BREAKING: Nivolumab (Opdivo) APPROVED for MSI-High CRC

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Maia
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BREAKING: Nivolumab (Opdivo) APPROVED for MSI-High CRC

Postby Maia » Tue Aug 01, 2017 10:42 am

FDA Approves Nivolumab for MSI-H or dMMR Colorectal Cancer

Tuesday, Aug 01, 2017

The FDA has granted an accelerated approval to nivolumab (Opdivo) for the treatment of adult and pediatric patients with microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) metastatic colorectal cancer (mCRC) that has progressed following treatment with a fluoropyrimidine, oxaliplatin, and irinotecan.

“Patients with metastatic colorectal cancer who have dMMR or MSI-H tumors are less likely to respond to conventional chemotherapy,” Heinz-Josef Lenz, MD, J. Terrence Lanni Chair in Gastrointestinal Cancer Research, University of Southern California, said in a statement. “While the challenges of treating these patients have been significant, tumors characterized by these biomarkers are immunogenic. Therefore, advances in immunotherapy research are encouraging in presenting new treatment options for appropriate patients with MSI-H metastatic colorectal cancer.”

http://www.onclive.com/web-exclusives/f ... tal-cancer

LMighty
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Location: Hong Kong

Re: BREAKING: Nivolumab (Opdivo) APPROVED for MSI-High CRC

Postby LMighty » Tue Aug 01, 2017 11:12 am

Another monumental progress! Hope more good news for MSS soon.
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

veckon
Posts: 131
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Re: BREAKING: Nivolumab (Opdivo) APPROVED for MSI-High CRC

Postby veckon » Tue Aug 01, 2017 3:46 pm

Hi Maia, do you know/understand the difference between this drug and keytruda? Looks like both are pd-1 inhibitors. I wonder if you stop responding to one, another might work depending on what exactly differentiates this drug.
27 yo male
Metastatic rectal cancer diagnosed 12/16
Liver metastases and peritoneal carcinomatosis
Lynch syndrome, MSI-H
Failed liver resection 3/17
FOLFOX6 12/16 - 05/17
Keytruda 5/17 - present
@Memorial Sloan Kettering

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wwroam
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Re: BREAKING: Nivolumab (Opdivo) APPROVED for MSI-High CRC

Postby wwroam » Tue Aug 01, 2017 7:39 pm

Last week it was accepted onto the Pharmaceutical benefits Scheme for Lung ( my current hobby) and Breast Cancers in Australia.
It certainly appears versatile.
Stage 3a DX 25/06/07
Folfox complete 30/01/08
7 years NED
Port scheduled for removal 8/02/10 Gone.
PSA .54 No prostate problems
Diagnosed Type 2 Diabetic
SO diagnosed CC Stage IV Liver Mets 23/03/15

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Maia
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Re: BREAKING: Nivolumab (Opdivo) APPROVED for MSI-High CRC

Postby Maia » Wed Aug 02, 2017 8:33 am

veckon wrote:the difference between this drug and keytruda? Looks like both are pd-1 inhibitors. I wonder if you stop responding to one, another might work depending on what exactly differentiates this drug.


Keytruda (pembrolizumab) and Opdivo (nivolumab) are both anti PD-1. They are too similar. Even drugs that are anti PD-L1 (those that act on the same pathway, but attach to the ligand --the 'L'--in the cancer cell) are considered clinically similar (those drugs are Tecentriq --atezolizumab--, Imfinzi --durvalumab--, Bavencio --avelumab). If an MSI-high patient stops responding to any of them, the next rational step would be trying a combination, like the ones being tried for MSS: anti PD-1 + Avastin / anti PD-1 + targeted agent, like a MEK inhibitor, anti PD-1 + chemotherapy.
Maybe it does make sense to try, in that combination, an anti PD-L1, if one already had an anti PD-1.

About the difference of effectiveness between Keytruda and Opdivo, I'm still reading and trying to understand the numbers --and waiting for someone that really knows, no an aficionado like me, to publish an article today LOLOL
One difference is that Opdivo was approved only for MSH-high colorectal cancer and Keytruda for any type of cancer, like pancreatic, lung, ovarian, etc., that is MSI-High.

veckon
Posts: 131
Joined: Thu Jul 27, 2017 7:44 am

Re: BREAKING: Nivolumab (Opdivo) APPROVED for MSI-High CRC

Postby veckon » Wed Aug 02, 2017 8:46 am

Maia wrote:
veckon wrote:the difference between this drug and keytruda? Looks like both are pd-1 inhibitors. I wonder if you stop responding to one, another might work depending on what exactly differentiates this drug.


Keytruda (pembrolizumab) and Opdivo (nivolumab) are both anti PD-1. They are too similar. Even drugs that are anti PD-L1 (those that act on the same pathway, but attach to the ligand --the 'L'--in the cancer cell) are considered clinically similar (those drugs are Tecentriq --atezolizumab--, Imfinzi --durvalumab--, Bavencio --avelumab). If an MSI-high patient stops responding to any of them, the next rational step would be trying a combination, like the ones being tried for MSS: anti PD-1 + Avastin / anti PD-1 + targeted agent, like a MEK inhibitor, anti PD-1 + chemotherapy.
Maybe it does make sense to try, in that combination, an anti PD-L1, if one already had an anti PD-1.

About the difference of effectiveness between Keytruda and Opdivo, I'm still reading and trying to understand the numbers --and waiting for someone that really knows, no an aficionado like me, to publish an article today LOLOL
One difference is that Opdivo was approved only for MSH-high colorectal cancer and Keytruda for any type of cancer, like pancreatic, lung, ovarian, etc., that is MSI-High.



Thanks for the information. Very interesting. It was also really striking to see the differences in response for both drugs. Clinical complete response rate seems to be significantly higher with keytruda. I’m going to ask my doctor about it next week.
27 yo male
Metastatic rectal cancer diagnosed 12/16
Liver metastases and peritoneal carcinomatosis
Lynch syndrome, MSI-H
Failed liver resection 3/17
FOLFOX6 12/16 - 05/17
Keytruda 5/17 - present
@Memorial Sloan Kettering

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wwroam
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Re: BREAKING: Nivolumab (Opdivo) APPROVED for MSI-High CRC

Postby wwroam » Wed Aug 02, 2017 5:03 pm

Yesterday I had an appointment with my medical Oncologist to discuss chemo concurrent with my radiation.
This is for NSCLung Cancer and I took the opportunity to discuss Opdivo.
It has been most successful with NSCLC ( hes has trialled it with 50 patients over the past 12 months with success).
It's success with other cancers has not been as dramatic.
Stage 3a DX 25/06/07
Folfox complete 30/01/08
7 years NED
Port scheduled for removal 8/02/10 Gone.
PSA .54 No prostate problems
Diagnosed Type 2 Diabetic
SO diagnosed CC Stage IV Liver Mets 23/03/15

henry123
Posts: 135
Joined: Sun Oct 08, 2017 3:25 am

Re: BREAKING: Nivolumab (Opdivo) APPROVED for MSI-High CRC

Postby henry123 » Fri Dec 22, 2017 12:02 am

veckon wrote:
Maia wrote:
veckon wrote:the difference between this drug and keytruda? Looks like both are pd-1 inhibitors. I wonder if you stop responding to one, another might work depending on what exactly differentiates this drug.


Keytruda (pembrolizumab) and Opdivo (nivolumab) are both anti PD-1. They are too similar. Even drugs that are anti PD-L1 (those that act on the same pathway, but attach to the ligand --the 'L'--in the cancer cell) are considered clinically similar (those drugs are Tecentriq --atezolizumab--, Imfinzi --durvalumab--, Bavencio --avelumab). If an MSI-high patient stops responding to any of them, the next rational step would be trying a combination, like the ones being tried for MSS: anti PD-1 + Avastin / anti PD-1 + targeted agent, like a MEK inhibitor, anti PD-1 + chemotherapy.
Maybe it does make sense to try, in that combination, an anti PD-L1, if one already had an anti PD-1.

About the difference of effectiveness between Keytruda and Opdivo, I'm still reading and trying to understand the numbers --and waiting for someone that really knows, no an aficionado like me, to publish an article today LOLOL
One difference is that Opdivo was approved only for MSH-high colorectal cancer and Keytruda for any type of cancer, like pancreatic, lung, ovarian, etc., that is MSI-High.



Thanks for the information. Very interesting. It was also really striking to see the differences in response for both drugs. Clinical complete response rate seems to be significantly higher with keytruda. I’m going to ask my doctor about it next week.


My oncologist had started Keytruda on 1 patient before starting Opdivo with me. Both of us have responded well .
He is now of opinion , based on discussions with other oncologists and his observations, opdivo is better option. He is now recommending Opdivo for his patients.

I have a question as to why are patients on Opdivo told to avoid sunlight exposure.

Any new update on Keytruda or Opdivo?
46yo M
5/16 lap AR 14/21 L nodes +ve
T4N2M1
7/16 Capox 9 cyc
9/16 cea 2
1/17 550
PET CT mets in lung & peri
iri+ avast fail
3/17 10577
msi-h Lynch
4/17 regro fail
5/17 cea 28800
5/17 CT inc in size of mes nodes , new onset of multi nodules in liver.
6/17 Opdivo start
7/17 26754
8/17 5623
9/17 497
10/17 52
11/17 12
CT all clear exc a nodule in Lung. liver normal
1/18 3.6
2/18 2.3
4/18 2.0
opdivo continue
Aspirin start
6/18 1.5 CT clear
8/18 1.3
NED
Vegan yoga juicing apricot

henry123
Posts: 135
Joined: Sun Oct 08, 2017 3:25 am

Re: BREAKING: Nivolumab (Opdivo) APPROVED for MSI-High CRC

Postby henry123 » Wed Jan 03, 2018 12:29 am

Hello
My latest cea value is 3.6
Almost normal.
Hopefully under 3 by next month .
Fingers crossed.
46yo M
5/16 lap AR 14/21 L nodes +ve
T4N2M1
7/16 Capox 9 cyc
9/16 cea 2
1/17 550
PET CT mets in lung & peri
iri+ avast fail
3/17 10577
msi-h Lynch
4/17 regro fail
5/17 cea 28800
5/17 CT inc in size of mes nodes , new onset of multi nodules in liver.
6/17 Opdivo start
7/17 26754
8/17 5623
9/17 497
10/17 52
11/17 12
CT all clear exc a nodule in Lung. liver normal
1/18 3.6
2/18 2.3
4/18 2.0
opdivo continue
Aspirin start
6/18 1.5 CT clear
8/18 1.3
NED
Vegan yoga juicing apricot

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Robino1
Posts: 463
Joined: Fri Aug 11, 2017 12:09 pm
Facebook Username: Robin.lawthers
Location: Florida

Re: BREAKING: Nivolumab (Opdivo) APPROVED for MSI-High CRC

Postby Robino1 » Wed Jan 03, 2018 9:49 am

What an amazing drop in your CEA number!!!

Sounds like Opdivo is working splendidly for you :D
At 54 2014 1st colonoscopy colon cancer detect
Colon resect margins clear. No chemo Stage II
2017
Distend abd, pain in intestines.
CT scan seeding & Ascites
Lap diag - cancer on the omentum
CEA 217; 219
FOLFOX started 6/17
CEA 202
8/29/17 CT melting of tumor.
Latest CT scan shows 2 new tumors and return of ascites.
CEA: (2017)9/30 -109; 10/12 -99.1; 11/4 -90.7; 11/30 -70.7; 12/14 -83.4; (2018)1/4 -73.3; 2/1-84.2; 89.2; 89.8; 88.5; 81.8: 93.5; 107; 119
BRAF V600e

henry123
Posts: 135
Joined: Sun Oct 08, 2017 3:25 am

Re: BREAKING: Nivolumab (Opdivo) APPROVED for MSI-High CRC

Postby henry123 » Wed Jan 03, 2018 4:47 pm

Robino1 wrote:What an amazing drop in your CEA number!!!

Sounds like Opdivo is working splendidly for you :D

Thanks Robino
46yo M
5/16 lap AR 14/21 L nodes +ve
T4N2M1
7/16 Capox 9 cyc
9/16 cea 2
1/17 550
PET CT mets in lung & peri
iri+ avast fail
3/17 10577
msi-h Lynch
4/17 regro fail
5/17 cea 28800
5/17 CT inc in size of mes nodes , new onset of multi nodules in liver.
6/17 Opdivo start
7/17 26754
8/17 5623
9/17 497
10/17 52
11/17 12
CT all clear exc a nodule in Lung. liver normal
1/18 3.6
2/18 2.3
4/18 2.0
opdivo continue
Aspirin start
6/18 1.5 CT clear
8/18 1.3
NED
Vegan yoga juicing apricot

Lee
Posts: 5680
Joined: Sun Apr 16, 2006 4:09 pm

Re: BREAKING: Nivolumab (Opdivo) APPROVED for MSI-High CRC

Postby Lee » Wed Jan 03, 2018 5:48 pm

henry123 wrote:I have a question as to why are patients on Opdivo told to avoid sunlight exposure.

Any new update on Keytruda or Opdivo?


I was on FOLFOX only, butt I too was told to avoid the sun. If I remember correctly it makes you more susceptible to sunburns.

Are you just taking Opdivo alone or in conjunction with chemo?

Lee
rectal cancer - April 2004
46 yrs old at diagnoses
stage III C - 6/13 lymph positive
radiation - 6 weeks
surgery - August 2004/hernia repair 2014
permanent colostomy
chemo - FOLFOX
NED - 10 years and counting!

henry123
Posts: 135
Joined: Sun Oct 08, 2017 3:25 am

Re: BREAKING: Nivolumab (Opdivo) APPROVED for MSI-High CRC

Postby henry123 » Wed Jan 03, 2018 10:20 pm

Lee wrote:
henry123 wrote:I have a question as to why are patients on Opdivo told to avoid sunlight exposure.

Any new update on Keytruda or Opdivo?


I was on FOLFOX only, butt I too was told to avoid the sun. If I remember correctly it makes you more susceptible to sunburns.

Are you just taking Opdivo alone or in conjunction with chemo?

Lee

Monotherapy. Just Nivolumab.
Oncologist even stopped all supplements and multivitamins I was taking earlier.
He was especially strict that steroid or sterol based supplements and medicines should be avoided as they may interfere with working of Opdivo.
He emphasised on movement and light exercises a lot.
Now , he is telling me to get back into normal work routine . It is a bit tough mentally as just 6 7 months ago , I was in a different frame of mind ( with nothing working).
Can someone guide me how to make the transition from state of mind where you are ready to leave this world to possibility of being ok for whatever time
46yo M
5/16 lap AR 14/21 L nodes +ve
T4N2M1
7/16 Capox 9 cyc
9/16 cea 2
1/17 550
PET CT mets in lung & peri
iri+ avast fail
3/17 10577
msi-h Lynch
4/17 regro fail
5/17 cea 28800
5/17 CT inc in size of mes nodes , new onset of multi nodules in liver.
6/17 Opdivo start
7/17 26754
8/17 5623
9/17 497
10/17 52
11/17 12
CT all clear exc a nodule in Lung. liver normal
1/18 3.6
2/18 2.3
4/18 2.0
opdivo continue
Aspirin start
6/18 1.5 CT clear
8/18 1.3
NED
Vegan yoga juicing apricot

Lee
Posts: 5680
Joined: Sun Apr 16, 2006 4:09 pm

Re: BREAKING: Nivolumab (Opdivo) APPROVED for MSI-High CRC

Postby Lee » Thu Jan 04, 2018 11:07 am

henry123 wrote:Monotherapy. Just Nivolumab.
Oncologist even stopped all supplements and multivitamins I was taking earlier.
He was especially strict that steroid or sterol based supplements and medicines should be avoided as they may interfere with working of Opdivo.
He emphasised on movement and light exercises a lot.
Now , he is telling me to get back into normal work routine . It is a bit tough mentally as just 6 7 months ago , I was in a different frame of mind ( with nothing working).
Can someone guide me how to make the transition from state of mind where you are ready to leave this world to possibility of being ok for whatever time


Sounds like you are in the same boat I was in 13 years ago. FOXFOX was only approved for stage IV folks then as it was an experimental chemo. My Onc got me on board as a stage III. Butt I was her 1st and only patient getting this chemo for several months. I was not allowed to take anything without Onc approval. I was not allowed to take over the counter vitamins, supplements as it could interfere with what the chemo was trying to do. Opdivo is a new drug that is showing a lot of promise. Yes exercise is good for you. It has been shown to reduce recurrence and mets by up to 50%. It can also helps mentally.

Don't have any real advice making the transition from leaning this world to possibility of being okay. Personally that sound like a question to start a new thread with.

Good luck,

Lee
rectal cancer - April 2004
46 yrs old at diagnoses
stage III C - 6/13 lymph positive
radiation - 6 weeks
surgery - August 2004/hernia repair 2014
permanent colostomy
chemo - FOLFOX
NED - 10 years and counting!

deebashari
Posts: 12
Joined: Wed Feb 07, 2018 2:51 am

Re: BREAKING: Nivolumab (Opdivo) APPROVED for MSI-High CRC

Postby deebashari » Tue Feb 20, 2018 8:07 pm

Hello! I am interested in a nivolumab trial for my mom. What is your MSI status? Are you non MSI-HIGH or MSI-High?



henry123 wrote:Hello
My latest cea value is 3.6
Almost normal.
Hopefully under 3 by next month .
Fingers crossed.


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