Saturday, December 15, 2012

BMS anti-PD1 trial - 24months done...6 to go! An update on my cohort:

It is hard to realize that I have been going to and from Tampa every 2 weeks for 6 months and then every 3 months for the past year and a half!!! But....I have.  I return in March and then in June for the final two infusions assuming that scans remain clear. Despite some posts on various melanoma forums with patients alluding to continuing the meds indefinitely....that is NOT going to happen.  Dr. Weber let us know that, as I suspected, BMS is NOT going to supply the drug for patients in this study any longer than the prescribed 30 months.  I was not keen on doing that anyway...but that is the bottom line. When we asked about post trial follow-up, Weber said that he would like to continue to follow patients in this study every 3-6 months if possible, to collect data, to see what happens to us next, help us with side effects, etc.  Of course, there is no assistance offered (as has been the case all along) for fees related to travel/flights, accommodations, etc.  So...I'm not sure.  I think information over time is essential for strides toward a cure for melanoma.  It just amazes me that drug companies have so little concern or assistance for all of those things.  My R & B management team (that would be Ruthie and Brent) have decided I will be going every 6 months...but....we'll see about that.  There's another 6 months to get through before we worry about that business!!!

Stage III/IV, resected, NED arm of the MDX 1106/BMS 936558 trial with 6 months of  vaccines at Moffitt....latest intel:
N = 31.  Since start of trial, 2 patients have died and 6 have progressed.
According to Dr. Weber on this visit, "only one other patient has significant vitiligo". (He noted that he may look at the cells collected during my leukophoresis to try to ascertain whether or not there had been a development of antibodies against melanocytes.  In theory, this would mean that my cells are killing anything melanocyte related....from the basic pigment in my melanoma.  And, if that is the would be a desirable result to try to attain in all patients.)
Again, according to Weber, patients in this cohort with no treatment, experience progression within 6-8 months, while this group is now more than a year out with a rate of progression that is much decreased.
He notes that he would like to follow patients after the study is "completed", but no more drugs will be given and there is not a particular protocol (or assistance) for that.
Final results of this study will not be tallied until some time in 2014, however, there are plans for the initial data to be presented at ASCO in Chicago in June 2013.

Other news:
The Merck anti-PD1 product may be performing even a little better, but the numbers from its studies thus far are small and time will tell if its rates will hold.
N = more than 80 in the "nonresectable" arm of my same trial, and while results were deemed positive for that group as well, I have no new specific numbers to report other than a "30% response rate" per Dr. Weber.

From one rattie to another....hang in there.  Long tails are handy! - c

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