You can download the full data sheet from the threshold site, then click on clinical pipeline, then evofosfamide, then pancreatic caner, then click on the view presentation on the third paragraph.
You will clearly see that Abraxane was used along with 10 other treatment after the trial was over.
Great posts btw! thanks.
also to note: In the multivariate analysis, younger patients with a poor performance status had a significantly shorter overall survival compared to those with a good performance status (P=0.008). However, no significant prognostic factor affecting the outcome was identified in the elderly patients. In conclusion, patient age is a major prognostic factor affecting the survival of patients with metastatic pancreatic cancer and elderly patients without poor prognostic factors may be eligible for the available treatment options.
They stratified the age group to either 60 years old or older, or 59 and younger. In this study, ECOG played no role if above 60 years old. At least that is going for us. On the younger age, it did play a signficant role.
just doing some DD here and there.
quote from NCBI, US Pubmed.gov.
The performance status of a patient is the major prognostic factor predicting overall survival for all stages of pancreatic cancer. Severe weight loss, large tumor, and metastatic disease were found to be unfavorable prognostic factors in patients with poor performance status.
doesn't bold well for our Phase 3 trial .. however looking at this article above, ECOG of 2-4 were compared with ECOG of 0-1. so it won't be as bad. In any case pancreatic cancer is bad and progressive very fast.
to note, the crossever to TH-302 arm on the 340 arm was fantastic 13 months if my memory serves correct.
so bottom line is that, although the control group of the phase 2 trial was sicker in many ways (age, ECOG, metastic sites, etc), crossover can more than make up for our drug in our favor.
Its still a wash for me... i predict either both STS and PC will both fail or succeed. i don't see this making it in 1 trial and not another imo.
that said, i have a huge position which i will reevaluate in by end of the year.
you can download the presentation file at threshold website, clinical pipleline, evofosfamide, pancreatic caner, then click on the view presentation on the third paragraph. I will look at the JCO files you named right now. thanks. i will email laura why there is different data if different.
its a presentation from the THLD's website:
Control group: ECOG0, 20 patients (30%), ECOG1, 47 patients (70%), age avg 67
TH-302 (240mg/m2): ECOG0, 31 patients (45%), ECOG1, 38 patients (55%), age avg 63
TH-302 (340mg/m2): ECOG0, 28 patients (39%), ECOG1, 43 patients (61%), age avg 65
7 patients from control group went to Abraxane/ Gem+Abraxane
13 patients from 240 cohort went to Abraxane/ Gem+Abraxane
12 patients from 340 cohort went to Abraxane/ Gem+Abraxane
Also, the Metastatic Sites: Liver: control, 67%, 240 cohort 62%, 340 cohort 57%.
Its interesting that your JCO data is different from the slides I have. As you can see, control is clearly more sick and older and have more metastatic sites. Interesting that the control group got the most sick patiences in all stratifications such as age, ECOG levels, as well as mestatic sites. However if TH-302 is effective like we think, then crossover will hopefully nullify the differences.
Anyone who actually seen the full phase 2 results comment on this?
this has been bothering me.
Out of the three cohorts, it seems the control group was the oldest (age 67 avg, vs 65 and 63 on the th-302 arm). Im not too worried about this since 63, 65, or 67 is not that much difference.
ECOG level was highest on the control arm and i know for fact ECOG is related to OS on all cancer. This is the most important issue imo.
Lots of TH302 arm went on to Abraxane compared to the control group. We know that Abraxane can add rougly 2 month of OS.
Are the difference enought to bring down the results? I say yes but what we have going for us is that control group also crossed over to TH-302 arm that can add to the control OS, assuming TH-302 works that is.
There are the question one must answer b4 seeing the results imo.
kinda dangerous to do this. i think this is the last dip to 3s if it happens this time. stop doing fooling thing and just buy and hold .
i have my core holding which i will not let go until i see PaCa results. i hope that comes b4 STS. crossing fingers here.
I have lots of shares via 401k, so tax free or not, im good. BABA will be spinned off and i will make at least $20 buck imo when all said and done by end of the year.
nice little find.. interesting.. however i wouldn't put too much weight on it. I just bought some dec calls today.. 2.50s for $1.85 to 1.90. Lets hope we get good data by then and we blast off to the 30s.
next year this time, we will know result of two phase 3 trial. If those are succesful, it will be well over $20.
found the info on Glufosfamide... it is on phase 3 on pancreatic cancer as well.
A Randomized Phase 3 Study of the Efficacy and Safety of Glufosfamide Compared With Fluorouracil (5#$%$) in Patients With Metastatic Pancreatic Adenocarcinoma Previously Treated With Gemcitabine
Completion date: December 2016.. i guess its too far away still.
Hi hi, yea message betwen laura is all public information. I just just trying to get some points across and receive additinal info. I think she gave me EORTC presentation files, which was a bit more slides than the ones you can get from the website. They are aware of the picasso trial. She gave me list of possible endpoints STS can achieve and be successful etc.
Also EORTC and our P2 trial of STS has rather difference in subtypes enrolled and i was trying to see if that would make a difference in our P3 trials etc.
I hacve high hopes for the PC trial and that is why im betting large in this stock. STS i expect to fail so anything good is just that.. a bonus.
TH302 works.. its just how well is the problem. Evne if bodth were to fail, i think combo regiment can be achieved eventually.
Also to note, our old failed P3 study .. 4got the name was sold of to another company and that p3 trial is due sometimes this year... we still get royalty from that if it succeeds .. i have to dig my notes on that too when i get home.
GL. .... oh the fun times are going to start soon.
Agreed with expanded patient enrollement was due to EORTC trial. Picasso came out afterwards. No one even knew about picasso since they publised the OS way after ZIOP dropped the trial. I was digging around and found that info first and brought to this board.
I compared in detail difference betwn EORTC vs TH302 vs Picasso trial and bottom line was that although baseline should be similair, we just don't know the exact difference since they only posted. Im at work and havne't checked but if my memory serves correctly, PICASSO and our STS trial is very very similar in baseline except PICASSO allowed medium grade tumor... i have to check my notes at home.
bottom line is that extended trials are almost always bad for the trial like Phase III trials almost always is worse than P2.. etc. I excpect STS to fail and PC to make it. I still expect this to be over $30 whne approved by FDA for PC.
Can't wait for STS and PC trials.. fun times ahead indeed.
Awesome work.. musta taken you long time.
Couple of comments.
I found about the Picasso trial os of 17.9 months the day it was published.. or was it 17.. and thats when i realized that STS will probably not work imho. I give it rougly 30 percent chance.. STS has too many subtypes etc... plus it is taking way too long. most trials that get extended almost always fails.. lets hope this isn't the case here.
also to note: phase II results from PC was great.. but my biggest concern is that if you breatk down the cohorts of the trial, you'll find out that although it was random assignment, the control group was the sickest of the three, followed by 340, then the 240. so that probably skewed the results.. and yet im still very confident about the result. im expecting 2.2 months ish.. phase III showed 2.3.. but CEO says it can be as high as 2.9 months if you take account of crossover.
bottom line, great work on your part, and i DDed this very very carefully and emailed back and forth with Laura lady at THLD... and the result im expecting is STS will fail, and PC will make it with 2.2 months, which is GREAT!
also, STS just has too many different subtypes and almost impossible to get SS results imo. I thinking standard of care has gone up dramatically from the historically 10 to 12 months. Im betting control is closer to 17 months.
agree.. sts is taking too long.. i give it less than 50% chance. Im thining 30% chance in STS. PC in another hand i give 70% chance of success.. maybe around 2.2 months to 2.3 months.
TH-302 works... just not that well to blow anyone's mind.. but just enough to be used by many people in PC.. note.. needs to beat abraxane's 2.1 month advantage.
all that said, i still expect this to be $8 to $10 BEFORE data release.. I will sell at least half on the runup since i think STS chances are less than 50%.