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Exelixis, Inc. Message Board

  • wilderguide wilderguide Dec 17, 2013 6:25 PM Flag

    Next Showdown in BRAF Mutant Melanoma

    Just in case you missed this, posted 9/30/13 at Kantarhealthdotcom by Hawthorne and Jeffress. If you enjoy a bit of the devil's advocate in your investment planning, you'll like this...these two gals did a really good job. In addition, I figured the PDUFA for the GSK combo needed to get posted.

    "In terms of efficacy it appears that the Genentech/Roche combination has the advantage; however, the GSK combination has a significant first-mover advantage. Not only are both GSK agents already approved in the U.S., but GSK has already received FDA priority review for accelerated approval of its combination based on the randomized Phase II data, with a Prescription Drug User Fee Act (PDUFA) target date of January 8, 2014. In Europe, the pending approval for Mekinist includes a broad label which includes use in combination with Tafinlar. Further, GSK was the first to initiate two phase III trials in mid-2012 – one in comparison with Tafinlar monotherapy (NCT01584648) and one in comparison with Zelboraf (NCT01597908). Genentech/Roche initiated a trial of their combination against Zelboraf (NCT01689519) six months later, in January 2013, putting it two or more years behind GSK. Will the first-to-market advantage favor the GSK combination? Or will physicians, more familiar with Zelboraf, favor the Genentech/Roche combination? It is too early to predict what the phase III data will show, but it will certainly be a showdown."

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    • "Genentech/Roche initiated a trial of their combination against Zelboraf (NCT01689519) six months later, in January 2013, putting it two or more years behind GSK. Will the first-to-market advantage favor the GSK combination?"

      We had this discussion on this board about a year ago. With the caveats that I'm working off memory and things may have changed, my recollection is that Roche somewhat closed the gap by using a PFS endpoint in their phase 3 trial whereas GSK was using OS. Regardless, GSK upped the ante by filing on phase 2 data and it will be interesting to see if Roche responds in kind or as is more likely, waits for the phase 3 results which should be out shortly.

      Roche, by virtue of being first with Zelboraf, still holds the high ground, but GSK has an advantage in that both its drugs are already approved as monotherapy. My recollection of NCCN guidelines is that they made mention of the BRAF/MEK combination but stopped short of a recommendation that would have opened a pathway to reimbursement for GSK for the combination. The assumption is that the GSK combination will get accelerated approval soon and then the advantage shifts to GSK with Roche trying to play catch-up. My guess is that GSK will get nearly a full year as the exclusive provider of a BRAF/MEK combo.

      Usually FDA only gives a single accelerated approval within a class of drugs for the same indication except in this case, Roche can correctly point out that the development programs were simultaneous and its drug combination should get the same regulatory considerations as those given GSK, we will see soon how this all works out.

      • 1 Reply to erniewerner
      • $$$$
        "We had this discussion on this board about a year ago."
        I know, and that's what makes the appearance of this article so cool...
        My wife has her master's in communications and research, and favors the quote " You never know where that next great idea is going to come from..."
        ...and she's right, of course. The point is...this can be a very productive MB, and I often wonder if sometimes it catalyzes thought that leads to productive research for other YMB posters. I know it sometimes does the trick for me, and I try to return the effort by supplying fuel for the fire. It's not beyond possibility that these gals got their research idea similarly, and perhaps even from this MB.

1.51Oct 1 3:59 PMEDT

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