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admin | Category: Ed Treatment For Migraine | 15.12.2015
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Application of Survival Data Analysis- Introduction and Discussion (?????????- ?????), will give an overview of survival data analysis, including parametric and non-parametric approaches and proportional hazard model, providing a real life example of survival data-based field return analysis. Nearly four out of five children survive 10 years after a heart transplant at Freeman Hospital, compared with less than three children out of five, on average, in the rest of the world. Almost half of patients who have a double lung transplant at Freeman Hospital survive 10 years, compared with a third of patients on average in the rest of the world. Similarly, in patients who receive a lung transplant for cystic fibrosis, over half will survive for over 10 years at Freeman Hospital compared with a third of patients in the rest of the world.
Yesterday at the ECC meeting, BMS (BMY) and Exelixis (EXEL) presented data for their respective drugs ,Opdivo (nivolumab or nivo) and cabozantinib (cabo) in renal cancer (RCC).
Overall survival – Opdivo improves overall survival and cabo is very likely to do so as the data mature. Cabo improved PFS whereas Opdivo did not but given the strong survival benefit for both drugs, the relevance of PFS is unclear.
Safety and tolerability is going to be a major topic going forward, as the two agents have very distinguished profiles. Surprisingly, treatment-related discontinuation appears only slightly more common with cabo than with Opdivo. As can be seen in the summary table below, the two drugs are quite similar in terms of most clinical endpoints (survival, response rate, treatment discontinuation). If this is the case BMS should take out exel so they can control both 2nd and 3rd line rcc…sort of a one stop shop and then they can position them accordingly with a linear message to where it will be clear opdivo is 2nd and cabo is 3rd.
From the cc, Choueri specifically said that they reported all events regardless of whether it was treatment related and that the nivolumab trial reported only treatment related AE’s. I don’t think there is a consensus regarding 3rd line treatment as patients go through a mix of VEGFR and mTOR inhibitors. Wildbiftek (EXEL) – Correct but if you normalize AEs to the respective Afinitor arms it is clear Opdivo is better tolerated at least initially. Expounding on Eric’s thoughts, it seems to me that with Opdivo having such a high % of PR patients it means those 35% that have no response will immediately get moved over to Cobi. I also liked how excited Toni was about how well the sub set of patients did who had only had Sunitineb as their prior therapy. Bill13 (EXEL) – I agree there will be a significant group of patients who will show progression rather quickly on Opdivo and will look for the next treatment option. The PFS in Sutent failures is encouraging but it’s a subset analysis that I am not sure about its validity. Always better to have an independently reviewed response rates but in this case it’s a secondary issue. A further normalization to consider is the OS KM curve for both Checkmate 025 and METEOR of the everolimus arm. CABOSUN will give some clarity on this issue, and things look promising for Cabo as even post sunitinib it gives a 9.1 month PFS which are comparable firstline numbers. Wildbiftek (EXEL) – We need to be very careful when comparing the two Afinitor curves from METEOR and Checkmate-25, especially given the excessive censoring in METEOR. I don’t thinkoncologists need to see a head to head comparison with VEGFR inhibitor after such a strong performance vs. Positive CABOSUN data could be a positive but I don’t view it as a pre-requisite for widespread 3rd line adoption. Luis (ARQL) – The drug is active and looks better than other Akt inhibitors but it is still unclear whether the drug has a path forward as monotherapy.
Dave – I still intend to limit my exposure to biotech and selectively invest in stocks with significant near-term catalysts.
Alex (MRNS) – I agree it is cheap, the only question what level of exposure makes sense here as the stock is very high risk. What do you think about VSTM (much more cash than valuation right now) and QURE at current valuation?
Chris (BLCM) – I like their technology very much and believe they have a truly differentiated technology. QURE – I really liked the Sanfilippo B data but price is too high given development stage.
What do you think of PTLA, it has two drugs in phase 3, one is receive BTD and orphan drug. Looks like everyone is waiting for the European partnership to be announced by ARRY…do you see this has major catalyst ? I am probably the first of many who would like to hear your thoughts on EXEL’s P-III cobimetinib melanoma overall survival news this morning. MTRX reported recently good data in NSCLC patient with AXL gene amplification with a single agent.


Chris (ESPR) – Yes I plan to add more at the next portfolio update (hopefully this or next sunday). Am I missing something as you had purchased the stock at a avg of 37 per share.Doesnt seem like much of a premium if a buyout was to occur. Since then a major sell off after the June 29 announcement of no early P-III termination grant by regulators, followed by the general sell off. EXEL When do you anticipate the combo study with PDL1 to read out, and do you think they will wait until the results of this are out before doing a JV ? James – This is a good idea in principle but there are very few pure play immuno-oncology stocks. They just started Phase 2 with INCY – LADD+IDO1 vs LADD vs IDO1 in Platinum-resistant Ovarian Cancer.
I wonder if you could comment on CYAD, and especially their p3 cardio study is due in 2016… the company valuation seems low compared to peers.
Although many programs have their own input-file specification, data files can still be exchanged between most programs (black arrows), avoiding tedious reformatting processes. You’ve probably heard the oft quoted statistic that half of all businesses are gone within five years.
To show you how much difference industry sector makes, I have plotted the five year survival curves for the 2000 cohort (the most recent available) of start-up establishments using data from the Longitudinal Business Database of the U.S. I have loaded a larger chart — click the existing chart and it will load in a larger size in a new window. Through our work with start-ups, we also find that about one half survive beyond the five year mark. I also have found if you answer four key questions before you launch your odds of success increase exponentially.
Founded in 2003, Small Business Trends is an award-winning online publication for small business owners, entrepreneurs and the people who interact with them. Together with hundreds of expert contributors, Small Business Trends brings you the news, advice and resources you need. I'm looking for a rather large survival knife, something with a blade around 11-12 inches and weighs in at around the 17 ounce mark, with a wide blade.
Whtever suits you,I always carry my gear on me,but if you keep your gear in sight is no problem. You can find these knives cheaper on ebay, I just googled the knife and this was the first link I came to.I also think this is one of the best large survival knives you will find, for both performance and price. If you continue to use our site, we'll assume that you are happy to receive cookies from our site. Before delving into the inevitable comparison, it is important to note that cross-trial comparisons are tricky and it’s impossible to definitively say which drug is better without a direct comparison in the same study. As I previously discussed, PFS has been regarded as the basis for approving most RCC drugs to date as it was viewed as a surrogate endpoint for overall survival. The way the studies reported adverse events makes it challenging to compare the two agents but it is clear that cabo has more tolerability issues. This is explained by physicians’ ability to reduce or interrupt dosing while keeping patients on the drug. At the end of the day, Opdivo is better positioned because it has a confirmed survival benefit (based on a more mature data set) whereas cabozantinib has a strong survival trend with a better hazard ratio that requires validation. Choueiri, the principal investigator of the METEOR trial, pointed towards the very low percentrage of primary refractory patients in METEOR (14%) as compared to CHECKMATE 025 (35%). I was bothered by the high number of grade 5 events in METEOR until I heard this and they had a slide which reported just one g5 AE that may be cabo treatment related. That plus it’s higher HR I read as if Opdivo works for a patient it will work very well and if not the benefit is not that pronounced. This is when he mentions that the ORR was independently verified with the Meteor trial and only by the investigator in the Checkmate trial.
An acquisition is the only meaningful catalyst in the foreseeable future (initiation of P3 is another catalyst but not a big value creation event).
Note that sense there is a seperation between PFS and OS, Opdivo may still be benefcial even in non-responders. Everolimus is just a foot in the door and that the real comparison will be versus the other VEGFR TKIs which are already approved in this indication (sunitinib, sorafenib, axitinib, pazopanib) or coming up (lenvatinib).
Optimally I find them quite similar (at least up to 9 months where there is less censoring) but we’ll have to wait. The NRAS melanoma and BRAF CRC combo data have activity and may be differentiated but the true benefit is still unclear (a lot of unconfirmed responses). I really liked the responses in tumors with AKT1 mutation but the expansion cohort included only 2 such patients (both responded). Exelixis was discussing monetizing ex-US rights, do you see a 50-50 split in the revenues for US vs ex-US?


Market seems to be pricing in a 5 yr CVOT requirement prior to approval – which is still likely not the case.
Nothing changed fundamentally, the advantages and risks are the same as they were 2 months ago.
There are no selective AXL inhibitors in clinical development (but there may be soon) so this could be a more attractive opportunity but market opportunity is unclear. It is hard to predict but on paper rociletinib may lead to a lower incidence of ILD, which may be related to EGFR WT inhibition (seen also with Tarceva). Do you plan adding now that CETP inhibitors are of the table and ESPR makes an attractive buyout candidate? I think that if AMGN bought Dezima for $300M knowing it would have to do outcome studies before approval, a first in class P3 agent should be worth 2-3 times at minimum.
I would assume it is better to sell after the next catalyst and before Tivantinib resutls come out. It will be important to validate initial signals the company observed in order to increase visibility. Do you think, when the drugs are comparable, the valuation for Genfit ($884m) is reasonable?
By using this website, you consent to our use of cookies in accordance with the terms of this policy. While the number is true, it’s an average of what happens to start-ups in all industries, from biotechnology firms to dental offices to taxi services. Given what’s happened in the economy in the past couple of years, the odds that finance, insurance and real estate businesses started in 2008 and 2009 make it to their fifth birthday might be very different from the numbers shown in the figure. Malachi Mixon III, Professor of Entrepreneurial Studies at Case Western Reserve University. Not figured it out yet, but I think I'll be leaving it in the pack and carry the small stainless gerber on my belt as we'll be fishing most of the time.
Compared to Afinitor, cabo had led to a higher incidence of most toxicities (GI, appetite, Palmar-Plantar, hypertension etc.). Although dose reductions occurred in 60% of patients who got cabo, only 9% discontinued, demonstrating that with a daily oral pill it is possible to find an optimal dose without stopping treatment. Hopefully, cabozantinib will be the second agent to have a survival benefit in its label with more follow up. Opdivo has a superior safety profile even though cabozantinib-related toxicities can be managed with dose reductions that minimize discontinuations. He suggested that doctors and their patients may prefer cabo as it seems to control disease in 86% of patients (as measured after three months of therapy).
In the context of PD-1, renal cancer is not considered a huge opportunity but it’s still significant (~$1B for a successful drug).
It will take time and a lot of data to bring cabo to P1 (including a dosing regimen to minimize side effects imo).
All of these will likely slot after a Nivolumab + Ipilimumab combo and might either be given in combination with or followed by everolimus. Concerns about outcome studies are overblown in my opinion, even if the FDA will require outcome studies for approval (required anyway) ESPR is a very attractive acquisition candidate.
Do you think the increased short interest is a sign of manipulation to put more pressure on management to do a partnership or just correlated to increase short interest in the IBB index. Tivantinib should have a first interim analysis next year (should announce completion of enrollment before).
Blue ellipses represent multi-purpose packages, whereas individual-centred programs are shown in violet. This is also clear from the survival curves which already start to separate after 4 months (see below).
In contrast, Opdivo had a lower incidence of adverse events almost across the board compared to Afinitor. Lastly, Opdivo has the advantage of being branded as “immunotherapy” whereas cabozantinib belongs to an old class of drugs (kinase inhibitors) with many approved drugs.
Assuming that nivo and cabo have similar overall survival numbers do you think this is a valid argument?
Given the strong signal, cabozantinib has a high likelihood of demonstrating a statistically significant survival benefit at the next analysis (expected in 2016). Going forward both agents may be used in combination although previous experience with Opdivo and other kinase inhibitors revealed a problematic safety profile. Specialized programs are shown in green, and light grey ellipses represent programs that are not reviewed here, but the data formats of which are used by other programs allowing indirect data exchange (white arrows).



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