June 4, 2016 at 11:31 am #90214middlesister1Moderator
This is wonderful news!!! Best wishes coming your way.
CatherineJune 3, 2016 at 2:40 pm #90213
Thanks for the good wishes.
I think you need a cooperative oncologist who already has some experience
with the drug and with the company.
We got the approval in less than a week.
I feel privileged and grateful.
PaulJune 3, 2016 at 12:39 pm #90212kpaperaParticipant
Paul, that is terrific that you were able to get access to Keytruda, in a relatively quick timeframe no less! All the very best of luck to you with this treatment!
StevenJune 3, 2016 at 5:14 am #90211iowagirlMember
Paul….congratulations on the success with Merck. I’m so excited for you to get to try this. I realize it is a shot in the dark….but I hope it is a shot heard around the world!!!! We will all be waiting to hear results as they come along….and wish you the best.
Julie T.June 3, 2016 at 3:44 am #90210
Paul….you bet, I wish you luck. I had heard that Merck was moving forward in administering Keytruda to patients not presenting with predictive markers. You are the first I know of, dear Paul. So excited and hopeful for you.
MarionJune 2, 2016 at 7:46 pm #90209
I am happy to report that MERCK PATIENT ASSISTANCE PROGRAM approved my application for potentially 6 months of KEYTRUDA and I received my first infusion last week. Without information on predictive markers this is a shot in the dark but I think it is worth the effort.
Wish me luck
PaulJune 1, 2016 at 4:31 pm #90208
Paul…..Informed consent is required for participation in FDA-regulated clinical investigations. The PI (principal investigator) submits the consent form to the local IRB (institutional internal review board. Agios provides the drug -the institution conducts the trial. I am investigating further patient’s loss of right of obtaining results of tissue or blood sample they provide.
How are you doing, dear Paul.
MarionMay 27, 2016 at 5:16 am #90207
Paul….I couldn’t agree with you more in that patients should have the right to their test results. I think the problem with non-release of such are related to possible legal consequences companies want to avoid. By Tuesday I should know more and I will make sure to pass it on to you.
MarionMay 27, 2016 at 5:13 am #90206
Steven……I feel for you for having to make a decision with unknown outcome. Unlike the previous years, when few options were available, today’s patients have more choices than ever, but these choices don’t come with a guarantee for success. No one has the answer, but we have hope. You must believe, dear Steven, that whatever choice you make, it is a decision made to the best of your ability and whatever the outcome, you have given it your all.
Hugs and more hugs,
MarionMay 26, 2016 at 8:37 pm #90205spaperaMember
As a follow-up to the above thread, Sloan Kettering has a spot for my mother on the AG-881 trial I previously mentioned, which is a trial similar to the prior trial she was on that had some decent results (the AG-120). AG-881 is purported to be a next generation version of the AG-120 drug that, in the lab has been found to be a more potent inhibitor of the IDH 1-2 pathway. It is in Phase I stage so it is surely purely investigational and working towards determining appropriate dosage levels. It is a rather intensive trial and if she qualifies will require many batteries of testing and monitoring including biopsies, so it is no cake walk and, as with all trials, uncertain in efficacy. One positive with the biopsies is that Dr. Harding said they could test the tumors again for any other genetic driver mutations that might help with future treatment.
The other options are more standard line chemo, pursue other trials that might include pembro/Keytruda, or pursue obtaining pembro/Keytruda off label.
We also just recieved a call from Rutgers Cancer Institute of New Jersey letting us know they now have a spot open for Mom on the this immunotherapy trial (https://clinicaltrials.gov/ct2/show/NCT02586987?term=SELUMETINIB&state1=NA%3AUS%3ANJ&rank=2).
We basically need to make a go, no-go choice by the end of the long weekend so I am scrambling to try to understand what offers the best hope. If anyone has any thoughts, recommendations or experience with any of these options, I would really appreciate any information you could share.
On Tuesday, she had about 2.3 liters of fluid drained from her abdomen, which has offered her some relief, but I know we are surely at a critical juncture.
Thanks so much.
-StevenMay 25, 2016 at 2:28 pm #90204
Thank you for your efforts.
It would be very interesting to hear what AGIOS has to say.
How can they justify witholding essential information after submitting the patient to a hazardous and painful procedure? (risk of bleeding, infection, organ damage, tumor spread). Did they get any tumor tissue? (Often they do not) If so, are there any new mutations?
The signed consent has a total of 31 pages and few patients will read every sentence of it unless it is specifically pointed out to them.
In a general sense I feel it is extremely important that pharma companies show transparency in their trials, sharing gleaned information in order to make progress in the fight against cancer.
It has been said that not enough patients sign up for clinical studies. Yet it will be difficult to entice more people to submit to the often unpleasant procedures if they feel that their personal welfare is not being respected..
Paul.May 25, 2016 at 2:23 pm #90203spaperaMember
Thank you so much MarionMay 25, 2016 at 5:52 am #90202
Steven…..The ASLAN team will be meeting up with our team at ASCO, Chicago on June 5th (I believe.)
I will make sure to report back to you.
MarionMay 25, 2016 at 5:48 am #90201
Oh Paul, please forgive me, you are advocating for yourself and I am right with you on this.
So sorry for the mistake. On another note: The Agios clinical trial coordinator and I in the process of setting up a brief phone conference for clarification of the consent form. I should have the answer real soon.
MarionMay 24, 2016 at 1:19 pm #90200
Thanks a lot for the info.
Just a little correction – I’m not sure how the “mom” slipped in – the person I am advocating for is myself.
: ) Paul
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