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N4k, where does the seconf paragraph come from? TIA eom
good follow up article
http://www.xconomy.com/national/2017/05/23/fda-landmark-nod-cancer-drug-to-match-tumor-genes-not-tissue-type/#
The approval could help push adoption of broad cancer genetic tests, which insurers have been slow to cover. The more evidence that tests are steering patients to better results from expensive therapies—and away from therapies that are not likely to benefit them—the more chance insurers will pay for those tests, said Dana-Farber Cancer Institute president and CEO Laurie Glimcher at an Xconomy forum last week. “It’s going to cost some money to do those kinds of tests,” said Glimcher. “But ultimately you’re not going to be putting patients on drugs that you can predict they will not respond to. I have to believe that the economics will eventually triumph.”
“I worry that [so many companies] race into phase 3 trials and there’s not enough biomarker work to understand why things work and why they don’t work,” Pardoll said.
My guess is there will be a comprehensive test or tests that cover many markers... will PS be part of that equation.
And will the sunrise drama identify a group of patients where bavi has a good chance of working? Are they going thru the patent process for the fun of it?
yes and can you just imagine the prime time commercials for the viking plan and all the side effects...
if i was running health care i would have the option of the "Viking" plan..
rather than spend $150k on a drug that might give you three more months..
how bout a $20k payout for all the drugs, hookers, Disneyland's or whatever's on your bucket list... no questions asked ...
go out like a Viking..
it will be doctor driven imo... most patients will follow doctor advice... and insurance? if early detection saves money, insurers will follow... i would compare it with cologuard...
but probably easier w/ blood vs turd
cologuard $599
http://www.mayoclinic.org/medical-professionals/clinical-updates/digestive-diseases/cologuard-primed-to-change-landscape-of-crc-screening
good article..
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5402056/
bavi mentioned... north4k brought it up may 7 num 54
the missing link... everything went dark after feb 2016
and the old question did some patients get tested for safety?
seems to me they did a lot of paperwork for something that didn't happen.. or did it... ever get the feeling folks are holding back info? vienna comes to mind... when will the games stop?
http://meetinglibrary.asco.org/content/171161-176
legally as in delaware... the "do whatever you want cause we protect corporations and not shareholders" state.... different with nasdaq..
As soon as the institutions believe the foxes have been cleaned out of the hen house. IMO
yes but doing a R/S doesn't fix the problem and my guess and only a guess is nasdaq wants problems fixed...
mgmt has to act in the interests of shareholders, not the BOD's... already a DS which is still active and do you think Ronin and others let the BOD continue? the BOD has been using delaware laws as a shield and that won't hold up at nasdaq...
when i spoke with nasdaq, the primary goals of nasdaq are to protect the investing public and protect the nasdaq brand..
having a three person self serving BOD with basically no biotech experience that pays itself double a big cap firm and virtually no oversight when all three members are on the same committees is a train wreck in the making.. all imo...
nasdaq takes corporate governance very seriously... too bad mgmt does not..
https://listingcenter.nasdaq.com/Material_Search.aspx?cid=108&mcd=SI
a change of control will be a value driving event imo...
excellent link for sec stuff... can sort and cross reference
http://www.secinfo.com/$/SEC/Registrant.asp?CIK=1512282
free to sign up
one other thing to consider is when does the BOD know their "time" is up. when they go before nasdaq, how do they justify the status quo of the bod?
how do they prove up director independence? cj, es and dp affirm they are independent? cj employed by es while director? good luck on that one. nasdaq is not beholden to delaware's "do whatever you want" laws...
these guys have to know their self dealing party is nearing the end.. all imo
good find... yes... the IP needs some heavy duty funding to get it in high gear... i agree the end game is near...
from nilogen IASLC2015
www.nilogen.com/file/7/download?token=cmOHvF7J
§The ex-vivo system is reliable to demonstrate drug combination
effects on the tumor immune microenvironment of fresh patient
samples.
§Bavituximab, alone and in combination with docetaxel, induces
activation of tumor infiltrating lymphocytes as demonstrated by a
significant increase in IFN-?, TNF-a, and GM-CSF with
corresponding decrease in IL-10 secretion.
§Bavituximab’s response appears to correlate with low PD-L1
expression in the tumor samples.
§M1 polarization of tumor associated macrophages is likely
involved in bavituximab-mediated activation of tumor infiltrating
lymphocytes.
§Combination of bavituximab with PD-1/PD-L1 inhibitors may
enhance the immunomodulatory efficacy in lung cancer.
So does the Asco sunrise tie it all together...
http://abstracts.asco.org/199/AbstView_199_190902.html
Conclusions: Baseline PD-L1 expression in a subset of SUNRISE patients demonstrated that PD-L1 expression (TC0) was associated with a significantly prolonged OS compared to positive PD-L1 expression (TC1/2/3) in patients receiving D+B.
Granted the d+p did as well but the p value was worthless and lots of noise... So what does bavi plus a keytruda or opdivo do with low pdl-1 patients? And the MOS one might get would not be compared with the MOS of folks that respond... it will be compared with the folks that have low pdl ...
Just the thought of this working would be worth a lot more than zero IP value.
seems to me that some of the subsequent I-O folks were closely monitored... and what a way to get some prelim data with bavi "maintenence" in the I-O trial. how else did they get the data/patients? they knew what they were looking for and did they find it?
getting the low or negative pdl crowd to respond is the prize...
Is the second epub 2017 ASCO abstract a rehash of the 2015 or did they get more data with opdivo? Were some of the maintenance patients involved in sunrise involved with opdivo trials? Where did the opdivo patients come from?
They had planned a phase 2 w/ Opdivo... then sunrise got derailed... or did it to to the underground railroad?
http://ir.peregrineinc.com/releasedetail.cfm?ReleaseID=915699
The company plans to initiate an open-label multi-center, randomized Phase II trial of the anti-PD-1 monoclonal antibody nivolumab (marketed as Opdivo®) versus nivolumab plus bavituximab in patients with previously treated locally advanced or metastatic NSCLC.
Does the follow up confirm 2015 poster?
http://www.peregrineinc.com/images/stories/pdfs/asco_2015_lung.pdf
Summary of 2015
Bavituximab response appears to correlate with low PD-L1 expression in the tumor sample and low PD-1/Lag3 expression on CD8 TILs.
? Combination of Bavituximab with PD-1/PD-L1 inhibitors may enhance the immunomodulatory efficacy in lung cancer
2017 Abstract
Background: Bavituximab is a chimeric monoclonal antibody that targets the membrane phospholipid phosphatidylserine (PS) exposed on endothelial cells and cancer cells in solid tumors. Our previous studies showed that bavituximab enhances the activation of CD8+ TILs that correlates with increased cytokine production by lymphoid and myeloid cells in lung cancer with low PD-L1 expression suggesting that the interruption of the PD-1/PD-L1 axis by nivolumab may enhance the bavituximab effect in tumors. Methods: Fresh tumor tissues obtained from consented patients with NSCLC at the time of surgical resection were utilized in a 3D ex vivo tumor miscrosphere assay, where 3D tumor microspheres were treated with bavituximab or nivolumab alone or in combination at 10 mg/ml for 36 hours. At the end of the treatment, a multiplex human cytokine assay was used to simultaneously analyze the differential secretion of cytokines, including human IFNg, in culture media as a surrogate of TIL activation. In addition, a gene expression analysis using a NanoString platform containing probes to quantitate 770 immune function genes. Results: Preliminary results indicate the combination treatment with bavituximab and nivolumab led to increased expression of genes involved in M1 polarization of tumor associated macrophages in a subpopulation of lung tumors that closely correlated with release of cytokines such as MIP1b (CCL4) which is a chemoattractant for natural killer cells, monocytes and a variety of other cells involved in tumor immune response. Conclusions: This lung patient derived ex-vivo approach indicates that bavituximab in combination with nivolumab may enhance immune response. This response likely involves M1 polarization of tumor associated macrophages and suggests potential clinical implications in the treatment of lung cancer.
Leaders in the field on biomarkers have been playing with bavi for some time.
New method for immunoprofiling of the tumor microenvironment of cancer patients by opal multiplex quantitative immunofluorescence (IF) assay
Nikoletta L Kallinteris,corresponding author1 Joseph Shan,1 Jeffrey Meyer,2 Adam C Yopp,3 Athur Frankel,4 Sean R Downing,5 Brenda S Robertson,5 Cliff Hoyt,5 Steven King,1 Carlo Bifulco,6,7 Carmen Ballesteros-Merino,6,7 and Bernard Fox6,7,8
The purpose of this investigation was to develop OpalTM 6-plex quantitative immunofluorescence (IF) assays ImmunoProfiling the tumor microenvironment of rectal adenocarcinoma (seven), hepatocellular carcinoma (HCC) (six), and advanced melanoma (two) patients treated with bavituximab combination treatments and to identify biomarkers that correlate immune response to patient survival.
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4645491/
http://www.definiens.com/uploads/resources/presentations/Carlo-Bifulco_Providence_2014-Symposium.pdf
Hoyt and Fox on biomarker with Sanborn running trials… Providence… Chiles etc. Note the testing done on with other trials/indications and not sunrise
Note the same authors from Perkin and Bernard Fox.
http://www.sciencemag.org/custom-publishing/webinars/cancer-immunology-charting-course-forward-immunoprofiling
So the leaders in the field heavily involved w/ immunoscore, biomarkers and the actual trials all coming together at ASCO with Peregrine. One would think that there were many other trials the collective brain trust including BP would be working on besides PPHM. There’s no way this technology evaluation, testing ,confirmation etc was done on just the PPHM trial. And do you think it stopped when the PPHM trial stopped? No way and there are probably ten trials (if not dozens) doing the same verification fine tuning. So are all these folks going show up at the big party with no pony? And what a better way to sell one’s wares, the picks and shovels for data miners, is the ability to turn losers into winners with technology … sunrise failure into sunrise winner (so I hope).
What I find interesting is the dichotomy of having the very best scientists in the world on one end and perhaps the most undistinguished BOD in biotech on the other end.
A reverse split means nothing if the right forces are working... that is if more demand for company after R/S, market cap (the real measure of value) should go up. It's how they do a R/S that I'm concerned about. If they are trying to shake out retail and help the big player buying, they are doing a good job of creating doubt and they certainly are not promoting share price.
The big problem with the way they structured the potential R/S is that they did not reduce the number of AS relative to R/S. And with the dilution happy BOD, it sends a bad message.
If they announced a R/S with positive news related to IP, Avid or trials/partner and new members of the BOD to show that it's safe to invest (we have competent leadership now) with the statement that the R/S makes the company more institutionally attractive, the MC probably goes up.
If the announce a R/S with the statement that the R/S makes the company more institutionally attractive without fixing the reason why institutions are avoiding the company, the R/S does nothing to MC and probably hurts MC.
in the Ronin 13d
Item 4. Purpose of Transaction
Ronin Capital, LLC acquired the above reported shares of Common Stock and Series E Convertible Preferred Stock based on its belief that the securities represent an attractive investment opportunity, and such purchases have been made in the ordinary course of business. John S. Stafford, III is the indirect beneficial owner of all of the securities of Peregrine Pharmaceuticals, Inc. held of record by Ronin Capital, LLC.
The Reporting Persons may also wish to engage in a dialogue with officers, directors, and other representatives of the Issuer, as well as the Issuer’s shareholders; topics of discussion may include, but are not limited to, the Issuer’s markets, operations, competitors, prospects, strategy, personnel, directors, ownership and capitalization. The Reporting Persons may also enter into confidentiality or similar agreements with the Issuer and, subject to such an agreement or otherwise, exchange information with the Issuer. The factors that the Reporting Persons may consider in evaluating their equity interest in the Issuer include the following: (i) the Issuer’s business and prospects; (ii) the performance of the Common Stock and the availability of the Common Stock for purchase at particular price levels; (iii) the availability and nature of opportunities to dispose of the Reporting Persons’ interests; (iv) general economic conditions; (v) stock market conditions; (vi) other business and investment opportunities available to the Reporting Persons; and (vii) other plans and requirements of the Reporting Persons.
A R/S along with good news which they have been carroting (new word .. trademark *...).. and a change of control of the BOD or at least a new COB would could do the trick. I want a big move in market cap. And that will require institutional support or a BP wanting control or safeguards. And that won't happen until the coast is clear signal comes. And that IMO is a change of control of the BOD. Would you plop down $10 mil as institutional investor or much more for BP with the current stewardship? Hell no. Just the very make-up of overpaid insiders with no biotech experience and no real oversight is a major red flag.
The penny stock boys need to do what's best for shareholders.
A recent BOD meeting.
http://michiganradio.org/post/taking-aim-fish-eating-sea-lamprey
* carroting - to dangle the possibility of potential value driving events that may occur by stating words such as "partner", "partner discussions" etc in order to induce investors to become complacent.
Several folks including myself have submitted concerns about the BOD and how the BOD has impacted institutional investment and share price to the right folks at Nasdaq. And folks at Nasdaq have been helpful in providing guidance. And Nasdaq does not look at state laws like Delaware where directors can entrench themselves.
So mgmt has a ready and able well qualified BOD member with Stafford at the gate and given Ronin filed a 13d, it appears Stafford is ready to get involved. So if adding a qualified BOD member is not one of the paths mgmt is willing to take, then we know mgmt has not worked in good faith to fulfill their fiduciary duties and have only been providing lip service. And even if mgmt avoids the R/S (ie share price above $1), the problems with the BOD remain and will continue to have a negative impact on institutional investment.
We shall soon see.
lab kit to detect ps... not a drug that binds to ps... huge difference
got that... sunrise was randomized but the follow up I-O was probably not... normally the tco percentage would be 40 to 45% based on keynote est whereas the tco subset was 65% for sunrise followups...
which makes sense because the pdl testing would have been for the I-O and doctors could place more patients with low pdl (tco) in the bavi follow up .. they would not know whether the patient got bavi because it was blinded..
so was it by chance or were the subsequent I-O patients coming off bavi placed in the low pdl (tco) pool
this might explain it... from sept 2015 so seven months before feb 2016 trial stop
http://ir.peregrineinc.com/releasedetail.cfm?ReleaseID=930479
Findings demonstrated the ability of bavituximab, alone or in combination with docetaxel, to induce signs of immune activation in non-small cell lung cancer (NSCLC) patient-derived tumor samples, particularly when there was negative PD-L1 expression in the tumor sample.
"These new translational data suggest that bavituximab has the potential to activate a tumor specific immune response in patients with PD-L1 negative tumors that generally do not respond as well to immune checkpoint inhibitors. By doing so, it is believed that bavituximab may hold potential to increase the number of patients able to respond to PD-1 and PD-L1 targeting immunotherapies," said Jeff Hutchins, vice president preclinical development of Peregrine. "These findings continue to expand our collection of translational data supporting the mechanism of action for bavituximab and corroborate our wide range of previously published preclinical study results.
trying to reconcile figure 1 from aacr to better mos performance for low tco score for pd1
http://www.peregrineinc.com/images/stories/pdfs/aacr2017kallinteris.pdf
the only way for figure 1 to work is with a high amount of low pdl patients having success in order to get the curves and p value .... not enough tc123 patients to make plot...
so does bavi help low pdl-1 and get in the way of high pdl-1?
Precision Medicine in, Biodesix out...
The pony hunters...
Tobias Guennel
https://www.precisionmedicinegrp.com/pfm/
https://www.linkedin.com/in/tobias-guennel-91382b11
I am the Lead Developer of the PATH™ Analytics Platform, a next-generation analytics platform designed to accelerate R&D via cutting edge Bayesian engine geared towards patient stratification and informing decision making brought to life via real-time data exploration. For more information please visit http://www.precisionformedicine.com/path-analytics-platform/.
Perkin Elmer in... Cliff Hoyt plus...
Sean Downing group leader PerkinElmer .... biomarker discovery
https://www.linkedin.com/in/seandowningphd/
If these guys don't have a pony at asco, it's bad for business if you are a paid pony hunter...
note the same folks on the Vienna presentation (that was never presented) that are on the Asco presentation ..
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=130490015
#2 12-7-16/WCLC’16(IASLC): “Complement & IL-10 Pathways Id Pts Benefiting from Bavi+Doce”
PRESENTATION CANCELLED – IR said,”Data analysis not completed in time.”
David E. Gerber: LEAD AUTHOR: UTSW/Dallas (Sunrise PI)
Rachael Sanborn: SENIOR AUTHOR: Dir./Thoracic-Oncology, Providence CC/Portland
CO-AUTHORS: L.Horn/VANDY, G.Losonczy/BUDAPEST, R.Natale/CEDARS-SINAI, H.Roder, J.Roder/BIODESIX, PPHM’s N.Kallinteris, M.Tang, J.Shan.
Seems like Precision Med replaced Biodesix? or different function?
did they find a better way?
https://www.linkedin.com/in/tobias-guennel-91382b11
And PerkinElmer's stuff is showing what the tumor environment is doing ie MOA
And if you read the prelim results of what they were going to present in Vienna, it follows the pdl-1 mos pretty well...
so can they find a pony?
looks like cliff has been down this road..
http://ir.perkinelmer.com/releasedetail.cfm?releaseid=963858
Pre-existing Immunity and Treatment Outcome with Anti-PD1 in Melanoma
Monday, April 18, 3:00 to 4:00 P.M., AACR Exhibitor Spotlight Theater
Presenters:
Paul Tumeh, MD, Assistant Professor, UCLA Medical Center, Dept. of Medicine Clifford Hoyt, Oncology Fellow, PerkinElmer
Abstract:
Therapies that block the PD-1/PD-L1 axis have shown significant clinical activity in melanoma and other cancers. Recent evidence has shown that pre-existing CD8 T cells infiltrates at the invasive tumor margin of metastatic melanoma are associated with the presence of the PD-1/PD-L1 immune axis and may predict response to therapy. We examined the relationship between site of metastatic disease, local immune response, and treatment outcome in patients with advanced melanoma.
and good vid.. (if you're a nerd)
http://www.sciencemag.org/custom-publishing/webinars/cancer-immunology-charting-course-forward-immunoprofiling
link? thanks.. trying to see it for my own eyes.eom
cj where does it say "Senior Author" thanks eom
agree and with the d+b higher pdl TC1/2/3, the MOS goes down which is a disconnect with the premise that bavi helps I-O per the aacr presentation.
http://www.peregrineinc.com/images/stories/pdfs/aacr2017kallinteris.pdf
at the end of the day one wants good separation in the KM os curves (and a slice of the action as to where one adds benefits relative to competition).
figure 1 looks good...
bavi + doc with subsequent I-O is the way to go....
Figure 2a shows bavi and MOS is better with low IFN-y (interferon gamma)
https://en.wikipedia.org/wiki/Interferon_gamma
btw i looked at this stuff and realized i have no f-ing clue on the human body .. don't even know why blood is red... (sorry bro)... but this is black box investing...
and figure 3a shows pretty good km curve with bavi w/ low IFN-y and subsequent I-O...
so it would be interesting to see the pdl-1 overlay into all this..
the question is what is driving the separation? how does one recreate the separation..
and with hundreds of trials going on, the ist approach is a poor choice to advance the ball..
the more i research things, pdl-1 biomarker in it of itself is not a good biomarker so the ASCO abstract as written causes more confusion (typical pphm). and the numbers in the 35 percent tc123 (38 patients) divided into many groups is too small. maybe a retail flush?
so how does the comprehensive story come together? bavi is showing activity... fine tuning needed and dollars to find out.. and the current mgmt team w/ the BOD will not bring in optimal dollars and ATM has to stop...
https://cdn.intechopen.com/pdfs-wm/53985.pdf
The assessment of PD-L1 tumor expression is currently a controversial issue with more open questions than known facts. PD-L1 expression is
a dynamic rather than static process that varies
according to different tumor and host factors (15–30). Several data show that anti–PD-L1 drugs are more effective in patients whose tumors
express PD-L1, but responses in the population of patients without the
expression lead to the conclusion that these patients also benefit from this treatment. How to select right patients for anti–PD-L1 treatment remains an open question in these circumstances [5].
as for black box investing...
wolchok, birge, brekken and others would not be wasting their time...
the two msk posters basically say advance the ball... same with collective sunrise data... advance the ball...
how does that happen...
i think a quasi-hostile mgmt change w/ maybe some help from nasdaq is the way to go...
out of the 4 to 5 bp's out there, one of them will pay more than nothing which is where we're at...
and now is the time imo with the race in the early stages and no definitive winner is out there...
TCO was less than 1% crowd in sunrise
https://jitc.biomedcentral.com/articles/10.1186/s40425-016-0153-x
per two merck trials less than 1% pdl about 35% to 40% of population
many newer articles on pdl
http://ascopubs.org/doi/abs/10.1200/JCO.2016.34.15_suppl.11603
http://ascopubs.org/doi/abs/10.1200/JCO.2016.34.15_suppl.9028
it appears to me the less than 1% crowd needs some assistance.
agree ... the expectations of the sunrise partial snapshot of pdl-1 with disjointed trials w/ subsequent I-O is not going to cut it...
the only thing that will move the needle and makes sense is a BP jumping in and spending dollars.. pphm mgmt has lost the option of "going alone" with the resources they have.
i will say mgmt is getting the right players where bavi could work...
http://www.jto.org/article/S1556-0864(17)30212-5/fulltext
if the "cold" tumor story holds, the footprint is pretty big... the only problem is lots of folks chasing that footprint...
time is of the essence
yes ... all the more reason the pphm IP needs to be in big boy hands right now...
Gartman? Did you mean Garnick? eom
good article on pd1 etc...
http://www.oncotherapynetwork.com/cancer-and-genetics/pd-l1-predictive-biomarker-anti-pd-1anti-pd-l1-therapies-non-small-cell-lung-cancer
key takeaway from art..
"It may be that multiple companion predictive biomarkers (an immune panel of sorts) measuring components in the PD-1/PD-L1 axis, TILs, and various stimulatory molecules, will be required to predict response to immune therapies. While the idea of a companion predictive biomarker for immune therapies remains compelling, one must recognize the inherent difficulties in attempting to identify such a marker."
As for the sunrise data, the mos for TOC 0 is a good start .... but big bucks are needed to flush it out ...
yes and the other numbers p values etc are worthless and you can't compare them according to my statistics for dummies..
110 patients w/ pdl-1 testing
assuming equal dist between D+B and D+P arms... 55 patients each
65% tco est 35 patients each arm
35% tc 1/2/3 19 patients each arm
throw in complications of subsequent I-O with 91 patients which is what PDl-1 is all about, one can't really look too deep at these numbers.. really need to look at what the actual components are doing in the tumor microenvironment.
bottom line is more testing with right design parameters.. good news is they have a better understanding of whether something works a lot sooner than mos...
there is a pony in there...
yes one way of looking at it... but i think you have to look at all the factors... and i don't think they have enough data within the subsets and disjointed trials ie subsequent I-O...
look at the subsequent I-O plots and other biomarkers...
http://www.peregrineinc.com/images/stories/pdfs/aacr2017kallinteris.pdf
really need to put all this stuff together to make sense of it...
The question is whether Bavi can help a subset of patients in the NSCLC setting and how to identify them. And the results don't have to compare with the top PDL-1 drug MOS numbers where PDl-1 issues helps certain patients more than others. It's all relative to what options are available to a given situation. What patient population/treatment option does bavi help (or hurt)? With personalized medicine here right now and expanding, the market slice should be big enough to chase.
So combine all the biomarker stuff and my guess is that there is a good possibility that there is a pony in there... lots of questions and lots of dollars needed....
It's time to put the tech in capable hands that can play out all the angles/possibilities in a coordinated way. Right now the value of the IP is zero.
this is the horse race folks... you want to run in a couple of IST's or the derby...
get some horses in the race.. and get a new jockey, trainer and owner..
http://abstracts.asco.org/199/CatAbstView_199_725_AT.html
The statisticians must be going crazy. The pdl-1 data needs to be overlay-ed with the subsequent I-O data to see how it all fits. In sunrise, 110 folks tested for PDl-1 and 91 patients go on to subsequent I-O which makes sense and probably big overlap with the Pdl-1 and subsequent I-O story boards IMO. We have hints and the hints are very positive. They should be able to fine tune where the drug has the best chance of working IMO. But mucho resources need to be spent and the BOD needs to go IMO before BP commits to laying down big money. AZN is back in the race with Pacific trial and has some great manufacturing assets in Colorado but Merck and Roche could be there.
A change of control is needed at either the BOD level with a Stafford like coming in with others to gain control or BP with their own BOD members. The three stooges offer absolutely nothing IMO and BP knows it. BP will not ride in the back seat with current crew.
How could one not be able to do a deal with the toys in hand? No excuse for selling ATM at this juncture.
Also, they really lucked out getting 65% TCO less than 1% with 110 subjects. If it was the other way around with TC 1/2/3 getting 65%, they would not have enough samples to get the strong p-value. My guess is at the time of the sunrise design, pdl-1 expression level was not really known so one could not purposely bias patients to one arm.
If I am reading this correctly, this is what we have been waiting for.
Got low pd-l1 expression, not a problem. This IMO is the footprint expansion potential we have been waiting for. Will need verification. Also need to incorporate all the other biomarker stuff to see how big the pie might be. Per Merck trial, the less than 1 percenter's is 34%. Not a bad slice.
https://www.keytruda.com/static/pdf/keytruda-pd-l1-expression-testing-guide.pdf
MassH... what is your take? I'm just a finance guy.
Conclusions: Baseline PD-L1 expression in a subset of SUNRISE patients demonstrated that PD-L1 expression (TC0) was associated with a significantly prolonged OS compared to positive PD-L1 expression (TC1/2/3) in patients receiving D+B. No difference in OS was observed in the D+P group by PD-L1 expression. These observations are consistent with the hypothesis that bavituximab may demonstrate more effect in PD-L1 negative or low expressing “immune cold” tumors. Clinical trial information: NCT01999673