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

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Jack&KatiesMommy
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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 (18) and Katie (4) now (14)
(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: 436
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
LAR/Liver Resect 4/2018
Reversal 10/18
CEA highest 500, lowest .8 throughout process, waiting for latest
Recurrence left vesical/pelvic sidewall - 10/7/2019 resect perm bag,
CEA rise Feb/May 3.7, 8.8, 30, Recurrence in Pelvic
CEA 40 right now, but was 57, so folfiri to beat it back down.
Lots of chemo for the past 4 years.

claudine
Posts: 809
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

Tumors: L4 04/18; left adrenal gland & small lung nodules 03/19
rectum 02/22 (pT3 pN0 stage 2A); L3 09/22

Surgeries: intestinal resect. 05/18 (no cancer - Crohn's); adrenalectomy 02/20
L3-L4-L5 fusion and corpectomy 05/20; LAR 04/22; ileo reversal 09/22
L2-L3 fusion and corpectomy 09/22

Treatments: EBRT 04/18; SBRT 02/19; Failed adjuvant Xelox ; Folfiri/Avastin 03/19 - 01/20
adjuvant chemorad (Xeloda) 06/22; SBRT 11/22; Xeloda/Avastin since 01/24

Vana3
Posts: 59
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!
Dx 36 yr, F, 7/19
T4aN2M1 Cea 5
5 cm tumor in cecum removed, 17 + out of 45 LN
Cea 4.2
MSS, KRAS g12d, Braf WT
MT: 10.9
8/20/19 MRI & PET liver spots
9/19 - 3/20 FOLFOX
1/20 CEA 3.6,4.4, 4.6, 4.6
Liver resect 4/15/20
6/20 Ct scan clear
7/20 Cea 8.6
8/20 Cea 12.4, suspicious ovarian cyst
9/20 Hysterectomy SOB CRC
post surgery cea 2.6
11/20 clear scans
2/21 clear scans
4/21 spleen met
5/21 pet scan picks up subtle concerns in liver as well as confirms spleen
Cea 4.6
5/21 to current folfiri
Cea 10

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Jack&KatiesMommy
Posts: 640
Joined: Wed Dec 21, 2011 1:08 pm
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 (18) and Katie (4) now (14)
(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: 1034
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!!!
8/19 RC CEA 82.6 T3N0M0
5FU/rad 6 wk
IVC 75g 1 1/2 wks before surgery. Continue 2x a week
Surg 1/20 -margins T4bN1a IIIC G2 MSI- 1/20 LN+ LVI+ PNI-
pre cea 24 post 5.9
FOLFOX
7 rds 6-10 CEA 11.4 No more
CEA
7/20 11.1 8.8
8/20 7.8
9/20 8.8, 9, 8.6
10/20 8.1
11/20 8s
12/20 8s-9s
ADAPT++++ chrono
CEA
10/23/22 26.x
12/23/22 22.x
2023
1/5 17.1
1/20 15.9
3/30 14.9
6/12 13.3
8/1 2.1
Nodule RML SUV 1.3 5mm
Rolles 3 of 4 lung nodules cancer
KRAS
Chem-sens test failed Not enough ca cells to test

Rikimaroo
Posts: 436
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
LAR/Liver Resect 4/2018
Reversal 10/18
CEA highest 500, lowest .8 throughout process, waiting for latest
Recurrence left vesical/pelvic sidewall - 10/7/2019 resect perm bag,
CEA rise Feb/May 3.7, 8.8, 30, Recurrence in Pelvic
CEA 40 right now, but was 57, so folfiri to beat it back down.
Lots of chemo for the past 4 years.

WarriorSpouse
Posts: 220
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: 74
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 inoperable
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
10.19 -01.20: Centuximab+Irinotecan
03.20 - 06.20: STIVARGA
07.20 - present: lonsurf+Avanstin
MSS, KRAS wt, BRAF wt
131 rounds of chemos received (as of 12.31.20)

Siti
Posts: 269
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!
DH (54) DX on 5/7/19
Sigmoid|G3|LN:30/31|MSS|WT KRAS, NRAS, BRAF
7/19 PET distant LN para-aorta neck hip (0.5-1.5cm)
7/19 Lap resection
26/8 to 20/12/19 CAPEOX+Bev 7x
6/11/19 CT 3 cycle LN shrunk
1/20 Cap+Bev
4/20 TS-1+Bev due to bad HFS
NED 4 years
8/23 PET recurrence chest LN growing since Feb. CEA May(4.5>5.1>5.9)
9/23 Stopped Bev, CEA Sept(8.7) Radio 17x
11/23 PET 1+ supraclavicular LN, CEA (3.4>2.5)
12/23 Lymphadenectomy
1/24 Narrow margins, 1/5 +LN, 1.4cm +tissue, TMB (19)

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henry123
Posts: 218
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
CT all clear exc a nodule in Lung. liver norm
1/18 3.6
Aspirin start
6/18 1.5 CT clear
12/18 1.1 NED
1/20 NED Opdivo stop
8/23 1.0 All ok

brokenwings
Posts: 147
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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