FWIW - I just pulled this excerpt out of the Exelixis PR:
"Roche has submitted a Marketing Authorization Application (MAA) to the European Medicines Agency, and Genentech plans to submit a New Drug Application (NDA) to the U.S. Food and Drug Administration later this year."
The EMA MAA clock is ticking... More good news...
When I accessed the PRs, the abstracts were as yet unavailable. I see you are correct, the HR values are superior for V+C...and the lower "p" values with the same CI appear statsig. Good job, Dawg...
To me, the data appears very comparable - D+T vs V+C - with perhaps a slight advantage in risk of progression going to the Roche combo. Nonetheless, it's very close - and patient tolerability may become the optimum defining factor.
"Commenting on the results from these two studies, Dr Reinhard Dummer, from the University of Zurich Hospital, ESMO Faculty Coordinator for melanoma, says: “While monotherapy with a BRAF inhibitor is currently considered as a standard of care for patients with BRAF mutated advanced melanoma, the data from these two trials, along with trial data presented earlier this year, provide convincing evidence that combination therapy with either dabrafenib and trametinib, or vemurafenib and cobimetinib will be the standard systemic therapy for this patient population.”
I'd say we've got approvable data. We'll hafta see if Mr Markets' expectations have been met.
Good luck all...
"The ongoing CoBRIM study enrolled 495 treatment-naive patients with BRAFV600-mutation-positive unresectable locally advanced or metastatic melanoma. Patients were randomised to received a 28-day treatment cycle of vemurafenib (960 mg, twice daily), and either cobimetinib or placebo (60 mg daily from days 1-21), with a primary end-point of progression-free survival.
Patients in the combination arm of the study showed a significantly improved median progression-free survival of 9.9 months, compared to 6.2 months in the placebo arm, and a 49% reduction in the risk of progression. Researchers observed a response rate of 68% in the combination arm and 45% in the control arm, including a complete response in 10% of patients treated with combination therapy compared to 4% of patients treated with vemurafenib alone."
"Roche Gets Nearly 80% of InterMune Stock in Tender Offer"
Check out the status of Klee Acquisition Corporation, the wholly-owned Roche subsidiary utilized as a strategic takeover tool. Slicker'n boiled owl snot on a glass door #$%$...
Washington Post 9/27/14...Steven Pearlstein....sound at all familiar? Good read w/ Feuerstein implications...
"The shorts’ tactics, however, extend well beyond the trading room. As the nonprofit advocacy group Citizens for Responsibility and Ethics in Washington (CREW) lays out in a recent white paper, shorts are active in anonymously feeding false and misleading information about their target companies to friendly analysts and bloggers while using social media to attack the intelligence and motives of those who view the company favorably. They enlist plaintiffs law firms to issue press releases soliciting shareholders to sue the target companies for securities fraud. And they pepper regulators with threatening letters and fillings demanding that they investigate their targets or deny them product approvals."
OT- There's an interesting editorial that was posted as a JCO early release in the past weeks, and it is amply titled: "Success is not forever, and failure is not final"
Thumbs down? Guess you couldn't find it,eh? Here's an excerpt for your reading pleasure...
"Monday 16.00 – 17.20, Madrid) is dedicated to research in this tumour type. Three late- breaking abstracts of data from phase III trials, and with practice-changing potential, will be presented. Prof Jeffrey Weber from the H. Lee Moffitt Cancer Cener Research Institute, Tampa, FL, USA will present results investigating the immune checkpoint inhibitor antibody, nivolumab, in patients with previously treated advanced melanoma, including those with ipilimumab-refractory disease (LBA3_PR). Particularly exciting, I think, will be results from two studies comparing the use of first- line combined MEK and BRAF inhibition with BRAF inhibition alone in patients with tumours harbouring the BRAFV600E mutation. Results will be presented from two studies: one, from Dr Grant McArthur from the Peter MacCallum Cancer Centre, East Melbourne, VIC, Australia investigating the addition of cobimetinib to vemurafenib (LBA5_PR); and the other, reported by Dr Caroline Robert from the Institut Gustave Roussy, Villejuif, France comparing dabrafenib plus trametinib with vemurafenib (LBA4_PR)."
Let me begin by saying that I never met a PhD or a doctoral candidate that would waste their time on a YMB belittling others in an attempt to gain self-esteem. Next time I seek an informed opinion, I'd give wide berth to the nitwitted demetriusczech.
That said, Tinker, here's my take on nivolumab...and here's how I'm following it's progress. The Checkmate - 037 trial population was stratified not only by prior therapies, but also by PDL-1 expression. We should hear more on that at ESMO. The recent approval of Opdivo in Japan in unresectable melanoma is worth watching. Ono is committed to post-marketing data collection to confirm broad spectrum efficacy. The Japan approval is further reaching (includes front line) than the Intended FDA and there may be further data made available.
I wouldn't use the broad stroke of including "any PD-1 treatment" in future combination results with Cobi. It won't work that way from a regulatory standpoint. Each combination will be reviewed on its own merit, and no two PD inhibitors will be considered to be the same. EP Vantage has a good, free breakdown on the pending ESMO combo reviews...epvantagedotcom.
JMO, and I encourage you to develop your own & not take anyone on this MB too seriously...particularly those who would compel you to change your investment thesis to suit their need to feel important. What a crock...
From Targetedonc today 9/27/14...Silas Inman
"The application for nivolumab was based on phase III data from the CheckMate-037 trial that compared the PD-1 inhibitor with dacarbazine or carboplatin/paclitaxel in previously treated patients with unresectable or metastatic melanoma. Patients in this study could have received prior treatment with ipilimumab (Yervoy) or a BRAF inhibitor. Results from this study will be presented at the 2014 ESMO Congress on September 29, 2014."
That's about the silliest thing I've heard in a while, but good luck with your investment.
"I would like to know where you got that quote."
I've said it before - so intent on attacking me - you remain clueless.
Drown in your puddle of ignorance, fool.
"...but it sure sounded promising."
It is promising. Under the NCCN compendium guidelines dated 3/2014, cabozantinib has a listing in RET fusion NSCLC that gives payors a pathway to consider insurance coverage. I believe it is a C2a listing.
"What about the other presentations"
I'd look for PRs from the sources. BMS for nivolumab, GSK/Novartis for D&T, Roche for V&C. Exelixis might put out there own, but they are playing a tight PR game. To the best of my knowledge, they never even issued a PR for the Debbie Burke promotion.
One of the most important aspects of the Vemurafenib/ cobimetinib combination to me is simply this: There are currently some 90 clinical trials involving Vemurafenib in a variety of combination and cancer settings. Cobi is the only drug (to my awareness) that has leant enough promise to move directly from P1 to P3, skipping P2. This inspires confidence. Given that Cobi has shown to successfully mitigate paradoxical MAPK activation in melanoma, should this condition also present in additional indications, the V/C doublet will be the likely first choice for future BRAFi therapy need. Time'll tell, but IMO the V&C doublet could easily find its way into many additional treatment settings outside of melanoma.
"...any chance of listening to the presentations...?"
I suspect they'll become available following the conference, and YouTube or oncologyTV would be good guesses for googling. Madrid is on CEST - a full 9 hours ahead of me on PDST - so I expect there'll be an early Monday morning (likely premarket) PR with the presentation highlights.
I'm hopeful for some productive discussion on the results. Nivolumab will be the entry level player in the mix, and I expect some good results. It will take some time, poring over all 3 presentations, to gather any sense of how the treatment sequencing might be perceived by Mr Market. I anticipate good results from CoBRIM, but will they be good enough to guarantee durable commercial success in advanced melanoma? Unanswerable at this time...GL
"Let's back up because..."
Your self-proclaimed alter ego "Offsitehelp" has endlessly referred to Cobi as Voodoo therapy without value. Now own up or be the frick gone, loser boy....you can't own up to multiple aliases and not own up every piece of junk that y'all spout. Pack of frickin dipshizzles...
There aren't any...why not?
Look at biotechs that have run the same course as EXEL in terms of PPS...
There are litigations up the Royal Bazoo - law firms seeking lead clients...
Something quite extraordinary is taking place here, and legal counsel is not being sought.
Hasn't even yet been suggested on this YMB, where folks really oughta be free to vent...
Why? What is about to happen here? Is semanresu's head gonna explode...?
"...there is now compelling evidence in preclinical models that cabozantinib has direct anti tumor, which reintroduces theossibility that some portion of the bone scan resolution OS attributable to prostate cancer ablation."
I found it interesting that a coauthor of this study was Dr Charles Sawyers. This lends a credibility to the prospect of a future presentation on this topic as a veritable world-class PR event. Earlier publications by JS DeBono have suggested tumor-specific necrosis, and the Dave Smith UM trial has given us a positive aspect on the Cabo effect within the trabecular environ. Tying these implications to adjunct studies of bone remodeling, bone biomarker effects, and bone mets prevention should be given the highest priority IMO. I have to admit, this article shocked me at first, the positivity of it is taking some time to fully assimilate.
Something potentially remarkable is being witnessed at the molecular level, and the science is struggling to grasp it's significance.