May 24, 2016 at 12:40 pm #90199
Hi Paul, we have had many of the same experiences and concerns and we are also now searching for new options as my mom’s participation in the Trial of Ado-Trastuzumab Emtansine for Patients With HER2 Amplified or Mutant Cancers at Sloan Kettering has been halted due to progression and tolerability concerns. After taking a week to rescan, regroup and survey options, we are going back to Sloan tomorrow to visit with Dr. Harding to assess our options. My mom has not handled any chemo well so I know she is hoping and praying that we can find a way to get treated with an immunotherapy alternative like Keytruda, although we understand the difficult odds with Keytruda and we are in the same situation with the predictive tests and no access to trial biopsy results. I will be praying for you and your mom and will certainly share any meaningful news or information that I find.
Does anyone have any intimate knowledge of the new drugs developed by ASLAN Pharma out of Singapore? I know there has been some very positive news and awards for their cutting edge treatment, as well as FDA approval but I reached out to the only contact I could find and was graciously informed that there are no current US treatment options. If anyone knows of any other way to be considered for this treatment, I would be immensely appreciative of any information you can provide.
All the best,
StevenMay 23, 2016 at 4:05 pm #90190
Paul…..programs are in place for investigational (compassionate) use of agents not yet commercialized. This ruling applies to all drugs with investigational status. Physicians and Industry must comply with FDA rulings explained here: http://www.fda.gov/ForPatients/Other/ExpandedAccess/ucm20041768.htm
Additional information can be found on the respective websites:
Keytruda: Physicians can request Expanded Access (Compassionate Use)
THE MERCK CO-PAY ASSISTANCE PROGRAM
Bristol-Mayer-Scibbs Patient Assistance Program
http://www.bms.com/products/patient-ass … sured.aspx
Another option to consider is possible enrollment in the ASCO TAPUR study:
I too am puzzled by the consent form criteria and have reached out to Agios for detailed explanations and will report back with any information received.
Hang in there, dear Paul, you are a fantastic advocate for your Mom.
MarionMay 22, 2016 at 3:38 pm #90198
Steven….we did the repeat PET/CT and the results are not good. After 2 months of Ag-120 there is significant new growth, so I am off the trial.
I am now looking at Keytruda off label as a possible albeit costly alternative. This would be something of a crapshoot given that in my case the predictive tests are either negative or unavailable. I had hoped that the tumor biopsy might reveal some new genetic alterations that could help when looking at new approaches, yet when asking repeatedly about the results of my biopsy I have only received evasive answers.
Looking carefully at the trial consent I signed, I now came across the following statement that I had not seen before:
“YOU WILL NOT HAVE RIGHTS FOR INFORMATION OBTAINED FROM YOUR TISSUE OR BLOOD SAMPLES.”
Could somebody please explain to me why anybody would wish to withhold from a trial patient information that could potentially save his life?
PaulMay 18, 2016 at 12:06 pm #90197
Thank you very much MarionMay 18, 2016 at 7:59 am #90196
Steven…..i agree with your statement in that we don’t have data supporting the effectiveness of the monoclonal antibodies Keytruda or Opdiva, which have shown positive responses in a subset of melanoma or lung cancer patients. But we have seen some spectacular results in some cholangiocarcinoma patients harboring the ID-1 alteration or PD-L1 ligand. Ultimately, we will have to await the outcome of several clinical trials underway, but I believe given the few currently available options, Keytruda or Opdiva could be considered a choice for second or third line of treatment. It’s a tough choice to make, dear Steven, we don’t have the answers, but we have hope.
MarionMay 17, 2016 at 1:24 pm #90195
All the best to you Paul. You are correct that the primary goal of the Agios drugs is to shrink or stabilize the disease and the doctors are careful not to use the word “cure”.
I also agree that in the realm of possible cures, drugs like Keytruda and Opdivo are offering some of the best hope but seem to be effective in the minority of cases with apparently little certainty in the medical community as to what exactly dictates effectiveness. Some institutions test for pd1/pdl1 and some do not, partly, I understand, because those tests are not conclusive for all tumors/portions of tumors.
I am looking towards Keytruda as possibly the next best option for my mother because she is not at all tolerating the latest HER2 trial treatment at Sloan Kettering.
A quick question for Marion and the rest of the wonderful community here — do we have any sense of the Keytruda success rate in treating CC patients? Also, please do correct me or elaborate if you think anything I stated above is behind the times or not fully accurate.
StevenMay 7, 2016 at 1:24 am #90194
Thank you very much for responding.
I am due for new imaging studies in the next two weeks to see if I derive any benefit from Ag-120. My side effects have been relatively mild, mainly diarrhea, pretty well controlled with imodium.
I am aware, of course, that even under the best circumstances targeted therapies, such as Ag-120 for IGH1 mutations are unlikely to be curative. They can keep the disease stable for a while until – hopefully- some suitable immunotherapy exits the pipeline. Right now Keytruda sounds exiting but it seems only to work well in patients who are also positive for mismatch repair deficiency, if I am not mistaken.
Anyway, I’ll keep you posted and hope to hear from more people on this particular trial.
All the best for your mother.
PaulMay 6, 2016 at 2:00 pm #90193
Anatta, my Mother was on the trial for about 4 months with some success. She was recently removed from the trial and is now on the following trial at Sloan Kettering – https://clinicaltrials.gov/ct2/show/NCT02675829?term=Her2&lead=Sloan&state1=NA%3AUS%3ANY&phase=1&rank=8.
With the Agios trial, there was some very positive news with stability and shrinkage of some of the tumors in the liver area, and she tolerated the drug extremely well. Unfortunately, growth of a few of the lung tumors continued slowly so they apparently disqualified her from the trial.
The above-linked HER2 trial was suggested as a next step because she has HER2 amplification as well and we have no obviously better options. Unfortunately, after the first round she is not tolerating the chemo aspects very well.
We were also considering applying for Keytruda off label or another pd1/l1 related treatment but we are unsure if she has that amplification.
As for Agios, again, there were some very good results and reasons for hope. I understand also that Agios has another trial drug AG-881 that may be achieving even better results. Sloan told us mom is on the waiting list for that trial. We are also keeping an eye on the ASLAN developments out of Asia but apparently there are no options as of yet for the US.
Let me know if I can provide any other information.
Best of luck!
StevenMay 5, 2016 at 4:09 pm #90192
Anatta…..happy to hear that you too have been accepted in this trial. I hope this thread will be populated with others participating as well. Please don’t hesitate from reactivating your question on a regular basis.
Wishing the best of luck,
MarionMay 5, 2016 at 12:31 pm #90191
I have not written for a the longest time, more than 3 years to be exact, even though I have followed the board on a regular basis. After extensive surgery, SBRT to a portocaval node, a
short course of chemo followed by re-exploration and abdominal hernia repair one year ago,
I now experienced a more aggressive recurrence of the malignancy as I am running out of treatment options. Genetic profiling had revealed genomic alterations that included IDH1.
Therefore I applied and was just recently accepted into the Agios Ag-120 trial. I do not have follow-up results yet but would be interested to establish contact with other patients who are on that trial.
Thank you for being there,
Anatta23February 5, 2016 at 3:19 pm #90189
Thank you so much for your thoughts and kind words Marion and Melinda! I will definitely stay in touch.January 30, 2016 at 6:37 am #90188mbachiniModerator
Thanks for the update on your mom. Sorry for the conflicting results…..happy for the good news, but darn the pesky spots on the lungs!!
This is definitely not clinical…..but when I had a bad cough from my lung tumors…….orange tic tacs gave me the most relief!!!
Sending prayers and hugs!
MelindaJanuary 30, 2016 at 5:46 am #90187
Steven…..perhaps your Mom will continue to respond to the current treatments and the lung issue can be addressed at some later date. Fingers crossed for a successful biopsy and for the PET report to confirm the absolute best results. Please stay in touch.
MarionJanuary 29, 2016 at 6:44 pm #90186
Thank you very much Marion. We heard back from Dr. Harding that the PET scan indicates that the activity (FDG avidity) of the tumors in the liver and other sites has decreased while there has been increase in activity in the lung. Taken with the imaging findings on CT, he advised that this indicates a mixed response to treatment. The study radiologist felt that overall the disease was stable and the overall findings did not support progression of disease. Dr. Harding further advised that since she has been clinically well with stable cough and ascites and she has relatively chemo-insensitive disease, he thinks it would be reasonable to continue the current study at the present time. He also advised that if the cough worsened or she had any worsening pulmonary signs (shortness of breath, DOE, etc.), to contact MSK and that may mean we stop the study. Dr. Harding also recommend a short interval CT-chest at 4 weeks (to be discussed tomorrow in lieu of the PET findings) to make sure the disease is not continuing to grow.
Thanks again for all your well wishes!January 28, 2016 at 7:30 pm #90185
Steven….absolutely, you are helping others with reporting, hence we will move this thread to the Clinical Trials section of our site. Not only does it capture the information, but also it allows for study participant connection, which I believe is of high importance to all. I am so sorry to hear of the increased lung tumors. Has anything been suggested for suppression of coughing? Otherwise your Mom appears to hold her own and that is good news and which I hope will be confirmed by imaging and the upcoming biopsy. Fingers crossed.
Tons of good wishes,
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