FDA Approved Keytruda for MSS Tumors w/ TMB of 10+!!!

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Jack&KatiesMommy
Posts: 617
Joined: Wed Dec 21, 2011 1:08 pm
Location: Columbus, OH

FDA Approved Keytruda for MSS Tumors w/ TMB of 10+!!!

Postby Jack&KatiesMommy » Mon Jun 29, 2020 9:20 am

The FDA has approved the immunotherapy Keytruda for solid tumors with a tumor mutation burden of 10 or greater. This means that CRC patients with MSS tumors (with TMB of 10+) are able to get insurance coverage for the use of Keytruda! My oncologist had to petition and appeal to get my insurance to cover Keytruda for me. I have been in it for over 2 years and am a “complete responder.” I am MSS (and all my chemo options were no longer working. I had cancer in lymph nodes near my lungs when I started Keytruda in May 2018). My doctor ordered Foundation One testing and found that I had a TMB of 11....and thought that Keytruda was a final option to try. Today I am cancer free (9 years after initial diagnosis of stage IV colon cancer and lots and lots of chemo and surgeries and rfa’s.

https://www.fda.gov/drugs/drug-approval ... lid-tumors
Cynthia
Mommy to Jack (8) now (17) and Katie (4) now (13)
(My Most Precious Things)
Dx 8/11 Stage IV CRC (liver mets) CEA 2,600+
9/11 Folfiri 2/12: Failed Liver Resection
5/12 HAI pump/removed primary
4/13 Liver Resection
8/13-12/15 (10) RFAs lungs
5/17: Upper Left Lobe of lung resected.
02/18: 3 new lymph mets lung
05/18: Keytruda (MSS w/Intermediate TMB): NED CEA: 66.4, 39.2, 23.8, 13, 3.5 1.8, 1.0, 2.8 3.9, 5.0, 5.6, 1.5, .8,

Rikimaroo
Posts: 305
Joined: Tue Dec 20, 2016 8:48 pm
Location: Florida

Re: FDA Approved Keytruda for MSS Tumors w/ TMB of 10+!!!

Postby Rikimaroo » Mon Jun 29, 2020 11:57 am

This is great news. My Onc mentioned something about FDA approved something, not sure if it was Keytruda, but will talk to him. My TMB is 8, but I want him to do a new test from my last surgery, will talk to him about it.

So when you say your Cancer free, are you not doing any regimen at the moment? I hope this is the case and truly happy for you!!

Riki
RC T3N1M0 12/16
MSS - NRAS Mutation
Chemo Rad, CCR - W&W 5/2017
Recurrence 11/2017
CT Scan 11/2017 Liver Met 5.5cm Stable, Stage IV
Port Scheduled for 12/2017, folfox - avastin 12/2017
LAR/Liver Resect 4/2018
Chemo Finish 8/2018
Reversal 10/18
CEA highest 500, lowest .8 throughout process, waiting for latest
Recurrence left vesical/pelvic sidewall - 10/7/2019 resect perm bag,
FolFiri 11/6 - 5 rounds
CEA rise Feb/May 3.7, 8.8, 30, Recurrence in Pelvic
Maintenance Chemo begin 6/3/20 FolFiri

Claudine
Posts: 396
Joined: Tue Mar 12, 2019 2:41 pm
Location: Montana

Re: FDA Approved Keytruda for MSS Tumors w/ TMB of 10+!!!

Postby Claudine » Mon Jun 29, 2020 12:12 pm

Fantastic! We do not know DH's TMB but it's one more weapon in our arsenal for potential future fights. Thanks for sharing!
Wife of Dx 04/18 (51 yo). MSS, KRAS G12A
No primary (involuted?)
Lytic tumor L4 vertebrae, EBRT 04/18, SBRT 02/19
Resect small intestine 05/18 (no cancer - Crohn's)
Failed adjuvant Xelox
Folfiri + Avastin 03/19 to 01/20
6.7 cm left adrenal mass 03/19, successful resection 02/20
CEA since 03/19: high 58, low 3.2, now 4.4
Scan 03/19: Multiple small lung nodules up to 5mm
Scan 12/19: one 1mm stable nodule
PET 04/20 uptake by L4
L3-L4-L5 fusion surgery and residual tumor removal 05/20

Vana3
Posts: 39
Joined: Tue Aug 13, 2019 11:40 am
Facebook Username: ma

Re: FDA Approved Keytruda for MSS Tumors w/ TMB of 10+!!!

Postby Vana3 » Mon Jun 29, 2020 6:28 pm

That’s awesome!
Thank you so much for sharing this news!
36 year old mom of 3 kids (10 year old twins and a 6 month old)
T4aN2M1
5 cm tumor in cecum removed with clear margins
17 out of 45 lymph nodes positive
1 cm omental deposit removed
LVI present
prior to surgery CEA level 5, post surgery 4.2
MSS, KRAS g12d, Braf WT
Mutational burden: 10.9
8/20/19 more scans (CAT, MRI. PET) showed small spots on right lobe of liver
9/19 start Folfox with Avastin continued thru March 2020
1/02/20 CEA 3.6, 2/15- 4.4 3/15- 4.6, 6/05 4.6
Liver resection 4/15/20

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Jack&KatiesMommy
Posts: 617
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Location: Columbus, OH

Re: FDA Approved Keytruda for MSS Tumors w/ TMB of 10+!!!

Postby Jack&KatiesMommy » Mon Jun 29, 2020 10:29 pm

Rikimaroo wrote:This is great news. My Onc mentioned something about FDA approved something, not sure if it was Keytruda, but will talk to him. My TMB is 8, but I want him to do a new test from my last surgery, will talk to him about it.

So when you say your Cancer free, are you not doing any regimen at the moment? I hope this is the case and truly happy for you!!

Riki


Hi Riki:
I would definitely get your TMB checked again. My oncologist thinks that mne was so high due to to the prior 7 years of treatment I had gone through (multile years of chemo, rfa's etc.)

An I am currently still getting immunotherapy...but there is no evidence of disease. The immuntherapy worked...but there is no guidance as to when it is safe to stop and I am not ready to be the person to "give it a shot." It is an infusion every 3 weeks with very few side effects (fatigue ony for me).

Cynthia
Cynthia
Mommy to Jack (8) now (17) and Katie (4) now (13)
(My Most Precious Things)
Dx 8/11 Stage IV CRC (liver mets) CEA 2,600+
9/11 Folfiri 2/12: Failed Liver Resection
5/12 HAI pump/removed primary
4/13 Liver Resection
8/13-12/15 (10) RFAs lungs
5/17: Upper Left Lobe of lung resected.
02/18: 3 new lymph mets lung
05/18: Keytruda (MSS w/Intermediate TMB): NED CEA: 66.4, 39.2, 23.8, 13, 3.5 1.8, 1.0, 2.8 3.9, 5.0, 5.6, 1.5, .8,

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beach sunrise
Posts: 157
Joined: Thu Mar 05, 2020 7:14 pm

Re: FDA Approved Keytruda for MSS Tumors w/ TMB of 10+!!!

Postby beach sunrise » Mon Jun 29, 2020 11:45 pm

This is absolutely news to shout about!!!
Dx 8/19, RC, CEA 86, clinical T3N0M0
Neoadj 5FU/rad 6 wks
Surg 1-21-20 APR ostomy, - margins T4bN1a IIIC G2 MSI- 1/20 LN+ LVI+ PNI-
pre cea 24/post 5.9
Adj mFOLFOX6, cea 7
8 rds 6-10 CEA 11.4, 4 more no oxa
6-17: CEA 11.1 AFP 11.2 CA125 25.7 CA199 9
7-2: CEA 11.1 AFP 5.3 CA125 24.8 CA199 8
7-16: CEA 10.3 AFP 5.3 CA125 26.6 CA199 8
7-28 CEA 8.8 AFP 7.7 CA125 27 CA199 7
MHL1+
PMS2+
MSH2+
MSH6+
Chemo sensitivity test NCI "Test failed, neo-adj chemorad did its job. Not enough ca. cells to test."

Rikimaroo
Posts: 305
Joined: Tue Dec 20, 2016 8:48 pm
Location: Florida

Re: FDA Approved Keytruda for MSS Tumors w/ TMB of 10+!!!

Postby Rikimaroo » Tue Jun 30, 2020 5:15 pm

Cynthia,

That is awesome news. Very happy things are working and your here for a long time to enjoy your beautiful family. So the side effects Fatigue is nothing like being on FolFIRI? not even close right? How long does the fatigue last for? That CEA at .8 is the most wonderful number. I was there from my first surgery after I was 600+ CEA, love the .8 CEA.

Riki
RC T3N1M0 12/16
MSS - NRAS Mutation
Chemo Rad, CCR - W&W 5/2017
Recurrence 11/2017
CT Scan 11/2017 Liver Met 5.5cm Stable, Stage IV
Port Scheduled for 12/2017, folfox - avastin 12/2017
LAR/Liver Resect 4/2018
Chemo Finish 8/2018
Reversal 10/18
CEA highest 500, lowest .8 throughout process, waiting for latest
Recurrence left vesical/pelvic sidewall - 10/7/2019 resect perm bag,
FolFiri 11/6 - 5 rounds
CEA rise Feb/May 3.7, 8.8, 30, Recurrence in Pelvic
Maintenance Chemo begin 6/3/20 FolFiri

WarriorSpouse
Posts: 218
Joined: Tue Aug 16, 2016 9:02 pm

Re: FDA Approved Keytruda for MSS Tumors w/ TMB of 10+!!!

Postby WarriorSpouse » Thu Jul 02, 2020 1:30 am

Great news Cynthia! Thank You for sharing this with us. I am glad it is working well for you.
All the best!
WS
D/H 47 years old, 10/2014, Stage IV M/CRC, nodes 12/15, para-aortic, 5 cm sigmoid resection, positive Virchow. KRAS mut, MSS, Highly Differentiated, Lynch Neg, 5FU/LV and Avastin 1 YR (Oxi for 5 months), Zeloda/Bev since 01/2016. 02/2019 recurrence para-nodes, back to 5FU/LV Oxy/Bev. It is working again. "...Perseverance is not a long race; it is many short races one after the other."-Walter Elliot

boswind
Posts: 73
Joined: Fri Apr 11, 2014 12:04 pm

Re: FDA Approved Keytruda for MSS Tumors w/ TMB of 10+!!!

Postby boswind » Wed Jul 08, 2020 9:34 pm

Excellent!!! Unfortunately, I failed pembrolizumab last year although my TMB was 12.
01.24.14 Male, DX @54 Rectosigmoid Cancer, MRI: T3N0M0
03.19.14 Completed 5-week Radia+Xeloda
05.07.14 Had surgery
02.25.15 CT showed stage 4.
03.15 - 08.15, folfox + Avastin
08.15 - 07.17, 5FU+leucovorin+Avastin
07.17 - 01.18, Folfuri + Avastin
02.18 - 03.19, Centuximab + Irinotecan
03.19 - 05.19, Keytruda
05.19 - 9.19, Folfox+Avastin
10.22.19 - rechallenge Centuximab+Irinotecan
110 rounds of chemos received (as of 12.31.19)
MSS, KRAS wt, BRAF wt

Siti
Posts: 161
Joined: Thu Aug 01, 2019 10:58 am

Re: FDA Approved Keytruda for MSS Tumors w/ TMB of 10+!!!

Postby Siti » Thu Jul 09, 2020 4:05 am

Thank you for sharing and very happy you’re NED. Your fighting spirit is an inspiration!
Wife of DH (54) DX on 5/7/19
CEA value: 1.2
T loc: Sigmoid
T type: Adenocarcinoma
T grade: G3
Pos LNs: 30/31
Wild Type for KRAS, NRAS and BRAF
19/7/19 PET-CT Scan: Distant lymph nodes (para-aorta, neck & hip), est. size 0.5-1.5cm.
22/7/19 Surgery: Laparoscopic Colon Resection
26/8/19 Chemo: CAPEOX + Avastin x 9
6/11/19 CT Scan after 3rd cycle, all nodes have shrunk! Yay!!

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henry123
Posts: 212
Joined: Sun Oct 08, 2017 3:25 am

Re: FDA Approved Keytruda for MSS Tumors w/ TMB of 10+!!!

Postby henry123 » Sat Jul 11, 2020 1:07 am

That’s great news .
I stopped Nivolumab after 3 years of infusions and almost 2 yrs NED.
46yo M msi-high Lynch +ve
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
4/17 regro fail
5/17 cea 28800
5/17 CT inc in size of mes nodes ,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 norm
1/18 3.6
4/18 2
Aspirin start
6/18 1.5 CT clear
12/18 1.1 NED
6/19 .9 CT clear
1/20 NED Opdivo stop

brokenwings
Posts: 127
Joined: Mon Jan 07, 2019 1:50 am

Re: FDA Approved Keytruda for MSS Tumors w/ TMB of 10+!!!

Postby brokenwings » Thu Jul 16, 2020 9:31 am

Hi Cynthia,

I've been following your "journey" and I'm glad you're getting such extraordinary results from Keytruda.

Just a small question: was your primary tumor right-sided or left-sided?

Thanks in advance.

Paola
DX 2019 Adenocarcinoma Sigmoid colon. PC + ovarian met.
Obstruction. Temporary colostomy.
Folfirinox + Avastin: 6 cycles. Scans: partial response.
Surgery (CRS + HIPEC) 04/29: too much disease, surgery cancelled. Right ovary removed.
2nd ptotocol: IP chemo (oxaliplatin) + IV chemo (Folfiri + Avastin). 8 cycles
10/31/2019: 11 hour-long Hipec + 6 weeks in hospital
12/30/2019: liver met
02/05/2020: reversal surgery. New peri mets discovered
March 2020: 5fu+Avastin
May 2020: fistula
Back to 1957: 5fu.

jmmcg
Posts: 1
Joined: Thu Mar 05, 2020 7:55 am

Re: FDA Approved Keytruda for MSS Tumors w/ TMB of 10+!!!

Postby jmmcg » Sat Jul 25, 2020 6:39 pm

One important question/ Can your TMB escalate over time. Mine is now 6 but that was taken over 3 yrs ago using a lung met. My cancer has been growing as I have tried all chemo drugs and none are working anymore. Hoping to find something that will work!


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