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Keytruda....Working for MSS....Mutation Burden is the Key
Posted: Sun Aug 05, 2018 11:29 pm
by Jack&KatiesMommy
i wanted to give you all an update on my off-label use of Keytruda (since I am MSS it is not approved for use by me....since it doesn’t generally work for colon cancer patients which microsatellite stable tumors.)
HOWEVER, it looks like it is working for me....and here is the reason why (according to my doctor and the Foundation One reps): it is not whether the tumor is MSS or MSI that is determinative as to whether the immunotherapy will work....it is the THE TUMOR’S MUTATION BURDEN THAT DETERMINES WHETHER KEYTRUDA WILL WORK.
Foundation One is seeing evidence that people whose tumors have a high (or moderately high) mutation burden tend to respond to the immunotherapy treatments. Generally MSI tumors have a high mutation burden and MSS tumors have just one or two mutations if any. In my case (probably dilute to the fact that I’ve had many different courses of treatments over the last 7 years) my MSS tumor has a moderate mutation burden (11 mutations.). So my local oncologist (who has been doing tons of work with immunotherapy over the last 6 years) got permission to treat me with Keytruda off-label.
My CEA (which is super sensitive and very accurate over the last 7 years) was 39.6 before my first Keytruda treatment. Three weeks later, before my second treatment, my CEA had risen to 66.4. Before my third treatment, my CEA was back down to 39.2, and three weeks later before my 4th treatment it was down to 13.0. On Friday, before my 5th treatment my CEA was down to 3.5 and my CT scan showed shrinkage of the only slightly enlarged lymph nodes in my hilar lung area to normal size.
This is an amazing breakthrough for MSS patients. If you are MSS, please get Foundation One Testing to see if you have a moderate or high mutation burden. If you do, immunotherapy couldvwork for you.
Please feel free to contact me if you have questions.
Cynthia
Re: Keytruda....Working for MSS....Mutation Burden is the Key
Posted: Mon Aug 06, 2018 2:55 am
by stu
That is utterly amazing . You are pushing medical boundaries for sure.
So happy for you.
Stu
Re: Keytruda....Working for MSS....Mutation Burden is the Key
Posted: Mon Aug 06, 2018 8:34 am
by plastikos
Amazing news. Hoping for your continued response to Keytruda.
Re: Keytruda....Working for MSS....Mutation Burden is the Key
Posted: Mon Aug 06, 2018 10:52 am
by boxhill
Cynthia, this is great.
Is this something your health insurance will agree to pay for?
Re: Keytruda....Working for MSS....Mutation Burden is the Key
Posted: Mon Aug 06, 2018 12:30 pm
by crazylife
Such great news! Can someone tell me what this means? I can't tell if he has all of these or just the first two mentioned. This is from MSK-IMPACT:
Positive for the following somatic alterations in the clinically validated panel:
1. KRAS
2. TP53
Positive for the following somatic alterations in the investigational panel:
3. AMER1
4. APC
5. APC
6.PTEN
7. REL
Re: Keytruda....Working for MSS....Mutation Burden is the Key
Posted: Mon Aug 06, 2018 2:34 pm
by Jack&KatiesMommy
boxhill wrote:Cynthia, this is great.
Is this something your health insurance will agree to pay for?
Great question. Yes, actually my insurance IS covering this treatment even though it is off-label for me due to my MSS status. However, my local oncologist submitted a request along with all of his data as well as that from Foundation One showing the correlation between mutation burden and Keytruda effectiveness that resulted in approval.
Cynthia
Re: Keytruda....Working for MSS....Mutation Burden is the Key
Posted: Mon Aug 06, 2018 2:40 pm
by Jack&KatiesMommy
crazylife wrote:Such great news! Can someone tell me what this means? I can't tell if he has all of these or just the first two mentioned. This is from MSK-IMPACT:
Positive for the following somatic alterations in the clinically validated panel:
1. KRAS
2. TP53
Positive for the following somatic alterations in the investigational panel:
3. AMER1
4. APC
5. APC
6.PTEN
7. REL
Unfortunately, I am not sure what this means. To my understanding, the Foundation One test is the only one that does mutation burden testing.
Cynthia
Re: Keytruda....Working for MSS....Mutation Burden is the Key
Posted: Thu Aug 09, 2018 9:40 pm
by boswind
Great news! Thank you.
I contacted FoundationOne to get more information. For those who have advaced MSS colon cancer and have had targeted therapies for years, there is a chance that they have more gene mutations. Consequently, Keytruda may work for some of them. I am excited and will talk to my onc immediately.
The cost of the test is $5800 (listed price). The true price a insurance company will pay is likely:
Over $3000 if the testing sample is biopsy tissue and they will test 324 genes for mutations;
Under $2500 if the testing sample is peripheral blood and they test 62 genes for mutations.
Re: Keytruda....Working for MSS....Mutation Burden is the Key
Posted: Mon Aug 20, 2018 9:19 am
by Jack&KatiesMommy
Boswind:
This is excellent follow-up with Foundation One. I hope that others are able to take advantage of this. Foundation One (and my local oncologist) are finding that Keytruda has been working for many patients outside the scope of the typical responders...primarily based on tumor mutation. This is an avenue that may be available to many who think that they have no other options.
My Oncologist prepared a request for my insurance including his and Foundation One's research regarding mutation burden and response and my insurance agreed to cover the cost of Keytruda even though it was an "off-label" use for me as an MSS patient.
Cynthia
Re: Keytruda....Working for MSS....Mutation Burden is the Key
Posted: Fri Aug 24, 2018 11:31 pm
by Steph20021
I wonder, can Canadians get Foundation One testing? What exactly am I asking them for, (just for “mutation burden testing of my tumour”) and how much could I expect to pay, any ideas?
Re: Keytruda....Working for MSS....Mutation Burden is the Key
Posted: Fri Aug 24, 2018 11:43 pm
by Steph20021
It is amazing to me to see you doing so well 7 years out as a stage 4 patient!! It gives the rest of us hope!
Jack&KatiesMommy wrote:i wanted to give you all an update on my off-label use of Keytruda (since I am MSS it is not approved for use by me....since it doesn’t generally work for colon cancer patients which microsatellite stable tumors.)
HOWEVER, it looks like it is working for me....and here is the reason why (according to my doctor and the Foundation One reps): it is not whether the tumor is ZmSS or MSI that is determinative as to whether the immunotherapy will work....it is the THE TUMOR’S MUTATION BURDEN THAT DETERMINES WHETHER KEYTRUDA WILL WORK.
Foundation One is seeing evidence that people whose tumors have a high (or moderately high) mutation burden tend to respond to the immunotherapy treatments. Generally MSI tumors have a high mutation burden and MSS tumors have just one or two mutations if any. In my case (probably dilute to the fact that I’ve had many different courses of treatments over the kart 7 years) my ZmSS tumor has a moderate mutation burden (11 mutations.). So my local oncologist (who has been doing tons of work with immunotherapy over the last 6 years) got permission to treat me with Keytruda off-label.
My CEA (which is super sensitive and very accurate over the last 7 years) was 39.6 before my first Keytruda treatment. Three weeks later, before my second treatment, my CEA had risen to 66.4. Before my third treatment, my CEA was back down to 39.2, and three weeks later before my 4th treatment it was down to 13.0. On Friday, before my 5th treatment my CEA was down to 3.5 and my CT scan showed shrinkage of the only slightly enlarged lymph nodes in my hilar lung area to normal size.
This is an amazing breakthrough for MSS patients. If you are MSS, please get Foundation One Testing to see if you have a moderate or high mutation burden. If you do, immunotherapy couldvwork for you.
Please feel free to contact me if you have questions.
Cynthia
Re: Keytruda....Working for MSS....Mutation Burden is the Key
Posted: Tue Aug 28, 2018 5:49 pm
by erinnatacha
Amazing news!!!!
Re: Keytruda....Working for MSS....Mutation Burden is the Key
Posted: Wed Aug 29, 2018 12:16 am
by Steph20021
Heard back already from Foundation One. “ The price for our FoundationOne® test is $6193.60 CAD for patients of Canadian ordering physicians.“ However, it looks like there’s a trial still recruiting right now, and one location is at Princess Margaret Hospital in Toronto, it’s one of the OCTANE test trials, and while it doesn’t get everything that foundation one does, it’s free for us Canadians and I think it would be a good bet to do. I’ll be speaking with my oncology about this on Thursday. Hoping I can do it with a fresh biopsy on a current tumour.
Steph20021 wrote:I wonder, can Canadians get Foundation One testing? What exactly am I asking them for, (just for “mutation burden testing of my tumour”) and how much could I expect to pay, any ideas?
Re: Keytruda....Working for MSS....Mutation Burden is the Key
Posted: Wed Aug 29, 2018 12:42 am
by Dionca
Steph20021 wrote:I wonder, can Canadians get Foundation One testing? What exactly am I asking them for, (just for “mutation burden testing of my tumour”) and how much could I expect to pay, any ideas?
Steph - here is a recent article posted on Colorectal Cancer Canada, that makes reference to the Foundation's mutation burden testing. It says the test is $5,800.
"All Cancer Patients Should Have Access To Genomic Testing"
http://archive.colorectalcancercanada.c ... ting/,5275The novelty of Foundation’s approach—like that of a few other companies leading the field of cancer diagnostics—is the scope of testing. These laboratories examine hundreds of genes by a method called next-generation sequencing (NGS). For a price of $5800, in two weeks’ time, Foundation reports on tumor mutation burden (TMB), microsatellite instability (MSI), and mutations in any of 324 genes that may indicate sensitivity—or resistance—to oncology drugs.
Re: Keytruda....Working for MSS....Mutation Burden is the Key
Posted: Wed Aug 29, 2018 5:01 pm
by Steph20021
Thanks Dionca, I don’t know why foundation one quoted me more- unless cost has gone up or she quoted me for a different test. Either way I can’t afford it. So my plan is that I will start with getting a test done through a trial at PMH. I’ll speak with my oncologist tomorrow about it.
Hoping I can get a current biopsy done of a tumour I have now rather than my 4.5 year old banked stuff. I’ve done a lot of chemo since then.
Dionca wrote:Steph20021 wrote:I wonder, can Canadians get Foundation One testing? What exactly am I asking them for, (just for “mutation burden testing of my tumour”) and how much could I expect to pay, any ideas?
Steph - here is a recent article posted on Colorectal Cancer Canada, that makes reference to the Foundation's mutation burden testing. It says the test is $5,800.
"All Cancer Patients Should Have Access To Genomic Testing"
http://archive.colorectalcancercanada.c ... ting/,5275The novelty of Foundation’s approach—like that of a few other companies leading the field of cancer diagnostics—is the scope of testing. These laboratories examine hundreds of genes by a method called next-generation sequencing (NGS). For a price of $5800, in two weeks’ time, Foundation reports on tumor mutation burden (TMB), microsatellite instability (MSI), and mutations in any of 324 genes that may indicate sensitivity—or resistance—to oncology drugs.