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Seattle Genetics Inc. Message Board

slumdawg2011 2051 posts  |  Last Activity: 1 hour 7 minutes ago Member since: May 2, 2011
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  • slumdawg2011 by slumdawg2011 1 hour 7 minutes ago Flag

    After 1 year in adjuvant use of Herceptin, DFS 1 yrs after treatment ~ 86%. Treatment with neratinib improves DFS by 33%. CC said 33% of 86% is ~ 91%. I am not really sure how the numbers were arrived at. Differences are highly statistically significant.

    Neratinib's major AE is diarrhea in up to 30% of patients. There is no mention of other SAEs. If at 1 yr post Herceptin, I have a 14% chance of disease progression, I think I will be willing to take neratinib for 1 yr or more. If I have a problem with diarrhea then I'll stop using it. If I don't, I'll continue taking it. So really if you're looking at the numbers for efficacy, it would seem like it would make sense to exclude the subjects who decided to stop participating due to diarrhea. The unknown is diarrhea the only AEs? Will FDA ask for 2 yr DFS data? Or overall survival?

    Same question will be, "If you have the BRCA1 mutation, and there is a drug that may cause diarrhea in 30% of patients, but will slow down cancer in 86% of population, will you be willing to take the drug for 1 yr or more?" I think, I will want to have the drug as an option, and I will only stop taking it if I am in the 30% who'll have diarrhea.

    Now, I am thinking that mgmt made a smart decision in designing the trials. Should other drugs be tested in similar post-Herceptin adjuvant setting?

    Of course, I find that FDA approvals don't always follow logic.

  • Reply to

    Earnings expectations?

    by afro_bro_bro Jul 28, 2014 1:23 PM
    slumdawg2011 slumdawg2011 17 hours ago Flag

    Yes, Roche is aiming for Kadcyla plus Perjeta. The question is why Roche did not design the Kadcyla trials such that Kadcyla would at this time be already approved for those other indications for which Perjeta is approved for. The reason is not really clear to me. I really think Roche is dragging on Kadcyla, and wants to get as much from Perjeta plus Herceptin, because if Kadcyla without Perjeta already works great, then there goes their Perj revenues. NICE actually turned down Perjeta payment bec survival benefits are not clear. On the other hand, NICE rejected Kadcyla for its price and wants pricing negotiations, and does not question efficacy.
    I remember hearing or reading something about MARIANNE data in 2014. Was that mentioned in an earlier CC? Completion is not until 2016. Are they able to give updates because 1 arm is not blinded?

  • slumdawg2011 by slumdawg2011 Jul 27, 2014 11:04 PM Flag

    I guess what LPath is saying is about half of patients treated responded really well to Asonep treatment. If they can find biomarkers, like elevated VEGF, insulin, IGF or other overactive kinases, that differentiate the highly responsive group from the unresponsive group, they will be able to get PFS much longer when just treating that patient subset. How about S1P-R overexpression or overactivation? It seems like that will be a good candidate to look at. They can probably get accelerated approval if they can identify that patient subset and almost assured of Asonep approval. And, if they find the same biomarker in other cancers, then pps shoots to the moon.

  • slumdawg2011 slumdawg2011 Jul 26, 2014 12:29 PM Flag

    If the benefits are as good as reported, and there are no serious side fx, neratinib will get approved for sure, regardless of whether physicians will put their patients on the drug for a year or not. I'll also worry because the trials were done in 41 countries and data interpretation and integrity can be questioned. Remember too that these anti-HER2 drugs are hard on the heart and liver.

    Anyway, good luck to your investment and neratinib.

  • Reply to

    Sutent vs. Asonet

    by birdshooter_6 Jul 25, 2014 10:51 AM
    slumdawg2011 slumdawg2011 Jul 25, 2014 8:39 PM Flag

    Don't be too negative when you chat with Scott. Just tell him to have more frequent and "hypeful" PRs like this past one, but maybe with a more catchy title. Perhaps present the RCC data at ESMO or any upcoming big onco or kidney meeting.

    LPath's Asonep delays disease progression in kidney cancer patients. Instead of:
    "Lpath Reports Interim Data From Phase 2a Study for Anti-Cancer Drug, ASONEP"
    Maybe then WSJ or Bloomberg will follow up with their own spin.

  • Reply to

    Lows since 2011, Junius and BOD must go!

    by bioimmunomabman Jul 25, 2014 11:19 AM
    slumdawg2011 slumdawg2011 Jul 25, 2014 7:41 PM Flag

    He-he. I'm not even sure that Benlysta is selling that well. I just know that it's a "krappee" drug in terms of the trial results. I am not sure about the other HGSI pipeline then, like the anthrax vax. I owned HGSI and was glad to sell it.

  • Reply to

    Sutent vs. Asonet

    by birdshooter_6 Jul 25, 2014 10:51 AM
    slumdawg2011 slumdawg2011 Jul 25, 2014 4:55 PM Flag

    So if patients failed prior treatments, and they are not treated with any drug later, should they all be considered to have disease progression already by day 1? So without treatment, it would be 0% PFS by month 4? Pretty much the tumors will just keep growing without treatment and larger by month 4?

  • Reply to

    Sutent vs. Asonet

    by birdshooter_6 Jul 25, 2014 10:51 AM
    slumdawg2011 slumdawg2011 Jul 25, 2014 4:45 PM Flag

    Treatment naive patients for Sutent, unlike patients in Asonep who have progressed after at least 2 treatments, including Sutent.

    I went over an NEJM paper comparing pazopanib vs sutent for treatment-naive rcc and it has mPFS of 8.4 and 9.5 mos, respectively.

  • slumdawg2011 slumdawg2011 Jul 25, 2014 3:28 PM Flag

    Change remission above to relapse.

    BTW, neratinib was administered daily for 1 yr. Will you risk AEs with that? How frequently will you have to take imodium? Daily also?

    The important question really, is after relapse, what treatment options are there, and how successful is retreatment?

  • slumdawg2011 slumdawg2011 Jul 25, 2014 3:16 PM Flag

    Doctors will probably wait for those 14 to show remission then retreat, rather than treat all 100 with a drug with AEs, with 30% of them suffering from diarrhea as just one concern. Another question is how many of those 14 will not respond again to Herceptin, or Kadcyla, or other SOC upon retreatment?

  • slumdawg2011 slumdawg2011 Jul 25, 2014 11:17 AM Flag

    It turns out that there is no standard of care after Herceptin as adjuvant for 1 yr, because DFS by doing nothing is as high as 86%. Accepted practice is probably to monitor patients closely, and retreat when the cancer comes back, instead of taking a chance by continuously, and perhaps unnecessarily, taking a drug that has nasty side fx and that may do actually do more harm.

  • Perhaps Roche will be more inclined to promote Kadcyla in Europe and sales will accelerate.

    Would be nice if knowledgeable doctors will opt for off label use of Kadcyla instead of the Herceptin/Perjeta combo.

  • Reply to

    give it time

    by thebigfella1234 Jul 24, 2014 3:46 PM
    slumdawg2011 slumdawg2011 Jul 24, 2014 5:23 PM Flag

    We'll probably get an update on the 2nd cohort by EOY2014, while we wait for Isonep from Pfizer until 2015Q1. That's all the time I'm giving LPath to raise pps above $10.

  • Weird. That is all they wanted to part with. I think I might be helping someone in walking up the pps.

  • Reply to

    Perjeta

    by slumdawg2011 Jul 24, 2014 10:08 AM
    slumdawg2011 slumdawg2011 Jul 24, 2014 10:30 AM Flag

    Actually, if Kadcyla works as great as could be expected, it will decrease sales of both Her and Perj. That is why Roche is pushing Her/Perj rather than Kadcyla.

  • slumdawg2011 slumdawg2011 Jul 24, 2014 10:16 AM Flag

    They want to find out if they can see tumor regression with higher dose. The PFS might also be prolonged.

    Right now, only our suffering with this stock is not regressing, and is only being prolonged. He-he. No love at all.

  • slumdawg2011 by slumdawg2011 Jul 24, 2014 10:08 AM Flag

    Roche is pushing its sales because they make money from combo use with Herceptin. Roche should push for Kadcyla use and increase price by 20%, because it would work better than the Her/Per combo and would still cost less. If Gilead can charge for $1000 for a 10cent tablet, so can Roche if it wants to.

    I've moved to the dark side with my first shorted stock, PBYI. It just moved up too much on unimpressive data. I should have sold IMGN yesterday to be able to short more PBYI.

  • Reply to

    Roche Kadcyla sales

    by slumdawg2011 Jul 24, 2014 1:34 AM
    slumdawg2011 slumdawg2011 Jul 24, 2014 1:51 AM Flag

    Perjeta sales 388MCHF. How could sales of a less effective drug be higher than Kadcyla? Who will initiate a side by side comparison since both drugs are Roche owned?

  • Reply to

    Roche Kadcyla sales

    by slumdawg2011 Jul 24, 2014 1:34 AM
    slumdawg2011 slumdawg2011 Jul 24, 2014 1:35 AM Flag

    How's IMGN royalty structure again for US and ex-US?

  • slumdawg2011 by slumdawg2011 Jul 24, 2014 1:34 AM Flag

    Page 135 of slides with appendix:
    227M CHF for HY14. Is that the total for 1Q and 2Q?
    It was 102MCHF for 1Q. Does that mean sales for 2Q is only 125MCHF? I guess that's till 25% QOQ increase.
    So:
    1Q 102MCHF *1.25 =
    2Q 125MCHF * 1.25 =
    3Q: 157 ?? *1.25 =
    4Q: 197 ??
    = 580MCHF for the year global.
    Japan will probably accelerate next Q and have sales exceed 600MCHF easily = 660 USD. May hit 700M
    20M in sales royalties for 2014 + other approval milestones.
    So, it's looking like at least 1B in 2015.

    How's my fuzzy math?

SGEN
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