A strong case can be made that NKTR-102 has a net negative valuation within NKTR's current stock price. The potential increase in valuation from future NKTR-102 success is being more than offset by the negative view of the cash burn from NKTR-102 development in the next few years. This seems shortsighted in the sense that one option always open to NKTR is to simply put a freeze on further development of NKTR-102 and let other programs progress and increase in value: Cimzia, Mircera, Hematide, Levadex, NKTR-118, NKTR-061, NKTR-119, NKTR-181, even possibly Neulasta. I'm not suggesting at all that this should be done, but that it could be done and therefore the threat that the cash burn from NKTR-102 development might jeopardize the rest of the company is utter nonsense.
I happen to think it's irrational that the stock market would assign a net negative valuation to NKTR-102, but who ever claimed the stock market was rational in its valuations? Perceived negatives are often blown all out of proportion, and this seems to be the case with NKTR. Right now I think minor good news on the cash side would do wonders for this stock.
A figure that has been mentioned before is 6 months.
A study of studies that tried to make sense of the whole drug treatment landscape in platinum resistant patients had this to say:
"Based on a review of 54 studies, OS for recurrent platinum-resistant patients is <1 year from diagnosis with subsequent therapy.
Chemotherapy offers a small survival benefit over no further therapy.
Each successive chemotherapy regimen is assumed to be less effective than the previous treatment, with shorter PFI in comparison to the previous treatment.14"
So OS is 'less than 1 year' for patients overall somewhat healthier than nktr-102's study patients. At the very least it seems from the data that nktr-102 takes doxil's pfs exiting patients and gives them a median 5.4 months of further pfs and 13.9 months of OS.
This is shaky data as dcx has pointed out but the fact is that responses alone are hard to come by in this patient population let alone demonstrations of extended OS and PFS. Eribulin manages to do it but at very considerable cost in terms of AEs and general quality of life. Nktr-102, so far, seems to equal Eribulin at much less cost in these terms.
I just listened to Howard at the Jeffries conference and he sounded pretty good on the different approval strategies for nktr-102 in OC. The combination of nktr-102 with Doxil seems perfectly reasonable. The exilixis drug has had 6 treatment related deaths in the course of its trials and (I think) causes GI perforations in common with drugs with similar mechanisms. So it is unlikely to combine as well with Doxil, which itself has serious side effects.
Nktr-102 may not only be one of the best treatments post doxil, it may be better than Doxil on its own, and there are good reasons for thinking it may work better in combination with Doxil. These options are not woolly mindedness - they are the result of high activity plus low side effects. No other drug mentioned in this landscape has these same strengths and it makes nktr-102 a very versatile drug.
Gladpick - Yes, what I was suggesting is that comparing results that other drugs got in other subsets of MBC is not valid if NKTR-102 is going to be tested in a much more difficult to treat patient group, which is precisely what ATC failures represent.
As I posted previously, perhaps the best data for what happens to platinum refractory OC patients post-doxil can be found in the P3 study results from doxil itself. This study showed a PFS of about 4 months and an OS of about 14 months, so a conclusion that median OS after doxil failure is about 10 months is probably not too far off.
Hoyas - The biggest significance I saw with the eribulin approval in November, and I think I stated this clearly, was that it handed the P3 trial design to NKTR on a silver platter. I referred to this as a gift on more than one occasion. Look at what AZN is doing with NKTR-118. Is there any way on earth that NKTR would have come up with the multiplicity of P3 trials that AZN is now conducting? No. That's what makes the eribulin approval such a fortuitous event for NKTR. It shows what the FDA will accept - RIGHT NOW - in order to grant approval for a breast cancer indication for which no good treatment options exist. 750 or so patients, 2 to 1 randomized against TPC, median OS as the primary endpoint, a less than clean AE profile allowed. It's so easy a caveman could design it.
"The far right column, "Recurrent Disease Post Doxil", lists that nothing is currently approved for this patient subset, which as we know is the subset that makes up NKTR's P2 extension."
"One thing the NKTR-102 data has shown is that there are patients with very aggressive cancers who progress through all current treatment options but who see a response to NKTR-102. Given this and the fact that NKTR-102 comes with a mild side effect profile, there's a compelling reason to make this treatment option available. With the latest drop in stock price has come an irrational view of NKTR-102 and an irrational valuation for this company in total, in my opinion."
So what you are saying is that the market, DCX, Yours Truely, etc. are looking at the 102 results and comparing it with other drugs such as Doxil etc. and they are saying the results including OS may not be any better than present drug options. However, you are also saying that 102 is for those who do not have any other options left and, therefore, should not be compared with the present drugs?
Pardon me for asking because to be honest I have not taken a very close detailed look of the results announced so far. So has there been a comparison of OS of these subset of "no other options" patients who took 102 and a similar group (no other options) who just decided not to take any more drugs and live whatever months they had left?
"With the latest drop in stock price has come an irrational view of NKTR-102 and an irrational valuation for this company"
multi thanks for the novel but you said the same at 16. Perhaps the irrational one is you.
Hope this helps;)
Multi, what you're now hanging your hat on is a very, very small sub-sub-set of phase 2 patients to warrant a considerable expenditure of resources on a phase 3 trial. It is always possible to run a phase 3 trial against any particular subset of patients that has exhausted all other approved treatment options for their specific type of breast cancer. Whether it is warranted. of course, depends on clinical, competitive and commercial considerations. In any case, some of your posts from a few months ago, infused with confidence from Masuoka's statements and your early read of the data, suggested there was a lot of reason to believe that 102's OS data would look very good compared to Eribulin's. I think it is fair to say now that none of us have a high level of confidence that 102 would beat Eribulin on efficacy in phase 3. It is possible, of course, but the data to this point do not warrant a lot of confidence. That, of course, colors the phase 3 planning and target patient population analysis that Nektar is now going through.
"DCX's point about how the OS curves evolved, coupled with the way the OS numbers turned out generally, further solidifies the conclusion I reached previously that this was a case where the partner that had progressed far down the line with Nektar concluded that this program would no longer be as good an investment of its resources and declined to make available the terms that had previously been put on the table."
Total bs and an invalid conclusion based on pure speculation. There is no evidence whatsoever that there were any discussions with a potential partner to the extent indicated in the above statement.
"Multi, with all respect I don't think you're addressing the point dcx is making."
Hoyas - I do see what Dcx is pointing out with the data, but it's the step after that that I take exception to. Look at the slides from yesterday showing the subsets of OC and MBC that NKTR is targetting and what other approved drugs or drugs in P3 are in these subsets. For breast cancer, note that the slide is entitled "Current Treatment of HER2 Neg MBC". Under prior ATC, one approved drug is listed - Ixempra - but one of the researchers commented that this is an old drug that is not used in current practice. Under triple negative we see nothing approved but a combo of BSI 201 plus Gem/Carbo currently in P3. So for these patient subsets, what's there to compare NKTR-102 to? Nothing. Now look at the slide "Current Treatment of Ovarian Cancer". The far right column, "Recurrent Disease Post Doxil", lists that nothing is currently approved for this patient subset, which as we know is the subset that makes up NKTR's P2 extension. This lack of approved treatment options confirms the FDA decision a couple of months ago to assign orphan drug status to NKTR-102 for refractory/resistant doxil-failed patients. Orphan drug status implies unmet medical need which implies no treatment available.
So what does NKTR-102 need to show superiority to in the upcoming trials for these indications? The eribulin approval teaches us that putting a drug up against TPC in a situation like this is viewed favorably by the FDA. This is a very different situation than using a bar that was established on a less-difficult-to-treat subset of these diseases, which I believe is what Dcx was doing.
One thing the NKTR-102 data has shown is that there are patients with very aggressive cancers who progress through all current treatment options but who see a response to NKTR-102. Given this and the fact that NKTR-102 comes with a mild side effect profile, there's a compelling reason to make this treatment option available. With the latest drop in stock price has come an irrational view of NKTR-102 and an irrational valuation for this company in total, in my opinion.