I actually had planned on attending the shareholders meeting this year, but had a pre-emptive change of venue tossed my way by my employer. Typically, I travel extensively during the wildlands fire season, and my call-out this year was much earlier than what is usual. Fair warning to all, we're in for a good one...
I've been on the road for many days, and still haven't found my roost quite yet.
When I do, I'll be back in the MB rotation. No worries.
"The Comet's, especially Comet 2, are recruiting the most refractory population ever evaluated in PC."
This element is key.
When it comes down to the brass tacks of future trial comparatives, the fact that Cabo works when the others will not is what will create the compelling initiative for approval. Hopefully, Cabo's lower dose /more tolerant efficacy will carry the ball into earlier stages of the CRPC treatment algorithm, and the obvious revenue advantages. Dose-protocol corrupted - yet still positive - OS data is better than a kick in the curlies - eh?
Have a great weekend fellers...
If I read you correctly, aren't we further confounding our OS data by continued dose finding, dose reduction, and soft tissue considerations. IOW - stay with a bony mets pop, acknowledge & maintain an aptly efficacious dosage, keep the focus on the biomarker work-ups...perhaps even let them be your guide.
Isn't Mr Market being a bit unreceptive of this heavily pretreated, very sick patient group that actually did pretty derned good - extent of advanced disease taken into consideration?
Are these circumstantially intertwined?
Anyone good at contriving a conspiracy theory?
Look at AVEO's SP today on news that they are releasing "a subset analysis" of TIVO-1 P3 data.
Does this come under the heading of "if you didn't like us yesterday, well take a look at us now..." ??
With abstract submissions deadlines, strict abstract guidelines & all...how do they do this?
Can MMM just pull data off the shelf at will if he's of a mind to..??
How's that work?
Or...you might want to intiate Cabo therapy earlier in the algorithim to pre-empt the fatalistic morbidity of bone mets. Fact is...there are many ways this can play, but Cabo has the major play in a pre-treated population.
All things staying as they are...I don't see a rationale for denial of approval in a refractory setting. At this point in the Cabo evolution...what more can you expect?
Cabo works when the others don't...
Sorry. Considering the refractory patient pops, I like what I see.
All these patients were post-docetaxel...half were post-Abi or post Enzalutamide...
Half were heavily treated w/ existing approved bone targeted therapies, including a single percentile of RA-223. How many halfway-in -the -basket patients do you expect to save? I hate to be this crude, but this is a very sick, heavily pre-treated population we are addressing...and the statistics should bely this fact. For my own part, I'm not taking any action till I hear the presentation. This stock has been overplayed and over-manipulated by the financial community for too long, and it's time to truly pay attention to the science to see where this is going. The fact is that the shorts are departing the trade - slow that it may be - I'd pay attention to those numbers.
I'm still convinced that the shorts want your cheap shares, and will contrive any means to steal them from you...and steal is appropriate word.
If you are to build a case for a conspiratorial concept, take a look at what happened today wrt Tarceva and Roche's CDX. To protect the BP patent rights of currently approved drugs, I begin to fear that future drug approvals may tend to be based upon approved CDX platforms.
Where ya gonna run? Where ya gonna hide?
"You're all a bunch of spineless jellyfish."
"If you don't like what I have to say put me on ignore."
Enabler, you've made a good point wrt the endless FUD.
No need to backstab yer buddies here. We're all waiting on news while the MM graciously holds the short exit door open. MM makes money on all sides of this trade, and we all know it, don't we?
If this does not constitute blatant manipulation, I don't know what does.
Don't fault your MB cohorts. Call the SEC...
Though I know we've been blindsided by this management team before, I still contend that Dr Scher would not be a "first choice" to deliver bad news. I think we're going to see some of the most encouraging data reporting to date.
Call me Mr Optimistic, but I think we're OK here...
The quote below is Dr Pazdur from OncLive today 5/15/13...
"The approval was based on the results of the ALSYMPCA trial, a phase III, double-blind, randomized, multinational study designed to compare radium-223 with a placebo and best standard care in patients with CRPC and at least two bone metastases. According to updated results presented at the 2012 American Society of Clinical Oncology (ASCO) Annual Meeting, radium-223 significantly improved overall survival (OS), with patients in the radium-223 arm of the study experiencing a median OS of 14.9 months compared with 11.3 months in the placebo arm (hazard ratio [HR] = 0.695; 95% CI, 0.581-0.832; P = .00007). Additionally, the time to the first skeletal-related event was a median of 15.6 months in the radium-223 arm of the study, a significant prolongation over the 9.8 months in the placebo arm (HR = 0.658; 95% CI, 0.522-0.830; P = .00037)."
If I understand the way the FDA works, I believe this approval raises the bar for Cabo. I know it's a bit like comparing apples to oranges, but the approval stats quoted above will become a major play in the numbers to beat for future approvals...at least wrt bone mets management. Time'll tell...
Good interview w/ Dr Sledge of Stanford on the Genomic Era, the future of oncology, and overhaul of the clinical trials system. OncLive today 5/15/13.
Sneak peak at ASCO abstracts in about 8 hours. Fingers crossed.
The following abstract caught my attention at this year's ASCO GU, and like so many research projects, it got back-burnered for a bit. The authors' list is what initially caught my attention: these folks are a collaboration of Genentech, The Peter Kuhn lab at Scripps Institute, Epic Sciences (which actualy seems to be a Scripps affiliate - lots of shared personnel), and good ol' Doc De Bono of the Royal Marsden. Unless I'm mistaken, the conclusion may actually reinforce the current findings wrt CTC response to cabo treatment in CRPC.
Abstract Number: 62
Poster Title: Evaluation of PTEN status in circulating tumor cells (CTCs) and matched tumor tissue from patients with castrate-resistant prostate cancer (CRPC).
Authors: Elizabeth Punnoose, Eric Tucker, Dena Marrinucci, Edith Szafer-Glusman, Lukas Amler, Hartmut Koeppen, Premal Patel, Gerhardt Attard, Johann De Bono
Poster Number: D17
You can easily find full copy of this study at the Epic Sciences website.
It wasn't until I actually furthered my research into the tumor suppressor gene PTEN that I was made aware of the known and hypothecated interaction between PTEN and c-MET...and inferred that there may be some under-reported PTEN response that is a factor in Cabo's efficacy. Am I on course here?
I invite any commentary...
If you can find a bigger POS than mining_phd, ignore him too...
Sorry, tool...but it will never be forgotten that you brought CLSN to this MB at $7...
Shared yer hedge w/ us 3 days after an 85% haircut...
That - ol' dog - makes you an absolutely useless tool...
I believe that most of the MMM's EXEL holdings are co-held with his wife in the Morrissey family trust. I wouldn't fault him that tax strategy. If you look, you'll find he's only sold to pay his taxes. Can't fault him that strategy either...
"...and beyond this board almost no body knows about cabo..."
I'd sure enjoy a repeat of the excitement that we saw in the wake of the bone phenom in Nov 2010. It interests me that the medical perception of cabo's onco-utility has grown in so geometric a fashion, the data continues to support the benefit of that effect, and yet so little recognition of the potential.
Whatever politics control EXEL - they appear strengthy, well-strategized, and solidly orchestrated. I can't escape the feeling that we are awaiting key patent expirations on competitive bone-tageting agents... the date of which triggers some nefarious plot of BP intrigue.
No...I didn't say we were being manipulated. I said we were being strangled...
I agree, the CDX technologies are evolving quickly.
Every bit as promising s CTC prognostic technology is the research being conducted on circulating exosomes, or cMV's (circulating Micro Vesicles). I'm not yet as familiar with the research platforms, but there are a couple trials being initiated as I write.
I believe it's worth some familiarization as well...real cutting edge stuff.
medwire news May 6, 2013 by Kirsty Oswald
Baseline CTC count had significant ability to discriminate between poor and good survival, was greatest in patients with bone metastases, and also correlated significantly with Gleason scores. However, in contrast to some previous findings, it only had a weak relationship with prostate-specific androgen (PSA) levels.
"Collectively, these data reinforce the idea that the PSA level alone is not of sufficient prognostic value and must be considered in conjunction with additional biomarkers," say Robert Amato (University of Texas, Houston, USA) and colleagues.
The study included 202 patients with prostate cancer, of whom 164 (81%) had received previous localized treatment for prostate cancer. Overall, 40 (20%) patients had bone-only metastases, 15 (7%) had lymph node-only metastases, and 24 (12%) had bone and lymph node metastases.
Among patients with CTC counts over 100/7.5 mL blood (n=7), the median overall survival was 70.7 months, while survival among patients with 5-100 CTCs/7.5 mL (n=21), and fewer than five CTCs/7.5 mL (n=18) was significantly greater at a median 73.3 and 78.5 months, respectively. Among patients with undetectable CTC counts (n=46), the median overall survival was not reached during follow up.
Additionally, the authors found that patients with bone-only metastases or bone and lymph node metastases had greater CTC numbers than those with lymph node-only metastases (mean 41.1 and 57.0 vs 2.5 cells/7.5 mL).
"I imagine that if the FDA approved Cabo, it could mean that there wasn't a clearly worse trend in OS for MTC. On the other hand, when the EXAM trial started, it was granted Orphan status presumably because Vandetanib wasn't approved yet. "
Agreed. Ernie made a comment recently wrt "bringing something "new" to the party"...and in addition to it's novel MOA, Cabo brings bone scan resolution and pain reief. These create a very favorable approval climate even if OS improvement is minimal, doesn't it? Makes me wonder if cabo had gotten approval prior to Vandy...if vandetanib would've gotten approved in it's wake.
Cabo's apparent "ace-in-the-hole" seems to be efficacy in pre-treated pops, and it's approval in the wake of prior vandy treatment was undoubtedly a factor as well.
"...I thought they did with the phase 2. Any thought/concerns about this?"
I think it should be a concern for anyone that invests in biotech, though it sometimes seems so unfair to the patient pops... FYI, the EXAM P3 MTC Cabo trial has no provision for crossover, and it should report on OS later this year or next. In the case of the CRPC cohort of the P2 RDT that will update at next month's ASCO (including OS data), this trial's randomization was halted on advisement of the DMC for efficacy, and placebo patients were offered Cabo...the humane thing to do w/ obvious benefit, right...??
We'll see...fingers crossed. BTW - I bought AVEO on the breakdown - a small position. I feel Tivo still has a shot. I honestly thought the PFS data would equate favorably for OS.