Agios to Present Clinical Data from Ongoing AG-120 Phase 1 Trial

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
https://www.merckaccessprogram-keytruda.com/hcc/

Opdivo:

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:
http://www.tapur.org/

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.

Hugs,
Marion

Thank you very much Marion

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.

Many thanks,
Steven

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!

Steven

Good morning,
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,
Anatta23

Hi Steven,
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!
Melinda

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!