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460 patients total in the trial.
I'll say ~300 so far based on enrollment start and expected end.
The signal (the imbalance) should be large enough to justify a review.
Yet another (yet maybe convoluted) argument that points to the conclusion that the tivantinib is active.
Thanks. I had not seen this one.
The signal here is a little bit better but still not so clear. For example, the best PFS HR was in c-met negative(!) subgroup. (granted that n=8 means not much but my point is that c-met may not be the best biomarker for Tivantinib).
The following last sentence raised my eyebrows.
Re: ARQL
Here is a table I found which was not part of the pdf of the article I had. This appendix of the article shows PFS and OS According to MET GCN Status. This supports my thesis that increased MET GCN may not be a such a good biomarker for tivantinib.
http://jco.ascopubs.org/content/29/24/3307/T6.expansion.html
To confuse things further, the authors say that [based on the data presented in this table and ...]
I also would be very interested to hear about the possible reasons why EXEL did not yet announce the price of the offering. I am sure such a delay has happened to another co in the past. Thanks.
In my opinion, the most important lesson we should learn (but we wont, again) is that we need to tweak the current IP laws if we want the private sector to solve difficult problems like AD.
The issue is we dont know much about AD. We say that understanding AD is very valuable, we may even assign a monetary value to it but we provide no means to protect that knowledge.
With no such protection, companies rather than spending money to extend their/our understanding of the pathophysiology of AD, will continue to spend money in trials with no clear understanding of the underlying pathology as drugs are the only outcome they can protect.
I think it's time to take a look at the current IP laws in the context of AD to avoid repeating the timeline of peptic ulcer disease and helicobacter pylori. This time we may not have a Warren and/or Marshall.
Thurly:
I am a new investor and I am not experienced as most others on this board and probably as much as you are. However, here is how I approach this (and other similar press releases).
As any other public co, PPHM wants my money (as investment). It would have received it if the PR declared that the OS HR is less than a set value (the exact value is not important so I am not going to specify it in this message and avoid the discussion that the co doesnt know what my set value is). So I need to assume that HR did not meet it. In general, I assume a PR about a trial contains the best possible way of looking at a data set. Any missing headline news needs to be assumed false.
Thus, if all 40 patients in the control arm were dead, the co would have said it. So all 40 patients in the control arm are not yet dead.
I know this sounds stupid but this is how I look at this.
Yes. You are right on this as well. However, I also meant the points that iwfal discussed. The co probably read the median from the KM curve which is kosher but does not imply that 50% of the patients are dead as the PR implies.
You are right. I should have said most investors dont truly understand what KM plots are and how they are used/created and not that they know them.
Congrats to PPHM longs for the recent gains.
My issue with the current description of the trial is that it is way more than thousand words but could have been much better described by the following few words "Current OS HR is ...". I am not sure if it was written to mislead the investors or if there is any promise in this data set. For example, the following sentence looks like it is a fair comparison between two arms but it's not.
I had a chat with IR about this.
IR claims that Daiichi Sankyo wanted to be more conservative about the trial design as the data on the percentage of the patients in the MARQUEE trial (patients with nonsquamous histology) expected to have high MET overexpression as well is a little bit soft. That's why the co used a significance level of 0.01. The SPA is for 0.05 as usual. Even though I asked the question in many different ways as I can (and got the same answer), this answer does not satisfy me (why play with alpha rather than power or the effect size?). I dont know if I would trust the co on this one even after the chat.
Also, another question that also came up here on this bb was whether all the patients in the control arm of the second line P2 HCC trial, after the trial results were announced in January 17th, were allowed to crossover to the Tivantinib arm even though they did not have PD at that time. The answer was no.
Same here.
I meant to be able to publish the top-line date in May, the data was probably collected in March and maybe even earlier. It takes ~2m to collect and sift through trial data.
I agree with you on the first sentence.
However, I disagree with the second part. I havent done any DD on PPHM other than following the PRs. However, here are some of the mistakes I found after spending 20-30mins on PPHM.
It seems like mojojojo kills each patient @6m. OS in NSCLC is very asymptotic. Tail can be 10x of the median. e.g., see http://www.egfr.roche.es/TITAN/TITAN_EMCTO_Poster.pdf
It seems like mojojojo assumes that the trial started in June 2010. This site (I found it at PPHM intro page) states the first patient was on 1/31/2011. http://ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=2191
This data set is probably from March and not May.
There is no discussion of censoring. Remember that median is calculated from the KM not when 50% of the patients die.
I can go on.
My point on PPHM vs SNTA was not to promote PPHM but show that the numbers published by SNTA could be deceiving.
I also would like to thank you for figuring out the HR.
It seems like even adenocarcinoma subset was exploratory. They need to reveal the KM of the patients enrolled after they decided to drop the non-adeno patients to make any sense of the HR.
I think the lack of early OS advantage is due to the reverse relationship between the age of the patients and the PFS advantage vs direct relationship between the age of the patients and OS advantage.
For example, the median PFS (placebo) is 5.5m vs 11m for <65 vs >75yrs old patients. (Page 19 of the presentation). In absolute (median) terms Zytiga adds about the same # of months to the PFS for all patients. However, the OS advantage is as expected. Younger patients live longer.
This, I believe, is due to the prostate tumor growth being slow in the older patients.
I believe the OS advantage will kick in and there wont be a discussion whether zytiga provides OS advantage.
Furthermore, crossovers were already happening as Zytiga was available after the chemo. Page 17.
The reason of the differences seen in IRC and Investigator PFS values can be also different from the cited. It can be related to the fact that IRC is done later and thus if mismatches investigator's assessment, the mismatched patients are censored (due to the fact that the investigator might have moved the patient from the trial earlier or later than it should be).
Here is an amazing example that shows how much difference that can make. In the same study, the futility and efficacy boundaries were crossed at the same time based on whether PFS is measured by IRC or investigators.
I agree that OGXI doesnt have much leverage. However, the theory that OGXI secretly does not want its drug tested in NSCLC is a deeper conspiracy theory than mine. I guess I deserved it.
OGXI is presenting at ASCO and will present an update for OGX-427 in mCRPC. Based on the P2 results presented so far, I think the co should take it to P3 ASAP just it's the last opportunity to compare an agent to placebo in the prechemo space. However, the co wants to run another P2 (with abi).
I think early P2 results in bladder cancer is also quite exciting.
COU-AA-302 Data Summary & Perspectives on ZYTIGA® (abiraterone acetate) in chemotherapy-naive patients: Recorded Webcast Update for Analysts and Investors
http://www.investor.jnj.com/common/download/download.cfm?companyid=JNJ&fileid=573498&filekey=d69d9c36-61a7-4fb7-927a-fb7c802f3b31&filename=FINAL%20ZYTIGA%20Webcast%20Update%205-31-2012.pdf
Not that the behavior of the patients in the trial will truly reflect the behavior of the patients in the real world, I was nevertheless surprised to see docexatel usage after abi (Zytiga) to be above 50% even at the interim. (Yet another important input if you are an OGXI investor)