at the link below does NOT exclude OM, according to my father’s specialist. We haven’t actually gotten my father (who has OM) into the trial yet, but the doctor thinks there will be a slot in June, if his liver function and blood tests and all stay strong. Prior use of ipi also does not exclude you so long as it was more than six weeks before. There are many sites in the US and one in France. This Phase I trial has been ongoing for a few years and may be winding down by late summer, according to the doctor, so start calling around now. Best of luck to you!



    My husband (BRAF neg) was in the process of testing for admission to anti-pd1 trial at MSKCC & found out today that he now has 5 small brain mets. He will probably be getting radiation for the brain mets, but does anyone know if you can get anti pd1 ANYWHERE if you have brain mets?

    He unfortunately has tumors in his stomach & liver that have continued to grow after Ippi, radiation (to stop stomach tumor bleeding) & chemo.

    Not sure his liver will hold up long enough to shrink/control(?) brain mets & then get into PD1 trial.

    We are DESPERATE for info/suggestions … :(

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