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Inergy, L.P. Message Board

wilderguide 358 posts  |  Last Activity: 22 minutes ago Member since: Jan 13, 2011
  • Reply to

    my concern is

    by drscottpalmer 53 minutes ago
    wilderguide wilderguide 22 minutes ago Flag

    $$$$
    Roche is well-equipped to handle cobimetinib marketing, and I'm actually expecting an EMA-MAA application filing concurrent with ESMO congress closing ceremonies. I also expect there will be delays in reconfiguring the treatment algorithm to accommodate the latest label expansions and drug approvals in advanced mM. At the least, there is comfort in knowing - going into ESMO - that CoBRIM has met its primary endpoint of statsig PFS. Despite the recent gloomcasting, I feel pretty good about the V&C data inclusion in the Presidential Symposium...

  • Reply to

    Well I am holding.

    by conradfinklestein 5 hours ago
    wilderguide wilderguide 3 hours ago Flag

    $$$$
    "Do you really think it's over for Cabo in prostate cancer?"
    What I think you are really asking is this:
    "Isn't it possible that the FDA will consider the 'clinically meaningful outcome' potentials of cabozantinib to enable it's approval in CRPC?" My answer to that is "not soon enough to suit me"...
    Best hope lies in gathering a substantive filing platform of data based upon pain relief, hrQOL's, and measurable therapeutic benefit. I expect it'll prove to be a controversial filing, but I fully expect them to attempt such a filing whenever the regulatory politics appear most receptive. Keep in mind - biomarker sciences are evolving quickly.
    Labeling limitations proscribing modest (if any) OS benefit and biometrically-defined subset patient groups that might be best suited to benefit from Cabo will impede commercial valuation, and payors may simply elect not to pay without proof of OS.
    Nonetheless, I expect that for those willing to look, we'll see continued OL prescription just because some patients can afford it, and - as snowflake has mentioned - they'll find a doc willing to prescribe it. Without so much as a compendium listing, it'll remain a controversial treatment choice until some treatment comes along to replace it.

  • Reply to

    Well I am holding.

    by conradfinklestein 5 hours ago
    wilderguide wilderguide 5 hours ago Flag

    $$$$
    P2 NRE BSLA endpoint epublished ahead of print 9/15/14 Smith, et al
    "CONCLUSION:
    The evidence suggests that cabozantinib has clinically meaningful activity in CRPC. Cabozantinib resulted in improvements in bone scans, pain, analgesic use, measurable soft tissue disease, circulating tumor cells, and bone biomarkers. Taken together, these phase II observations warrant further development of cabozantinib in prostate cancer."

  • wilderguide wilderguide 18 hours ago Flag

    $$$$
    "You, of course, the great money manager and Biotech analyst who must resort to insults when the facts don't fit the Kool-Aid Agenda..."
    ...and to "You, of course, the great money manager and Biotech analyst who must resort to an endless array of aliases when the facts don't fit the nickel-per-post Agenda."
    Yer a frickin phony, hiding behind a pile of phony misinformation, lies, and deceit.

  • wilderguide wilderguide 18 hours ago Flag

    $$$$
    But let's try this out anyway...
    Keep in mind, I'm not suggesting any measure of positivity here...
    Just letting the MB know that EXAM has been updated as of 8/29/14...
    Some interesting results are posted. That's right - P3 study results. Go figure...
    Probly gonna need ol socialindignities to finger out what all them silly numbers mean...cuz they's sure a whole lotta them silly boogers...

  • wilderguide wilderguide 18 hours ago Flag

    $$$$
    "Can you do that?"
    Not without sounding just like another of your useless alias brethren...

  • wilderguide wilderguide 21 hours ago Flag

    $$$$
    Ok, cya downstream...
    JMO, but I think you are premature.
    I'll keep future positive results off the MB...
    ...and limit my posits to misguided rumor, mindless conjecture, and purposeless innuendo.
    Just for you, I'll not quote any positive sources here again...
    Regardless of credentials, academic affiliations, or medical prestige...
    Be good...

  • wilderguide wilderguide 23 hours ago Flag

    $$$$
    "As you can probably see from the spirit of his posts..."
    This dipshizzle has inundated this MB with multiple personalities...
    I give him at least 8 aliases, including the one I am assigning him now - the Schizoid Express...
    Another post, another nickel...

  • Reply to

    Semanresu thinks he invented the 10 foot pole

    by wilderguide Sep 16, 2014 5:41 PM
    wilderguide wilderguide 23 hours ago Flag

    $$$$
    "Reported for abuse"
    I'm torn...
    Which is larger...yer IQ or yer shoe size?

  • wilderguide wilderguide Sep 16, 2014 6:14 PM Flag

    $$$$
    Social = semanresu = milkman = offsite = nomad = dipshizzles fly free...
    Why can't we...??

  • wilderguide wilderguide Sep 16, 2014 6:04 PM Flag

    $$$$
    Cobimetinib has yet to receive approval anywhere, in any indication.

  • wilderguide wilderguide Sep 16, 2014 5:56 PM Flag

    $$$$
    I believe the CoBRIM P3 poster presentation will be web-available concurrent with the oral presentation on the 29th. There are also a couple of Cabo poster presentations that have been accepted. I don't expect anything to shake it up. I think one is a Dr Andrea Apolo GU poster - probably bladder ca. She's worked with Cabo for quite some time, and her NIH inferences are worth following. In addition, she's pretty easy on the eyes...
    If Cobi is well-received at ESMO, I expect an update on the Roche/EXEL partnership...

  • $$$$
    A thumb's up to this post will tell him where he should put that long, wide pole.
    GLTA

  • wilderguide wilderguide Sep 16, 2014 5:00 PM Flag

    $$$$
    "No Whammies!"
    Another frickin waste of air...

  • wilderguide wilderguide Sep 16, 2014 4:59 PM Flag

    $$$$
    CoBRIM has met its primary endpoint of statsig PFS, and will present 9/29/14 at ESMO.
    OS survival data will likely be immature, but I'd expect a small preview based upon KM projections.
    If you listen to Social, yer doomed to a lifetime of misinformation.

  • wilderguide wilderguide Sep 16, 2014 4:55 PM Flag

    $$$$
    "The sooner you all snap out of it, the better off you all will be."
    We gotta be close to a bottom here if yer gonna pull that "good cop - bad cop" stuff...
    What's next? Yer other alter egos are gonna threaten to horsewhip us if we don't do as we're told?
    Yer a frickin waste of air...

  • Reply to

    RCC

    by csanderson1805 Sep 16, 2014 1:47 PM
    wilderguide wilderguide Sep 16, 2014 4:06 PM Flag

    $$$$
    For continuity sake, here're the basics of METEOR design from the May '13 PR:
    "METEOR is an open-label trial of cabozantinib in patients with mRCC that is being conducted at up to 200 sites in up to 26 countries. The trial is expected to enroll 650 patients with clear cell RCC who have received and progressed on at least one VEGFR-TKI. Patient enrollment will be weighted toward Western Europe, North America, and Australia, and patients will be stratified based on the number of prior VEGFR-TKI therapies received and commonly applied RCC risk criteria developed by Motzer et al. Patients will be randomized 1:1 to receive 60 mg of cabozantinib daily or 10 mg of everolimus daily. No cross-over is allowed between the study arms.
    The primary endpoint is progression-free survival (PFS) and the secondary endpoint is overall survival (OS). Exploratory endpoints include patient-reported outcomes, biomarkers, safety, and pharmacokinetics. PFS is an established acceptable endpoint for RCC clinical trials and has been used to support approval of sorafenib, sunitinib, everolimus, axitinib, and pazopanib in this indication.
    Based on available clinical trial data, the primary endpoint assumes a median PFS of 5 months for the everolimus arm and 7.5 months for cabozantinib arm. This provides for a hazard ratio (HR) of 0.67 and 90% power and requires 259 PFS events among the first 375 patients randomized. The secondary endpoint assumes a median OS of 15 months for the everolimus arm and 20 months for the cabozantinib arm. This provides for a HR of 0.75 and 80% power and requires 413 events."

  • Reply to

    RCC

    by csanderson1805 Sep 16, 2014 1:47 PM
    wilderguide wilderguide Sep 16, 2014 3:28 PM Flag

    $$$$
    "Is there anything in that data that could sway regulators?"
    This is the question that will carry us to year's end, and there is no simple answer. There is great potential for Comet-2 to deliver compelling pain response data, which - though an approvable endpoint...may not be an affordable endpoint - given the comparably cheap affordability of palliative opioid meds. I would take it at face value that the decision to close Comet-2 recruiting mirrors the lack of confidence EXEL management has in a successful sNDA regulatory filing at this time. If push comes to shove, and Comet-2 delivers statsig pain data and enough supportive hrQOL benefit data to constitute a filing, I expect it to be a hugely controversial issue - loaded with argument from every quarter of the industry.
    On the less conspicuous upside, I expect to see a future filing with the NCCN for off-label salvage Cabo prescription in CRPC, but such a filing necessarily comes with the downside of negated marketing value in that indication.

  • Reply to

    RCC

    by csanderson1805 Sep 16, 2014 1:47 PM
    wilderguide wilderguide Sep 16, 2014 2:41 PM Flag

    $$$$
    "...does the pod cast content infer any difficulty for the METEOR...?"
    No. Different disease, different patient group, with much different pretreatment regimens. Each cancer indication must be considered based upon its own merits, and cross-referencing trial data -especially between indications- should be avoided. Here's the ASCO 2012 data mostly responsible for METEOR design:
    "Tumor Regression. Objective evidence of tumor regression was observed in 19 of 21 patients (90%) with ≥1 post-baseline assessment. Best overall response was determined per RECIST criteria with 7 of 25 patients (28%) showing a confirmed partial response (PR). Importantly, PRs were observed in heavily pretreated patients, including 3 patients with 2-4 prior systemic therapies, and 2 patients with 4 prior systemic therapies. Thirteen additional patients (52%) had stable disease (SD) as their best response, and only a single patient (4%) demonstrated evidence of primary refractoriness to cabozantinib with a best overall response of progressive disease. The rate of disease control (PR + SD) at week 16 for all 25 patients is 72%.
    Progression-Free Survival, Overall Survival, and Treatment Duration. Kaplan Meier estimate of median progression-free survival (PFS) is 14.7 months (95% CI, lower limit 7.3 months – upper limit not reached). Median overall survival (OS) has not yet been reached after median follow-up of 14.7 months. The estimated 1-year survival rate is 60%. Seven patients remain on study and progression free with treatment durations ranging up to 21.8+ months."
    In CRPC, Cabo displays dramatic efficacy (and perhaps incomparable) in the wake of prior treatment with docetaxel and AR modification in a very difficult to treat population. In mRCC, Cabo displays dramatic efficacy in the wake of prior treatment with up to 3 lines of therapy, including sorafenib, sunitinib, and everolimus - essentially, another salvage group with extremely limited treatment options. Statsig PFS looks doable.

  • Reply to

    JCO Early Release podcast

    by wilderguide Sep 15, 2014 6:27 PM
    wilderguide wilderguide Sep 15, 2014 7:23 PM Flag

    $$$$
    Of course I am paraphrasing here, but the brunt of the Antonarakis commentary is this:
    Despite cabozantinib's compelling and apparently beneficial impact on the bone micro-environment in mCRPC, the therapeutic window is likely too narrow to display a measurable impact on survival in this patient population. Follow-up has shown 4 months DOR in both 100mg and 40mg cohorts.
    You really need to find a venue to download it and listen to it in it's entirety. It's approx 9 minutes long, and I can't do it justice other than to convey that IMO it is not favorable news, though it's impact on palliative therapy (re:Comet-2) remains to be seen.

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