Info on test for PD-L1 and the availability of anti-PD1

As I mentioned in my June 10th post, I agreed (as did most other patients in my study) for BMS to test my tumor for the expression of PD-L1 on its surface.  The presence of this ligand on tumors, as reported June 2, 2012, New England Journal of Medicine, from the BMS-936558 anti-PD1 study of patients with a variety of tumor types, indicated that 25 of the 42 patients [tested] had tumors that were positive for PD-L1. "Of these 25 patients, 9 (36%) had an objective response. NONE of the 17 patients with PD-L1 NEGATIVE tumors had an objective response....These preliminary results must be interpreted with caution..." Yada yada yada!!!!  So...at this point BMS....as well as innumerable anxious melanoma patients would like to know if their tumor expresses PD-L1 or not.  Since, given the data (minimal though it is), it is unlikely that a tumor WITHOUT PD-L1 would respond to anti-PD1, while a tumor that does have that ligand....might.

So....Where's the test?  Where's the result?  Dr. Weber still does not have the results himself.  He says that BMS keeps giving him the run-around, saying that they have to create a test that is valid, reliable, etc. (Important to be sure.) Currently, he is under the impression that he might get results in October.  When will I get results?  On MY tumor?  Probably....about never.  I am told that to give me results is tricky because this is still an experimental test on an experimental point about an experimental ligand whose implications are unclear, ambiguous, and with questionable import.  SERIOUSLY??????  Do you think, that at this point in the game, there are any folks in this study who do not realize that this is all a crap shoot?????  Do you not see that we deal with the ambiguities of the whole entire thing.....DAILY?????  Is it not clear to you peeps, that I, and all my fellow ratties, sign, and acknowledge said crap shoot papers, repeatedly...putting in writing that we KNOW this is an EXPERIMENT and the outcome is variable...at best?????  You think, at this point, that we will not be able to comprehend that the results of this test for PD-L1 were acquired with a new technology, yet to be fully proven?  You think, we are unable to realize that the ramifications of the presence of PD-L1, or not, on our tumors, is not fully determined?????  I'm not sure what any of you really think, but, I suspect you know we understand all the bull, much better than you do.  However, here's the rub...for you and BMS....you think we will run for the hills and leave your study in the lurch, and seek better treatment elsewhere, if we learn our tumors are negative for PD-L1.

So, folks keep asking me...."When will the test for PD-L1 be available for us like the BRAF testing currently is, so we can make more informed decisions about taking anti-PD1 or not?"  My answer....not soon.  It all depends on when BMS (or some other company) is ready to put it out there.  And that, depends on many things.  It depends on how well their anti-PD1 product really does in its Phase 1 trials.  Then, how it does in Phase 2 trials.  And then, what the correlation between those results and the presence of PD-L1 on those tumors turns out to be.  For all the folks who want anti-PD1 to be magically available TODAY....I have some sobering news.  While there is talk, of starting Phase 3 trials as early as 2013 with a BMS statement regarding a 'registrational development program' in which they are reportedly trying to move via a filing they have made with the FDA, 'from early clinical development in Phase 1 trials straight to a Phase 3 registrational program and expect the registrational trials for melanoma to begin at the end of this year, early next year'.  The Phase 1 trials are not completed. In fact, they are not even close.  Take my trial for instance. It is set up to last 2 1/2 years from start to finish. Some of us have been in that trial for almost 2 years.  That's just the first group.  They didn't start ENROLLING the third group until around January or so of this year.  In March, only one patient was two doses in, in the 10mg/kg group.  So, that means, that the results for my study, that started treating patients in 2010 will not be reported out, with final results, until the last patient (yet to be enrolled!!) has completed 2 1/2 years in the study.  At best, that will be roughly in 2015!  At, best.  Sorry.  But, that is the sad truth.

So, when will anti-PD1 be made available?  When will a test for the PD-L1 ligand be out?  I don't know.  And, it is very frustrating indeed...to be the rat...with no say or voice in the decision.  Well....maybe a little voice!  I'll keep speaking, if you keep reading.  Hang in there my friends - c.