BREAKING: Pembrolizumab/Keytruda APPROVED for MSI-High CRC

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Maia
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BREAKING: Pembrolizumab/Keytruda APPROVED for MSI-High CRC

Postby Maia » Tue May 23, 2017 2:56 pm

MAY 23th

There you go, our first approved immunotherapy for a subset of CRC.
Again: find out your microsatellite status --If MSS or MSI

http://www.onclive.com/web-exclusives/f ... nt-cancers
Last edited by Maia on Sun May 28, 2017 10:30 am, edited 1 time in total.

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juliej
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Re: BREAKING: Pembrolizumab/Keytruda APPROVED for MSI-High CRC

Postby juliej » Tue May 23, 2017 6:05 pm

Thanks, Maia, my zombie-fighting budddy! :D

What's interesting is it's the first time the FDA has approved a cancer treatment based on a specific genetic marker rather than the location in the body. Keytruda is approved for adult and pediatric patients with unresectable solid tumors that are MSI-H or dMMR. Period. That means endometrial, breast, prostate, bladder, thyroid gland, etc tumors with MSI-H or dMMR biomarkers would qualify, as well as colorectal. This is an important "first" for the immunotherapy field and cancer treatment!!!

xo,
Juliej
Stage IV, liver/lung mets 8/4/2010
Xelox+Avastin 8/18/10 to 10/21/11
LAR, liver resec, HAI pump 11/11
Double lung surgery + ileo reversal 2/12
Adjuvant Xeloda 3-9/12
VATS rt. lung 12/21/12 - benign granuloma!
NED 3/17/12 to 10/2/2017, CEA<1

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CRguy
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Re: BREAKING: Pembrolizumab/Keytruda APPROVED for MSI-High CRC

Postby CRguy » Tue May 23, 2017 6:19 pm

Totally agreed !

This is also the genesis for the POG initiative :

This tumor expresses this behavior / marker ..
SO HERE is what is known to block / intensify / identify this particular oncogenesis

REGARDLESS of whether it may be BC, CRC, lung, prostate. ovarian ... whatever,
THIS tumor does THIS
and now we now we can do THAT to stop it !!!!!

That IS WORD ! in my world

Cheers and Harmony
CR
Caregiver x 3
Stage IV A rectal cancer/lung met
10 Year survivor
my life is an ongoing totally randomized UNcontrolled experiment with N=1 !
Review of my Journey so far

BIG ROB 69
Posts: 62
Joined: Sun Aug 28, 2016 2:00 am
Location: Long Island, NY

Re: BREAKING: Pembrolizumab/Keytruda APPROVED for MSI-High CRC

Postby BIG ROB 69 » Wed May 24, 2017 3:24 am

GO KEYTRUDA GO!!!
3/18/2015 DX CC Stage3/4 49YO MALE IN NEW YORK
Inoperable...hepatic artery
11/15 oper to rem block...colon bypass
4/16 oper to remove scar tissue
5/16 Lynch pos.
10/16 Two bile tubes installed to relieve jaundice
So far I have done the three main chemo drug rounds and on 12/19/16 start Keytruda.
No chemo after 8/3/16 CEA: 10/14/16-409 12/19/16- 887 Mostly my CEA was in the 140-180 range.
CEA: 1/9/17-415 1/30/17-156.2 2/20/17-120.8 3/13/17-98 4/21/17-83.6 5/12/17-64.7 6/1/17-32.1
7/25/17-32.6

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Hannah Faulkner
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Re: BREAKING: Pembrolizumab/Keytruda APPROVED for MSI-High CRC

Postby Hannah Faulkner » Wed May 24, 2017 4:52 am

I heard about the effectiveness of keytruda but what about the side effects it comes with? Also cost are high Merck making money..

LMighty
Posts: 98
Joined: Sun Aug 28, 2016 6:16 am
Location: Hong Kong

Re: BREAKING: Pembrolizumab/Keytruda APPROVED for MSI-High CRC

Postby LMighty » Wed May 24, 2017 10:25 am

Great info. What about Keytruda's effectiveness to MSS though?

My mom is starting Keytruda soon but her MS status is not yet determined so I am wondering about its efficacy. From what I have read so far, it seems Keytruda only benefits those with MSI-H which is a really small percentage of stage IV patients?
Supporter to my mom (64 yr); KRAS wild type; MSS

2012: DX Stage I, rectal cancer; resection and colostomy
5/16: DX Stage III, mets found; right groin lymph node and soft tissue
5-6/16: Radiation + Xeloda
7/16: DX Stage IV, pleural effusion; cancer cells found in fluid
7-12/16: Xelox + Avastin X 6
1/17: Clean PET scan, NED
2/17: Pleural effusion; recurrence
4/17: Iri + Erb X 3
5/17: Ascites; Chemo failed
6/17: Keytruda X 1
7/17: TECENTRIQ (atezolizumab) + COTELLIC (cobimetinib)
9/17: At peace

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Maia
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Joined: Fri Aug 24, 2012 8:00 am

Re: BREAKING: Pembrolizumab/Keytruda APPROVED for MSI-High CRC

Postby Maia » Wed May 24, 2017 3:26 pm

LMighty wrote:Great info. What about Keytruda's effectiveness to MSS though?

My mom is starting Keytruda soon but her MS status is not yet determined so I am wondering about its efficacy. From what I have read so far, it seems Keytruda only benefits those with MSI-H which is a really small percentage of stage IV patients?


You're right: as monotherapy, that is, alone, on its own, pembrolizumab (Keytruda) benefits to those MSI-High, which is about 10-15% of all CRC patients. A very little number of MSS has benefit from a checkpoint inhibitor of anti PD-1/ L1 --like pembrolizumab, nivolumab, atezolizumab, duravalumab, avelumab.
It is thought that those immunotherapies will work for MSS in some sort of combination: with other immunotherapies, chemotherapies, targeted agents, etc.
For that reason, you will see that the current most promising clinical trials for MSS have such design, more often:

immunotherapy + [something else]

I see in your other post that your mom's oncologist is willing to try Keytruda, regardless of MSS status. That is fantastic, there are reports of some MSS patients with responses from 'just' it. A really good thing is that from the moment he's able to get her the immunotherapy, it will be possible also combine it with 'something else', mimicking some of the ongoing trials.
Just as an example:

Keytruda+ Erbitux, that she was taking, as seen in your signature. Remember it failed in other combo; that doesn't mean the drug itself is not longer of use. A trial with that combination is ongoing at Roswell Park:
Cetuximab and Pembrolizumab in Treating Patients With Colorectal Cancer That is Metastatic or Cannot Be Removed by Surgery https://clinicaltrials.gov/ct2/show/NCT02713373

Keytruda + Folfox Study of Pembrolizumab in Combination With Chemotherapy for Patients With Advanced Colorectal Cancer https://clinicaltrials.gov/ct2/show/NCT02375672
This study is presenting the results in a couple of weeks at ASCO 17. Abstract to print for her doc: http://abstracts.asco.org/199/AbstView_199_183499.html

Opdivo (nivolumab, other brand of anti PD-1) + Lonsurf
: A Study Evaluating TAS-102 Plus Nivolumab in Patients With MSS CRC https://clinicaltrials.gov/ct2/show/NCT02860546

So, just without participating in a clinical trial, that you mention you have not in a location near you, those combination would be possible.
And some more. If your mom oncologist is willing to, he could explore the MSS clinical trial finder:

http://trialfinder.fightcrc.org/

I wish you and your mom the best!!

recruiter
Posts: 78
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Facebook Username: Bill Wilson

Re: BREAKING: Pembrolizumab/Keytruda APPROVED for MSI-High CRC

Postby recruiter » Thu May 25, 2017 2:39 pm

Trying to get qualified for this myself. Watching this one with a lot of interest.
DX Stage 4 2/16 with lung mets
4/16 CT, PET show "marked improvement" in size and number of lung mets, rectal tumor.
8/16 "Great report" from scans, lung mets continue to shrink in size and number, CEA 1.6, cancer "in remission" but surgeon believes tumor remains too large.
10/16 Xrays for constipation problems reveal tumor occupies 25 percent of rectal canal: Occupied 80 percent upon diagnosis 2/16
12/16 Back on Avastin; tumor can be removed, but need better margins.

LMighty
Posts: 98
Joined: Sun Aug 28, 2016 6:16 am
Location: Hong Kong

Re: BREAKING: Pembrolizumab/Keytruda APPROVED for MSI-High CRC

Postby LMighty » Fri May 26, 2017 9:00 pm

[url][/url]
Maia wrote:
LMighty wrote:Great info. What about Keytruda's effectiveness to MSS though?

My mom is starting Keytruda soon but her MS status is not yet determined so I am wondering about its efficacy. From what I have read so far, it seems Keytruda only benefits those with MSI-H which is a really small percentage of stage IV patients?


You're right: as monotherapy, that is, alone, on its own, pembrolizumab (Keytruda) benefits to those MSI-High, which is about 10-15% of all CRC patients. A very little number of MSS has benefit from a checkpoint inhibitor of anti PD-1/ L1 --like pembrolizumab, nivolumab, atezolizumab, duravalumab, avelumab.
It is thought that those immunotherapies will work for MSS in some sort of combination: with other immunotherapies, chemotherapies, targeted agents, etc.
For that reason, you will see that the current most promising clinical trials for MSS have such design, more often:

immunotherapy + [something else]

I see in your other post that your mom's oncologist is willing to try Keytruda, regardless of MSS status. That is fantastic, there are reports of some MSS patients with responses from 'just' it. A really good thing is that from the moment he's able to get her the immunotherapy, it will be possible also combine it with 'something else', mimicking some of the ongoing trials.
Just as an example:

Keytruda+ Erbitux, that she was taking, as seen in your signature. Remember it failed in other combo; that doesn't mean the drug itself is not longer of use. A trial with that combination is ongoing at Roswell Park:
Cetuximab and Pembrolizumab in Treating Patients With Colorectal Cancer That is Metastatic or Cannot Be Removed by Surgery https://clinicaltrials.gov/ct2/show/NCT02713373

Keytruda + Folfox Study of Pembrolizumab in Combination With Chemotherapy for Patients With Advanced Colorectal Cancer https://clinicaltrials.gov/ct2/show/NCT02375672
This study is presenting the results in a couple of weeks at ASCO 17. Abstract to print for her doc: http://abstracts.asco.org/199/AbstView_199_183499.html

Opdivo (nivolumab, other brand of anti PD-1) + Lonsurf
: A Study Evaluating TAS-102 Plus Nivolumab in Patients With MSS CRC https://clinicaltrials.gov/ct2/show/NCT02860546

So, just without participating in a clinical trial, that you mention you have not in a location near you, those combination would be possible.
And some more. If your mom oncologist is willing to, he could explore the MSS clinical trial finder:

http://trialfinder.fightcrc.org/

I wish you and your mom the best!!


Maia,

I would like you to know that our onc promised he will take a look at the trial finder in considering possible regimens. I will keep you updated on our decision!
Supporter to my mom (64 yr); KRAS wild type; MSS

2012: DX Stage I, rectal cancer; resection and colostomy
5/16: DX Stage III, mets found; right groin lymph node and soft tissue
5-6/16: Radiation + Xeloda
7/16: DX Stage IV, pleural effusion; cancer cells found in fluid
7-12/16: Xelox + Avastin X 6
1/17: Clean PET scan, NED
2/17: Pleural effusion; recurrence
4/17: Iri + Erb X 3
5/17: Ascites; Chemo failed
6/17: Keytruda X 1
7/17: TECENTRIQ (atezolizumab) + COTELLIC (cobimetinib)
9/17: At peace

User avatar
Maia
Posts: 2443
Joined: Fri Aug 24, 2012 8:00 am

Re: BREAKING: Pembrolizumab/Keytruda APPROVED for MSI-High CRC

Postby Maia » Sat May 27, 2017 11:35 am

LMighty, that's nice to hear --I looks like your mom's oncologist is very inclined to work as a team.
I also was glad to know that the possibility of using drugs off label is easier in Hong Kong.
Given that she's dealing with peritoneal mets, it might be helpful for you to know that a treatment called PIPAC (Pressurized Intraperitoneal Aerosol Chemotherapy) is approved in many countries --not in USA--- and that you have a recently open location in Singapore: ishttp://coloncancersupport.colonclub.c ... 1&p=448006


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