The study was designed to include only Her2+ patients. ER+ patienta were supposed to be excluded, as were double negative patients. I would agree that if the cancer has already disseminated even after surgery. Either drug, Herceptin or neratinib, would be less effective in the adjuvant setting. Nevertheless, adding neratinib in the 2nd year results in improved DFS overall. Sure, it would be better if neratinib extended DFS for longer than 2 years. At this time, those studies haven't been done or haven't been reported. You can't expect to see "numbers needed to treat ratio" in a short abstract. Wait for the presentation. How did you determine that there was manipulation of statistics from the abstract? Not that is matters, but I also did cancer research.
Thanks for that excellent explanation and for your time. Really appreciated.
I don't know what is your background but I Did research in Breast CA at MD Anderson. And the stage does matter(Also Her2nu, estrogen receptor+) at time of diagnosis is a predictive factor for recurrence. DCIS is a type of cancer that has not invaded yet, thus in situ, versus any T1+ N1+ M1+ which means there is already invasion and presumed to be already disseminated. The data presented that showed , yes, statistically significance 3%, is for this early type of breast CA (only one fraction of all breast CA and only for another subset of CA that is Her2nu +), thus only a very select group may benefit at least improving their survival for 2 years. @ years that's nothing. In other types of breast CA, a pill Arimidex, extends survival and disease free for even 10 yrs. And also to clarify one thing is statistically significant and other thing is clinically significant 3% is not clinically significant. Show me the numbers needed to treat ratio, that's what I want to see.
You see PUMA realized that the data yield in this study was not as impressive as they planned but now they want to do a spinoff and manipulate statistics to prove that all the money they spent was not in vane.
Sir, you are correct. There is a nuance to the data which most people would not have noticed in the abstract, but which should be made clear in the presentation. It involves how the patients were evaluated for their Her2 status. The control group patients were evaluated at a central location, while the neratinib group were evaluated locally. It turned out that the local evaluations for Her2 status were not as accurate as those which were evaluated at the central location. A subsequent evaluation of the neratinib group at the central location showed that a portion of the patients in that group were not Her2 positive. Those patients didn't and shouldn't respond to neratinib treatment. If one now corrects for those misassigned patients, the hazard ratio is greatly improved and the percentage of those patients benefiting from the neratinib treatment will be much closer to what the investor expected. This should be made clear at the actual presentation.
Thanks Allen. It's an honor to receive some clarification information from someone who knows how the trial works and so forth. I do not understand the hazard ratio (.52 I think it was), which the CEO said was acceptable (compared to the .70 hazard ratio of Herceptin). Clarification would be tremendous if you have insight there. Thanks for your knowledge. It appears as if the ASCO presentation could potentially shed some light on some possible positive results. I have thought that the results could be statistically significant, and that the overall results just "appeared" not below expectations. I have also thought that the CEO is not allowed to clarify, or chooses not to clarify, until at the ASCO presentation. Is this your feeling as well? That, in a nutshell, is my thoughts....... Your thoughts.....??
Sorry Doc, but it seems you don't understand this study at all. It is an extended adjuvant study. Meaning that the patients do not currently have detectable breast cancer ( the cancer was removed by surgery). The patients then receive standard adjuvant treatment with Herceptin for 1 year (clinical studies showed no benefit for a second year of Herceptin treatment). This is an extended adjuvant study with neratinib where the drug is given for the second year. The goal of the treatment is to prevent a recurrence of the cancer. it appears that 2nd year treatment with neratinib gives better results than a 2nd year treatment with Herceptin (that's the placebo of this study). In contrast to what you say, the study results are statically significant. Your comments about the stage of the disease in the treatment groups are meaningless since the patients don't have detectable cancer at the start of the study. Finally, prophylactic treatment with imodium greatly reduces the occurrence of grade 3 diarrhea. I suggest you wait for the full ASCO presentation before making conclusions about these results.
excellent analysis doc. I appreciate all information that helps all of us decide which way these stocks are headed. Some good perspectives, and thanks for sharing......
I just read the ASCO abstract and this one won't fly
Data presented is only for survival rates for 2 yrs, that's nothing, what happens at 5 yrs? They have patients enrolled in 2009, they should have data on survival rates after 5 yrs. And even at 2 yrs, not statistically significant. What happened to the original 33%. now is only 2-3%. Who is willing to take 12 extra months of chemotherapy with an incidence rate of 40% to have ongoing diarrhea, more chances of having hearth failure and only to have a 3% improvement survival at 2 yrs? It does not justifies the cost. An there is more the non statistical significant benefits are not for everybody just for early disease (they did not specify what stage), most Breast CA diagnosed are beyond this stage.
Brilliant analysis. Wishing you good luck with this to low 20's. Company has 6 billion dollar market cap, with great CEO, and promising drug. Good luck being short, wish you the best. Bought at 169.7, and now stock is 188. Money in the bank is ok with me.....short or long. Best Wishes..
from 4/15 high 234 steep slide to low 170 on 5/18
now on its way back up again +12 points alone today at 193 now
gotta love the fresh young promising biotech stocks babey
unfortunately, it takes only about $50 million to develop generic Herceptin. why would anyone spend over $1 billion to buy a Herceptin equivalent with severe diarrhea complications? short this one to low 20s
Wishing everyone good luck, shorts or longs. I could be dead wrong, but below is my analysis, and I welcome your thoughts. Knowledgeable and insightful comments are appreciated......
I could be wrong, but I consider this the best value play on the stock market, at the moment. If PBYI is 190+ going into ASCO, uptrends into the 200's afterwards, it will be good. Also, and this is not to be counted on, but there is a small chance of a buyout in the future. Analysts, generally speaking, have included PBYI on their list of top 10-15 biotech companies for possible Biotech acquisitions going forward.
My take is this: I place Clinical Research Associates at pharma companies nationwide. I analyze resumes for a living. This CEO has a world class resume and accomplishments, it is one of the highest qualified resumes I have ever seen. He did it previously with another Biotech company, and it was acquired. Drug has promise, and should be validated again at ASCO and beyond. I think it could be 190+ going into ASCO....not an unrealistic scenario considering it is 181 now. I expect a slight uptrend to continue into ASCO conference on June 1st. More details about phase 111 and their top drug neratinib should be released then.
The CEO's leadership should shine through in the longrun, as he has hired some of the most talent individuals in the Biotech field to navigate PBYI.
CEO compared the Hazard ratio (.5) to the leading cancer drug on market Herceptin, from Roach, with a (.7) Hazard ratio. Apparently the .5 ratio is acceptable compared to the .7. Additional information on the phase 111 trials will probably be released and explained then. The trials are not that easy to interpret. I am sure the CEO, who has world-class, impeccable qualifications, will amplify upon results at ASCO.
WOW! Can someone really be this ignorant? You are likely doing too much of what your handle suggests and it's killing some brain cells.
the hope is gone, analyst try to calm your down, be careful here. Unless something up for good. it will be lots of sell from institution and insiders. I could be wrong, but i can't sleep well now.
It is not that difficult to understand. The drug is very approvable. Secondary endpoints, subset analyses all point to clinical benefit and the side effect is very manageable based on other data. Don't forget that these early BC patients have all been treated with Herceptin for a year already so the survival is gonna to good. The question will be the market uptake. The projection was $3.5 billion which would translate into at least $17 billion take over price. If they can do half for $1.7 billion, it will still demand $8-9 billion market cap. That's why the issue will have support.