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Thanks for the detailed feedback. We are in a compromised position because we do not have the level of details needed to attempt a KM curve construction and analysis.
We have no idea what impact the patient censoring has on the data analysis. All we know is that the % of censored patients should be much lower in the Zenith20 trial and that the ITT and evaluable patients should be higher.
The most I can hope to do is look at the raw data provided and do simple analysis in hopes of predicting approximate likely outcomes. For instance should the ORR, DOR, mPFS ect get better or worse in the Zenith20 trial.
We started this discussion trying to explain why the FDA rejected the BTD. Most of us don't fully accept the suggestion that it was because of ORR. I think that you and I agree that the N used for DoR was very small and that that may be a good reason for rejection.
It does not really matter, but I feel a bit better with that conclusion than the idea that it was ORR.
It is what it is.
Most important is that we both agree that the target readouts will be better in the Zenith20 cohorts.
Thanks for the thoughtful feedback.
The way I read the graphs is that there were 12 responders.
Only 7 responders were available for DOR, the other 5 were censored.
Six of the seven measured responders had DOR > 6 months.
However since there were 12 initial responders they had to use that as the denominator: i.e. 50% of the responder were over 6 months.
I look at the data for prediction purposes, not for stringent filing purposes.
So. If only 7 patients were available for actual DOR and 6 were over six months, I extrapolate that to the Zenith trial and predict that most of the responders will be available for DOR analysis (few censored) and that 85% will be over 6 months. Also some of the responders had not had an event at filing time. That's why I expect a DOR of 8+ months. 9 or 10 months won't surprise me.
And yes catching more responders at one month should help lengthen the mDOR
What has my interest is that of the 7 patients used in the DOR analysis, 6 out of 7 were past 6 months and counting.
We know why there were only 7 patients in the subset and my specualtion is that we will have 40+ patients for the DOR analysis in the first cohort of Zenith20. If we have 86% of those beyond 6 months we may see a mDOR much longer than 6 months. 9+ months won't surprise me.
Regarding the scan times. SPPI claims they have guidance from the FDA, so we are forced to assume or accept that 1 month and 2 months are agreed to.
This is what I wanted to say on the Yahoo board:
There were 30 patients in the BTD sub-group. Of these 40% 12/30 were confirmed responders (cORR). 5 of these 12 responders were censored (lost to evaluation for unknown reasons). 7 of the 12 responders were evaluated to provide the DOR of 6.6 months. Of the 7 evaluated responders 6 have a DOR over 6 months.
Of the evaluated confirmed responders 6 out of 7 have a DOR of over 6 months which is fantastic. However, the FDA wanted SPPI to provide evidence of cORR and 6 month+ DOR.
The 40% cORR was solid, BUT we believe that there were too few confirmed responders in the DOR analysis (just 7 patients) to satisfy the FDA.
Let me know if you agree with this. TIA
Am I reading this correctly that the DOR was based on just 7 confirmed responders? If the FDA wanted to see DOR data, this small number used for DOR would be a red flag and reasonable reason for denial of BTD.
Also it looks like 6 of these 7 confirmed responders have a DOR greater than 6 months. I think that is great news.
Thanks. Makes sense. FDA wanted data on 30 patients ORR and DOR as I recall. This number of censored patients may have resulted in the FDA saying you have not provided enough data.
In any event we move forward. I agree there should be less censored patients in the Zenith20 trial. Hopefully, SPPI has a good handle on what the FDA expects for approval.
We always have to hope SPPI has their act together.
I am not sure what slides you are referring to. I can't find the breakout of censored patients. Which Presentation. TIA.
Looks like we are in agreement on most points.
Regarding Qapzola. I really believe that the phase III will show efficacy needed for approval. I don't have a problem with SPPI ultimately selling or out-licensing it, but I want it approved. I still think messing up Apaziquone was the biggest unforced error in SPPI's history. A billion dollar screw-up.
Agree that Focus is the game. Can't wait to see some combo data with Poziotinib.
Do you think MDACC will present at Feb 2019 IASLC?
SPPI did pay the fees, but SPPI hedged on whether they expected a decision before shut-down ends.
Well said Antihama.
I would like to see them sell their CASI stock as soon as they can. Makes no sense to me that a small biotech holds stock in another small biotech, especially since we are now disinterested in their drugs.
I would like to see a filing for Rolontis approval in Europe and a follow on co-licensing deal for Europe.
I still think JT may be making a mistake with Qapzola. Looks like they are not making any efforts to push the recruiting through. I believe Qapzola is a $100M+ product and they should get it approved and co-license it. This is a bird in hand.
I want them to find another late stage portfolio complimenting drug, but think they need to get Rolontis selling or the PPS up substantially before they can afford a new late stage drug. Perhaps in late 2020.
SPPI is now positioned to go it alone. We don't need to accept any low ball BO.
Fun times and a new beginning.
JT and TR have not waivered in their enthusiasm around Rolontis. I also note the recent additions to the BOD are Neulasta Rolontis people.
I think Qapzola could be a $100-200M or higher drug and JT can't even remember its name. That said he is excited about Rolontis.
Anything less than $300M would likely be a failure in JT's eyes.
For whatever reason these guys insist they know how to take market.
Should be fun to watch, especially since I don't think the market is giving it any value even as we approach getting a PDUFA.
I've been saying on the Yahoo board that SPPI has been a TWO drug company for the last 2 years. SPPI just gained maximum flexibility and leverage to go forward alone or negotiate a BO.
I continue to believe that they know the Zenith20 cohort 1 ORR and that it's great. My guess is 60% +/- 10% is likely and 70%+ is possible. I think the SD will be close to 100% and the mPFS will be 8+months.
JT seem extremely confident in their ability to position and sell Rolontis. He claims that their models always included up to three generics.
From what we know only a major miss-step can derail us-possible (witness the BTD), still unlikely.
In any event this just got a lot more interesting and REAL.
One year from now SPPI is going to be a whole different company.
NO. We have TWO drugs. Rolontis can and likely will pay all of the bills. Poziotinib will take us to a new level.
SPPI now has several options, we incurred some risk for much greater flexibility.
Antihama: Any comments on the major news from SPPI announced this a.m.? Sold existing on market drugs for $160M.
I agree that posting results in the abstract should always be seen as a red flag. I don't know why companies can't provide the SOC and the data around the SOC as a point of reference. Sometimes a 14% response rate is outstanding and sometimes its poor. Too often companies don't do a good job supplying context.
Looks like this study is timed for inclusion into EGFRexon20 2L+ accelerated filing in early 2020.
Not sure how or why it would/should have affected a BTD.
I'm most interested in the combo's. I'd love to see some CRs showing up. I don't know if MDACC has an IRB in place for combo's, but hope to see one soon.
SPPI plans combo(s) for second half, so we should be seeing some pre-clinical data from MDACC. I hope.
I hope MDACC presents some combo data. That could be very exciting. I think they are focused on Bevicizumab + Pozi.
I'm not too sure I want to see more EGFRexon20 data since I think it is compromised by the logistics of patient treatment and access.
I think MDACC stopped the HER2 study to funnel patients into Zenith20 cohort.
Fair enough.
My broader point is that small companies such as SPPI can't afford to get too arrogant (JT) and they need to explore any real opportunities they get.
I strongly believe that Qapzola/Apaziquone will be bigger than any of the current six drugs we have. SPPI can shoot for the moon with Poziotinib, but Apaziquone may be a great insurance policy. It alone could double our current revenue stream-IMO.
I bring up Vicinium because it and Apaziquone together could cover most of the NMIBC space and help put a nice floor under SPPI's PPS.
To just license Qapzola out seems to be a waste, unless SPPI has another new late stage drug target to add to the quiver.
I see Apaziquone as a bird in hand.
Let's return to this when we see the Apaziquone phase III read-out, hopefully next year.
I don't know if you are aware of the NMIBC bladder cancer drug Vicinium that is in phase III trials for BCG refractive NMIBC. The company SESEN Bio is very small cap.
If SPPI were to acquire SESEN, they would have the beginnings of a NMIBC bladder cancer franchise.
Both drugs are intra-vesiclular administration and I think they may have utility in combination. Bladder cancer is not a small market and SPPI could actually become a leader if they wanted to.
The above would be far more likely to be feasible if Rolontis sales materialize.
We could sell CASI to finance most of SESN acquisiton.
If your numbers are even in the ball park I'll consider Rolontis a major screw up. JT refuses to give numbers, but his enthusiasm and statements do not suggest such a low market penetration. I do think the street is in a "show me" status. NO value given to Rolontis, YET.
Why do you think JT got two Neulasts/Rolontis marketing experts onto the BOD? To support a $50M product?
I agree that JT is probably looking to out-license Qapzola after approval.
My concern is that if Rolontis and Qapzola are so-so products we are a ONE product company.
My hope is that SPPI has a workable strategy to take significant share from Neulasta. That's what JT has been signalling.
Do you have any opinion on potential Rolontis sales? My only point of reference for this is the enthusiasm shown by JT and the fact that he has added Rolontis veterans to the BOD.
I don't think JT would/should be excited about Rolontis unless he expects to make a significant dent in the market. To me that a minimum of $300M and more likely $500M+. For me this is a first major test of JTs credibility.
I think Qapzola is $200M+ per year even if it eventually faces generics. JT is very low key about Qapzola. That angers me.
I don't think they need to wait for the 87 patients to mature. FDA might agree to 40 or 50 patients. In that case, SPPI could probably re-submit in the 1st quarter. Wouldn't it be a nice surprise to get BTD in the second quarter?
It is possible.
BTW: I've been arguing that cORR is likely to be 60% +/- 10% based on close analysis of the MDACC data and the Zenith20 trial improvements.
Thanks for the update and context.
Based upon JTs stated strategy I don't see Spectrum making any efforts with Marqibo other than possible use of the Optimal>60 results to support or extent miserable current sales (around 4M per annum).
I really don't see them doing any phase III trials with Marqibo.
I just hope they complete Qapzola on schedule and file for approval.
Otherwise this is a Rolontis and Poziotinib company.
Best
TTB
Thanks for the welcome!
We discussed the Marqibo trial a bit on Yahoo, but I'm unclear about its potential to change anything. Do you have any insights?
I think I'm limited to only three posts today since I'm new here, so I may not be able to have much dialogue with you on this today.
Hello IHUB SPPI Board.