| Wednesday, 12/21/16 07:12:16 PM | | Re: marzan post# 91298 | | | Post # of 91349 | | |
Hi Marzan.
1. In my opinion the information arm indeterminates will prove to be hybrids (each patient some part psPD some part rapid.) It's been my sense this is the case for some time, and Dr. Liau's presentation indirectly only strengthened thinking on this. Therefore, I'm not as pessimistic about this group as shorts, nor as positive as some longs. Out of all the cohorts, it is the most challenging to compare with. I think time will show it increased PFS and OS judged against a yet to be selected comparator group. IMHO
2. On the other hand, the double rapid progressors from the information arm definitely showed improvement compared to historical controls. IMHO.
3. The 32 psPD arm will be unblinded at the same time as the 331 P3 trial. This fact was disclosed in a poster presented a while back. I expect this group of patients to have extraordinary results (near cure), and the crossovers should also obtain long OS.
4. Larry is unsure about PFS statistical significance in the main group because there is not enough information for a solid conclusion (and he has seen many more trial outcomes in real time fail), but like LL and LP he believes there is more than one way for NWBO to.... strike that.....there are more than two ways for NWBO to win, and I firmly believe he is preparing people for a strong long tail with the possibility we may not hit conventional primary or secondary endpoints.
In other words he does not know, but he is wise, so are LP and LL, and they are attempting to educate us, their colleagues and regulators that immunotherapy is different, and a strong tail of 25% or more with near cure results is sometimes better than say a couple months improvement in mPFS or mOS. I am not as wise as they are, because I am not as smart and experienced as they are, but I do know that three or four ways to win is better than two, and I've discussed this a bit in the past.
Most wise people somewhat lower expectations in these situations and prepare instead for any potential battle or opportunity in front of them, particularly the battles that might be most difficult. That includes educating us over and over about the long tail survival (near cure) potential of immunotherapy in some patients, and its therapeutic effect even when administered later.
I can almost guarantee you that Dr. Liau is also preparing us and regulators for new (faster) endpoints in the upcoming combination trials.
These windows of learning while we are all desperate for a breakthrough should not be lost on me, you or regulators. This is an extremely promising technology that is somewhat handicapped by chemo technology and chemo trial structure which often have "long heads," if you will. Patients show great results at the fromt end -- i.e.., short term complete remission -- but then fall victim to the treatment and the escaped cancer shortly thereafter....no long tail. Some Immunotherapy is the opposite. Slow to work on the front end, but then surprising longevity on the backend.
We have to be smarter than the disease, and take up the Beau Biden Moonshot mantle that a sense of urgency, insightfulness and flexibility in this field must replace bureaucratic and large corporate intransigence.
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