I guess what LPath is saying is about half of patients treated responded really well to Asonep treatment. If they can find biomarkers, like elevated VEGF, insulin, IGF or other overactive kinases, that differentiate the highly responsive group from the unresponsive group, they will be able to get PFS much longer when just treating that patient subset. How about S1P-R overexpression or overactivation? It seems like that will be a good candidate to look at. They can probably get accelerated approval if they can identify that patient subset and almost assured of Asonep approval. And, if they find the same biomarker in other cancers, then pps shoots to the moon.
If the benefits are as good as reported, and there are no serious side fx, neratinib will get approved for sure, regardless of whether physicians will put their patients on the drug for a year or not. I'll also worry because the trials were done in 41 countries and data interpretation and integrity can be questioned. Remember too that these anti-HER2 drugs are hard on the heart and liver.
Anyway, good luck to your investment and neratinib.
Don't be too negative when you chat with Scott. Just tell him to have more frequent and "hypeful" PRs like this past one, but maybe with a more catchy title. Perhaps present the RCC data at ESMO or any upcoming big onco or kidney meeting.
LPath's Asonep delays disease progression in kidney cancer patients. Instead of:
"Lpath Reports Interim Data From Phase 2a Study for Anti-Cancer Drug, ASONEP"
Maybe then WSJ or Bloomberg will follow up with their own spin.
He-he. I'm not even sure that Benlysta is selling that well. I just know that it's a "krappee" drug in terms of the trial results. I am not sure about the other HGSI pipeline then, like the anthrax vax. I owned HGSI and was glad to sell it.
So if patients failed prior treatments, and they are not treated with any drug later, should they all be considered to have disease progression already by day 1? So without treatment, it would be 0% PFS by month 4? Pretty much the tumors will just keep growing without treatment and larger by month 4?
Treatment naive patients for Sutent, unlike patients in Asonep who have progressed after at least 2 treatments, including Sutent.
I went over an NEJM paper comparing pazopanib vs sutent for treatment-naive rcc and it has mPFS of 8.4 and 9.5 mos, respectively.
Change remission above to relapse.
BTW, neratinib was administered daily for 1 yr. Will you risk AEs with that? How frequently will you have to take imodium? Daily also?
The important question really, is after relapse, what treatment options are there, and how successful is retreatment?
Doctors will probably wait for those 14 to show remission then retreat, rather than treat all 100 with a drug with AEs, with 30% of them suffering from diarrhea as just one concern. Another question is how many of those 14 will not respond again to Herceptin, or Kadcyla, or other SOC upon retreatment?
It turns out that there is no standard of care after Herceptin as adjuvant for 1 yr, because DFS by doing nothing is as high as 86%. Accepted practice is probably to monitor patients closely, and retreat when the cancer comes back, instead of taking a chance by continuously, and perhaps unnecessarily, taking a drug that has nasty side fx and that may do actually do more harm.
Perhaps Roche will be more inclined to promote Kadcyla in Europe and sales will accelerate.
Would be nice if knowledgeable doctors will opt for off label use of Kadcyla instead of the Herceptin/Perjeta combo.
We'll probably get an update on the 2nd cohort by EOY2014, while we wait for Isonep from Pfizer until 2015Q1. That's all the time I'm giving LPath to raise pps above $10.
Actually, if Kadcyla works as great as could be expected, it will decrease sales of both Her and Perj. That is why Roche is pushing Her/Perj rather than Kadcyla.
They want to find out if they can see tumor regression with higher dose. The PFS might also be prolonged.
Right now, only our suffering with this stock is not regressing, and is only being prolonged. He-he. No love at all.
Roche is pushing its sales because they make money from combo use with Herceptin. Roche should push for Kadcyla use and increase price by 20%, because it would work better than the Her/Per combo and would still cost less. If Gilead can charge for $1000 for a 10cent tablet, so can Roche if it wants to.
I've moved to the dark side with my first shorted stock, PBYI. It just moved up too much on unimpressive data. I should have sold IMGN yesterday to be able to short more PBYI.
Perjeta sales 388MCHF. How could sales of a less effective drug be higher than Kadcyla? Who will initiate a side by side comparison since both drugs are Roche owned?
Page 135 of slides with appendix:
227M CHF for HY14. Is that the total for 1Q and 2Q?
It was 102MCHF for 1Q. Does that mean sales for 2Q is only 125MCHF? I guess that's till 25% QOQ increase.
1Q 102MCHF *1.25 =
2Q 125MCHF * 1.25 =
3Q: 157 ?? *1.25 =
4Q: 197 ??
= 580MCHF for the year global.
Japan will probably accelerate next Q and have sales exceed 600MCHF easily = 660 USD. May hit 700M
20M in sales royalties for 2014 + other approval milestones.
So, it's looking like at least 1B in 2015.
How's my fuzzy math?
~86% DFS after 1 yr of Herceptin is probably acceptable, and physicians just watch out for relapse, then start retreating, instead of continuous treatment bec of anti-HER2 drug adverse fx.
I listened to Puma CC and the numbers they give for placebo is ~86% DFS and ~91% for neratinib 2 yrs after initial neratinib treatment. I am not sure how 33% improvement was calculated from that. CEO was very vague about the actual numbers. It seems the difference in DFS increased with time. I am not sure if the %DFS are based on ITT numbers. ~30% experience diarrhea and up to 10% dropped out because of it. Benefit to risks is still questionable.
Analysts who asked questions all appear to be wowed by the data. For early stage Her2+ BC, after surgery, it seems that only neratinib had been tested. Perhaps physicians have been content with the ~86% DFS without any other treatment because of the cardio and diarrhea AEs of continued treatment.
The patients here are different from mBC treated now with Kadcyla. However, CEO mentioned, without giving specific numbers, that there are Kadcyla-unresponsive patients who responded to neratinib, which is to be expected.